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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01829815
Other study ID # 5108
Secondary ID
Status Completed
Phase N/A
First received April 8, 2013
Last updated January 22, 2016
Start date August 2012
Est. completion date March 2013

Study information

Verified date January 2016
Source International Rescue Committee
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 270
Est. completion date March 2013
Est. primary completion date March 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Behavioral:
Parents Make the Difference
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.

Locations

Country Name City State
Liberia International Rescue Committee Voinjama Lofa County

Sponsors (2)

Lead Sponsor Collaborator
International Rescue Committee Duke University

Country where clinical trial is conducted

Liberia, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Primary 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 No
Primary 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 No
Primary 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 No
Primary 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 No
Secondary Mosquito net usage 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) 1 month No
See also
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Completed NCT02850510 - Evaluating a Shortened Version of the Incredible Years (IY) Basic Programme in a Non-clinical Community Sample N/A