NCT02852291

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
201

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

March 7, 2016

Completed
5 months until next milestone

First Posted

Study publicly available on registry

August 2, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

July 17, 2024

Status Verified

July 1, 2024

Enrollment Period

9 months

First QC Date

March 7, 2016

Last Update Submit

July 15, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (10)

  • Caregiver use of harsh discipline practices; assessed using Discipline Interview, Locally-derived items

    12 months post treatment

  • Parent-Child Interactions (Parental Acceptance-Rejection Questionnaire; Locally-derived items assessing positive 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

    1 and 12 months post treatment

  • Child behavior: Locally-derived measure of disruptive/non-compliant behaviors; Strengths and Difficulties Questionnaire (conduct problems subscale)

    1 and 12 months post treatment

  • Parental Stress: Parental Stress Scale

    1 and 12 months post treatment

  • +5 more secondary outcomes

Study Arms (3)

Parents Make the Difference

EXPERIMENTAL

Parents Make the Difference (Caregivers attend 10 group parent training sessions)

Behavioral: Parents Make the Difference

Parents Make the Difference Plus

EXPERIMENTAL

Parents Make the Difference Plus (Caregivers attend 10 group parent training sessions and receive 3 home visits)

Behavioral: Parents Make the Difference Plus

Waitlist Control

NO INTERVENTION

No parenting intervention until the end of the study period

Interventions

10 parent training sessions delivered to groups of caregivers

Parents Make the Difference

10 parent training sessions delivered to groups of caregivers, with 3 home visits

Parents Make the Difference Plus

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • does not live with child

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

International Rescue Committee

Monrovia, Liberia

Location

Study Officials

  • Eve Puffer, PhD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2016

First Posted

August 2, 2016

Study Start

March 1, 2016

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

July 17, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will share

following anonymization and publication

Locations