Parents Make the Difference II: Trial of a Parenting Intervention

Parenting Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02852291
• Other study ID #: pmd2
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Est. completion date: December 2016

Study information

• Verified date: February 2024
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 201
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Child Abuse
• Parenting

Intervention

Behavioral:
• Parents Make the Difference
10 parent training sessions delivered to groups of caregivers
• Parents Make the Difference Plus
10 parent training sessions delivered to groups of caregivers, with 3 home visits

Locations

Country	Name	City	State
Liberia	International Rescue Committee	Monrovia

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	International Rescue Committee

Country where clinical trial is conducted

Liberia, 

Outcome

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