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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05531812
Other study ID # IPA-2022-UG
Secondary ID 14649-ECD
Status Completed
Phase N/A
First received
Last updated
Start date September 14, 2022
Est. completion date October 18, 2022

Study information

Verified date September 2023
Source Innovations for Poverty Action
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 1515
Est. completion date October 18, 2022
Est. primary completion date October 18, 2022
Accepts healthy volunteers No
Gender All
Age group 27 Months to 42 Months
Eligibility Inclusion Criteria: - Child born between April 2019 and June 2020 - Household enrolled in G2R intervention trial Exclusion Criteria: - None

Study Design


Related Conditions & MeSH terms


Intervention

Other:
G2R with individual coaching
Consumption support in the form of a monthly cash transfer for 12 months, totaling US$280-$320; A one-time "asset" transfer of US$300 delivered ~7 months into the program; Enrollment, training, and support to participate in a Village Savings and Loans Association (VSLA) or similar group; 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 group coaching
Consumption support in the form of a monthly cash transfer for 12 months, totaling US$280-$320; A one-time "asset" transfer of US$300 delivered ~7 months into the program; Enrollment, training, and support to participate in a Village Savings and Loans Association (VSLA) or similar group; 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.

Locations

Country Name City State
Uganda Innovations for Poverty Action Uganda Kampala

Sponsors (3)

Lead Sponsor Collaborator
Doug Parkerson AVSI Foundation, United States Agency for International Development (USAID)

Country where clinical trial is conducted

Uganda, 

References & 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

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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 Caregiver Reported Early Development Instruments (CREDI) cognitive z-score 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
Secondary CREDI language z-score 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
Secondary CREDI motor z-score 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
Secondary CREDI social-emotional z-score 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
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