Clinical trial NCT05531812: Impact of Graduating to Resilience on Child Development in Uganda
Official title: Impact of Graduating to Resilience on Child Development in Uganda
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Development
Lead sponsor: Innovations for Poverty Action
Sponsor class: OTHER
Collaborators: name: United States Agency for International Development (USAID)
name: AVSI Foundation
First posted: 2022-09-08
Enrollment: 1515
Sex: ALL
Minimum age (years): 27
Maximum age (years): 42
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* None

Primary outcomes:
measure: Bayley Scale of Infant and Toddler Development version III (BSID-III) cognitive z-score
timeFrame: Assessed once approximately 43 months after launch of the intervention in February 2019
measure: BSID-III language z-score
timeFrame: Assessed once approximately 43 months after launch of the intervention in February 2019
measure: BSID-III motor z-score
timeFrame: Assessed once approximately 43 months after launch of the intervention in February 2019
measure: BSID-III social-emotional z-score
timeFrame: Assessed once approximately 43 months after launch of the intervention in February 2019
measure: BSID-III adaptive behavior z-score
timeFrame: Assessed once approximately 43 months after launch of the intervention in February 2019
Secondary outcomes:
measure: Caregiver Reported Early Development Instruments (CREDI) cognitive z-score
timeFrame: Assessed once approximately 43 months after launch of the intervention in February 2019
measure: CREDI language z-score
timeFrame: Assessed once approximately 43 months after launch of the intervention in February 2019
measure: CREDI motor z-score
timeFrame: Assessed once approximately 43 months after launch of the intervention in February 2019
measure: CREDI social-emotional z-score
timeFrame: Assessed once approximately 43 months after launch of the intervention in February 2019
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: Innovations for Poverty Action Uganda
Study officials:
affiliation: Northwestern University
name: Lasse Brune, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Innovations for Poverty Action
name: Nathanael Goldberg, MPA
role: PRINCIPAL_INVESTIGATOR
affiliation: Northwestern University
name: Dean Karlan, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Northwestern University
name: Christopher Udry, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Boston University
name: Peter Rockers, ScD
role: PRINCIPAL_INVESTIGATOR
affiliation: Innovations for Poverty Action
name: Doug Parkerson, MA
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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