NCT05531812

Brief Summary

This study is an intervention trial that aims to estimate the impact of the Graduating to Resilience (G2R) program on child development in Uganda. In previous trials, the G2R program has generated large, positive impacts on household assets, consumption, income and food security. The investigators will revisit a sample of households enrolled in a G2R trial conducted in Uganda in 2019-2021 (AEARCTR-0004080) and assess children born during the intervention period.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,515

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 26, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 8, 2022

Completed
6 days until next milestone

Study Start

First participant enrolled

September 14, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 18, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 18, 2022

Completed
Last Updated

October 2, 2023

Status Verified

September 1, 2023

Enrollment Period

1 month

First QC Date

August 26, 2022

Last Update Submit

September 29, 2023

Conditions

Outcome Measures

Primary Outcomes (5)

  • Bayley Scale of Infant and Toddler Development version III (BSID-III) cognitive z-score

    Raw item data will be converted to norm-referenced z-scores using the Bayley-III Scoring Assistant software.

    Assessed once approximately 43 months after launch of the intervention in February 2019

  • BSID-III language z-score

    Raw item data will be converted to norm-referenced z-scores using the Bayley-III Scoring Assistant software.

    Assessed once approximately 43 months after launch of the intervention in February 2019

  • BSID-III motor z-score

    Raw item data will be converted to norm-referenced z-scores using the Bayley-III Scoring Assistant software.

    Assessed once approximately 43 months after launch of the intervention in February 2019

  • BSID-III social-emotional z-score

    Raw item data will be converted to norm-referenced z-scores using the Bayley-III Scoring Assistant software.

    Assessed once approximately 43 months after launch of the intervention in February 2019

  • BSID-III adaptive behavior z-score

    Raw item data will be converted to norm-referenced z-scores using the Bayley-III Scoring Assistant software.

    Assessed once approximately 43 months after launch of the intervention in February 2019

Secondary Outcomes (4)

  • Caregiver Reported Early Development Instruments (CREDI) cognitive z-score

    Assessed once approximately 43 months after launch of the intervention in February 2019

  • CREDI language z-score

    Assessed once approximately 43 months after launch of the intervention in February 2019

  • CREDI motor z-score

    Assessed once approximately 43 months after launch of the intervention in February 2019

  • CREDI social-emotional z-score

    Assessed once approximately 43 months after launch of the intervention in February 2019

Study Arms (3)

G2R with individual coaching

EXPERIMENTAL
Other: G2R with individual coaching

G2R with group coaching

EXPERIMENTAL
Other: G2R with group coaching

Control

NO INTERVENTION

Interventions

1. Consumption support in the form of a monthly cash transfer for 12 months, totaling US$280-$320; 2. A one-time "asset" transfer of US$300 delivered \~7 months into the program; 3. Enrollment, training, and support to participate in a Village Savings and Loans Association (VSLA) or similar group; 4. Individual coaching at home from a trained coach using a structured curriculum focused on essential topics, including: child nutrition; infant and young child feeding (IYCF) best practices; Water, Sanitation and Hygiene (WASH) practices and practical solutions; preventative health care; positive parenting and life skills; gender; climate risk mitigation strategies; rights, linkages, and access to services.

G2R with individual coaching

1. Consumption support in the form of a monthly cash transfer for 12 months, totaling US$280-$320; 2. A one-time "asset" transfer of US$300 delivered \~7 months into the program; 3. Enrollment, training, and support to participate in a Village Savings and Loans Association (VSLA) or similar group; 4. Group coaching in a community setting from a trained coach using a structured curriculum focused on essential topics, including: child nutrition; infant and young child feeding (IYCF) best practices; WASH practices and practical solutions; preventative health care; positive parenting and life skills; gender; climate risk mitigation strategies; rights, linkages, and access to services.

G2R with group coaching

Eligibility Criteria

Age27 Months - 42 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Child born between April 2019 and June 2020
  • Household enrolled in G2R intervention trial

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Innovations for Poverty Action Uganda

Kampala, Uganda

Location

Related Publications (1)

  • Waldman M, McCoy DC, Seiden J, Cuartas J, CREDI Field Team, Fink G. Validation of motor, cognitive, language, and socio-emotional subscales using the caregiver reported early development instruments: an application of multidimensional item factor analysis. International Journal of Behavioral Development 2021;45(4):368-77

    BACKGROUND

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 INVESTIGATOR
PI Title
Senior Research Scientist, Director Path-to-Scale Research

Study Record Dates

First Submitted

August 26, 2022

First Posted

September 8, 2022

Study Start

September 14, 2022

Primary Completion

October 18, 2022

Study Completion

October 18, 2022

Last Updated

October 2, 2023

Record last verified: 2023-09

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