Families First Program Evaluation in Indonesia

NCT03374761 | Unknown

• 1 other identifier: A10-B53-16B
• Study Type: interventional
• Target: 720
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Child Abuse; Parent-Child Relations

Keywords

child abuse; parenting; low and middle income countries; child discipline; Indonesia

Outcome Measures

Primary Outcomes (1)

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

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

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

Secondary Outcomes (4)

• Positive and involved parenting

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

• Positive discipline

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

• Opinion on discipline

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

• Setting limits

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

Other Outcomes (8)

• Inter-parental conflict regarding child rearing

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

• Caregiver mental health

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

• Child social and emotional well-being

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

Study Arms (2)

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.

Other: Families First Home Visiting Program

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.

Interventions

Families First Home Visiting Program OTHER

10 group sessions and 4 home visits with community facilitators emphasizing positive parenting

Families First Home Visiting Program

Eligibility Criteria

• Age: 14 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Have at least one child aged up to 7 years, regardless of whether the child is their biological child or not;
• Have at least one of the risk factors associated with the placement of children into residential care: live below the government poverty line; be a single and teenage mother; father or mother has migrated/or mother is considering migration;
• Have basic needs met or be referred to social protection program before start of program;
• Reside in the village;
• Not been previously identified as having cognitive impairment
• Able to speak and read in Bahasa;
• Have never engaged in another parenting program;
• Does not plan to move from this village for a year ahead

Sponsors & Collaborators

• McGill University: lead
• European Network of Foundations Children and Violence Evaluation Challenge Fund: collaborator
• Save the Children: collaborator
• SMERU Research Institute: collaborator

Study Sites (1)

Division fo Clinical epidemiology

Montreal, Quebec, H3A 1A1, Canada

Location

Related Publications (1)

• Ruiz-Casares M, Lilley S, Thombs BD, Platt RW, Scott S, Isdijoso W, Hermanus E, Andrina M, Mayo N. 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. BMJ Open. 2019 Jan 15;9(1):e021751. doi: 10.1136/bmjopen-2018-021751.

  PMID: 30782674 DERIVED

Study Officials

• Monica Ruiz-Casares, PhD

  McGill University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: It is not possible to mask as it is a behavioral intervention and the outcomes are self-reported.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Stratified, clustered randomized pragmatic trial

Study Record Dates

• First Submitted: November 30, 2017
• First Posted: December 15, 2017
• Study Start: March 22, 2017
• Primary Completion: March 24, 2018
• Study Completion: August 31, 2019
• Last Updated: August 7, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)