RINEW Randomized Controlled Trial 7-year Follow-up

NCT06802250 | Completed

• 1 other identifier: 2024-02-17211
• Study Type: interventional
• Target: 620
• Locations: 1 country
• Sites: 1

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.

Conditions

Child Development

Keywords

Child development; Water, Sanitation, and Hygiene; Nutrition; Intervention

Outcome Measures

Primary Outcomes (4)

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

  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.

  6 years after intervention completion

• Child Socioemotional Development

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

  6 years after intervention completion

• Self-regulation

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

  6 years after intervention completion

• Academic Achievement

  Direct assessments of children's reading and math performance

  6 years after intervention completion

Secondary Outcomes (7)

• 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

Other Outcomes (4)

• Knowledge of 7 factors related to children's intelligence

  6 years after intervention completion

• Knowledge of ways to avoid harm from lead

  6 years after intervention completion

• Child screen time

  6 years after intervention completion

Study Arms (3)

Control arm

NO INTERVENTION

No intervention administered

Group only arm

EXPERIMENTAL

Participants were encouraged to attend fortnightly courtyard group meetings

Behavioral: RINEW intervention

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.

Behavioral: RINEW intervention

Interventions

RINEW intervention BEHAVIORAL

The intervention included behavioral recommendations and guidance on the topics of Nutrition, WASH, Lead exposure prevention, Mental Health, and child stimulation. The intervention also included the provision of nutritional supplements based on age and nutritional status, low-cost picture books and toys, and soapy water bottles.

Combined delivery arm; Group only arm

Eligibility Criteria

• Age: 6 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh: collaborator
• University of California, Berkeley: lead
• Stanford University: collaborator
• Purdue University: collaborator

Study Sites (1)

International Centre for Diarrhoeal Disease Research, Bangladesh

Dhaka, 1212, Bangladesh

Location

Study Officials

• Lia Fernald, PhD

  University of California, Berkeley

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2024
• First Posted: January 31, 2025
• Study Start: November 20, 2024
• Primary Completion: February 28, 2025
• Study Completion: February 28, 2025
• Last Updated: May 4, 2026

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: Within 5 years following the completion of data collection.
• Access Criteria: Completion of a signed data-sharing agreement access agreement; use for research purposes only.

Locations

BA (1)