Parents Make the Difference II: Trial of a Parenting Intervention

February 19, 2024 updated by: Duke University

Parents Make the Difference II: A Randomized Experiment of a Parent Training Program for Caregivers of Young Children Designed to Reduce the Use of Harsh Punishment and Improve Child-caregiver Relationships

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.

Study Overview

Detailed Description

This is a multisite randomized trial of a parenting intervention in Liberia for caregivers of young children. The "Parents Make the Difference" program is designed 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. 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 the intervention will prevent future abuse and poor developmental outcomes in the long-term. This study will randomize 816 caregivers of children ages 3 or 4 years to 1 of 3 study arms: standard group program, group program plus home visits, waitlist control.

Study Type

Interventional

Enrollment (Actual)

201

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Monrovia, Liberia
        • International Rescue Committee

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • caregiver of child ages 3 or 4
  • live within catchment area of each study site
  • caregiver is at least 18 years old

Exclusion Criteria:

  • does not live with child

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Parents Make the Difference
Parents Make the Difference (Caregivers attend 10 group parent training sessions)
10 parent training sessions delivered to groups of caregivers
Experimental: Parents Make the Difference Plus
Parents Make the Difference Plus (Caregivers attend 10 group parent training sessions and receive 3 home visits)
10 parent training sessions delivered to groups of caregivers, with 3 home visits
No Intervention: Waitlist Control
No parenting intervention until the end of the study period

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Caregiver use of harsh discipline practices; assessed using Discipline Interview, Locally-derived items
Time Frame: 1 month post treatment
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)
Time Frame: 1 month post treatment
Quality of parent-child relationships and interactions
1 month post treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Caregiver use of harsh discipline practices; assessed using Discipline Interview, Locally-derived items
Time Frame: 12 months post treatment
Use of harsh discipline practices, including physical and verbal strategies
12 months post treatment
Parent-Child Interactions (Parental Acceptance-Rejection Questionnaire; Locally-derived items assessing positive interactions)
Time Frame: 12 months post treatment
Quality of parent-child relationships and 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
Time Frame: 1 and 12 months post treatment
Indicators of child emotional problems and problems in peer relationships
1 and 12 months post treatment
Child behavior: Locally-derived measure of disruptive/non-compliant behaviors; Strengths and Difficulties Questionnaire (conduct problems subscale)
Time Frame: 1 and 12 months post treatment
Frequency of disruptive behaviors / SDQ items related to behavioral problems
1 and 12 months post treatment
Parental Stress: Parental Stress Scale
Time Frame: 1 and 12 months post treatment
Level of caregiver parenting-related stress
1 and 12 months post treatment
Parental knowledge of child development: Locally-derived scale
Time Frame: 1 and 12 months post treatment
Locally relevant indicators of parental knowledge about child development
1 and 12 months post treatment
Marital relationship quality: selected items from Conflict Tactics Scale and locally-derived scale of marital relationship quality
Time Frame: 1 and 12 months post treatment
Indicators of quality of marital interactions, including relationship violence
1 and 12 months post treatment
Caregiver mental health: General Health Questionnaire (subscale A), Patient Health Questionnaire-9
Time Frame: 1 and 12 months post treatment
Indicators of caregiver mental health symptoms
1 and 12 months post treatment
Handwashing Behavior Indicators (e.g., access to hand washing station)
Time Frame: 1 and 12 months post treatment
Basic indicators of hand washing behavior and resources
1 and 12 months post treatment
Child cognitive skills (verbal ability); assessed with a story comprehension task and instruction-following task
Time Frame: 1 and 12 months post treatment
Child verbal abilities (brief assessment)
1 and 12 months post treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Eve Puffer, PhD, Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2016

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

March 7, 2016

First Submitted That Met QC Criteria

July 28, 2016

First Posted (Estimated)

August 2, 2016

Study Record Updates

Last Update Posted (Estimated)

February 21, 2024

Last Update Submitted That Met QC Criteria

February 19, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • pmd2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

following anonymization and publication

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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