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Bahir Dar Child Development Study, Ethiopia

NCT06648863 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 471

Last updated 2026-03-11

No results posted yet for this study

Summary

The goal of this observational study is to learn about typical neurodevelopment in children aged 6 months to 5 years who live in Bahir Dar, Ethiopia. The main aims of the study are:

Aim 1: To characterize typical neurodevelopment as measured by i) brain volume using low-field MRI and ii) scores on behavioral assessments of early child neurodevelopment.

Aim 2: To characterize typical pre-academic school skills in early childhood as measured by tasks of visual processing, reasoning, verbal expression and school readiness.

Aim 3: To identify factors influencing child development in a community in Bahir Dar, Amhara region of Ethiopia, as measured by validated measures of maternal mental health, home environment, and childhood adversity.

Participants will complete one low-field MRI scan at enrollment, have a hemoglobin blood test, and undergo age-appropriate neurodevelopmental assessments and surveys that may include:

* WHO Global Scales for Early Development (GSED) \[ages 6 - 36 months\]
* Tasks of visual reasoning and verbal expression \[ages 48-60 months\]
* Executive Functions test using the tablet-based NIH Toolbox \[ages 48-60 months\]
* School Readiness questionnaire assessing knowledge of literacy, numeracy, early reading, crystallized knowledge, memory, and self-regulation \[ages 48-60 months\]
* Maternal report of child's motor, cognitive and socioemotional skillsChild Anthropometrics assessment

Additional assessments of the participant's family and environment will include

* Medical History questionnaire
* Family socioeconomic status
* Maternal Mental Health
* Recent Life Events and hardship
* Home Environment and Parenting UNICEF's MICs Family Care Indicators)
* Food security and feeding practices

Conditions

  • Development, Child
  • Behavior, Social

Sponsors & Collaborators

  • Addis Continental Institute of Public Health

    collaborator OTHER

  • New York University

    collaborator OTHER

  • Boston Children's Hospital, Boston, MA, USA

    collaborator OTHER

  • Brigham and Women's Hospital

    lead OTHER

Principal Investigators

  • Anne C Lee, MD, MPH · Brigham and Women's Hospital

  • Yemane Berhane, MD, PhD · Addis Continental Institute of Public Health

Eligibility

Min Age
6 Months
Max Age
60 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-04-29
Primary Completion
2024-11-11
Completion
2024-12-01

Countries

  • Ethiopia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06648863 on ClinicalTrials.gov