Impact of Graduation on Child Development in Uganda - Wave 2 (Ancillary/Extension)

Innovations for Poverty Action

Status: Active, not recruiting

Conditions: Anemia; School Readiness; Child Development; Under Nutrition

Treatments: Other: Graduation

Study type: Interventional

Funder types: Other

Identifiers

NCT07212374

AEARCTR-0004080 (Registry Identifier)

NCT05531812 (IPA-2022-UG) (Registry Identifier)

IPA-2025-UG-Wave2

Details and patient eligibility

About

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.

Full 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].

Enrollment: 2,100 estimated patients

Sex: All

Ages: 6 to 119 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• Caregiver declines consent or child declines assent.
• Not resident in the study communities at time of assessment.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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2,100 participants in 2 patient groups

Pure ("Spillover") Control (C2)

No Intervention group

Description:

Children aged 0-9 years living in host-community households in pure control communities (no Graduation program) from the parent RCT

Graduation (T1)

Experimental group

Description:

Children aged 0-9 years living in host-community households assigned to receive the Graduation program in the parent RCT (no new assignment in Wave 2).

Treatment:

Other: Graduation