Impact of Graduation on Child Development in Uganda - Wave 2 (Ancillary/Extension)
- Conditions
- Child DevelopmentUnder NutritionSchool ReadinessAnemia
- Registration Number
- NCT07212374
- Lead Sponsor
- Innovations for Poverty Action
- Brief Summary
This ancillary/extension study ("Wave 2") measures child development and school readiness outcomes among children residing in households within host communities that participated in the Graduation to Resilience (G2R) randomized controlled trial in Uganda (G2R trial: AEARCTR-0004080 \[AEA RCT Registry\]; Wave 1 child assessments: NCT05531812). No new randomization or intervention assignment occurs in Wave 2; rather, we assess outcomes in children linked to households in communities previously randomized in the parent study.
Wave 2 expands the eligible child age range (0-9 years) and includes age-appropriate outcomes (e.g., IDELA for school readiness; Raven's Progressive Matrices and executive function tasks for older children). We will compare children in households assigned to receive the Graduation program in the parent RCT (T1) to children in pure ("spillover") control households (C2) in host communities. Primary completion is anticipated in October 2025. Pre-analysis plans for Wave 1 and Wave 2 are posted.
- Detailed Description
Parent RCT \& groups: The G2R trial used staged randomization at the community level. In Wave 2 we sample host-community households only, comparing:
T1 (Graduation): households in host communities assigned to receive the Graduation program in the parent trial;
C2 (pure "spillover" control): households in host control communities.
Wave 2 purpose: To measure child development and school readiness outcomes in an expanded age range (0-9 years) using validated, age-appropriate instruments.
Design note: Wave 2 is observational with exposure defined by prior random assignment in the parent RCT; there is no new assignment of interventions in Wave 2.
Documents: The Pre-Analysis Plan (PAP) for this Wave 2 is available under Study Documents and cross-references the PAP from Wave 1 (NCT05531812).
Linkage to parent study: This record is explicitly linked to NCT05531812 and AEARCTR-0004080 \[AEA RCT Registry\].
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 2100
- Child aged 0-9 years at time of Wave 2 assessment.
- Resides in a host-community household within the G2R trial sample
- Caregiver provides informed consent; child provides assent where applicable.
- Caregiver declines consent or child declines assent.
- Not resident in the study communities at time of assessment.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Height-for-age z-score (HAZ) 6 years after the introduction of Graduation Based on WHO Growth Standards
Anemia 6 years after the introduction of Graduation Hemoglobin levels captured using HemoCue devices and categorized according to anemia status (\<11.5 g/dL)
Forward Digit Span score 6 years after the introduction of Graduation Children are asked to repeated a sequence of numbers. Children who are successful are presented with progressively longer sequences.
Head-Toes-Knees-Shoulders-Revised (HTKS-R) score 6 years after the introduction of Graduation A self-regulation game which taps children's cognitive flexibility, memory, and self-control. Children are presented with instructions and must remember the rules of a game, which require them to: inhibit the more natural response to instructions in favor of the correct, unnatural one; flexibly shift between old and new rules to commands when given, and; regulate their behavior in accordance with all of the above.
Raven's Progressive Matrices Second Edition score 6 years after the introduction of Graduation A direct assessment of fluid intelligence. Children are presented with 36 items and for each item they are asked to identify the missing piece from a set of options that finishes the matrix/picture that is presented.
IDELA total score 6 years after the introduction of Graduation International Development and Early Learning Assessment (IDELA) total score. Direct assessment of children with items across four domains: literacy, numeracy, motor, and socio-emotional.
Caregiver-Reported Early Development Index (CREDI) overall z-score 6 years after the introduction of Graduation Caregivers report on their child's abilities in the domains of cognitive, language, motor, and social-emotional skills.
- Secondary Outcome Measures
Name Time Method Diet diversity 6 years after the introduction of Graduation Number of food groups consumed by the child in the previous 24 hours as reported by the caregiver
Caregiver-child interactions 6 years after the introduction of Graduation Number of different types of interactions between caregiver and child in previous 3 days
Trial Locations
- Locations (1)
Innovations for Poverty Action Uganda
🇺🇬Kampala, Uganda
Innovations for Poverty Action Uganda🇺🇬Kampala, Uganda