Clinical trial NCT02852291: Parents Make the Difference II: Trial of a Parenting Intervention
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parenting
Child Abuse
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: International Rescue Committee
First posted: 2016-08-02
Enrollment: 201
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Caregiver use of harsh discipline practices; assessed using Discipline Interview, Locally-derived items
timeFrame: 1 month post treatment
measure: Parent-Child Interactions (Parental Acceptance-Rejection Questionnaire; Locally-derived items assessing positive interactions)
timeFrame: 1 month post treatment
Secondary outcomes:
measure: Caregiver use of harsh discipline practices; assessed using Discipline Interview, Locally-derived items
timeFrame: 12 months post treatment
measure: Parent-Child Interactions (Parental Acceptance-Rejection Questionnaire; Locally-derived items assessing positive interactions)
timeFrame: 12 months post treatment
measure: Child social-emotional development and functioning: Ages and Stages Questionnaire; Strengths and Difficulties Questionnaire: emotion problems and peer problems subscales
timeFrame: 1 and 12 months post treatment
measure: Child behavior: Locally-derived measure of disruptive/non-compliant behaviors; Strengths and Difficulties Questionnaire (conduct problems subscale)
timeFrame: 1 and 12 months post treatment
measure: Parental Stress: Parental Stress Scale
timeFrame: 1 and 12 months post treatment
measure: Parental knowledge of child development: Locally-derived scale
timeFrame: 1 and 12 months post treatment
measure: Marital relationship quality: selected items from Conflict Tactics Scale and locally-derived scale of marital relationship quality
timeFrame: 1 and 12 months post treatment
measure: Caregiver mental health: General Health Questionnaire (subscale A), Patient Health Questionnaire-9
timeFrame: 1 and 12 months post treatment
measure: Handwashing Behavior Indicators (e.g., access to hand washing station)
timeFrame: 1 and 12 months post treatment
measure: Child cognitive skills (verbal ability); assessed with a story comprehension task and instruction-following task
timeFrame: 1 and 12 months post treatment
Other outcomes:
Locations:
city: Monrovia
country: Liberia
facility: International Rescue Committee
Study officials:
affiliation: Duke University
name: Eve Puffer, PhD
role: PRINCIPAL_INVESTIGATOR
References: