Child DevelopmentNCT07212374
Impact of Graduation on Child Development in Uganda - Wave 2 (Ancillary/Extension)
A study testing Graduation in people with Child Development and Under Nutrition, run by Innovations for Poverty Action at 1 site in Uganda.
Trial summary
This ancillary/extension study ("Wave 2") measures child development and school readiness outcomes among children residing in households within host communities that participated in the Graduation to Resilience (G2R) randomized controlled trial in Uganda (G2R trial: AEARCTR-0004080 [AEA RCT Registry]; Wave 1 child… Read more about this study
- Who is it for?
- Ages 6 to 119 monthsHealthy volunteers can take part
- Conditions the study is for
- Child Development, Under Nutrition, School Readiness
- What is being tested?
- Graduation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,100 participants
- Where
- 1 siteUganda
- Study dates
- 20 Aug 2025to Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 6 to 119 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Child aged 0-9 years at time of Wave 2 assessment.
- Resides in a host-community household within the G2R trial sample
- Caregiver provides informed consent; child provides assent where applicable.
Who cannot join
- Caregiver declines consent or child declines assent.
- Not resident in the study communities at time of assessment.
Trial locations and contacts
1 site in 1 country.
About this study
This ancillary/extension study ("Wave 2") measures child development and school readiness outcomes among children residing in households within host communities that participated in the Graduation to Resilience (G2R) randomized controlled trial in Uganda (G2R trial: AEARCTR-0004080 [AEA RCT Registry]; Wave 1 child assessments: NCT05531812). No new randomization or intervention assignment occurs in Wave 2; rather, we assess outcomes in children linked to households in communities previously randomized in the parent study.
Wave 2 expands the eligible child age range (0-9 years) and includes age-appropriate outcomes (e.g., IDELA for school readiness; Raven's Progressive Matrices and executive function tasks for older children). We will compare children in households assigned to receive the Graduation program in the parent RCT (T1) to children in pure ("spillover") control households (C2) in host communities. Primary completion is anticipated in October 2025. Pre-analysis plans for Wave 1 and Wave 2 are posted.
Read the detailed description
Parent RCT \& groups: The G2R trial used staged randomization at the community level. In Wave 2 we sample host-community households only, comparing:
T1 (Graduation): households in host communities assigned to receive the Graduation program in the parent trial;
C2 (pure "spillover" control): households in host control communities.
Wave 2 purpose: To measure child development and school readiness outcomes in an expanded age range (0-9 years) using validated, age-appropriate instruments.
Design note: Wave 2 is observational with exposure defined by prior random assignment in the parent RCT; there is no new assignment of interventions in Wave 2.
Documents: The Pre-Analysis Plan (PAP) for this Wave 2 is available under Study Documents and cross-references the PAP from Wave 1 (NCT05531812).
Linkage to parent study: This record is explicitly linked to NCT05531812 and AEARCTR-0004080 [AEA RCT Registry].
- Conditions
- Child Development, Under Nutrition, School Readiness, Anemia
- Being tested
- Graduation
- Keywords
- Uganda, ultra-poor graduation, executive function, IDELA, Raven's Progressive Matrices, hemoglobin, HAZ, WHZ
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GraduationOther
"Graduation" is a multifaceted approach that aims to support ultra-poor households in permanently escaping poverty traps. The standard version of Graduation tested in this study includes: a one-time asset transfer; monthly cash transfers; life skills coaching on topics like health and nutrition; technical skills training on topics like financial literacy; and access to savings services.
| Study group | Role | What they receive |
|---|---|---|
| Pure ("Spillover") Control (C2) | No intervention | Children aged 0-9 years living in host-community households in pure control communities (no Graduation program) from the parent RCT |
| Graduation (T1) | Experimental | Children aged 0-9 years living in host-community households assigned to receive the Graduation program in the parent RCT (no new assignment in Wave 2). Receives: Other: Graduation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Height-for-age z-score (HAZ)
Based on WHO Growth Standards
Measured: 6 years after the introduction of Graduation
Anemia
Hemoglobin levels captured using HemoCue devices and categorized according to anemia status (<11.5 g/dL)
Measured: 6 years after the introduction of Graduation
Forward Digit Span score
Children are asked to repeated a sequence of numbers. Children who are successful are presented with progressively longer sequences.
Measured: 6 years after the introduction of Graduation
Head-Toes-Knees-Shoulders-Revised (HTKS-R) score
A self-regulation game which taps children's cognitive flexibility, memory, and self-control. Children are presented with instructions and must remember the rules of a game, which require them to: inhibit the more natural response to instructions in favor of the correct, unnatural one; flexibly shift between old and new rules to commands when given, and; regulate their behavior in accordance with all of the above.
Measured: 6 years after the introduction of Graduation
Raven's Progressive Matrices Second Edition score
A direct assessment of fluid intelligence. Children are presented with 36 items and for each item they are asked to identify the missing piece from a set of options that finishes the matrix/picture that is presented.
Measured: 6 years after the introduction of Graduation
IDELA total score
International Development and Early Learning Assessment (IDELA) total score. Direct assessment of children with items across four domains: literacy, numeracy, motor, and socio-emotional.
Measured: 6 years after the introduction of Graduation
Caregiver-Reported Early Development Index (CREDI) overall z-score
Caregivers report on their child's abilities in the domains of cognitive, language, motor, and social-emotional skills.
Measured: 6 years after the introduction of Graduation
Secondary outcomes (2)
Diet diversity
Number of food groups consumed by the child in the previous 24 hours as reported by the caregiver
Measured: 6 years after the introduction of Graduation
Caregiver-child interactions
Number of different types of interactions between caregiver and child in previous 3 days
Measured: 6 years after the introduction of Graduation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2025
- Study start20 Aug 2025
- Primary completionNov 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 2,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Innovations for Poverty Action
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lasse Brune, PhD, Principal investigator, Northwestern UniversityNathanael Goldberg, MPA, Principal investigator, Innovations for Poverty ActionDean Karlan, PhD, Principal investigator, Northwestern UniversityChristopher Udry, PhD, Principal investigator, Northwestern UniversityPeter Rockers, ScD, Principal investigator, Boston UniversityDoug Parkerson, MA, Principal investigator, Innovations for Poverty Action
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07212374
- Sponsor's protocol ID
- IPA-2025-UG-Wave2
- Other IDs
- NCT05531812 (IPA-2022-UG), AEARCTR-0004080
- Status last verified
- Sep 2025
- First submitted
- 1 Oct 2025
- Last updated
- 8 Oct 2025
- 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
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Graduation on Child Development in Uganda - Wave 2 (Ancillary/Extension)
- ClinicalTrials.gov ID
- NCT07212374
- Acronym / sponsor ID
- IPA-2025-UG-Wave2
- Conditions
- Child Development, Under Nutrition, School Readiness, Anemia
- Keywords
- Uganda, ultra-poor graduation, executive function, IDELA, Raven's Progressive Matrices, hemoglobin, HAZ, WHZ
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,100 participants (estimated)
- Lead sponsor
- Innovations for Poverty ActionUniversity, hospital or other
- Study start
- 20 Aug 2025 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 8 Oct 2025 (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.
This ancillary/extension study ("Wave 2") measures child development and school readiness outcomes among children residing in households within host communities that participated in the Graduation to Resilience (G2R) randomized controlled trial in Uganda (G2R trial: AEARCTR-0004080 [AEA RCT Registry]; Wave 1 child assessments: NCT05531812). No new randomization or intervention assignment occurs in Wave 2; rather, we assess outcomes in children linked to households in communities previously randomized in the parent study.
Wave 2 expands the eligible child age range (0-9 years) and includes age-appropriate outcomes (e.g., IDELA for school readiness; Raven's Progressive Matrices and executive function tasks for older children). We will compare children in households assigned to receive the Graduation program in the parent RCT (T1) to children in pure ("spillover") control households (C2) in host communities. Primary completion is anticipated in October 2025. Pre-analysis plans for Wave 1 and Wave 2 are posted.
Detailed description
Parent RCT \& groups: The G2R trial used staged randomization at the community level. In Wave 2 we sample host-community households only, comparing:
T1 (Graduation): households in host communities assigned to receive the Graduation program in the parent trial;
C2 (pure "spillover" control): households in host control communities.
Wave 2 purpose: To measure child development and school readiness outcomes in an expanded age range (0-9 years) using validated, age-appropriate instruments.
Design note: Wave 2 is observational with exposure defined by prior random assignment in the parent RCT; there is no new assignment of interventions in Wave 2.
Documents: The Pre-Analysis Plan (PAP) for this Wave 2 is available under Study Documents and cross-references the PAP from Wave 1 (NCT05531812).
Linkage to parent study: This record is explicitly linked to NCT05531812 and AEARCTR-0004080 [AEA RCT Registry].
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pure ("Spillover") Control (C2) | No intervention | –Children aged 0-9 years living in host-community households in pure control communities (no Graduation program) from the parent RCT |
| Graduation (T1) | Experimental | Other: GraduationChildren aged 0-9 years living in host-community households assigned to receive the Graduation program in the parent RCT (no new assignment in Wave 2). |
Who may qualify
- Ages
- 6 to 119 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Child aged 0-9 years at time of Wave 2 assessment.
- Resides in a host-community household within the G2R trial sample
- Caregiver provides informed consent; child provides assent where applicable.
Key exclusion criteria (2 listed)
- Caregiver declines consent or child declines assent.
- Not resident in the study communities at time of assessment.
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 |
|---|---|---|
| Graduation"Graduation" is a multifaceted approach that aims to support ultra-poor households in permanently escaping poverty traps. The standard version of Graduation tested in this study includes: a one-time asset transfer; monthly cash transfers; life skills coaching on topics like health and nutrition; technical skills training on topics like financial literacy; and access to savings services. | Other | Graduation (T1) |
Primary outcome
Height-for-age z-score (HAZ)
Time frame: 6 years after the introduction of Graduation
Based on WHO Growth Standards
Anemia
Time frame: 6 years after the introduction of Graduation
Hemoglobin levels captured using HemoCue devices and categorized according to anemia status (<11.5 g/dL)
Forward Digit Span score
Time frame: 6 years after the introduction of Graduation
Children are asked to repeated a sequence of numbers. Children who are successful are presented with progressively longer sequences.
Head-Toes-Knees-Shoulders-Revised (HTKS-R) score
Time frame: 6 years after the introduction of Graduation
A self-regulation game which taps children's cognitive flexibility, memory, and self-control. Children are presented with instructions and must remember the rules of a game, which require them to: inhibit the more natural response to instructions in favor of the correct, unnatural one; flexibly shift between old and new rules to commands when given, and; regulate their behavior in accordance with all of the above.
Raven's Progressive Matrices Second Edition score
Time frame: 6 years after the introduction of Graduation
A direct assessment of fluid intelligence. Children are presented with 36 items and for each item they are asked to identify the missing piece from a set of options that finishes the matrix/picture that is presented.
IDELA total score
Time frame: 6 years after the introduction of Graduation
International Development and Early Learning Assessment (IDELA) total score. Direct assessment of children with items across four domains: literacy, numeracy, motor, and socio-emotional.
Caregiver-Reported Early Development Index (CREDI) overall z-score
Time frame: 6 years after the introduction of Graduation
Caregivers report on their child's abilities in the domains of cognitive, language, motor, and social-emotional skills.
2 secondary outcomes
Diet diversity
Time frame: 6 years after the introduction of Graduation
Caregiver-child interactions
Time frame: 6 years after the introduction of Graduation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2025.
- Individual participant dataSharing planned: Yes. Study data will be published in a public repository
Related trials for Child Development
RecruitingPhase 1
Cannabidiol (CBD) in Adults With ASD
Autism Spectrum Disorder
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Sensory-integration Therapy Verses Augumented Reality-based Training in ASD
Autism Spectrum Disorder
Not yet recruiting
Hearing Intervention Effects on Brain and Language Development in Children With Bilateral Mild Hearing Loss
Hearing Loss, Bilateral
Recruiting
Cumulative and Booster Effects of Multisession Prefrontal tDCS in ASD Adolescents
Transcranial Direct Current Stimulation, Autistic Spectrum Disorder
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 Graduation in people with Child Development and Under Nutrition, run by Innovations for Poverty Action 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 3 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 8 Oct 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Height-for-age z-score (HAZ) (time frame: 6 years after the introduction of Graduation). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Oct 2025.