Impact of Graduating to Resilience on Child Development in Uganda

September 29, 2023 updated by: Doug Parkerson
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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

1515

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Kampala, Uganda
        • Innovations for Poverty Action Uganda

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 1 week (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Experimental: 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. 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.
Experimental: G2R with group 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bayley Scale of Infant and Toddler Development version III (BSID-III) cognitive z-score
Time Frame: Assessed once approximately 43 months after launch of the intervention in February 2019
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
Time Frame: Assessed once approximately 43 months after launch of the intervention in February 2019
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
Time Frame: Assessed once approximately 43 months after launch of the intervention in February 2019
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
Time Frame: Assessed once approximately 43 months after launch of the intervention in February 2019
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
Time Frame: Assessed once approximately 43 months after launch of the intervention in February 2019
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Caregiver Reported Early Development Instruments (CREDI) cognitive z-score
Time Frame: Assessed once approximately 43 months after launch of the intervention in February 2019
The CREDI long-form will be administered. Raw item data will be converted to norm-referenced z-scores using the CREDI scoring procedure (Waldman et al. 2021).
Assessed once approximately 43 months after launch of the intervention in February 2019
CREDI language z-score
Time Frame: Assessed once approximately 43 months after launch of the intervention in February 2019
The CREDI long-form will be administered. Raw item data will be converted to norm-referenced z-scores using the CREDI scoring procedure (Waldman et al. 2021).
Assessed once approximately 43 months after launch of the intervention in February 2019
CREDI motor z-score
Time Frame: Assessed once approximately 43 months after launch of the intervention in February 2019
The CREDI long-form will be administered. Raw item data will be converted to norm-referenced z-scores using the CREDI scoring procedure (Waldman et al. 2021).
Assessed once approximately 43 months after launch of the intervention in February 2019
CREDI social-emotional z-score
Time Frame: Assessed once approximately 43 months after launch of the intervention in February 2019
The CREDI long-form will be administered. Raw item data will be converted to norm-referenced z-scores using the CREDI scoring procedure (Waldman et al. 2021).
Assessed once approximately 43 months after launch of the intervention in February 2019

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Peter Rockers, ScD, Boston University
  • Principal Investigator: Dean Karlan, PhD, Northwestern University
  • Principal Investigator: Lasse Brune, PhD, Northwestern University
  • Principal Investigator: Nathanael Goldberg, MPA, Innovations for Poverty Action
  • Principal Investigator: Christopher Udry, PhD, Northwestern University
  • Principal Investigator: Doug Parkerson, MA, Innovations for Poverty Action

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 14, 2022

Primary Completion (Actual)

October 18, 2022

Study Completion (Actual)

October 18, 2022

Study Registration Dates

First Submitted

August 26, 2022

First Submitted That Met QC Criteria

September 2, 2022

First Posted (Actual)

September 8, 2022

Study Record Updates

Last Update Posted (Actual)

October 2, 2023

Last Update Submitted That Met QC Criteria

September 29, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • IPA-2022-UG
  • 14649-ECD (Other Identifier: Innovations for Poverty Action)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Study data will be published in a public repository

IPD Sharing Time Frame

Study data will be published concurrent with the publication of the manuscript describing the study results.

IPD Sharing Access Criteria

All interested researchers will be able to access and download study data without restrictions.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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