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Clinical Trials/NCT06802250
NCT06802250CompletedNot Applicable

Effects of a Multi-component Early Child Development Intervention in Middle- Childhood: a Follow-up Study of the RINEW Randomized Controlled Trial

University of California, Berkeley1 site in 1 country620 target enrollmentStarted: November 20, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
620
Locations
1
Primary Endpoint
Wechsler Intelligence Scale for Children: 5th Edition (WISC-V)

Study Overview

Brief Summary

This study is designed to evaluate the impact of the RINEW multicomponent early child development intervention on child development and risk factors for poor child development in middle childhood. This study is a follow-up assessment of the children and primary caregivers enrolled in the RINEW cluster randomized controlled trial approximately 6 years following intervention completion.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Outcomes Assessor)

Masking Description

The outcome assessment team is separate from the implementation team, and are not aware of intervention components. Materials provided in the intervention (books, toys) may be visible in the participants homes, but the outcome assessment team was not aware that these are related to the intervention.

Eligibility Criteria

Ages
6 Years to 9 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Child's primary caregiver was enrolled in the RINEW cluster randomized trial

Exclusion Criteria

  • Not provided

Arms & Interventions

Control arm

No Intervention

No intervention administered

Group only arm

Experimental

Participants were encouraged to attend fortnightly courtyard group meetings

Intervention: RINEW intervention (Behavioral)

Combined delivery arm

Experimental

Participants were visited by community health promoters once a month in their home as well as receive encouragement to attend monthly courtyard group meetings in between the monthly home visits.

Intervention: RINEW intervention (Behavioral)

Outcomes

Primary Outcomes

Wechsler Intelligence Scale for Children: 5th Edition (WISC-V)

Time Frame: 6 years after intervention completion

The WISC-V assessment measures cognitive development and general intellectual abilities in children 6 years 0 months to 16 years 11 months of age (6:0-16:11). Higher scores represent better outcomes.

Self-regulation

Time Frame: 6 years after intervention completion

Observation of children's self-regulation during the administration of the WISC-V assessment.

Child Socioemotional Development

Time Frame: 6 years after intervention completion

Maternal-report questionnaire designed to measure psychological adjustment in children and aims to detect any emotional or behavioural problems.

Academic Achievement

Time Frame: 6 years after intervention completion

Direct assessments of children's reading and math performance

Secondary Outcomes

  • Knowledge of lead(6 years after intervention completion)
  • Bone Lead Levels(6 years after intervention completion)
  • Caregiver Mental Health(6 years after intervention completion)
  • Home Environment(6 years after intervention completion)
  • School Grade Level(6 years after intervention completion)
  • Presence of Improved Latrine(6 years after intervention completion)
  • Presence of Handwashing Station with Soap and Water(6 years after intervention completion)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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