Clinical Trials Logo

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
See also
  Status Clinical Trial Phase
Completed NCT06315036 - Effects of Developmental Gymnastics on Preschoolers' Motor Skills N/A
Active, not recruiting NCT05143294 - Conectar Jugando: Board Games in Elementary Classrooms (6-12 Years Old) to Improve Executive Functions N/A
Completed NCT05267730 - Conectar Jugando: Board Games in Rural Elementary Classrooms (6-12 Years Old) to Improve Executive Functions N/A
Completed NCT03680157 - Comparing Rater Reliability of Familiar Practitioners to Blinded Coders
Completed NCT00362076 - The Role of Motion in Infants' Ability to Categorize N/A
Recruiting NCT05525962 - Vulnerability/Resilience Factors Influencing the Developmental Trajectories and Adaptive Methods of Children and Adolescents in Child Welfare System.
Completed NCT03232606 - Physical Activity of Asthmatic Children
Completed NCT05955755 - The Effect of Butterfly Vacuum Blood Collection Set and Standard Vacutanier Needle on the Level of Pain and Fear N/A
Recruiting NCT04443855 - WASH Benefits Child Development Follow up N/A
Not yet recruiting NCT06335524 - Infant-Maternal Partnership and Cognitive Training Study for Preterm Infants N/A
Not yet recruiting NCT05783141 - Prebiotic Effects in Healthy Toddlers N/A
Completed NCT02451059 - Reducing Socioeconomic Disparities in Health at Pediatric Visits N/A
Completed NCT02539251 - Arabic Ages and Stages Questionnaire-III
Completed NCT02800616 - The Healthy Elementary School of the Future N/A
Completed NCT02242539 - Tools to Improve Parental Recognition of Developmental Deficits in Children N/A
Completed NCT03010306 - CASITA Intervention for Children at Risk of Delay in Carabayllo, Peru N/A
Completed NCT01683565 - Preemie Tots: A Pilot Study to Understand the Effects of Prematurity in Toddlerhood Phase 4
Completed NCT00989859 - Photo-Plethysmographic Camera to Monitor Heart Rate, Respiration Rate and Oxygen Saturation in Infants
Recruiting NCT00980733 - Efficacy of Micronutrient Fortified Yoghurt in School Children for Health Benefits Phase 3
Terminated NCT04347707 - Building Regulation in Dual Generations N/A