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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1515

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Uganda
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 year to 3 months (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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control
Experimental: G2R with individual coaching
Other: G2R with individual coaching
  1. Consumption support in the form of a monthly cash transfer for 12 months, totaling US$280-$320;
  2. A one-time "asset" transfer of US$300 delivered ~7 months into the program;
  3. Enrollment, training, and support to participate in a Village Savings and Loans Association (VSLA) or similar group;
  4. 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.
Experimental: G2R with group coaching
Other: G2R with group coaching
  1. Consumption support in the form of a monthly cash transfer for 12 months, totaling US$280-$320;
  2. A one-time "asset" transfer of US$300 delivered ~7 months into the program;
  3. Enrollment, training, and support to participate in a Village Savings and Loans Association (VSLA) or similar group;
  4. 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Doug Parkerson

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
United States Agency for International Development (USAID)
AVSI Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 14, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 18, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 18, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 26, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 2, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 8, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 2, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 29, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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