NCT01829815

Brief Summary

The aim of this study is to assess the impact of an intervention to improve parenting practices, pre-academic and developmental skills, and use of mosquito nets for children in kindergarten in Liberia. A rigorous impact evaluation using a randomized, waitlist controlled design will be conducted to measure the impact of the intervention on three primary outcomes: positive parenting skills, children's cognitive and educational skills, and malaria knowledge and prevention behaviors.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
270

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2012

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

August 1, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 8, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 11, 2013

Completed
Last Updated

January 25, 2016

Status Verified

January 1, 2016

Enrollment Period

7 months

First QC Date

April 8, 2013

Last Update Submit

January 22, 2016

Conditions

Keywords

ChildParentsParentingChild DevelopmentParent Child RelationsMalariaPrimary PreventionPunishmentEducation

Outcome Measures

Primary Outcomes (5)

  • Parenting Behavior Assessment (adapted from multiple scales for this context)

    This is a caregiver-report survey measures including items on various parenting practices, including: caregiver-child communication; discipline and behavior management practices; caregiver-child affection and shared activities; caregiver involvement in child's school and educational activities. These items will yield several subscores for these different domains. Some items may also be analyzed as single items, as they measure specific and important outcomes (e.g., use of a harsh discipline strategy)

    1 month

  • Parenting Self-Efficacy and Beliefs Assessment (adapted from other scales for this context; includes unique items developed for this context)

    These items assess parents' confidence in their parenting abilities and their beliefs about caregiving practices. This measure will yield separate scores for self-efficacy and beliefs about caregiving practices. Some items may also be analyzed as single items, as they measure specific and important outcomes (e.g., parents' belief about an aspect of harsh discipline)

    1 month

  • Child Behavior Assessment (items adapted from the Strengths and Difficulties Questionnaire)

    This tool assess children's behaviors and emotional well-being in the domains of hyperactivity, anger, aggression, mood, and peer relationships. They will be analyzed as an overall score, and single items may be analyzed for certain behaviors or indicators of emotional well-being.

    1 month

  • Parent-Child Interaction Observation

    Caregivers and children in the study will be asked to engage in a play interaction for five minutes, and their verbal interactions will be audio-recorded. Recordings will be coded for specific behaviors. The coding system is adapted from the Dyadic Parent Child Interaction Coding System.

    1 month

  • Child Cognitive / Pre-Academic Abilities and Emotional Well-being

    Children will be administered activity-based items to assess a range of cognitive and learning skills, including verbal and language skills (as measured by several activities), numeracy, and pattern recognition. Items will be combined into composite scores but may also be analyzed separately to measure outcomes on specific abilities (e.g., counting). Children will also be asked five questions related to their emotional well-being adapted from the Strengths and Difficulties Questionnaire. These items will be analyzed as a sum score, and individual items may be analyzed for specific indicators of emotional well-being.

    1 month

Secondary Outcomes (1)

  • Mosquito net usage

    1 month

Study Arms (2)

"Parents Make the Difference"

EXPERIMENTAL

Caregivers are enrolled in the 10-session Parents Make the Difference intervention.

Behavioral: Parents Make the Difference

Waitlist Control

OTHER

Caregivers assigned to the control group received the 10-session Parents Make the Difference intervention after the study was completed.

Behavioral: Parents Make the Difference

Interventions

The intervention, entitled "Parents Make the Difference," will include 10 sessions. Parents will attend in a group, and sessions will include didactic information, guided discussion, and modeling and practice of new skills. All sessions focus on positive parenting skills, with specific skills across three domains that have strong links to child outcomes: (a) positive, non-physical behavior management strategies, (b) strategies for promoting children's early learning, and (c) strategies, primarily use of bed nets, for preventing malaria in children.

"Parents Make the Difference"Waitlist Control

Eligibility Criteria

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

You may qualify if:

  • Parents or primary caregivers (age 18 or above) of children ages 3-7 enrolled in kindergarten
  • Resident in one of five study sites

You may not qualify if:

  • Severe cognitive disability of caregiver affecting ability to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

International Rescue Committee

Voinjama, Lofa County, Liberia

Location

Related Publications (2)

  • Puffer ES, Green EP, Chase RM, Sim AL, Zayzay J, Friis E, Garcia-Rolland E, Boone L. Parents make the difference: a randomized-controlled trial of a parenting intervention in Liberia. Glob Ment Health (Camb). 2015 Aug 4;2:e15. doi: 10.1017/gmh.2015.12. eCollection 2015.

  • Annan J, Sim A, Puffer ES, Salhi C, Betancourt TS. Improving Mental Health Outcomes of Burmese Migrant and Displaced Children in Thailand: a Community-Based Randomized Controlled Trial of a Parenting and Family Skills Intervention. Prev Sci. 2017 Oct;18(7):793-803. doi: 10.1007/s11121-016-0728-2.

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Study Officials

  • Eve Puffer, PhD

    Duke University

    PRINCIPAL INVESTIGATOR
  • Rhea Chase, PhD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 8, 2013

First Posted

April 11, 2013

Study Start

August 1, 2012

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

January 25, 2016

Record last verified: 2016-01

Locations