protocol for a cluster randomised controlled trial evaluating a parenting with home visitation programme to prevent physical and emotional abuse of children in indonesia: the families first programme

Every year, as many as one billion children are victims of violence around the world.
Most child abuse occurs in the context of punishment.
The family first programme is to adapt the positive discipline in the day-to-day parenting programme to the situation in West Java, and is a child-rights-based parenting support programme that provides parents with guidance on child development, practice of parenting and positive discipline.
Compared to the waiting list control group, this trial will evaluate the effectiveness of the family priority program.
This is a pragmatic, parallel approach and analysis.
Hierarchical grouping-
Randomized controlled trial
20 rural and urban villages in the Cianjur district of Indonesia will have 720 caregivers for children under the age of 7.
The village will accept parenting programmes consisting of 10 group meetings and 4 home visits and standard community health and social services within 3 months, or only the latter.
After the end of the trial period, the programme will be provided to the postponed team members.
The result data will be collected before random grouping (baseline)
Immediately after the intervention (
3 months later)
Six months later.
9 months later).
The main result will be the frequency of physical and emotional punishment, measured by the weighted sum of the three selvesreport items.
The primary outcome analysis will use a Poisson regression with a generalized estimation equation and evaluate the interaction between intervention and time in the baseline and 3 and 9 months post-evaluation.
Process assessments will be conducted at the same time to assess programme satisfaction and facilitators and barriers to programme implementation.
The University of McGill and the University of Katolik Atma Jaya in Indonesia are approved for ethics and for the dissemination of ethics.
Results will be published in the peer
Review journals and publish at scientific conferences and events for decision-making
Including manufacturers involved in the community.
Try to register numbernct03374761.
Each year, as many as one billion children are victims of violence around the world.
Most child abuse occurs in the context of punishment.
The family first programme is to adapt the positive discipline in the day-to-day parenting programme to the situation in West Java, and is a child-rights-based parenting support programme that provides parents with guidance on child development, practice of parenting and positive discipline.
Compared to the waiting list control group, this trial will evaluate the effectiveness of the family priority program.
This is a pragmatic, parallel approach and analysis.
Hierarchical grouping-
Randomized controlled trial
20 rural and urban villages in the Cianjur district of Indonesia will have 720 caregivers for children under the age of 7.
The village will accept parenting programmes consisting of 10 group meetings and 4 home visits and standard community health and social services within 3 months, or only the latter.
After the end of the trial period, the programme will be provided to the postponed team members.
The result data will be collected before random grouping (baseline)
Immediately after the intervention (
3 months later)
Six months later.
9 months later).
The main result will be the frequency of physical and emotional punishment, measured by the weighted sum of the three selvesreport items.
The primary outcome analysis will use a Poisson regression with a generalized estimation equation and evaluate the interaction between intervention and time in the baseline and 3 and 9 months post-evaluation.
Process assessments will be conducted at the same time to assess programme satisfaction and facilitators and barriers to programme implementation.
The University of McGill and the University of Katolik Atma Jaya in Indonesia are approved for ethics and for the dissemination of ethics.
Results will be published in the peer
Review journals and publish at scientific conferences and events for decision-making
Including manufacturers involved in the community.
Try to register numbernct03374761.
Physical and mental abuse of children is a major global public health, human rights and social problem.
1 worldwide, 25 adults have reported physical abuse during childhood, with as many as 1 billion children being victims of violence each year, with the highest low/middle ratio
Income country (LMIC).
3 A National Survey on violence against children in Indonesia showed that 39% of boys and 21% of girls under the age of 18 experienced some type of violence in the 12 months before the survey, with physical objects (
29% boys and 12% girls)and emotional (
13% boys and 9% girls)
Violence is the most common.
The main social norms supporting severe punishment of children and women and the lack of family support services are among the factors contributing to violence against children.
Most of the physical and emotional abuse of children occurs in the context of punishment;
In the context of corporal punishment, cross-generational continuity of abuse 12 and parenting practices was also documented (eg,ref13).
Although countries vary widely, corporal punishment is common in 14 low-income countries, including Indonesia.
Violence against children can last for a long time
The long-term impact on the child\'s physical, social, emotional and neurological development is the social and economic burden of the family and society as a whole.
20 recent system reviews and meta-
Analysis of estimated prevalence of child abuse in East Asia and the Pacific (EAP)
Countries have concluded that the economic burden of child abuse in the region is high.
21 A systematic review of the consequences of child abuse in EAP areas shows that children who have been abused are four times more likely to think of and attempt suicide than the former, the possibility of a close relationship is that the latter\'s partner violence after two years
22 similarly, there is sufficient evidence that corporal punishment has a negative impact on the development and health of children and mental illness after adulthood. 23–26Evidence-
Based on parental education, home visits to young children and multiple interventions, it has become a promising strategy to prevent child violence.
27-30 the recent systematic review of parenting programmes aimed at reducing the rate of physical abuse recidivism documented statistical importance, although to a lesser extent, reducing physical abuse of children, and called for further rigorous research in this area.
29 similarly, a systematic review of family access programmes, including access programmes provided by prospective professionals to vulnerable families, found to be effective in preventing child abuse and increasing active parenting.
28 31 however, combined with the mixed intervention of the parenting group --
There are very few 32 home visits-based programmes, and there is no violence prevention against lmic.
Overall, reviews and meta of the system
The analysis highlights the need for more research on the effectiveness of child violence prevention interventions in low-income groups.
33 it is important that, in order to ensure acceptability and effectiveness, the programme is culturally appropriate for participants.
34 there are some examples of promising results in the delivery of parenting programmes in countries to address child behavior, 35 but the researchers have raised concerns about the applicability of the current evidence outside of English --speaking, high-
Income country.
In Indonesia, there are few contemporary parenting studies and effective parenting measures.
The review of the parenting education program in Indonesia concluded that more attention needs to be paid to non-
Provide violent discipline techniques to early childhood parents and conduct research and evaluation of parenting education.
36 sole assessment of evidence
A parenting plan for Indonesian parents based on a randomized controlled trial (RCT)
Test the efficacy and acceptability of Triple P-
Compared to parents in the waiting list control group, the active parenting program Workshop showed the effect and confidence of continuous intervention in children\'s behavior, parental stress and parenting practice.
The 37 participants in the study were parents of children aged 2-12 who had \"relatively good financial conditions\" and education.
The cluster randomized controlled trial will first assess the effect of family visit program 38 on the frequency of physical and mental punishment of children aged 0-7 in West Java, Indonesia.
Family First is to adapt to the positive discipline in daily parenting (PDEP)
Support programmes.
It is based on research on children\'s health development and effective parenting and is based on the principle of children\'s rights.
The programme is held in 10 group meetings with four components :(1)
Identify parents-
Pursue long-term goals; (2)
Provide warmth and structure; (3)
Understand the child\'s thoughts and feelings; and (4)problem-solving.
39. In other cases, 40 evaluations before and after the PDEP programme showed a lower level of recognition of corporal punishment and a higher level of self-education for parents
The effectiveness and satisfaction of the participants with the program.
The programme adapts to the environment in West Java, requires cultural adaptation and translation of teaching materials, and adds four home visits to group meetings organized by trained community presenters.
The results of the 2015 program pilot test were used to further refine the program before starting this trial.
This trial responds to a rigorous assessment of lmic violence prevention interventions and their need for cultural adaptation to different environments.
43 The Ministry of Social Affairs, through its project Keluarga Harapan (PKH)
Or the family hope program and the ministry of women\'s empowerment and children\'s protection, through Pembelajaran Keluarga, Busan (PUSPAGA)
Or The Family Learning Center program is dedicated to integrating and expanding the program nationwide.
The main purpose of this study was to estimate the extent of the family\'s first protocol\'s influence on the frequency of use of physical and emotional punishment, measured by a weighted total score of the three self
Reporting items, among caregivers of children aged 0-7 in Cianjur district, West Java, Indonesia, were compared with caregivers of the waiting list control group.
We assume that the frequency change in the use of physical and emotional punishment by caregivers reported by the intervention group will be more positive than the change in the waiting list control group.
Methods and analysis industry registered the trial in clinical trials. Gov nct03374761.
Trial registration started before participant recruitment, but only when data collection was performed due to changes in staff and relocation of the three-person group Laboratory.
Changes to the protocol will be updated online.
This is a pragmatic, delayedParallel entrance
Group, layered, in a real threadworld setting (figure 1).
Twenty rural and urban villages, including caregivers of 720 children under the age of 7, will be randomly assigned to two parallel branches.
A waiting list control design will be adopted to facilitate the community acceptance of the research process.
There will be a major result, that is, the frequency of physical and emotional punishment reported by caregivers.
Only one child is assessed by each caregiver.
The results of the study will be evaluated using a hybrid method and a causal chain diagram from the program objectives to the results will be drawn.
Download the new tabDownload figureOpen powerpointFigure monthly trial flow chart.
Qualified Community data will be collected in 20 villages or clusters representing the general population in four partitions (
Campaka, Ciranjang, Karangtengah and Naringgul)
In Cianjur district, West Java, Indonesia.
This is a priority area for implementing agencies because of the high incidence of child protection issues such as well-being
Trafficking in Persons and migrant workers are known to be sent to regions in the Middle East or Asia, as well as to the aircraft of children.
The selected 44 villages will include (A)
Rural and urban/urban neighborhood communities with similar scale and average household income; (B)
Have not touched the family before; (C)
1 hour drive from the capital of the street, 1 hour drive from the regional capital Cianjur Regency; (D)
Clusters with sufficient distance from other clusters (
Reduce pollution as much as possible); and (E)
Local political leaders expressed strong support for intervention and assessment.
Families who can participate will :(A)
Having at least one biological or adopted child under the age of 7, based on the executive\'s focus on early childhood education, laying a good foundation for parenting and complementing existing government programs for early childhood parents; (B)
According to Indonesia\'s save children\'s protection framework, there is at least one risk factor 16 related to the placement of children in residential institutions, including living below the government poverty line or receiving social protection programmes, as a single mother and a mother in her teens having an immigrant father or mother or a mother considering immigration; (C)
Living in the village, do not want to move away in the second year; (D)
There was at least one female caregiver who had not previously been identified as a cognitive impairment and was able to provide informed consent to speak and read in bahaza; (E)
Has never been involved in other parenting programs; and (F)
Provide informed consent for participation.
A ProcedureA database containing all the maps and information incorporated into the criteria in each of the four streets will be created to assess the eligibility of the village.
The executive body will approach and obtain agreements with local authorities.
The local research team will work with the executive agencies to finalize the selection of 20 villages to ensure representation of all streets and strong political support from village leaders while reducing the risk of pollution.
The executive body will verify this option with the village authorities and introduce it to the research team for further communication on the assessment.
Members of the local research team will contact individual families in each village to obtain informed consent to participate in the trial.
Random and assigned hidden Hierarchical random will be used to allocate 20 clusters in 47 qualified clusters in rural areas (65%)and urban (35%)
Intervention and control weapons are set in four partitions in a ratio of 1: 1.
Clusters will be randomly assigned to avoid resentment or contamination that may occur due to providing interventions to some families rather than other families in the community.
The random allocation will take place at the random allocation ceremony led by the study group, and all chiefs involved in the village and staff of the executive agency participated in the random allocation ceremony.
The ceremony will follow one stepby-
Includes step sweepstakes and documentation programs using 20 sequential numbers (
1-7 \'Cities\' and 1-13 \'villages \')
Opaque, sealed and bound envelopes independently prepared by the chief investigator.
The aluminum foil inside the envelope does not penetrate the envelope into the strong light.
First, the city village draws envelopes and the rural village draws envelopes.
The ceremony will be a video. recorded.
Before the village is randomly assigned, qualified families in each village will be identified.
In each village, the executive agency will create a list of 50 eligible families by reviewing village administrative records and discussing with local providers and authorities.
The study team will randomly select participants from these lists and verify eligibility until 36 families are successfully recruited and agreed to in each village.
In addition to the standard intervention, the government-
Running the services currently provided by community health volunteers in West Java, the intervention site will receive 10-
Weekly programme with group meetings and four home visits for caregivers, each meeting/visit lasts about 1 time. 5u2009hours.
Three groups of 12 caregivers will be provided in each village, and most of them are expected to be mothers.
The government will receive standard control sites
Run services provided by community health workers in West Java.
Once the assessment of the intervention group is completed, the intervention will be provided to the participants in the control group.
Programme delivery and training interventions will include 10 group meetings and 4 home visits to provide information to parents on child development, parenting and positive discipline practices (table 1).
The intervention followed the PDEP course, which has been adapted first to a family course based on the situation in Indonesia (
Family Plan 1).
The main changes presented include the addition of home visits, cultural adaptations of examples and illustrations, and the translation of all materials into bahaza Indonesian.
Following the implementation of the adapted programme in seven villages in Barat and Cianjur Bandung in 2015 and 2016, the materials and language were improved before the trial began.
The 10 group meetings will combine group activities and case studies with the teaching of the host.
Visual materials and characters will be used for home visits-
Positive parenting methods.
Community promoters will provide referrals for social protection and other community services as needed.
Each parenting group will be led by two Programme presenters who will also conduct home visits. Catch-
The Up meeting will be arranged separately by participants who are unable to attend the meeting with the community moderator.
View this table: View inline View pop-up table 1 intervention topic by type this item will be managed by Save Children
Indonesia, and locally recruited programme hosts such as community health workers and preschool teachers, are provided to parents and other social assistance workers who live in the community and are recommended by local rural authorities.
The host must be the mother herself, or at least 19 years old, with experience working with the family;
Open mind and have the ability to listen and promote;
At least high school education and reading and writing skills;
Interested in this topic;
Complete training and delivery of complete courses are available.
All Programme facilitators will receive a 1-week initial training for save children and PDEP developers at the University of Manitoba, Canada.
This training will be participatory and activity-based, and the training materials of the weekly course plan will be provided to them in the form of bahaza and will contain a wide range of visual effects and hands-on capabilitieson exercises.
The moderator will be supervised weekly by Indonesian programme mentors, which are fully trained by PDEP developers in the programme and have had experience in implementing the programme in the past.
In addition to the same criteria for selecting a moderator, the tutor must be willing to spend half a day a week (
Travel time is not included)
Guide the host throughout the programme implementation process.
In turn, the mentor will be supported by the University of Manitoba team to save the children --
A faculty member at the University of Indonesia and pajadaran (Indonesia)
Experience in delivering and teaching the programme.
Measurement strategies and measurement of child disciplinary behavior occur in a socio-cultural, personal and family environment described by three nested squares.
45 in these cases, we illustrate three types of results: one is the main or confirmed result, and the other is the result of interpretation and exploration.
Explanatory results are the results that are directly targeted by activities that suggest Family First programmes.
Suppose that the change in the main outcome, the frequency of physical or emotional abuse, is due to changes in knowledge, attitude and behavior in these areas.
Due to changes in these results, we assume that there will be positive changes in measuring children\'s health
The presence, monitoring and supervision of children\'s machine models and the attitude of caregivers.
In order to implement this measurement strategy,
The established measures were initially identified, giving priority to the use of free, used in lmic, culturally appropriate measures for the Cianjur context, and the use of language focused on parental change
However, pilot testing of all the measures previously applied in this area has raised concerns about the measures and the number of projects, many of which are unsuitable or have nothing to do with the background.
Therefore, an alternative measurement strategy using outcome indicators was adopted.
The result indicator can be either a single item or an index based on a summary of responses to several related items;
Or use Rasch analysis to verify a complete measure or subscale of the total score to test to what extent the project is suitable for a one-dimensional hierarchical model with intervals
Attributes like this, the total score can be used in mathematical transformation.
47-49 all measures are independent forward and backwardtranslated (
Malay, Fang)
Local consultants
Families will be assessed based on the main results at study entry/Baseline (T1)
Immediately after the intervention (T2)
6 months after the intervention (T3).
All measures except programme satisfaction (
Evaluation of intervention only)
Will be managed at three measurement points.
We will visit all sites and meet with local authorities before returning to collect data.
In turn, they will be able to inform residents of the upcoming visit of the research team.
In the family of more than one child, one child (index child)
Random selection will be made at the beginning of the baseline interview and data collection will be concentrated on that child.
Only data about non-reasons
Participation will be collected from participants who have withdrawn from the study.
The outcome measures created or adjusted for the trial are included in the online Supplementary Appendix, and the items related to the specific results are shown below.
Measure the main frequency of use of physical and emotional punishment with three self
Report item on international screening tools for child abuse prevention and neglect (ICAST-Parent)
, 50-52, including a program on severe physical abuse, a program on moderate physical abuse and a program on emotional abuse.
Each project asks the caregiver how many physical or emotional penalties have been imposed on index children in the past month and at any time in the past, such as the penalties described in the project (
Supplementary Annex a).
Frequency will calculate the frequency of each person at each point in time by creating a total penalty eventdays.
The project response for each of these three projects is almost daily, at least once a week, once a month, sometimes but not in the last month, never.
Responses to each item will be assigned a value within a few days of the month: almost daily = 30;
At least once a week = 8; once a month=1;
Sometimes but not in the last month = 0. 5; never=0.
These values will be summed up by physical and emotional punishment.
This format gives more attention to changes from almost every day to at least once a week.
Sensitivity analysis will be used to determine whether different weights will affect the results.
Supplementary Document 1 [bmjopen-2018-021751-supp1. pdf]
Parenting that explains results active and involved will be measured by self
Report items adapted from the positive parenting component table (six items)
And participation component table (one item)
Alabama parenting questionnaire (APQ)53 54 (
Supplementary Appendix B1).
Positive Discipline will be measured by four programs
Violence component table of ICAST50 51 (
Supplementary Appendix B2).
The set limit will be measured by two items in the set limit component table of the child care child 55 (
Supplementary Appendix B3).
Opinions on discipline will be measured in two items of ICAST --Parent50 51 (
Supplementary Appendix B4).
Findings of social and emotional health
The Strengths and Difficulties Questionnaire will be used to measure (SDQ)
Parent version for 2-3 years
Children aged 4-17olds.
23 56 57 according to the SDQ guidelines, the mood, behavioral issues, ADHD and peer issues scales will be fully included and their scores will be aggregated to generate a total difficulty score for each index child.
Pro-social scale projects (
It is helpful if someone is injured, friendly to young children and often volunteer to help others)
Will be excluded from this calculation.
Four items 58 and four new items that will be adapted to the knowledge, attitudes and practices of child protection will measure children\'s attitudes towards machine models (
Supplementary Appendix C1).
Monitoring/supervision will be measured by items with poor monitoring/supervision (10 items)
Questionnaire on APQ and parent supervision attributes (one item)59 (
Supplementary Appendix C2).
The background and other influencing factors of parental stress and child abuse parental stress will be measured by the parental stress scale (18 items).
WHO Health Index (WHO-5)(five items).
61 perceived social support will be measured by items supported by tangible/tools (four items)
And emotional support (four items)
Revised Medical Outcomes Study subscales of social support surveys.
One of the instrument support subscales (
Help when restricted to bed)
Will be replaced by \"help you take care of your child.
One item in the emotional support scale (
\"To Love, to make you feel loved \")
Change to \"love you and show you love \"(
Supplementary Appendix D1).
Stimuli in the home environment will be measured using items in the early childhood development module (six items)
In the multi-index cluster survey, of the 63 64 projects, one was adapted according to the participation component table of APQ, and two others (
Share food and explore toys on your own)(
Supplementary Appendix D2).
Parent-to-parent conflicts on parenting will be measured by 11 items in the parent question Checklist65-67 (
Supplementary Appendix D3).
The social demographic features recorded include :(A)
Children: age, gender, sibling and orphan status, physical health/disability and schooling; (B)
Caregivers: age, gender, marital status, educational level, physical and mental health, national cultural background, employment status; (C)
Family: City/rural location, type of residence, family structure and family structure, function and socio-economic status.
Blink of an eye cannot make investigators turn a blind eye to the allocation of participants because it is a behavioral intervention and the result is self-reported.
However, the data collection research assistant will be trained in ongoing management measures and awareness of bias.
Process assessment and qualitative assessment process assessment 68 69 will be conducted to assess variability in implementation and to identify environmental and operational factors that are most likely to lead to successful implementation in other environments.
Figure 2 is a theoretical model of how we assume the effects of intervention on physical and emotional punishment.
Variables in the path from the intervention to the result (punishment)
Considered as a mediator, including active and involved parenting, active discipline and setting restrictions.
The contextual factor is considered to be the effect modifier or hybrid.
We will also focus on the presence and participation of interventions and implementers.
Process Evaluation results will be evaluated through a checklist to track loyalty and program exposure/attendance for implementation and provide a short programme for caregivers, facilitators and mentors who intervene on site
The moderator\'s tracking form will be used to record the attendance and level of participation of caregivers, as well as the extent to which the facilitator complies with the programme manual.
Programme satisfaction questionnaires will be distributed to all participating caregivers (17 items)Host (23 items)and mentors (22 items)
Intervention in the village.
They will all be asked to identify two of their favorite and least liked meetings and to assess the likelihood of their participation (A)
Use materials and (B)
Recommend the scheme to others (4-point scale). An open-
The closing questions will suggest improvements to the programme and how it can be made available.
Caregivers and presenters will be required to assess their satisfaction with the different aspects of the programme (
Duration, frequency and convenience of meetings, for example)
Overall satisfaction with group meetings and home visits (5-point scale).
Hosts and mentors will be asked to evaluate the hosts they work with in a range of skills (
Explain the course materials according to the course and the situation where the family is involved).
Programme attendance and loyalty records of Implementers at the time of their intervention (
Evaluation by the instructor\'s observation of the course)
A review will also be conducted.
Detailed information on the implementation and experience of the intervention will also be obtained from a sample of purposefully selected participants using qualitative methods.
Download the new tabDownload powerpoint figure 2 project general conceptual model that affects parenting and child health-being.
Social and economic status.
Association qualitative methods will be used to develop and validate data collection measures (pilot)
Increase depth and understanding of processes and results.
70 71 after the implementation of the programme, they will explore the experience of caregivers and implementers in the programme and how service delivery, socio-economic, cultural and other factors affect the effectiveness and scalability of the intervention.
Qualitative methods (
In bahaza and Fang)
Semi-structured interviews with caregivers and implementers will be included (
Save Children staff, mentors and facilitators)
Community Leadership (n≈35);
Focus group interviews with participating caregivers and implementers (n≈10–15);
Independent observation of group meetings;
And record the analysis.
The interview will explore the factors and perceived effects that support or hinder the implementation of the intervention (
Positive and negative)
Interventions and comparisons of other local community services for children and families.
Participants will be selected from all 36 groups in the intervention village and will also include special circumstances (
For example, dropping out of school and \"Model participants\"
It was determined through the opinion and program satisfaction questionnaire.
Data collection personnel will be selected by the local research team among female university graduates who are proficient in Sundanese and Bahasa who have interview experience and can be found during scheduled data collection
Data collectors will be trained in interview protocols, interview techniques and how to avoid bias, ethical behavior of research, use of tablets and visual scales (for survey)
Maintain procedures for children and data management and communication.
The training will include lectures, presentations, roles
Play a few days-
Test before data collection.
A systematic review was conducted to identify existing measures for the results used in Indonesia and/or other lmic.
The measures that best suit the Cianjur background are complemented by the social Population Program adapted from Indonesia\'s annual socio-economic survey.
The questionnaire is forward and backward.
Translated into Bahasa, pilot tests were conducted in two villages in Cianjur with 10 similar respondents, not included in the sample, translated into Sundanese and programmed into the censusCSPro). Tablet-
A questionnaire-based questionnaire will be given orally to caregivers at home.
Data management CSPro will be used to collect data and upload it to a secure server hosted by McGill University on a daily basis.
Quantitative data to be entered (
Tracking form for host)
, Will be double-
Check the input data through the pre-programming software. Non-
Electronic data will be stored securely in locked cabinets, electronic data text and audio files with ID-
The identified case will be maintained in the password
Protect your tablet, computer, and online storage.
In all analyses, an ID will be assigned for each case.
Only a small number of study group members have access to personal identifiers.
In reporting the results of the study, personal names and specific research sites will not be provided.
After 5 years of completion of the study, all nominal information will be destroyed.
Statistical analysis and sample size calculation This study aims to detect a change that is considered meaningful and credible for the main results.
The sample size of 720 households will allow a reduction of 15. 2% in parent-
It is reported that violence discipline is used by families from the initial estimated prevalence of 30% (SKTA 2013)
Alpha level is 4 of 0.
05% and 90% power, assuming 0.
The relevant 73 74 and 80% participation rates in Category 02.
One child per family will be selected as index child.
An administrative analysis will be conducted to ensure ongoing data accuracy.
Once all participants are random, descriptive statistics will be used to compare the two groups at baseline, recognizing that cluster randomization does not necessarily balance covariates at the individual level.
Once the data collection is over, the analysis of the results will begin.
The main results of the past month, the frequency of physical and emotional punishment practices, will be aggregated into the cumulative number of punishments within 30 days.
This ratio will determine all participants in the two trial groups at three time points.
The main analysis will be the Poisson regression using the generalized estimation equation (GEE)
Test the main assumptions related to the program\'s superiority in reducing the rate of physical and emotional punishmentmonth period.
The results will be measured at baseline and at the end of the intervention (
3 months later)
6 months after the intervention (
9 months later).
Incorporating the main impact of the programme and time and the time-based interaction programme into the programme will test the superiority of the programme.
A linear relationship with time will be considered to allow non-
Linear Association.
Variables that include reducing the difference in results will be considered (
For example, gender and position (Parents or children)
Reported family members, number of children in the family, etc).
Although hybrid is not expected to be a problem due to random factors, villages will be compared on key factors, and random groups show that any variable with a huge imbalance will be added to the model.
All results will be analyzed with one intent. to-
The principles of treatment and all personnel will be analyzed in a randomized group.
Although every effort will be made to keep the lost data to a minimum, any potential bias will be minimized by performing multiple padding on longitudinal data.
All variables considered for final analysis will be included in the estimation model.
The sub-analysis will estimate the impact of the programme on other related outcomes.
GEE will also be used to check program effects to accommodate the gathering of family members and village family members.
The count will be analyzed using Poisson regression, binary results of logistic regression, and continuous scale of linear regression.
In addition, genderBased on analysis (
Gender of child)
For exploration purposes, an analysis will also be conducted to determine whether the child\'s gender or the family with more children or children of different age groups, or whether the family with different children with disabilities responds to the program
Another group analysis will explore the impact of single intervention
First, household heads
Time parents and parents in their teens.
The analysis and report of the results will follow the comprehensive criteria for the expansion of the Southern and non-randomized controlled trials of the trials reporting randomized controlled trials
Drug therapy intervention
76-78 descriptive quantitative process information will accompany qualitative analysis of the data.
69 qualitative data will be transcribed, translated and encoded using tivvo.
79 initial codes related to research questions and interview guidelines will be supplemented with open coding for the entire dataset, around factors that facilitate or hinder programme implementation and satisfaction of participating families and staff, refine it and classify it as a broader title.
To illustrate the findings, a striking citation will be extracted.
Quantitative and qualitative results will be analyzed in turn to triangulate results, identify convergence/differences, interpret abnormal data, and enhance the overall interpretation of findings.
80 preliminary findings will be shared with the Advisory Committee and explained in conjunction with relevant policies.
Scientific support and supervision are provided by researchers and academics at McGill University and all trial activities are coordinated.
Researchers at the SMERU Institute in Jakarta are responsible for the field work and coordinate with the Advisory Committee and local actors to obtain permission and disseminate the findings.
The quality of the study, environmental suitability and regulatory compliance will be monitored.
Closely monitor the interviewer during data collection, instant messaging (
WhatsApp and email)
Timely data monitoring between researchers in Canada and Indonesia can correct problems early.
An independent advisory committee consisting of government, non-governmental organizations and academics and experts with expertise in child protection in Indonesia
Government organization (NGO)
Donor agencies will be involved in the ongoing monitoring of this study.
Programme executives will monitor interventions through weekly meetings of facilitators and instructors, as well as local visits by other programme staff.
Adverse events affecting study participants observed by researchers or implementers will be assessed by the lead researcher and partner NGOs to determine whether additional investigations or modified interventions can be conducted.
All data collectors and other research team members who are in contact with children will be trained in the SC child protection policy and committed to respect the policy, 81 including the obligation to report child abuse cases.
With the consent of the participants, the relevant services will be recommended in due course.
The plan will be explained to the trial participants during the consent process.
The experience of the participants and the public involved in the nursing staff of the West Java participation pilot programme provides information for improving interventions and developing outcome measures.
The nursing staff\'s point of view is also key to testing and improving research materials and procedures (
For example, shorten the questionnaire and data collection forms, rephrase/replace several items, and plan data collection around individual availability/preferences and community activities).
As part of the process assessment, participant satisfaction with the intervention, including burden, will be assessed.
Results will be shared through community meetings and all participants will be invited to attend.
The trial registration trial is registered in the clinical trial. Gov nct03374761.
Trial registration started before participant recruitment, but only when data collection was performed due to changes in staff and relocation of the three-person group Laboratory.
Changes to the protocol will be updated online.
This is a pragmatic, delayedParallel entrance
Group, layered, in a real threadworld setting (figure 1).
Twenty rural and urban villages, including caregivers of 720 children under the age of 7, will be randomly assigned to two parallel branches.
A waiting list control design will be adopted to facilitate the community acceptance of the research process.
There will be a major result, that is, the frequency of physical and emotional punishment reported by caregivers.
Only one child is assessed by each caregiver.
The results of the study will be evaluated using a hybrid method and a causal chain diagram from the program objectives to the results will be drawn.
Download the new tabDownload figureOpen powerpointFigure monthly trial flow chart.
Qualified Community data will be collected in 20 villages or clusters representing the general population in four partitions (
Campaka, Ciranjang, Karangtengah and Naringgul)
In Cianjur district, West Java, Indonesia.
This is a priority area for implementing agencies because of the high incidence of child protection issues such as well-being
Trafficking in Persons and migrant workers are known to be sent to regions in the Middle East or Asia, as well as to the aircraft of children.
The selected 44 villages will include (A)
Rural and urban/urban neighborhood communities with similar scale and average household income; (B)
Have not touched the family before; (C)
1 hour drive from the capital of the street, 1 hour drive from the regional capital Cianjur Regency; (D)
Clusters with sufficient distance from other clusters (
Reduce pollution as much as possible); and (E)
Local political leaders expressed strong support for intervention and assessment.
Families who can participate will :(A)
Having at least one biological or adopted child under the age of 7, based on the executive\'s focus on early childhood education, laying a good foundation for parenting and complementing existing government programs for early childhood parents; (B)
According to Indonesia\'s save children\'s protection framework, there is at least one risk factor 16 related to the placement of children in residential institutions, including living below the government poverty line or receiving social protection programmes, as a single mother and a mother in her teens having an immigrant father or mother or a mother considering immigration; (C)
Living in the village, do not want to move away in the second year; (D)
There was at least one female caregiver who had not previously been identified as a cognitive impairment and was able to provide informed consent to speak and read in bahaza; (E)
Has never been involved in other parenting programs; and (F)
Provide informed consent for participation.
Community data will be collected in 20 villages or clusters representing the general population in four partitions (
Campaka, Ciranjang, Karangtengah and Naringgul)
In Cianjur district, West Java, Indonesia.
This is a priority area for implementing agencies because of the high incidence of child protection issues such as well-being
Trafficking in Persons and migrant workers are known to be sent to regions in the Middle East or Asia, as well as to the aircraft of children.
The selected 44 villages will include (A)
Rural and urban/urban neighborhood communities with similar scale and average household income; (B)
Have not touched the family before; (C)
1 hour drive from the capital of the street, 1 hour drive from the regional capital Cianjur Regency; (D)
Clusters with sufficient distance from other clusters (
Reduce pollution as much as possible); and (E)
Local political leaders expressed strong support for intervention and assessment.
Families who can participate will :(A)
Having at least one biological or adopted child under the age of 7, based on the executive\'s focus on early childhood education, laying a good foundation for parenting and complementing existing government programs for early childhood parents; (B)
According to Indonesia\'s save children\'s protection framework, there is at least one risk factor 16 related to the placement of children in residential institutions, including living below the government poverty line or receiving social protection programmes, as a single mother and a mother in her teens having an immigrant father or mother or a mother considering immigration; (C)
Living in the village, do not want to move away in the second year; (D)
There was at least one female caregiver who had not previously been identified as a cognitive impairment and was able to provide informed consent to speak and read in bahaza; (E)
Has never been involved in other parenting programs; and (F)
Provide informed consent for participation.
A ProcedureA database containing all the maps and information incorporated into the criteria in each of the four streets will be created to assess the eligibility of the village.
The executive body will approach and obtain agreements with local authorities.
The local research team will work with the executive agencies to finalize the selection of 20 villages to ensure representation of all streets and strong political support from village leaders while reducing the risk of pollution.
The executive body will verify this option with the village authorities and introduce it to the research team for further communication on the assessment.
Members of the local research team will contact individual families in each village to obtain informed consent to participate in the trial.
Random and assigned hidden Hierarchical random will be used to allocate 20 clusters in 47 qualified clusters in rural areas (65%)and urban (35%)
Intervention and control weapons are set in four partitions in a ratio of 1: 1.
Clusters will be randomly assigned to avoid resentment or contamination that may occur due to providing interventions to some families rather than other families in the community.
The random allocation will take place at the random allocation ceremony led by the study group, and all chiefs involved in the village and staff of the executive agency participated in the random allocation ceremony.
The ceremony will follow one stepby-
Includes step sweepstakes and documentation programs using 20 sequential numbers (
1-7 \'Cities\' and 1-13 \'villages \')
Opaque, sealed and bound envelopes independently prepared by the chief investigator.
The aluminum foil inside the envelope does not penetrate the envelope into the strong light.
First, the city village draws envelopes and the rural village draws envelopes.
The ceremony will be a video. recorded.
Before the village is randomly assigned, qualified families in each village will be identified.
In each village, the executive agency will create a list of 50 eligible families by reviewing village administrative records and discussing with local providers and authorities.
The study team will randomly select participants from these lists and verify eligibility until 36 families are successfully recruited and agreed to in each village.
In addition to the standard intervention, the government-
Running the services currently provided by community health volunteers in West Java, the intervention site will receive 10-
Weekly programme with group meetings and four home visits for caregivers, each meeting/visit lasts about 1 time. 5u2009hours.
Three groups of 12 caregivers will be provided in each village, and most of them are expected to be mothers.
The government will receive standard control sites
Run services provided by community health workers in West Java.
Once the assessment of the intervention group is completed, the intervention will be provided to the participants in the control group.
In addition to the standard intervention, the government-
Running the services currently provided by community health volunteers in West Java, the intervention site will receive 10-
Weekly programme with group meetings and four home visits for caregivers, each meeting/visit lasts about 1 time. 5u2009hours.
Three groups of 12 caregivers will be provided in each village, and most of them are expected to be mothers.
The government will receive standard control sites
Run services provided by community health workers in West Java.
Once the assessment of the intervention group is completed, the intervention will be provided to the participants in the control group.
Programme delivery and training interventions will include 10 group meetings and 4 home visits to provide information to parents on child development, parenting and positive discipline practices (table 1).
The intervention followed the PDEP course, which has been adapted first to a family course based on the situation in Indonesia (
Family Plan 1).
The main changes presented include the addition of home visits, cultural adaptations of examples and illustrations, and the translation of all materials into bahaza Indonesian.
Following the implementation of the adapted programme in seven villages in Barat and Cianjur Bandung in 2015 and 2016, the materials and language were improved before the trial began.
The 10 group meetings will combine group activities and case studies with the teaching of the host.
Visual materials and characters will be used for home visits-
Positive parenting methods.
Community promoters will provide referrals for social protection and other community services as needed.
Each parenting group will be led by two Programme presenters who will also conduct home visits. Catch-
The Up meeting will be arranged separately by participants who are unable to attend the meeting with the community moderator.
View this table: View inline View pop-up table 1 intervention topic by delivery type this plan will be managed by Save children-
Indonesia, and locally recruited programme hosts such as community health workers and preschool teachers, are provided to parents and other social assistance workers who live in the community and are recommended by local rural authorities.
The host must be the mother herself, or at least 19 years old, with experience working with the family;
Open mind and have the ability to listen and promote;
At least high school education and reading and writing skills;
Interested in this topic;
Complete training and delivery of complete courses are available.
All Programme facilitators will receive a 1-week initial training for save children and PDEP developers at the University of Manitoba, Canada.
This training will be participatory and activity-based, and the training materials for the weekly course plan will be available to them in bahaza language and will contain a wide range of practiceson exercises.
The moderator will be supervised weekly by Indonesian programme mentors, which are fully trained by PDEP developers in the programme and have had experience in implementing the programme in the past.
In addition to the same criteria for selecting a moderator, the tutor must be willing to spend half a day a week (
Travel time is not included)
Guide the host throughout the programme implementation process.
In turn, the mentor will be supported by the University of Manitoba team to save the children --
A faculty member at the University of Indonesia and pajadaran (Indonesia)
Experience in delivering and teaching the programme.
Measurement strategies and measurement of child disciplinary behavior occur in a socio-cultural, personal and family environment described by three nested squares.
45 in these cases, we illustrate three types of results: one is the main or confirmed result, and the other is the result of interpretation and exploration.
Explanatory results are the results that are directly targeted by activities that suggest Family First programmes.
Suppose that the change in the main outcome, the frequency of physical or emotional abuse, is due to changes in knowledge, attitude and behavior in these areas.
Due to changes in these results, we assume that there will be positive changes in measuring children\'s health
The presence, monitoring and supervision of children\'s machine models and the attitude of caregivers.
In order to implement this measurement strategy,
The established measures were initially identified, giving priority to the use of free, used in lmic, culturally appropriate measures for the Cianjur context, and the use of language focused on parental change
However, pilot testing of all the measures previously applied in this area has raised concerns about the measures and the number of projects, many of which are unsuitable or have nothing to do with the background.
Therefore, an alternative measurement strategy using outcome indicators was adopted.
The result indicator can be either a single item or an index based on a summary of responses to several related items;
Or use Rasch analysis to verify a complete measure or subscale of the total score to test to what extent the project is suitable for a one-dimensional hierarchical model with intervals
Attributes like this, the total score can be used in mathematical transformation.
47-49 all measures are independent forward and backwardtranslated (
Malay, Fang)
Local consultants
Families will be assessed based on the main results at study entry/Baseline (T1)
Immediately after the intervention (T2)
6 months after the intervention (T3).
All measures except programme satisfaction (
Evaluation of intervention only)
Will be managed at three measurement points.
We will visit all sites and meet with local authorities before returning to collect data.
In turn, they will be able to inform residents of the upcoming visit of the research team.
In the family of more than one child, one child (index child)
Random selection will be made at the beginning of the baseline interview and data collection will be concentrated on that child.
Only data about non-reasons
Participation will be collected from participants who have withdrawn from the study.
The outcome measures created or adjusted for the trial are included in the online Supplementary Appendix, and the items related to the specific results are shown below.
Measure the main frequency of use of physical and emotional punishment with three self
Report item on international screening tools for child abuse prevention and neglect (ICAST-Parent)
, 50-52, including a program on severe physical abuse, a program on moderate physical abuse and a program on emotional abuse.
Each project asks the caregiver how many physical or emotional penalties have been imposed on index children in the past month and at any time in the past, such as the penalties described in the project (
Supplementary Annex a).
Frequency will calculate the frequency of each person at each point in time by creating a total penalty eventdays.
The project response for each of these three projects is almost daily, at least once a week, once a month, sometimes but not in the last month, never.
Responses to each item will be assigned a value within a few days of the month: almost daily = 30;
At least once a week = 8; once a month=1;
Sometimes but not in the last month = 0. 5; never=0.
These values will be summed up by physical and emotional punishment.
This format gives more attention to changes from almost every day to at least once a week.
Sensitivity analysis will be used to determine whether different weights will affect the results.
Supplementary Document 1 [bmjopen-2018-021751-supp1. pdf]
Parenting that explains results active and involved will be measured by self
Report items adapted from the positive parenting component table (six items)
And participation component table (one item)
Alabama parenting questionnaire (APQ)53 54 (
Supplementary Appendix B1).
Positive Discipline will be measured by four programs
Violence component table of ICAST50 51 (
Supplementary Appendix B2).
The set limit will be measured by two items in the set limit component table of the child care child 55 (
Supplementary Appendix B3).
Opinions on discipline will be measured in two items of ICAST --Parent50 51 (
Supplementary Appendix B4).
Findings of social and emotional health
The Strengths and Difficulties Questionnaire will be used to measure (SDQ)
Parent version for 2-3 years
Children aged 4-17olds.
23 56 57 according to the SDQ guidelines, the mood, behavioral issues, ADHD and peer issues scales will be fully included and their scores will be aggregated to generate a total difficulty score for each index child.
Pro-social scale projects (
It is helpful if someone is injured, friendly to young children and often volunteer to help others)
Will be excluded from this calculation.
Four items 58 and four new items that will be adapted to the knowledge, attitudes and practices of child protection will measure children\'s attitudes towards machine models (
Supplementary Appendix C1).
Monitoring/supervision will be measured by items with poor monitoring/supervision (10 items)
Questionnaire on APQ and parent supervision attributes (one item)59 (
Supplementary Appendix C2).
The background and other influencing factors of parental stress and child abuse parental stress will be measured by the parental stress scale (18 items).
WHO Health Index (WHO-5)(five items).
61 perceived social support will be measured by items supported by tangible/tools (four items)
And emotional support (four items)
Revised Medical Outcomes Study subscales of social support surveys.
One of the instrument support subscales (
Help when restricted to bed)
Will be replaced by \"help you take care of your child.
One item in the emotional support scale (
\"To Love, to make you feel loved \")
Change to \"love you and show you love \"(
Supplementary Appendix D1).
Stimuli in the home environment will be measured using items in the early childhood development module (six items)
In the multi-index cluster survey, of the 63 64 projects, one was adapted according to the participation component table of APQ, and two others (
Share food and explore toys on your own)(
Supplementary Appendix D2).
Parent-to-parent conflicts on parenting will be measured by 11 items in the parent question Checklist65-67 (
Supplementary Appendix D3).
The social demographic features recorded include :(A)
Children: age, gender, sibling and orphan status, physical health/disability and schooling; (B)
Caregivers: age, gender, marital status, educational level, physical and mental health, national cultural background, employment status; (C)
Family: City/rural location, type of residence, family structure and family structure, function and socio-economic status.
Measure the main frequency of use of physical and emotional punishment with three self
Report item on international screening tools for child abuse prevention and neglect (ICAST-Parent)
, 50-52, including a program on severe physical abuse, a program on moderate physical abuse and a program on emotional abuse.
Each project asks the caregiver how many physical or emotional penalties have been imposed on index children in the past month and at any time in the past, such as the penalties described in the project (
Supplementary Annex a).
Frequency will calculate the frequency of each person at each point in time by creating a total penalty eventdays.
The project response for each of these three projects is almost daily, at least once a week, once a month, sometimes but not in the last month, never.
Responses to each item will be assigned a value within a few days of the month: almost daily = 30;
At least once a week = 8; once a month=1;
Sometimes but not in the last month = 0. 5; never=0.
These values will be summed up by physical and emotional punishment.
This format gives more attention to changes from almost every day to at least once a week.
Sensitivity analysis will be used to determine whether different weights will affect the results.
Supplementary Document 1 [bmjopen-2018-021751-supp1. pdf]
Parenting that explains results active and involved will be measured by self
Report items adapted from the positive parenting component table (six items)
And participation component table (one item)
Alabama parenting questionnaire (APQ)53 54 (
Supplementary Appendix B1).
Positive Discipline will be measured by four programs
Violence component table of ICAST50 51 (
Supplementary Appendix B2).
The set limit will be measured by two items in the set limit component table of the child care child 55 (
Supplementary Appendix B3).
Opinions on discipline will be measured in two items of ICAST --Parent50 51 (
Supplementary Appendix B4).
Findings of social and emotional health
The Strengths and Difficulties Questionnaire will be used to measure (SDQ)
Parent version for 2-3 years
Children aged 4-17olds.
23 56 57 according to the SDQ guidelines, the mood, behavioral issues, ADHD and peer issues scales will be fully included and their scores will be aggregated to generate a total difficulty score for each index child.
Pro-social scale projects (
It is helpful if someone is injured, friendly to young children and often volunteer to help others)
Will be excluded from this calculation.
Four items 58 and four new items that will be adapted to the knowledge, attitudes and practices of child protection will measure children\'s attitudes towards machine models (
Supplementary Appendix C1).
Monitoring/supervision will be measured by items with poor monitoring/supervision (10 items)
Questionnaire on APQ and parent supervision attributes (one item)59 (
Supplementary Appendix C2).
The background and other influencing factors of parental stress and child abuse parental stress will be measured by the parental stress scale (18 items).
WHO Health Index (WHO-5)(five items).
61 perceived social support will be measured by items supported by tangible/tools (four items)
And emotional support (four items)
Revised Medical Outcomes Study subscales of social support surveys.
One of the instrument support subscales (
Help when restricted to bed)
Will be replaced by \"help you take care of your child.
One item in the emotional support scale (
\"To Love, to make you feel loved \")
Change to \"love you and show you love \"(
Supplementary Appendix D1).
Stimuli in the home environment will be measured using items in the early childhood development module (six items)
In the multi-index cluster survey, of the 63 64 projects, one was adapted according to the participation component table of APQ, and two others (
Share food and explore toys on your own)(
Su