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

Child Development Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06165315
• Other study ID #: ISERC/JOOTRH/736/23
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: October 30, 2024

Study information

• Verified date: January 2024
• Source: Harvard School of Public Health (HSPH)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 620
• Est. completion date: October 30, 2024
• Est. primary completion date: October 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 0 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Child Development

Intervention

Behavioral:
• Parenting program
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.

Locations

Country	Name	City	State
Kenya	B&M Consult	Nairobi

Sponsors (4)

Lead Sponsor	Collaborator
Harvard School of Public Health (HSPH)	B&M Consult, ChildFund Kenya, Conrad N. Hilton Foundation

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Child socioemotional development	Child socioemotional development based on observational rating by a research assistant using an adapted version of the Wolke Scales (e.g., child affect, vocalization, cooperation with the research assistant). An average score will be calculated across the items with higher scores indicating more positive child behaviors.	10 months
Secondary	Attitudes towards parenting	Primary caregivers will report the extent to which they agree with various statements about parental roles and engagement in nurturing care practices. A total score will be calculated with higher scores indicating more supportive parenting attitudes.	10 months
Secondary	Caregiving environment	Caregiving environment will be assessed using the Home Observation for Measurement of the Environment for infants and toddlers aged 0 to 3 years (HOME-IT). It combines caregiver-reported items and observations of parenting behaviors to assess early learning opportunities at home and responsive caregiving behaviors of primary caregiver with the child. A total score will be calculated with higher scores indicate more responsive caregiving and enriched home learning environments.	10 months
Secondary	Caregiver stimulation practices	Caregiver stimulation practices reported by primary caregiver about their engagement in early learning activities with the child (e.g. singing, telling stories). Activities adapted from the Family Care Indicators. A total score will be calculated with higher scores indicating more engagement in stimulation activities.	10 months
Secondary	Caregiver disciplinary practices	Caregiver disciplinary practices reported by primary caregivers in terms of harsh punishment (e.g., shook the child, shouted at child) and positive disciplinary practices (e.g., explained why the behavior was wrong) used towards the child. Items adapted from Child Discipline Module of Multiple Indicator Cluster Survey. Separate indicators will be created for use of any harsh disciplinary practices or any positive disciplinary practices.	10 months
Secondary	Infant and young child feeding practices	Infant and young child feeding (IYCF) practices including caregiver-reported breastfeeding and exclusive breastfeeding practices and child dietary diversity score (number of food groups the child consumed in previous 24 hours) based on WHO guidelines.	10 months
Secondary	Parenting stress	Parenting distress reported by the primary caregiver using the Parenting Stress Index-Short Form, Parental Distress subscale. Higher total scores indicate greater parenting distress.	10 months
Secondary	Depressive symptoms	Depressive symptoms reported by the primary caregiver using the Centre for Epidemiological Studies Depression Scale-10 items (CESD-10). Caregivers report on the frequency of depressive symptoms in the previous week. Items are summed to create an overall depression score, with higher scoring indicating greater depressive symptoms.	10 months