RINEW Randomized Controlled Trial 7-year Follow-up

Not Applicable

Recruiting

• Conditions: Child Development

• Registration Number: NCT06802250
• Lead Sponsor: University of California, Berkeley

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-11-20
• Study First Submitted: 2024-12-30
• Study First Submitted QC: 2025-01-29
• Study First Posted: 2025-01-31
• Status Verified: 2025-02
• Primary Completion: 2025-02
• Study Completion: 2025-02
• Last Update Submitted: 2025-02-24
• Last Update Posted: 2025-02-26

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 620

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Wechsler Intelligence Scale for Children: 5th Edition (WISC-V)	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.
Child Socioemotional Development	6 years after intervention completion	Maternal-report questionnaire designed to measure psychological adjustment in children and aims to detect any emotional or behavioural problems.
Self-regulation	6 years after intervention completion	Observation of children's self-regulation during the administration of the WISC-V assessment.
Academic Achievement	6 years after intervention completion	Direct assessments of children's reading and math performance

Secondary Outcome Measures

Name	Time	Method
Caregiver Mental Health	6 years after intervention completion	Center for Epidemiologic Studies Depression Scale (20 questions). Higher scores represent more depressive symptoms experienced.
Home Environment	6 years after intervention completion	The middle childhood Home Observation for Measurement of the Environment (HOME) includes both caregiver report and observational items to assess the quality and quantity of stimulation and support available to the child at home.
School Grade Level	6 years after intervention completion	Parental report of child's current (or previous if no longer in school) grade level.
Presence of Improved Latrine	6 years after intervention completion	Observation
Presence of Handwashing Station with Soap and Water	6 years after intervention completion	Observation
Knowledge of lead	6 years after intervention completion	Participant response to question "do you know what lead is?"
Bone Lead Levels	6 years after intervention completion	X-ray fluorescence analysis of micrograms of lead per gram bone material

Trial Locations

Locations (1)

International Centre for Diarrhoeal Disease Research, Bangladesh; 🇧🇩 Dhaka, Bangladesh