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Completed

NCT Number: NCT06802250

RINEW Randomized Controlled Trial 7-year Follow-up

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.

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Key information

Conditions

Child Development

Age range

6 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

International Centre for Diarrhoeal Disease Research, Bangladesh

Dhaka, 1212, Bangladesh

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

  3. Self-regulation

    Time frame: 6 years after intervention completion

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

  4. Academic Achievement

    Time frame: 6 years after intervention completion

    Direct assessments of children's reading and math performance

Secondary outcomes

  1. Caregiver Mental Health

    Time frame: 6 years after intervention completion

    Center for Epidemiologic Studies Depression Scale (20 questions). Higher scores represent more depressive symptoms experienced.

  2. Home Environment

    Time frame: 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.

  3. School Grade Level

    Time frame: 6 years after intervention completion

    Parental report of child's current (or previous if no longer in school) grade level.

  4. Presence of Improved Latrine

    Time frame: 6 years after intervention completion

    Observation

  5. Presence of Handwashing Station with Soap and Water

    Time frame: 6 years after intervention completion

    Observation

  6. Knowledge of lead

    Time frame: 6 years after intervention completion

    Participant response to question "do you know what lead is?"

  7. Bone Lead Levels

    Time frame: 6 years after intervention completion

    X-ray fluorescence analysis of micrograms of lead per gram bone material

Other outcomes

  1. Knowledge of 7 factors related to children's intelligence

    Time frame: 6 years after intervention completion

    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.

  2. Knowledge of ways to avoid harm from lead

    Time frame: 6 years after intervention completion

    Correct response to question "What ways do you know to avoid harm from lead?"

  3. Child screen time

    Time frame: 6 years after intervention completion

    Number of hours spent using a digital screen per week (on average, caregiver report)

  4. Parental perceived intelligence

    Time frame: 6 years after intervention completion

    Parental rating of child's intelligence (1-7)

Sponsors and collaborators

Lead sponsor

University of California, Berkeley

Other

Collaborators

  • International Centre for Diarrhoeal Disease Research, Bangladesh
  • Purdue University
  • Stanford University

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 31, 2025
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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