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

NCT06165315 | Unknown

• 1 other identifier: ISERC/JOOTRH/736/23
• Study Type: interventional
• Target: 620
• Locations: 1 country
• Sites: 1

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.

Conditions

Child Development

Outcome Measures

Primary Outcomes (1)

• Child development

  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.

  10 months

Secondary Outcomes (8)

• Child socioemotional development

  10 months

• Attitudes towards parenting

  10 months

• Caregiving environment

  10 months

• Caregiver stimulation practices

  10 months

• Caregiver disciplinary practices

  10 months

Study Arms (2)

Parenting Program

EXPERIMENTAL

This community-based group parenting program aims improve caregiver knowledge, attitudes, and practices on nurturing care to ultimate improve early childhood development. A secondary aim of the program is to support caregiver psychosocial wellbeing. The curriculum covers various topics relating to responsive caregiving, early learning, child protection, maternal and child health and nutrition, and caregiver mental health. Intervention will be delivered through existing community group networks. Each parenting group will comprise of 10 caregivers that will be facilitated by trained volunteers.

Behavioral: Parenting program

Waitlist-Control

NO INTERVENTION

Villages in the control group will not immediately receive the parenting program. Instead, they will receive whatever standard of care services are delivered at the community-level (e.g., routine services from community health volunteers that are primarily focused on maternal and child health and nutrition). After endline data collection is completed for the trial, then villages in the control group will receive the parenting program.

Interventions

Parenting program BEHAVIORAL

Villages in the intervention group will receive the parenting program. The parenting program consists of 20 total sessions, whereby groups will meet twice a month for 10 months.

Parenting Program

Eligibility Criteria

• Age: 0 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• none

Sponsors & Collaborators

• Harvard School of Public Health (HSPH): lead
• ChildFund Kenya: collaborator
• Conrad N. Hilton Foundation: collaborator
• B&M Consult: collaborator

Study Sites (1)

B&M Consult

Nairobi, Kenya

Location

Related Publications (2)

• Kalam MA, McCann JK, Shakil Z, Gambari A, Ochieng M, Jeong J. Maternal Mental Health and Child Dietary Diversity in Rural Kenya: Findings From a Pooled Analysis of 2 Baseline Studies. Curr Dev Nutr. 2025 Jun 24;9(7):107497. doi: 10.1016/j.cdnut.2025.107497. eCollection 2025 Jul.

  PMID: 40718429 DERIVED

• Jeong J, McCann JK, Onyango S, Ochieng M. A parenting program delivered through existing community-based peer groups to improve early child development in Homabay and Busia Counties, Kenya: study protocol for a cluster-randomized controlled trial. BMC Pediatr. 2024 Sep 17;24(1):592. doi: 10.1186/s12887-024-05065-7.

  PMID: 39289646 DERIVED

Study Officials

• Joshua Jeong, ScD

  Harvard School of Public Health (HSPH)

  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: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate

Study Record Dates

• First Submitted: December 2, 2023
• First Posted: December 11, 2023
• Study Start: November 1, 2023
• Primary Completion: October 30, 2024
• Study Completion: October 30, 2024
• Last Updated: January 3, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

KE (1)