Child DevelopmentNCT06802250
RINEW Randomized Controlled Trial 7-year Follow-up
A study testing RINEW intervention in people with Child Development, run by University of California, Berkeley at 1 site in Bangladesh.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 9 years
- Conditions the study is for
- Child Development
- What is being tested?
- RINEW intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 620 participants
- Where
- 1 siteBangladesh
- Study dates
- 20 Nov 2024to 28 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 9 years
- All sexes
- No healthy volunteers
- Child
Inclusion Criteria: Child's primary caregiver was enrolled in the RINEW cluster randomized trial
Trial locations and contacts
1 site in 1 country.
Bangladesh1 site
International Centre for Diarrhoeal Disease Research, Bangladesh
Dhaka, 1212
About this study
Official title: 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.
- Conditions
- Child Development
- Being tested
- RINEW intervention
- Keywords
- Child development, Water, Sanitation, and Hygiene, Nutrition, Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RINEW interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control arm | No intervention | No intervention administered |
| Group only arm | Experimental | Participants were encouraged to attend fortnightly courtyard group meetings Receives: 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. Receives: Behavioral: RINEW intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 years after intervention completion
Self-regulation
Observation of children's self-regulation during the administration of the WISC-V assessment.
Measured: 6 years after intervention completion
Academic Achievement
Direct assessments of children's reading and math performance
Measured: 6 years after intervention completion
Secondary outcomes (7)
Caregiver Mental Health
Center for Epidemiologic Studies Depression Scale (20 questions). Higher scores represent more depressive symptoms experienced.
Measured: 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.
Measured: 6 years after intervention completion
School Grade Level
Parental report of child's current (or previous if no longer in school) grade level.
Measured: 6 years after intervention completion
Presence of Improved Latrine
Observation
Measured: 6 years after intervention completion
Presence of Handwashing Station with Soap and Water
Observation
Measured: 6 years after intervention completion
Knowledge of lead
Participant response to question "do you know what lead is?"
Measured: 6 years after intervention completion
Bone Lead Levels
X-ray fluorescence analysis of micrograms of lead per gram bone material
Measured: 6 years after intervention completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2025
- Study start20 Nov 2024
- Primary completion28 Feb 2025
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child DevelopmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 620 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Berkeley
- Sponsor type
- University, hospital or other
- Collaborators
- Stanford University, Purdue University, International Centre for Diarrhoeal Disease Research, Bangladesh
- Responsible party
- Sponsor
- Investigators
- Lia Fernald, PhD, Principal investigator, University of California, Berkeley
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06802250
- Sponsor's protocol ID
- 2024-02-17211
- Status last verified
- Feb 2025
- First submitted
- 30 Dec 2024
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified data collected for this study will be available on request within 5 years following the completion of data collection.
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Multi-component Early Child Development Intervention in Middle- Childhood: a Follow-up Study of the RINEW Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06802250
- Acronym / sponsor ID
- 2024-02-17211
- Conditions
- Child Development
- Keywords
- Child development, Water, Sanitation, and Hygiene, Nutrition, Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 620 participants (actual)
- Lead sponsor
- University of California, BerkeleyUniversity, hospital or other
- Collaborators
- Stanford University, Purdue University, International Centre for Diarrhoeal Disease Research, Bangladesh
- Study start
- 20 Nov 2024 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 31 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control arm | No intervention | –No intervention administered |
| Group only arm | Experimental | Behavioral: RINEW interventionParticipants were encouraged to attend fortnightly courtyard group meetings |
| Combined delivery arm | Experimental | Behavioral: RINEW interventionParticipants 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. |
Who may qualify
- Ages
- 6 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RINEW interventionThe 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. | Behavioural | Combined delivery arm, Group only arm |
Primary outcome
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.
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.
Self-regulation
Time frame: 6 years after intervention completion
Observation of children's self-regulation during the administration of the WISC-V assessment.
Academic Achievement
Time frame: 6 years after intervention completion
Direct assessments of children's reading and math performance
7 secondary outcomes
Caregiver Mental Health
Time frame: 6 years after intervention completion
Home Environment
Time frame: 6 years after intervention completion
School Grade Level
Time frame: 6 years after intervention completion
Presence of Improved Latrine
Time frame: 6 years after intervention completion
Presence of Handwashing Station with Soap and Water
Time frame: 6 years after intervention completion
Knowledge of lead
Time frame: 6 years after intervention completion
Bone Lead Levels
Time frame: 6 years after intervention completion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Individual participant dataSharing planned: Yes. The de-identified data collected for this study will be available on request within 5 years following the completion of data collection.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lia Fernald, PhD principal investigator
University of California, Berkeley
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RINEW intervention in people with Child Development, run by University of California, Berkeley at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wechsler Intelligence Scale for Children: 5th Edition (WISC-V) (time frame: 6 years after intervention completion). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.