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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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06802250
Enrollment
620
Registered
2025-01-31
Start date
2024-11-20
Completion date
2025-02-28
Last updated
2026-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Child Development

Keywords

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

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.

Interventions

BEHAVIORALRINEW 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.

Sponsors

University of California, Berkeley
Lead SponsorOTHER
Stanford University
CollaboratorOTHER
Purdue University
CollaboratorOTHER
International Centre for Diarrhoeal Disease Research, Bangladesh
CollaboratorOTHER

Study design

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

Sex/Gender
ALL
Age
6 Years to 9 Years
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Wechsler Intelligence Scale for Children: 5th Edition (WISC-V)6 years after intervention completionThe 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 Development6 years after intervention completionMaternal-report questionnaire designed to measure psychological adjustment in children and aims to detect any emotional or behavioural problems.
Self-regulation6 years after intervention completionObservation of children's self-regulation during the administration of the WISC-V assessment.
Academic Achievement6 years after intervention completionDirect assessments of children's reading and math performance

Secondary

MeasureTime frameDescription
Caregiver Mental Health6 years after intervention completionCenter for Epidemiologic Studies Depression Scale (20 questions). Higher scores represent more depressive symptoms experienced.
Home Environment6 years after intervention completionThe 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 Level6 years after intervention completionParental report of child's current (or previous if no longer in school) grade level.
Presence of Improved Latrine6 years after intervention completionObservation
Presence of Handwashing Station with Soap and Water6 years after intervention completionObservation
Knowledge of lead6 years after intervention completionParticipant response to question "do you know what lead is?"
Bone Lead Levels6 years after intervention completionX-ray fluorescence analysis of micrograms of lead per gram bone material

Countries

Bangladesh

Contacts

PRINCIPAL_INVESTIGATORLia Fernald, PhD

University of California, Berkeley

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 5, 2026