Impact of Graduating to Resilience on Child Development in Uganda

Child Development Clinical Trial

Official title:

Impact of Graduating to Resilience on Child Development in Uganda

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
• 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
• 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

Related Conditions & MeSH terms

• Child Development

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