RINEW Randomized Controlled Trial 7-year Follow-up

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

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 Overview

• Status: Completed
• Conditions: Child Development
• Intervention / Treatment: Behavioral: RINEW intervention

• Study Type: Interventional
• Enrollment (Actual): 620
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Bangladesh
  • Dhaka, Bangladesh, 1212
    • International Centre for Diarrhoeal Disease Research, Bangladesh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control arm; No intervention administered
Experimental: Group only arm; Participants were encouraged to attend fortnightly courtyard group meetings	Behavioral: RINEW intervention; 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.
Experimental: Combined delivery arm; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Caregiver Mental Health	Center for Epidemiologic Studies Depression Scale (20 questions). Higher scores represent more depressive symptoms experienced.	6 years after intervention completion
Home Environment	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.	6 years after intervention completion
School Grade Level	Parental report of child's current (or previous if no longer in school) grade level.	6 years after intervention completion
Presence of Improved Latrine	Observation	6 years after intervention completion
Presence of Handwashing Station with Soap and Water	Observation	6 years after intervention completion
Knowledge of lead	Participant response to question "do you know what lead is?"	6 years after intervention completion
Bone Lead Levels	X-ray fluorescence analysis of micrograms of lead per gram bone material	6 years after intervention completion

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knowledge of 7 factors related to children's intelligence	Record of mention of 7 factors in response to question "What are the things that affect a child's intelligence?". Factors are: clean environment, parental involvement, nutrition, learning/education at home, learning/education outside of the home, communication, social stimulation.	6 years after intervention completion
Knowledge of ways to avoid harm from lead	Correct response to question "What ways do you know to avoid harm from lead?"	6 years after intervention completion
Parental perceived intelligence	Parental rating of child's intelligence (1-7)	6 years after intervention completion
Child screen time	Number of hours spent using a digital screen per week (on average, caregiver report)	6 years after intervention completion

Collaborators and Investigators

• Sponsor: University of California, Berkeley
• Collaborators: Stanford University; International Centre for Diarrhoeal Disease Research, Bangladesh; Purdue University
• Investigators: Principal Investigator: Lia Fernald, PhD, University of California, Berkeley

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2024
• Primary Completion (Actual): February 28, 2025
• Study Completion (Actual): February 28, 2025

Study Registration Dates

• First Submitted: December 30, 2024
• First Submitted That Met QC Criteria: January 29, 2025
• First Posted (Actual): January 31, 2025

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Nutrition; Intervention; Child development; Water, Sanitation, and Hygiene
• Other Study ID Numbers: 2024-02-17211

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The de-identified data collected for this study will be available on request within 5 years following the completion of data collection.
• IPD Sharing Time Frame: Within 5 years following the completion of data collection.
• IPD Sharing Access Criteria: Completion of a signed data-sharing agreement access agreement; use for research purposes only.
• IPD Sharing Supporting Information Type: SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No