Parents Make the Difference II: Trial of a Parenting Intervention
PMD2
1 other identifier
interventional
201
1 country
1
Brief Summary
Multisite randomized trial of a parenting intervention in Liberia for caregivers of young children. Two main objectives of the "Parents Make the Difference" program are to teach parents (a) skills for decreasing harsh punishments and replacing those with positive ways to manage children's behavior and (b) skills for having more positive interactions with their children, including interactions that encourage learning. As a result of positive changes in parenting, the investigators expect that, over time, children's behavioral and cognitive well-being will improve and that future abuse and poor developmental outcomes will be prevented in the long-term.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2016
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2016
CompletedFirst Submitted
Initial submission to the registry
March 7, 2016
CompletedFirst Posted
Study publicly available on registry
August 2, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedJuly 17, 2024
July 1, 2024
9 months
March 7, 2016
July 15, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Caregiver use of harsh discipline practices; assessed using Discipline Interview, Locally-derived items
Extent to which caregivers engage in harsh discipline practices
1 month post treatment
Parent-Child Interactions (Parental Acceptance-Rejection Questionnaire; Locally-derived items assessing positive interactions)
Quality of parent-child relationships and interactions
1 month post treatment
Secondary Outcomes (10)
Caregiver use of harsh discipline practices; assessed using Discipline Interview, Locally-derived items
12 months post treatment
Parent-Child Interactions (Parental Acceptance-Rejection Questionnaire; Locally-derived items assessing positive interactions)
12 months post treatment
Child social-emotional development and functioning: Ages and Stages Questionnaire; Strengths and Difficulties Questionnaire: emotion problems and peer problems subscales
1 and 12 months post treatment
Child behavior: Locally-derived measure of disruptive/non-compliant behaviors; Strengths and Difficulties Questionnaire (conduct problems subscale)
1 and 12 months post treatment
Parental Stress: Parental Stress Scale
1 and 12 months post treatment
- +5 more secondary outcomes
Study Arms (3)
Parents Make the Difference
EXPERIMENTALParents Make the Difference (Caregivers attend 10 group parent training sessions)
Parents Make the Difference Plus
EXPERIMENTALParents Make the Difference Plus (Caregivers attend 10 group parent training sessions and receive 3 home visits)
Waitlist Control
NO INTERVENTIONNo parenting intervention until the end of the study period
Interventions
10 parent training sessions delivered to groups of caregivers
10 parent training sessions delivered to groups of caregivers, with 3 home visits
Eligibility Criteria
You may qualify if:
- caregiver of child ages 3 or 4
- live within catchment area of each study site
- caregiver is at least 18 years old
You may not qualify if:
- does not live with child
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Universitylead
- International Rescue Committeecollaborator
Study Sites (1)
International Rescue Committee
Monrovia, Liberia
Study Officials
- PRINCIPAL INVESTIGATOR
Eve Puffer, PhD
Duke University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 7, 2016
First Posted
August 2, 2016
Study Start
March 1, 2016
Primary Completion
December 1, 2016
Study Completion
December 1, 2016
Last Updated
July 17, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will share
following anonymization and publication