- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05531812
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
Status
Completed
Conditions
Intervention / Treatment
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
|
|
|
Experimental: G2R with group coaching
|
|
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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