Clinical trial NCT06165315: Evaluation of a Group-based Parenting Intervention for Early Childhood Development
Official title: Evaluation of a Group-based Parenting Intervention for Early Childhood Development
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Child Development
Lead sponsor: Harvard School of Public Health (HSPH)
Sponsor class: OTHER
Collaborators: name: ChildFund Kenya
name: Conrad N. Hilton Foundation
name: B&M Consult
First posted: 2023-12-11
Enrollment: 620
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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:

* none

Primary outcomes:
measure: Child development
timeFrame: 10 months
Secondary outcomes:
measure: Child socioemotional development
timeFrame: 10 months
measure: Attitudes towards parenting
timeFrame: 10 months
measure: Caregiving environment
timeFrame: 10 months
measure: Caregiver stimulation practices
timeFrame: 10 months
measure: Caregiver disciplinary practices
timeFrame: 10 months
measure: Infant and young child feeding practices
timeFrame: 10 months
measure: Parenting stress
timeFrame: 10 months
measure: Depressive symptoms
timeFrame: 10 months
Other outcomes:
Locations:
city: Nairobi
country: Kenya
facility: B&M Consult
Study officials:
affiliation: Harvard School of Public Health (HSPH)
name: Joshua Jeong, ScD
role: PRINCIPAL_INVESTIGATOR
References: