Caregiver Interventions for Developmental Delays in Young Kenyan Children

NCT03612505 | Completed

• 1 other identifier: 1801879405
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, the investigators will only administer the intervention to children known to have neurodevelopmental delays. By focusing on adapting the intervention to be only a clinic-based treatment, a small number of community members could be trained to administer the program and increase the potential for sustainability. If the clinic-based group sessions prove to be effective for young children with neurodevelopmental delays, this would help inform the key areas of fidelity needed to maintain effectiveness of the intervention. This study is a critical first step to evaluating the Care for Child Development Intervention (CCDI) program's potential as a cross-cultural intervention that is sustainable and effective for the children at highest risk for neurodevelopmental delay. These results will have significant impacts in improving early childhood neurodevelopment both in Kenya and worldwide.

Conditions

Child Development; Parenting; Cognitive Developmental Delay

Outcome Measures

Primary Outcomes (1)

• Change in Bayley Scales of Infant and Toddler Development, 3rd edition (BSID-III) scores

  Measures cognitive, language, and motor development. Composite scores for cognitive (range of scores 55-145), language (range of scores 47-153), and motor (range of scores 46-154) development. Lower scores indicate worse development. Subscales (e.g. fine and gross motor for motor and expressive and receptive language for language) are summed to create the composite score.

  Baseline, 6 months, 12 months

Secondary Outcomes (6)

• Change In Perspectives around Child Development, gathered by Focus Group Discussions

  Baseline and 6 months

• Change In Perspectives around Child Development, gathered by Focus Group Discussions

  6 months and 12 months

• Change in mother interactions, gathered by video-taped mother interactions

  Baseline and 6 months

• Change in mother interactions, gathered by video-taped mother interactions

  6 months and 12 months

• Change in Home Observations Measurement of the Environment (HOME) scores

  Baseline, 6 months, 12 months

Study Arms (2)

Intervention

ACTIVE COMPARATOR

Behavioral: Mother groups using principles of UNICEF/World Health Organization's Care for Child Development

Control

NO INTERVENTION

Interventions

Mother groups using principles of UNICEF/World Health Organization's Care for Child Development BEHAVIORAL

The intervention is expected to occur every two weeks for a total of ten sessions. On the study day, the child- caregiver dyads randomised to intervention group will be shown to the study room. Each intervention session will be estimated to last 90 minutes allocated as follows: 6 * Introduction (10 minutes) * Lesson on \*Early Childhood Development\* topic (20 minutes) * Discussions on strengthens in caregiving around this topic and areas for improvement (30 minutes) * Observe caretakers one-on-one in play role with the child (25 minutes) * Wrap up/Re-cap (5 minutes) Early Childhood development topics that will be covered include per session are: i) Importance of early childhood development ii) Showing love and building trust iii) Awareness of child's well-being iv) Consistency and daily routines v) Discipline and correction vi) consistency and daily routines vii) Nutrition and cleanliness Viii) Importance of play iX) Dealing with life stresses X) Planning for the future

Intervention

Eligibility Criteria

• Age: 18 Months - 24 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• age 18-24 months
• communicate in either English or Kiswahili
• Score \< 85 on one of the BSID-III subscales (mild/moderate/severe delay in cognitive, motor, or language).
• Have a caregiver who can communicate in English or Kiswahili
• Have a caregiver responsible for child's daily activities

You may not qualify if:

• Profound neurological impairment, such as severe cerebral palsy, deafness, or blindness preventing them from participating in the groups.

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Moi University School of Medicine

Eldoret, Uasin Gishu County, Kenya

Location

MeSH Terms

Interventions

Child Development

Intervention Hierarchy (Ancestors)

Human Development; Growth and Development; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Study Record Dates

• First Submitted: July 27, 2018
• First Posted: August 2, 2018
• Study Start: July 13, 2018
• Primary Completion: February 14, 2019
• Study Completion: September 30, 2019
• Last Updated: June 18, 2024

Record last verified: 2024-06

Locations

KE (1)