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Clinical Trials/NCT06165315
NCT06165315
Active, Not Recruiting
N/A

Evaluation of a Group-based Parenting Intervention for Early Childhood Development

Harvard School of Public Health (HSPH)1 site in 1 country620 target enrollmentNovember 1, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Child Development
Sponsor
Harvard School of Public Health (HSPH)
Enrollment
620
Locations
1
Primary Endpoint
Child development
Status
Active, Not Recruiting
Last Updated
2 years ago

Overview

Brief Summary

This implementation research study aims to evaluate the impact and implementation of a group-based parenting program for improving early child development and caregiver outcomes. This study is enrolling primary caregivers with children 0 to 24 months of age to promote caregiver knowledge and skills about nurturing care for young children and support caregiver psychosocial wellbeing. Parenting groups will leverage existing community group networks and be facilitated by trained volunteers for 20 total sessions (groups will meet twice a month for 10 months). ChildFund Kenya and its community partners will implement the program in Busia and Homabay counties. The research study design will involve a cluster-randomized controlled trial and a qualitative implementation evaluation. This research is being led by Emory University with funding from the Conrad N. Hilton Foundation.

Detailed Description

This research has two study components and aims. First, a cluster-randomized controlled trial will be used to quantitatively estimate the effectiveness of the parenting program on early child development and caregiver outcomes. For the research study sample, villages in Busia and Homabay counties were randomly selected and randomly assigned in each county to either the intervention or waitlist control group. Villages in the intervention group will receive the parenting program first, while villages in the control group will receive the program after the completion of the research study. In total, 64 villages have been selected into this study. Then in each village, 10 primary caregivers with children 0-24 months of age will be enrolled into the study for a total of 640 caregiver-child dyads. A caregiver survey and observational assessment of early child development skills will be administered to study participants at baseline and endline to evaluate changes in outcomes between groups over time. Second, and following the completion of the program, qualitative in-depth interviews will be conducted with participants and various stakeholders (e.g., program participants, parenting group facilitators, community health volunteers, ChildFund program staff) to understand their roles and experiences with the parenting program as well as the challenges and successes to inform future implementation. This qualitative implementation evaluation will seek to identify the barriers and facilitators to program impact, quality delivery, scale-up, and sustainability.

Registry
clinicaltrials.gov
Start Date
November 1, 2023
End Date
October 30, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Harvard School of Public Health (HSPH)
Responsible Party
Principal Investigator
Principal Investigator

Joshua Jeong

Research Associate

Harvard School of Public Health (HSPH)

Eligibility Criteria

Inclusion Criteria

  • primary caregiver of a child aged 0-24 months at the time of enrollment
  • the household resides within the geographic boundary of the village that was sampled into the research study
  • primary caregiver provides informed consent for themselves and their child to participate

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Child development

Time Frame: 10 months

Child development measured using the Global Scales of Early Development - Long Form (GSED-LF). GSED-LF is based on direct administration by a research assistant. GSED-LF provides one score for the overall development of children 0-36 months of age. GSED scores will be age-standardized to a mean of 0 and a standard deviation of 1. Higher scores will indicate improved early developmental skills.

Secondary Outcomes

  • Child socioemotional development(10 months)
  • Attitudes towards parenting(10 months)
  • Caregiving environment(10 months)
  • Caregiver stimulation practices(10 months)
  • Parenting stress(10 months)
  • Caregiver disciplinary practices(10 months)
  • Infant and young child feeding practices(10 months)
  • Depressive symptoms(10 months)

Study Sites (1)

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