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NCT Number: NCT07212374

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Child Development Anemia Hematologic Diseases Hemic and Lymphatic Diseases School Readiness Under Nutrition

Age range

6 month–119 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Innovations for Poverty Action Uganda

Kampala, Uganda

About this study

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].

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Graduation

Other

"Graduation" is a multifaceted approach that aims to support ultra-poor households in permanently escaping poverty traps. The standard version of Graduation tested in this study includes: a one-time asset transfer; monthly cash transfers; life skills coaching on topics like health and nutrition; technical skills training on topics like financial literacy; and access to savings services.

Primary outcomes

  1. Height-for-age z-score (HAZ)

    Time frame: 6 years after the introduction of Graduation

    Based on WHO Growth Standards

  2. Anemia

    Time frame: 6 years after the introduction of Graduation

    Hemoglobin levels captured using HemoCue devices and categorized according to anemia status (<11.5 g/dL)

  3. Forward Digit Span score

    Time frame: 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.

  4. Head-Toes-Knees-Shoulders-Revised (HTKS-R) score

    Time frame: 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.

  5. Raven's Progressive Matrices Second Edition score

    Time frame: 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.

  6. IDELA total score

    Time frame: 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.

  7. Caregiver-Reported Early Development Index (CREDI) overall z-score

    Time frame: 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 outcomes

  1. Diet diversity

    Time frame: 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

  2. Caregiver-child interactions

    Time frame: 6 years after the introduction of Graduation

    Number of different types of interactions between caregiver and child in previous 3 days

Other outcomes

  1. Stunting status

    Time frame: 6 years after the introduction of Graduation

    Height-for-age z-score (HAZ) < -2 based on WHO Growth Standards

  2. Weight-for-height z-score (WHZ)

    Time frame: 6 years after the introduction of Graduation

    Based on WHO Growth Standards

  3. Hemoglobin level

    Time frame: 6 years after the introduction of Graduation

    Hemoglobin levels captured using HemoCue devices

  4. IDELA domain scores

    Time frame: 6 years after the introduction of Graduation

    International Development and Early Learning Assessment (IDELA) scores in the domains of literacy, numeracy, motor, and socio-emotional.

Sponsors and collaborators

Lead sponsor

Innovations for Poverty Action

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Oct 8, 2025
Registry last updated
Oct 8, 2025

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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