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Families First Program Evaluation in Indonesia

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ClinicalTrials.gov Identifier: NCT03374761
Recruitment Status : Enrolling by invitation
First Posted : December 15, 2017
Last Update Posted : January 17, 2018
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Child Abuse Parent-Child Relations Other: Families First Home Visiting Program

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Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 720 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Stratified, clustered randomized pragmatic trial
Masking: None (Open Label)
Masking Description: It is not possible to mask as it is a behavioral intervention and the outcomes are self-reported.
Primary Purpose: Prevention
Official Title: Families First Positive Discipline for Everyday Parenting With Home Visiting Program in Indonesia
Actual Study Start Date : March 22, 2017
Estimated Primary Completion Date : April 1, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Parenting
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Families First Home Visiting Program
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
10 group sessions and 4 home visits with community facilitators emphasizing positive parenting
No Intervention: Control Group
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.


Outcome Measures

Primary Outcome Measures :
  1. Change in frequency of physical and emotional punishment at 3 and 6 months [ Time Frame: 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.


Secondary Outcome Measures :
  1. Positive and involved parenting [ Time Frame: Baseline, post-intervention (3 months), and 6 months follow-up ]
    Positive Parenting Subscale (6 self-report items) and 1 single self-report item from Involvement Subscale of the Alabama Parenting Questionnaire (APQ).

  2. Positive discipline [ Time Frame: Baseline, post-intervention (3 months), and 6 months follow-up ]
    Four self-report items adapted from the International Society for Prevention of Child Abuse and Neglect Child Abuse Screening Tool (ICAST) Nonviolent Subscale.

  3. Opinion on discipline [ Time Frame: Baseline, post-intervention (3 months), and 6 months follow-up ]
    Two items from the International Society for Prevention of Child Abuse and Neglect Child Abuse Screening Tool (ICAST)-Parent.

  4. Setting limits [ Time Frame: Baseline, post-intervention (3 months), and 6 months follow-up ]
    2 items from the Setting Limits Subscale of the Parenting Young Children (PARYC)


Other Outcome Measures:
  1. Inter-parental conflict regarding child rearing [ Time Frame: Baseline, post-intervention (3 months), and 6 months follow-up ]
    11 items from the Parent Problem Checklist (PPC)

  2. Caregiver mental health [ Time Frame: Baseline, post-intervention (3 months), and 6 months follow-up ]
    Wold Health Organization Well-Being Index-5 (WHO-5) comprising 5 items

  3. Child social and emotional well-being [ Time Frame: Baseline, post-intervention (3 months), and 6 months follow-up ]
    Strengths and Difficulties Questionnaire (SDQ): emotional problems (5-items), conduct problems (5-items), hyperactivity (5-items), peer problems (5-items), and pro-social (3 items)

  4. Monitoring and supervision [ Time Frame: Baseline, post-intervention (3 months), and 6 months follow-up ]
    Poor Monitoring/Supervision Subscale of the Alabama Parenting Questionnaire (APQ: 10-items), 1 item from the Involvement Subscale of the APQ, and 1 item from the Parent Supervision Attributes Profile Questionnaire (PSAPQ)

  5. Parenting stress [ Time Frame: Baseline, post-intervention (3 months), and 6 months follow-up ]
    Parental Stress Scale comprising 18-items

  6. Stimulating home environment [ Time Frame: Baseline, post-intervention (3 months), and 6 months follow-up ]
    6 items from the Early Childhood Development Module from the Multiple Indicator Cluster Survey and two items (sharing meals and exploring toys alone)

  7. Institutionalization of children [ Time Frame: Baseline, post-intervention (3 months), and 6 months follow-up ]
    Modified Child Protection Knowledge, Attitudes, and Practices (CP-KAP)

  8. Perceived Social Support [ Time Frame: Baseline, post-intervention (3 months), and 6 months follow-up ]
    Tangible/Instrumental Support Subscale (3 items) and Emotional Support Subscale (4 items) from the Modified Social Support Survey of the Medical Outcomes Study (mMOS-SS)


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion:

  • 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03374761


Locations
Canada, Quebec
Division fo Clinical epidemiology
Montreal, Quebec, Canada, H3A 1A1
Sponsors and Collaborators
McGill University
European Network of Foundations Children and Violence Evaluation Challenge Fund
Save the Children
SMERU Research Institute
Investigators
Principal Investigator: Monica Ruiz-Casares, PhD McGill University
More Information

Responsible Party: McGill University
ClinicalTrials.gov Identifier: NCT03374761     History of Changes
Other Study ID Numbers: A10-B53-16B
First Posted: December 15, 2017    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by McGill University:
child abuse
parenting
low and middle income countries
child discipline
Indonesia