跳至主要内容
临床试验/NCT03374761
NCT03374761Unknown不适用

Families First Positive Discipline for Everyday Parenting With Home Visiting Program in Indonesia

McGill University2 个研究点 分布在 1 个国家目标入组 720 人开始时间: 2017年3月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
720
试验地点
2
主要终点
Change in frequency of physical and emotional punishment at 3 and 6 months

研究概览

简要总结

Families First Home Visiting Program (Families First) is a parenting support program anchored on children's rights that gives parents clear guidance on child development, parenting, and positive discipline practices. Families First is an adaptation of the Positive Discipline in Everyday Parenting (PDEP) Program for the West Java context. This trial aims to evaluate the effectiveness of Families First. This is a pragmatic, delayed-entry, parallel-group, stratified, cluster-randomized controlled trial in a real-world setting. Twenty rural and urban villages in the Cianjur district of Indonesia, involving 720 caregivers of children up to 7 years of age, are randomized to two parallel arms. Villages receive either a parenting program consisting of 10 group sessions and 4 home visits or the standard community health and social services. After completion of the trial period, the delayed group is offered the program. The primary outcome is self-reported frequency of corporal/physical and emotional punishment. The secondary outcomes are indicators of involved and positive parenting. Concurrent process evaluation and qualitative research are conducted to identify program satisfaction and facilitators and barriers to the implementation. Outcome data are collected immediately after the intervention and six months later. The results will be used to inform a violence prevention strategy in West Java and possible scale up in of the intervention in Indonesia.

详细描述

Aims and objectives The primary objective of this study is to compare, among caregivers of children aged 0-7 years in Cianjur district, Indonesia, the effectiveness of the Families First Program in reducing rates of violent discipline episodes in the home in comparison to rates observed under the standard community health and social service provision. The study will also identify unintended positive and negative effects of this program; determine facilitators and barriers to its implementation in this context; and assess facilitators, mentors, and families' satisfaction with the program.

Site eligibility Data will be collected across 20 villages or clusters that represent the general population in four sub-districts (Campaka, Ciranjang, Karang tengah, and Naringgul) in Cianjur district, West Java Province, Indonesia. Selected villages will consist of (a) rural and urban/peri-urban communities; (b) not been exposed to the Families First Program; (c) reachable within a 1-hour driving distance of the sub-district office and 1-8 hours driving distance of the district capital; (d) located at ample distance from other clusters; and (e) local political leaders provide approval for the intervention and the evaluation.

Randomization Stratified randomization will be used to select 20 clusters among the eligible 38 study clusters in rural and urban settings in the four sub-districts in a 1:1 ratio for the intervention and the control arms. Clusters will be randomized to avoid the resentment or contamination that might occur as a result of delivering the intervention to some families but not others in the community. Randomization will be done in a Random Allocation Ceremony led by the research team and attended by the chiefs from all participating villages as well as staff from the implementing agency. The ceremony will follow a step-by-step lottery and documentation procedure that includes the use of 20 sequentially numbered, opaque, sealed and stapled envelopes independently prepared by the lead investigator. Aluminium foil inside the envelope will render the envelope impermeable to intense light. The ceremony will be video-recorded. Eligible families will be identified before randomly assigning villages.

Measurement strategy The outcome measures for this study are given in the measurement section of the registration document. The original measurement strategy was to use full measures that have already been applied in this field. Piloting of the original plan indicated that this would not be feasible as there were too many items, many of which would not be appropriate or relevant to the context. Instead, the measurement strategy was to use outcome indicators: single items; indices by cumulating responses over several related items; or full measures/subscales with total scores validated using Rasch analysis.

Socio-demographic covariates Socio-demographic characteristics that will be documented include: a) Child: age, gender, orphanhood status, siblings, physical health, and school status; (b) Mother/caretaker: age, gender, marital status, education level, physical and mental health, ethnicity and cultural background, school/employment status; (c) Family: urban/rural location & type of residence, household structure, family structure, economy, and functioning.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

盲法说明

It is not possible to mask as it is a behavioral intervention and the outcomes are self-reported.

入排标准

年龄范围
14 Years 至 —(Child, Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Families First Home Visiting Program

Experimental

10 group sessions conducted weekly and 4 home visits for the duration of the program. Sessions and visits of the Families First Home Visiting Program cover child development, parenting skills, parent-child communications, and positive discipline practices. The intervention is delivered by para-professional community facilitators, trained in the program.

干预措施: Families First Home Visiting Program (Other)

Control Group

No Intervention

The control group receives the standard, government run, services provided by community health workers in West Java. Once the evaluation of the intervention arm is completed, participants in the control arm will be offered the intervention.

结局指标

主要结局

Change in frequency of physical and emotional punishment at 3 and 6 months

时间窗: Baseline, post-intervention (3 months), and 6 months follow-up

Self-report frequency in the past month of use of physical discipline including harsh physical discipline, and verbal/emotional discipline.

次要结局

  • Positive and involved parenting(Baseline, post-intervention (3 months), and 6 months follow-up)
  • Opinion on discipline(Baseline, post-intervention (3 months), and 6 months follow-up)
  • Positive discipline(Baseline, post-intervention (3 months), and 6 months follow-up)
  • Setting limits(Baseline, post-intervention (3 months), and 6 months follow-up)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验

Families First Program Evaluation in Indonesia | 临床试验