NCT07212374

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,100

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 20, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 1, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 8, 2025

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

October 8, 2025

Status Verified

September 1, 2025

Enrollment Period

2 months

First QC Date

October 1, 2025

Last Update Submit

October 1, 2025

Conditions

Keywords

Ugandaultra-poor graduationexecutive functionIDELARaven's Progressive MatriceshemoglobinHAZWHZ

Outcome Measures

Primary Outcomes (7)

  • Height-for-age z-score (HAZ)

    Based on WHO Growth Standards

    6 years after the introduction of Graduation

  • Anemia

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

    6 years after the introduction of Graduation

  • Forward Digit Span score

    Children are asked to repeated a sequence of numbers. Children who are successful are presented with progressively longer sequences.

    6 years after the introduction of Graduation

  • Head-Toes-Knees-Shoulders-Revised (HTKS-R) score

    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.

    6 years after the introduction of Graduation

  • Raven's Progressive Matrices Second Edition score

    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 years after the introduction of Graduation

  • IDELA total score

    International Development and Early Learning Assessment (IDELA) total score. Direct assessment of children with items across four domains: literacy, numeracy, motor, and socio-emotional.

    6 years after the introduction of Graduation

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

    Caregivers report on their child's abilities in the domains of cognitive, language, motor, and social-emotional skills.

    6 years after the introduction of Graduation

Secondary Outcomes (2)

  • Diet diversity

    6 years after the introduction of Graduation

  • Caregiver-child interactions

    6 years after the introduction of Graduation

Other Outcomes (4)

  • Stunting status

    6 years after the introduction of Graduation

  • Weight-for-height z-score (WHZ)

    6 years after the introduction of Graduation

  • Hemoglobin level

    6 years after the introduction of Graduation

  • +1 more other outcomes

Study Arms (2)

Pure ("Spillover") Control (C2)

NO INTERVENTION

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

Graduation (T1)

EXPERIMENTAL

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).

Other: Graduation

Interventions

"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.

Graduation (T1)

Eligibility Criteria

Age6 Months - 119 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Innovations for Poverty Action Uganda

Kampala, Uganda

Location

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Lasse Brune, PhD

    Northwestern University

    PRINCIPAL INVESTIGATOR
  • Nathanael Goldberg, MPA

    Innovations for Poverty Action

    PRINCIPAL INVESTIGATOR
  • Dean Karlan, PhD

    Northwestern University

    PRINCIPAL INVESTIGATOR
  • Christopher Udry, PhD

    Northwestern University

    PRINCIPAL INVESTIGATOR
  • Peter Rockers, ScD

    Boston University

    PRINCIPAL INVESTIGATOR
  • Doug Parkerson, MA

    Innovations for Poverty Action

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 1, 2025

First Posted

October 8, 2025

Study Start

August 20, 2025

Primary Completion

November 1, 2025

Study Completion

November 1, 2025

Last Updated

October 8, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share

Study data will be published in a public repository

Shared Documents
STUDY PROTOCOL
Time Frame
Study data will be published concurrent with the publication of the manuscript describing the study results.
Access Criteria
All interested researchers will be able to access and download study data without restrictions.

Locations