Child DevelopmentNCT05531812

Impact of Graduating to Resilience on Child Development in Uganda

A study testing G2R with individual coaching and G2R with group coaching in people with Child Development, run by Doug Parkerson at 1 site in Uganda.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 27 to 42 months
Conditions the study is for: Child Development
What is being tested?: G2R with individual coaching and G2R with group coaching
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,515 participants
Where: 1 siteUganda
Study dates: 14 Sep 2022to 18 Oct 2022
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 27 to 42 months
All sexes
No healthy volunteers
Child

Who may be able to join

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

Who cannot join

None

Trial locations and contacts

1 site in 1 country.

Uganda1 site

Innovations for Poverty Action Uganda
Kampala

Other trials in Uganda

About this study

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.

Conditions: Child Development
Being tested: G2R with individual coaching, G2R with group coaching

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

G2R with individual coachingOther
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.
G2R with group coachingOther
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.

Study groups in NCT05531812
Study group	Role	What they receive
G2R with individual coaching	Experimental	Not described Receives: Other: G2R with individual coaching
G2R with group coaching	Experimental	Not described Receives: Other: G2R with group coaching
Control	No intervention	Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Assessed once approximately 43 months after launch of the intervention in February 2019
BSID-III language z-score
Raw item data will be converted to norm-referenced z-scores using the Bayley-III Scoring Assistant software.
Measured: Assessed once approximately 43 months after launch of the intervention in February 2019
BSID-III motor z-score
Raw item data will be converted to norm-referenced z-scores using the Bayley-III Scoring Assistant software.
Measured: Assessed once approximately 43 months after launch of the intervention in February 2019
BSID-III social-emotional z-score
Raw item data will be converted to norm-referenced z-scores using the Bayley-III Scoring Assistant software.
Measured: Assessed once approximately 43 months after launch of the intervention in February 2019
BSID-III adaptive behavior z-score
Raw item data will be converted to norm-referenced z-scores using the Bayley-III Scoring Assistant software.
Measured: Assessed once approximately 43 months after launch of the intervention in February 2019

Secondary outcomes (4)

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).
Measured: Assessed once approximately 43 months after launch of the intervention in February 2019
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).
Measured: Assessed once approximately 43 months after launch of the intervention in February 2019
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).
Measured: Assessed once approximately 43 months after launch of the intervention in February 2019
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).
Measured: Assessed once approximately 43 months after launch of the intervention in February 2019

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Sep 202218 Oct 2022

First posted8 Sep 2022
Study start14 Sep 2022
Primary completion18 Oct 2022
Study completion18 Oct 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Child DevelopmentStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 1,515 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05531812
Sponsor's protocol ID: IPA-2022-UG
Other IDs: 14649-ECD
Status last verified: Sep 2023
First submitted: 26 Aug 2022
Last updated: 2 Oct 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Study data will be published in a public repository

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Child Development trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Impact of Graduating to Resilience on Child Development in Uganda
ClinicalTrials.gov ID: NCT05531812
Acronym / sponsor ID: IPA-2022-UG
Conditions: Child Development
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,515 participants (actual)
Lead sponsor: Doug ParkersonUniversity, hospital or other
Collaborators: United States Agency for International Development (USAID), AVSI Foundation
Study start: 14 Sep 2022 (actual)
Primary completion: 18 Oct 2022 (actual)
Study completion: 18 Oct 2022 (actual)
First posted: 8 Sep 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3

Arm	Type	Receives
G2R with individual coaching	Experimental	Other: G2R with individual coaching
G2R with group coaching	Experimental	Other: G2R with group coaching
Control	No intervention	–

Who may qualify

Ages: 27 to 42 months
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (2 listed)

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

Key exclusion criteria (1 listed)

None

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
G2R with individual coaching1. 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.	Other	G2R with individual coaching
G2R with group coaching1. 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.	Other	G2R with group coaching

Primary outcome

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.
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.
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.
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.
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.

4 secondary outcomes

Caregiver Reported Early Development Instruments (CREDI) cognitive z-score
Time frame: 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
CREDI motor z-score
Time frame: 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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2023.
BackgroundWaldman 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
Individual participant dataSharing planned: Yes. Study data will be published in a public repository

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Lasse Brune, PhD principal investigator

Northwestern University

Nathanael Goldberg, MPA principal investigator

Innovations for Poverty Action

Dean Karlan, PhD principal investigator

Northwestern University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing G2R with individual coaching and G2R with group coaching in people with Child Development, run by Doug Parkerson at 1 site in Uganda.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05531812, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2023.