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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02852291
Other study ID # pmd2
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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