- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02852291
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
Status
Completed
Conditions
Intervention / Treatment
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
-
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Monrovia, Liberia
- International Rescue Committee
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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
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Experimental: Parents Make the Difference Plus
Parents Make the Difference Plus (Caregivers attend 10 group parent training sessions and receive 3 home visits)
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10 parent training sessions delivered to groups of caregivers, with 3 home visits
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No Intervention: Waitlist Control
No parenting intervention until the end of the study period
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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
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1 month post treatment
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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
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12 months post treatment
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Parent-Child Interactions (Parental Acceptance-Rejection Questionnaire; Locally-derived items assessing positive interactions)
Time Frame: 12 months post treatment
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Quality of parent-child relationships and interactions
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12 months post treatment
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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
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Indicators of child emotional problems and problems in peer relationships
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1 and 12 months post treatment
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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
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Frequency of disruptive behaviors / SDQ items related to behavioral problems
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1 and 12 months post treatment
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Parental Stress: Parental Stress Scale
Time Frame: 1 and 12 months post treatment
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Level of caregiver parenting-related stress
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1 and 12 months post treatment
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Parental knowledge of child development: Locally-derived scale
Time Frame: 1 and 12 months post treatment
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Locally relevant indicators of parental knowledge about child development
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1 and 12 months post treatment
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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
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Indicators of quality of marital interactions, including relationship violence
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1 and 12 months post treatment
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Caregiver mental health: General Health Questionnaire (subscale A), Patient Health Questionnaire-9
Time Frame: 1 and 12 months post treatment
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Indicators of caregiver mental health symptoms
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1 and 12 months post treatment
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Handwashing Behavior Indicators (e.g., access to hand washing station)
Time Frame: 1 and 12 months post treatment
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Basic indicators of hand washing behavior and resources
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1 and 12 months post treatment
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Child cognitive skills (verbal ability); assessed with a story comprehension task and instruction-following task
Time Frame: 1 and 12 months post treatment
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Child verbal abilities (brief assessment)
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1 and 12 months post treatment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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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