- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01829815
Impact of a Parenting Program in Liberia to Improve Parenting, Education, and Health Outcomes for Children in Liberia
January 22, 2016 updated by: International Rescue Committee
Impact Evaluation of a Parenting Program to Improve Parenting, Education, and Health Outcomes for Young Children in Liberia
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
270
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Lofa County
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Voinjama, Lofa County, Liberia
- International Rescue Committee
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Parents or primary caregivers (age 18 or above) of children ages 3-7 enrolled in kindergarten
- Resident in one of five study sites
Exclusion Criteria:
- Severe cognitive disability of caregiver affecting ability to provide informed consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: "Parents Make the Difference"
Caregivers are enrolled in the 10-session Parents Make the Difference intervention.
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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.
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Other: Waitlist Control
Caregivers assigned to the control group received the 10-session Parents Make the Difference intervention after the study was completed.
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Parenting Behavior Assessment (adapted from multiple scales for this context)
Time Frame: 1 month
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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)
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1 month
|
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Parenting Self-Efficacy and Beliefs Assessment (adapted from other scales for this context; includes unique items developed for this context)
Time Frame: 1 month
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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)
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1 month
|
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Child Behavior Assessment (items adapted from the Strengths and Difficulties Questionnaire)
Time Frame: 1 month
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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.
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1 month
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Parent-Child Interaction Observation
Time Frame: 1 month
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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.
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1 month
|
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Child Cognitive / Pre-Academic Abilities and Emotional Well-being
Time Frame: 1 month
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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.
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1 month
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mosquito net usage
Time Frame: 1 month
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A survey will be used to assess mosquito net usage by household members.
Items will be analyzed separately to assess discrete behaviors (e.g., whether child him/herself slept under the net; whether any adult(s) slept under the net)
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1 month
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Eve Puffer, PhD, Duke University
- Principal Investigator: Rhea Chase, PhD, Duke University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2012
Primary Completion (Actual)
March 1, 2013
Study Completion (Actual)
March 1, 2013
Study Registration Dates
First Submitted
April 8, 2013
First Submitted That Met QC Criteria
April 8, 2013
First Posted (Estimate)
April 11, 2013
Study Record Updates
Last Update Posted (Estimate)
January 25, 2016
Last Update Submitted That Met QC Criteria
January 22, 2016
Last Verified
January 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5108
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
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