InflammationNCT05477901
Impacts of Cash Transfers on Child Neurodevelopment (Auxilio Brasil)
A study testing Supplemental cash transfer in people with Inflammation and HPA, run by New York State Psychiatric Institute at 2 sites in 2 countries.
Trial summary
This study examines the impact of Auxilio Brasil (AB), a cash transfer program to mothers of school-age children, on resource-deprived populations in Brazil and its protective effects on child neurodevelopment and mental health. Read more about this study
- Who is it for?
- Ages 23 to 45 years
- Conditions the study is for
- Inflammation, HPA, CBCL
- What is being tested?
- Supplemental cash transfer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 28 May 2025to 31 Jan 2029
- 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 23 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 23-45 years old
- Receiving AB cash transfers
- Has at least two or more children ages 7- 10 years old at time of recruitment (up to 4 children per family)
- Able to consent
- Age 7-10 years old
- Intellectual Disability
Who cannot join
- 1. Mother and child do not reside in same household
- Child:
- Does not reside in same household as the mother
- Major Axis I disorder (e.g., Autism, Schizophrenia, Bipolar)
- Severe Disability
- MRI contradictions (index child only)
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
United States1 site, 1 recruiting
- Not yet recruiting
New York State Psychiatric Institute
New York, New York, 10032
Cristiane Duarte, PhD, (646)774-5801, Cristiane.Duarte@nyspi.columbia.edu
Brazil1 site, 1 recruiting
- Recruiting
UNIFESP
São Paulo, São Paulo, 04023
Andrea Jackowski, PhD, +55-11985855785, andrea.jackowski@gmail.com
About this study
Official title: Mental Health and Bolsa Familia: A Mechanistically Focused Clinical Trial of a Cash Transfer Intervention on Child Brain, Behavior, and Mental Health
This study examines the impact of Auxilio Brasil (AB), a cash transfer program to mothers of school-age children, on resource-deprived populations in Brazil and its protective effects on child neurodevelopment and mental health. The investigators will conduct a randomized clinical trial (RCT) among those already receiving AB in which 300 families will be randomized in a 1:1 ratio to receive either a high ($40/month) or low ($2/month) supplemental transfer for 2 years. Three hundred children (index child participants; 7-10 years old) will be enrolled across both study arms. Additionally, up to 150 siblings ("sibling participants;" 7-10 years old) will be enrolled. Eligible families who decide to participate will sign a study-specific informed consent (mother) and assent (child) form. The UNIFESP team will conduct the respective assessments at baseline, approximately 8- and 16- months, 24-months and approximately 6-months post-RCT.
Aim 1: Determine the impact of high vs low cash transfers on children's exposure to adversities (ACEs) and neurodevelopment.
Read more
Aim 2: Determine the impact of cash transfers on children's inflammatory markers and HPA activity/cortisol.
Exploratory Aim: The investigators will explore (i) whether sex/gender of the children moderates the pathways in the above mediation model; and (ii) whether cash transfer-related effects persist 6 months post-RCT.
Read the detailed description
Numerous studies link childhood poverty with altered neurodevelopment with the most robust effects often in brain substrates related to executive functions (EF). Poverty is associated with reduced grey matter thickness and surface area of the prefrontal cortex (PFC), a key structure underlying EF (4,5) Poverty is also associated with altered structure and function of the hippocampus - a region essential for memory and cognitive control (5,6). Effects of poverty on brain development are thought to give rise to the well described associations between poverty, impairments in EF, and risk for mental illness (18). The possibility of lifting children out of poverty and thereby tempering poverty's malignant neurodevelopmental effects remains largely untested, particularly with brain and behavioral measures and within LMICs where poverty is widespread. To address this gap, the investigators propose a randomized clinical trial (RCT) to be conducted in low-income families in Sao Paulo, Brazil that will examine causal effects of a cash transfer program on neurodevelopment in youth. Our study builds off an existing cash transfer program (CTP) - Auxilio Brasil (AB) - and augments the cash transfer amount to a level sufficient to lift a family out of extreme poverty and poverty. Our RCT design will allow for novel causal inferences linking cash transfers to brain/behavior outcomes, while testing mechanistic hypotheses. Because the investigators are building off AB, a well-established program with a successful, national infrastructure for transferring cash, our findings could rapidly move toward implementation. Our study will inform critical unanswered questions about pasting, and CTPs generally, that could support their broader and more targeted implementation - First, if augmenting AB removes a family from poverty, does this protect child neurodevelopment? And second, if this augmented AB program protects neurodevelopment, what are the mechanisms that explain this? Providing this mechanistic framework is a key step toward refining AB and other CTPs, facilitating for example, studies aimed at targeting populations most likely to benefit, optimizing the dose/amount of the transfers, and determining the ideal timing/duration of CTPs.
Aims and Hypotheses
Aim 1: Determine the impact of high vs low cash transfers on children's exposure to adversities (ACEs) and neurodevelopment. Eligible families will be those already enrolled in Brazil's national AB program. Relative to low cash transfers, children of mothers who received high cash transfers will have:
Hypothesis 1A (H1A) - [ACEs] fewer new onset ACEs over the 24-month course of the RCT; H1B - [Neurodevelopment] greater pre-vs-post RCT increases in prefrontal activation during an EF fMRI task (Simon task),10 increased connectivity within EF-related PFC/mesolimbic circuits (resting fMRI and diffusion MRI), and improvements in EF behaviors.
Aim 2: Determine the impact of cash transfers on children's inflammatory markers and HPA activity/cortisol.
Hypothesis 2A (H2A) - Relative to low cash transfers, children of mothers who received high cash transfers will have lower pre vs-post RCT levels of pro-inflammatory markers (e.g., CRP, Il-6, TNF-a; from blood draws) and hair cortisol (HPA activity over past 2-3 months).
Hypothesis 2B (H2B) - Inflammatory and HPA activity levels (H2A) will be lower in children with fewer new onset ACEs (i.e., new ACEs occurring during the 24-month RCT). H2C [Mediation] - The effects of high cash transfers on neurodevelopment (H1B) will be mediated by the impact of cash transfers on reducing new onset ACEs (H1A) and lower inflammation and HPA activity (H2A \& H2B), while taking into account covariates and three additional pathways (see A.9 And C.6.3).
Exploratory Aim: The investigators will explore (i) whether sex/gender of the children moderates the pathways in the above mediation model (H2C); and (ii) whether cash transfer-related effects - reducing new onset ACEs and symptoms (CBCL), and improved EF behavior - persist 6 months post-RCT.
Impact: Designed to decrease inequalities, AB is one of the largest social interventions in the world, yet its impact on child mental health is unknown. Our strategy, rather than relying on prohibitively expensive multi-site designs, proposes to generate evidence about the impact of AB on child neurodevelopmental outcomes by focusing on specific, well-supported mechanisms that may underlie mental illness risk. Our findings will have strong implications for tailoring the impact of cash transfer policies to maximize child mental health gains.
- Conditions
- Inflammation, HPA, CBCL, Family Relations
- Being tested
- Supplemental cash transfer
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supplemental cash transferOther
Supplemental cash transfer ($40/month)
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | High supplemental transfer: $40 a month Receives: Other: Supplemental cash transfer |
| Control | No intervention | Low supplemental transfer: $2 a month |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Childhood Experiences (ACEs) - FHE
Family History Epidemiologic screener is a 9-item (+subitems) checklist to asses child's ACEs, more checked items mean more ACEs.
Measured: Baseline
Changes in Adverse Childhood Experiences (ACEs) - FHE
Family History Epidemiologic screener is a 9-item (+subitems) checklist to asses child's ACEs, more checked items mean more ACEs.
Measured: 8 months
Changes in Adverse Childhood Experiences (ACEs) - FHE
Family History Epidemiologic screener is a 9-item (+subitems) checklist to asses child's ACEs, more checked items mean more ACEs.
Measured: 16 months
Changes in Adverse Childhood Experiences (ACEs) - FHE
Family History Epidemiologic screener is a 9-item (+subitems) checklist to asses child's ACEs, more checked items mean more ACEs.
Measured: 24 months
Changes in Adverse Childhood Experiences (ACEs) - FHE
Family History Epidemiologic screener is a 9-item (+subitems) checklist to asses child's ACEs, more checked items mean more ACEs.
Measured: 6 months post-RCT
Adverse Childhood Experiences (ACEs) - CTC
Brazilian version of the Parent-Child Conflict Tactics Scale: 22-item checklist with following subscales: non-violent discipline (NVD), psychological aggression (PSY), corporal punishment (CP), and physical maltreatment (PM). More checks in each subscales means behavior is performed more often.
Measured: Baseline
Changes in Adverse Childhood Experiences (ACEs) - CTC
Brazilian version of the Parent-Child Conflict Tactics Scale: 22-item checklist with following subscales: non-violent discipline (NVD), psychological aggression (PSY), corporal punishment (CP), and physical maltreatment (PM). More checks in each subscales means behavior is performed more often.
Measured: 8 months
Changes in Adverse Childhood Experiences (ACEs) - CTC
Brazilian version of the Parent-Child Conflict Tactics Scale: 22-item checklist with following subscales: non-violent discipline (NVD), psychological aggression (PSY), corporal punishment (CP), and physical maltreatment (PM). More checks in each subscales means behavior is performed more often.
Measured: 16 months
Changes in Adverse Childhood Experiences (ACEs) - CTC
Brazilian version of the Parent-Child Conflict Tactics Scale: 22-item checklist with following subscales: non-violent discipline (NVD), psychological aggression (PSY), corporal punishment (CP), and physical maltreatment (PM). More checks in each subscales means behavior is performed more often.
Measured: 24 months
Changes in Adverse Childhood Experiences (ACEs) - CTC
Brazilian version of the Parent-Child Conflict Tactics Scale: 22-item checklist with following subscales: non-violent discipline (NVD), psychological aggression (PSY), corporal punishment (CP), and physical maltreatment (PM). More checks in each subscales means behavior is performed more often.
Measured: 6 months-post RCT
Child internalizing and externalizing symptoms
Maternal report of The Child Behavior Checklist, internalizing (score ranges from 0 to 33) and externalizing (score ranges from 0 to 35) scales. More checks in each scale means more internalizing or externalizing symptoms.
Measured: Baseline
Changes in Child internalizing and externalizing symptoms
Maternal report of The Child Behavior Checklist, internalizing (score ranges from 0 to 33) and externalizing (score ranges from 0 to 35) scales. More checks in each scale mean more internalizing or externalizing symptoms.
Measured: 8 months
Changes in Child internalizing and externalizing symptoms
Maternal report of The Child Behavior Checklist, internalizing (score ranges from 0 to 33) and externalizing (score ranges from 0 to 35) scales. More checks in each scale mean more internalizing or externalizing symptoms.
Measured: 16 months
Changes in Child internalizing and externalizing symptoms
Maternal report of The Child Behavior Checklist, internalizing (score ranges from 0 to 33) and externalizing (score ranges from 0 to 35) scales. More checks in each scale mean more internalizing or externalizing symptoms.
Measured: 24 months
Changes in Child internalizing and externalizing symptoms
Maternal report of The Child Behavior Checklist, internalizing (score ranges from 0 to 33) and externalizing (score ranges from 0 to 35) scales. More checks in each scale mean more internalizing or externalizing symptoms.
Measured: 6 months-post RCT
Access to health care
The assessment will be based on maternal report about each child's health care utilization history including primary care, urgent care, and hospital care. Primary care visits will be classified by purpose: vaccination, routine check-up, or sick visits. Similar procedures to the ones in place in our ongoing study will be used to obtain child medical records in the primary care unit.
Measured: Baseline
Changes in Access to health care
The assessment will be based on maternal report about each child's health care utilization history including primary care, urgent care, and hospital care. Primary care visits will be classified by purpose: vaccination, routine check-up, or sick visits. Similar procedures to the ones in place in our ongoing study will be used to obtain child medical records in the primary care unit.
Measured: 8 months
Changes in Access to health care
The assessment will be based on maternal report about each child's health care utilization history including primary care, urgent care, and hospital care. Primary care visits will be classified by purpose: vaccination, routine check-up, or sick visits. Similar procedures to the ones in place in our ongoing study will be used to obtain child medical records in the primary care unit.
Measured: 16 months
Changes in Access to health care
The assessment will be based on maternal report about each child's health care utilization history including primary care, urgent care, and hospital care. Primary care visits will be classified by purpose: vaccination, routine check-up, or sick visits. Similar procedures to the ones in place in our ongoing study will be used to obtain child medical records in the primary care unit.
Measured: 24 months
Child brain MRI scan
Child participants will undergo an MRI scan (~1 hour) to examine the function and connectivity of EF-related brain systems
Measured: Baseline
Changes in Child brain MRI scan
Child participants will undergo an MRI scan (~1 hour) to examine the function and connectivity of EF-related brain systems
Measured: 24 months
Child Executive Function
Brazilian version of the Child Executive Functions Battery (CEF-B) assesses working memory, inhibition, flexibility and planning. Score ranges vary by domain. Higher scores mean higher capacity on specific domain.
Measured: Baseline
Changes in Child Executive Function
Brazilian version of the Child Executive Functions Battery (CEF-B) assesses working memory, inhibition, flexibility and planning. Score ranges vary by domain. Higher scores mean higher capacity on specific domain.
Measured: 24 months
Changes in Child Executive Function
Brazilian version of the Child Executive Functions Battery (CEF-B) assesses working memory, inhibition, flexibility and planning. Score ranges vary by domain. Higher scores mean higher capacity on specific domain.
Measured: 6 months-post RCT
Biospecimen - Child hair sample
Child hair samples to measure HPA activity (cortisol)
Measured: Baseline
Biospecimen - Changes in Child hair sample
Child hair samples to measure HPA activity(cortisol)
Measured: 24 months
Biospecimen - Blood Draw - IL-6
Primary immune measures will consist of IL-6 and CRP, consistent with prior research on inflammation and neurodevelopment.
Measured: Baseline
Biospecimen - Blood Draw - Change in IL-6
Primary immune measures will consist of IL-6 and CRP, consistent with prior research on inflammation and neurodevelopment.
Measured: 24 months
Biospecimen - Blood Draw - CRP
Primary immune measures will consist of IL-6 and CRP, consistent with prior research on inflammation and neurodevelopment.
Measured: Baseline
Biospecimen - Blood Draw - Change in CRP
Primary immune measures will consist of IL-6 and CRP, consistent with prior research on inflammation and neurodevelopment.
Measured: 24 months
Family Adaptability and Cohesion Evaluation Scale-III (FACES-III)
This 20-item parent-report scale assesses family cohesion and adaptability. Cohesion: scores range from 0-50, higher scores mean a more cohesive family. Adaptability: scores range from 0-50, higher scores mean a more adaptable family.
Measured: Baseline
Change in Family Adaptability and Cohesion Evaluation Scale-III (FACES-III)
This 20-item parent-report scale assesses family cohesion and adaptability. Cohesion: scores range from 0-50, higher scores mean a more cohesive family. Adaptability: scores range from 0-50, higher scores mean a more adaptable family.
Measured: 24 months
Secondary outcomes (4)
Food insecurity
Mothers will be interviewed using the Brazilian adaptation of the Household Food insecurity. Scores range from 0-8. Higher scores mean more food insecurity.
Measured: Baseline, 24 months
Changes in Food insecurity
Mothers will be interviewed using the Brazilian adaptation of the Household Food insecurity. Scores range from 0-8. Higher scores mean more food insecurity.
Measured: 24 months
Home observation/environment
The quality of the child's home environment will be assessed with the Home Observation Measurement of the Environment (HOME) Inventory. Scores range from 0 to 55. Higher scores mean more quality and quantity of stimulation and support available to child in the home.
Measured: Baseline
Changes in Home observation/environment
The quality of the child's home environment will be assessed with the Home Observation Measurement of the Environment (HOME) Inventory. Scores range from 0 to 55. Higher scores mean more quality and quantity of stimulation and support available to child in the home.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2022
- Study start28 May 2025
- Primary completion30 Jun 2028 (estimated)
- Study completion31 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InflammationStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Post-baseline Procedure -- Random Assignment to Intervention After baseline, families will be randomized in a 1:1 ratio to receive either a high ($40/month) or low ($2/month) supplemental transfer for 2 years and remains in their study arm throughout the study after randomization
- Masking
- None (open label)
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Cristiane Duarte, New York State Psychiatric Institute
- Investigators
- Cristiane Duarte, PhD, Principal investigator, New York State Psychiatric InstituteAndrea Jackowsi, PhD, Principal investigator, Federal University of São PauloJonathan Posner, MD, Principal investigator, Duke UniversityTenneill Murray, MPH, Study director, New York State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05477901
- Sponsor's protocol ID
- IRB #8245/Pro00077397
- Other IDs
- 1R01MH128937-01
- Status last verified
- Apr 2026
- First submitted
- 15 Jul 2022
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mental Health and Bolsa Familia: A Mechanistically Focused Clinical Trial of a Cash Transfer Intervention on Child Brain, Behavior, and Mental Health
- ClinicalTrials.gov ID
- NCT05477901
- Acronym / sponsor ID
- IRB #8245/Pro00077397
- Conditions
- Inflammation, HPA, CBCL, Family Relations
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 28 May 2025 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 31 Jan 2029 (estimated)
- First posted
- 28 Jul 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.
This study examines the impact of Auxilio Brasil (AB), a cash transfer program to mothers of school-age children, on resource-deprived populations in Brazil and its protective effects on child neurodevelopment and mental health. The investigators will conduct a randomized clinical trial (RCT) among those already receiving AB in which 300 families will be randomized in a 1:1 ratio to receive either a high ($40/month) or low ($2/month) supplemental transfer for 2 years. Three hundred children (index child participants; 7-10 years old) will be enrolled across both study arms. Additionally, up to 150 siblings ("sibling participants;" 7-10 years old) will be enrolled. Eligible families who decide to participate will sign a study-specific informed consent (mother) and assent (child) form. The UNIFESP team will conduct the respective assessments at baseline, approximately 8- and 16- months, 24-months and approximately 6-months post-RCT.
Aim 1: Determine the impact of high vs low cash transfers on children's exposure to adversities (ACEs) and neurodevelopment.
Aim 2: Determine the impact of cash transfers on children's inflammatory markers and HPA activity/cortisol.
Exploratory Aim: The investigators will explore (i) whether sex/gender of the children moderates the pathways in the above mediation model; and (ii) whether cash transfer-related effects persist 6 months post-RCT.
Detailed description
Numerous studies link childhood poverty with altered neurodevelopment with the most robust effects often in brain substrates related to executive functions (EF). Poverty is associated with reduced grey matter thickness and surface area of the prefrontal cortex (PFC), a key structure underlying EF (4,5) Poverty is also associated with altered structure and function of the hippocampus - a region essential for memory and cognitive control (5,6). Effects of poverty on brain development are thought to give rise to the well described associations between poverty, impairments in EF, and risk for mental illness (18). The possibility of lifting children out of poverty and thereby tempering poverty's malignant neurodevelopmental effects remains largely untested, particularly with brain and behavioral measures and within LMICs where poverty is widespread. To address this gap, the investigators propose a randomized clinical trial (RCT) to be conducted in low-income families in Sao Paulo, Brazil that will examine causal effects of a cash transfer program on neurodevelopment in youth. Our study builds off an existing cash transfer program (CTP) - Auxilio Brasil (AB) - and augments the cash transfer amount to a level sufficient to lift a family out of extreme poverty and poverty. Our RCT design will allow for novel causal inferences linking cash transfers to brain/behavior outcomes, while testing mechanistic hypotheses. Because the investigators are building off AB, a well-established program with a successful, national infrastructure for transferring cash, our findings could rapidly move toward implementation. Our study will inform critical unanswered questions about pasting, and CTPs generally, that could support their broader and more targeted implementation - First, if augmenting AB removes a family from poverty, does this protect child neurodevelopment? And second, if this augmented AB program protects neurodevelopment, what are the mechanisms that explain this? Providing this mechanistic framework is a key step toward refining AB and other CTPs, facilitating for example, studies aimed at targeting populations most likely to benefit, optimizing the dose/amount of the transfers, and determining the ideal timing/duration of CTPs.
Aims and Hypotheses
Aim 1: Determine the impact of high vs low cash transfers on children's exposure to adversities (ACEs) and neurodevelopment. Eligible families will be those already enrolled in Brazil's national AB program. Relative to low cash transfers, children of mothers who received high cash transfers will have:
Hypothesis 1A (H1A) - [ACEs] fewer new onset ACEs over the 24-month course of the RCT; H1B - [Neurodevelopment] greater pre-vs-post RCT increases in prefrontal activation during an EF fMRI task (Simon task),10 increased connectivity within EF-related PFC/mesolimbic circuits (resting fMRI and diffusion MRI), and improvements in EF behaviors.
Aim 2: Determine the impact of cash transfers on children's inflammatory markers and HPA activity/cortisol.
Hypothesis 2A (H2A) - Relative to low cash transfers, children of mothers who received high cash transfers will have lower pre vs-post RCT levels of pro-inflammatory markers (e.g., CRP, Il-6, TNF-a; from blood draws) and hair cortisol (HPA activity over past 2-3 months).
Hypothesis 2B (H2B) - Inflammatory and HPA activity levels (H2A) will be lower in children with fewer new onset ACEs (i.e., new ACEs occurring during the 24-month RCT). H2C [Mediation] - The effects of high cash transfers on neurodevelopment (H1B) will be mediated by the impact of cash transfers on reducing new onset ACEs (H1A) and lower inflammation and HPA activity (H2A \& H2B), while taking into account covariates and three additional pathways (see A.9 And C.6.3).
Exploratory Aim: The investigators will explore (i) whether sex/gender of the children moderates the pathways in the above mediation model (H2C); and (ii) whether cash transfer-related effects - reducing new onset ACEs and symptoms (CBCL), and improved EF behavior - persist 6 months post-RCT.
Impact: Designed to decrease inequalities, AB is one of the largest social interventions in the world, yet its impact on child mental health is unknown. Our strategy, rather than relying on prohibitively expensive multi-site designs, proposes to generate evidence about the impact of AB on child neurodevelopmental outcomes by focusing on specific, well-supported mechanisms that may underlie mental illness risk. Our findings will have strong implications for tailoring the impact of cash transfer policies to maximize child mental health gains.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Post-baseline Procedure -- Random Assignment to Intervention After baseline, families will be randomized in a 1:1 ratio to receive either a high ($40/month) or low ($2/month) supplemental transfer for 2 years and remains in their study arm throughout the study after randomization
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Supplemental cash transferHigh supplemental transfer: $40 a month |
| Control | No intervention | –Low supplemental transfer: $2 a month |
Who may qualify
- Ages
- 23 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age 23-45 years old
- Receiving AB cash transfers
- Has at least two or more children ages 7- 10 years old at time of recruitment (up to 4 children per family)
- Able to consent
- Age 7-10 years old
Key exclusion criteria (6 listed)
- 1. Mother and child do not reside in same household
- Does not reside in same household as the mother
- Major Axis I disorder (e.g., Autism, Schizophrenia, Bipolar)
- Severe Disability
- MRI contradictions (index child only)
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 |
|---|---|---|
| Supplemental cash transferSupplemental cash transfer ($40/month) | Other | Intervention |
Primary outcome
Adverse Childhood Experiences (ACEs) - FHE
Time frame: Baseline
Family History Epidemiologic screener is a 9-item (+subitems) checklist to asses child's ACEs, more checked items mean more ACEs.
Changes in Adverse Childhood Experiences (ACEs) - FHE
Time frame: 8 months
Family History Epidemiologic screener is a 9-item (+subitems) checklist to asses child's ACEs, more checked items mean more ACEs.
Changes in Adverse Childhood Experiences (ACEs) - FHE
Time frame: 16 months
Family History Epidemiologic screener is a 9-item (+subitems) checklist to asses child's ACEs, more checked items mean more ACEs.
Changes in Adverse Childhood Experiences (ACEs) - FHE
Time frame: 24 months
Family History Epidemiologic screener is a 9-item (+subitems) checklist to asses child's ACEs, more checked items mean more ACEs.
Changes in Adverse Childhood Experiences (ACEs) - FHE
Time frame: 6 months post-RCT
Family History Epidemiologic screener is a 9-item (+subitems) checklist to asses child's ACEs, more checked items mean more ACEs.
Adverse Childhood Experiences (ACEs) - CTC
Time frame: Baseline
Brazilian version of the Parent-Child Conflict Tactics Scale: 22-item checklist with following subscales: non-violent discipline (NVD), psychological aggression (PSY), corporal punishment (CP), and physical maltreatment (PM). More checks in each subscales means behavior is performed more often.
Changes in Adverse Childhood Experiences (ACEs) - CTC
Time frame: 8 months
Brazilian version of the Parent-Child Conflict Tactics Scale: 22-item checklist with following subscales: non-violent discipline (NVD), psychological aggression (PSY), corporal punishment (CP), and physical maltreatment (PM). More checks in each subscales means behavior is performed more often.
Changes in Adverse Childhood Experiences (ACEs) - CTC
Time frame: 16 months
Brazilian version of the Parent-Child Conflict Tactics Scale: 22-item checklist with following subscales: non-violent discipline (NVD), psychological aggression (PSY), corporal punishment (CP), and physical maltreatment (PM). More checks in each subscales means behavior is performed more often.
Changes in Adverse Childhood Experiences (ACEs) - CTC
Time frame: 24 months
Brazilian version of the Parent-Child Conflict Tactics Scale: 22-item checklist with following subscales: non-violent discipline (NVD), psychological aggression (PSY), corporal punishment (CP), and physical maltreatment (PM). More checks in each subscales means behavior is performed more often.
Changes in Adverse Childhood Experiences (ACEs) - CTC
Time frame: 6 months-post RCT
Brazilian version of the Parent-Child Conflict Tactics Scale: 22-item checklist with following subscales: non-violent discipline (NVD), psychological aggression (PSY), corporal punishment (CP), and physical maltreatment (PM). More checks in each subscales means behavior is performed more often.
Child internalizing and externalizing symptoms
Time frame: Baseline
Maternal report of The Child Behavior Checklist, internalizing (score ranges from 0 to 33) and externalizing (score ranges from 0 to 35) scales. More checks in each scale means more internalizing or externalizing symptoms.
Changes in Child internalizing and externalizing symptoms
Time frame: 8 months
Maternal report of The Child Behavior Checklist, internalizing (score ranges from 0 to 33) and externalizing (score ranges from 0 to 35) scales. More checks in each scale mean more internalizing or externalizing symptoms.
Changes in Child internalizing and externalizing symptoms
Time frame: 16 months
Maternal report of The Child Behavior Checklist, internalizing (score ranges from 0 to 33) and externalizing (score ranges from 0 to 35) scales. More checks in each scale mean more internalizing or externalizing symptoms.
Changes in Child internalizing and externalizing symptoms
Time frame: 24 months
Maternal report of The Child Behavior Checklist, internalizing (score ranges from 0 to 33) and externalizing (score ranges from 0 to 35) scales. More checks in each scale mean more internalizing or externalizing symptoms.
Changes in Child internalizing and externalizing symptoms
Time frame: 6 months-post RCT
Maternal report of The Child Behavior Checklist, internalizing (score ranges from 0 to 33) and externalizing (score ranges from 0 to 35) scales. More checks in each scale mean more internalizing or externalizing symptoms.
Access to health care
Time frame: Baseline
The assessment will be based on maternal report about each child's health care utilization history including primary care, urgent care, and hospital care. Primary care visits will be classified by purpose: vaccination, routine check-up, or sick visits. Similar procedures to the ones in place in our ongoing study will be used to obtain child medical records in the primary care unit.
Changes in Access to health care
Time frame: 8 months
The assessment will be based on maternal report about each child's health care utilization history including primary care, urgent care, and hospital care. Primary care visits will be classified by purpose: vaccination, routine check-up, or sick visits. Similar procedures to the ones in place in our ongoing study will be used to obtain child medical records in the primary care unit.
Changes in Access to health care
Time frame: 16 months
The assessment will be based on maternal report about each child's health care utilization history including primary care, urgent care, and hospital care. Primary care visits will be classified by purpose: vaccination, routine check-up, or sick visits. Similar procedures to the ones in place in our ongoing study will be used to obtain child medical records in the primary care unit.
Changes in Access to health care
Time frame: 24 months
The assessment will be based on maternal report about each child's health care utilization history including primary care, urgent care, and hospital care. Primary care visits will be classified by purpose: vaccination, routine check-up, or sick visits. Similar procedures to the ones in place in our ongoing study will be used to obtain child medical records in the primary care unit.
Child brain MRI scan
Time frame: Baseline
Child participants will undergo an MRI scan (~1 hour) to examine the function and connectivity of EF-related brain systems
Changes in Child brain MRI scan
Time frame: 24 months
Child participants will undergo an MRI scan (~1 hour) to examine the function and connectivity of EF-related brain systems
Child Executive Function
Time frame: Baseline
Brazilian version of the Child Executive Functions Battery (CEF-B) assesses working memory, inhibition, flexibility and planning. Score ranges vary by domain. Higher scores mean higher capacity on specific domain.
Changes in Child Executive Function
Time frame: 24 months
Brazilian version of the Child Executive Functions Battery (CEF-B) assesses working memory, inhibition, flexibility and planning. Score ranges vary by domain. Higher scores mean higher capacity on specific domain.
Changes in Child Executive Function
Time frame: 6 months-post RCT
Brazilian version of the Child Executive Functions Battery (CEF-B) assesses working memory, inhibition, flexibility and planning. Score ranges vary by domain. Higher scores mean higher capacity on specific domain.
Biospecimen - Child hair sample
Time frame: Baseline
Child hair samples to measure HPA activity (cortisol)
Biospecimen - Changes in Child hair sample
Time frame: 24 months
Child hair samples to measure HPA activity(cortisol)
Biospecimen - Blood Draw - IL-6
Time frame: Baseline
Primary immune measures will consist of IL-6 and CRP, consistent with prior research on inflammation and neurodevelopment.
Biospecimen - Blood Draw - Change in IL-6
Time frame: 24 months
Primary immune measures will consist of IL-6 and CRP, consistent with prior research on inflammation and neurodevelopment.
Biospecimen - Blood Draw - CRP
Time frame: Baseline
Primary immune measures will consist of IL-6 and CRP, consistent with prior research on inflammation and neurodevelopment.
Biospecimen - Blood Draw - Change in CRP
Time frame: 24 months
Primary immune measures will consist of IL-6 and CRP, consistent with prior research on inflammation and neurodevelopment.
Family Adaptability and Cohesion Evaluation Scale-III (FACES-III)
Time frame: Baseline
This 20-item parent-report scale assesses family cohesion and adaptability. Cohesion: scores range from 0-50, higher scores mean a more cohesive family. Adaptability: scores range from 0-50, higher scores mean a more adaptable family.
Change in Family Adaptability and Cohesion Evaluation Scale-III (FACES-III)
Time frame: 24 months
This 20-item parent-report scale assesses family cohesion and adaptability. Cohesion: scores range from 0-50, higher scores mean a more cohesive family. Adaptability: scores range from 0-50, higher scores mean a more adaptable family.
4 secondary outcomes
Food insecurity
Time frame: Baseline, 24 months
Changes in Food insecurity
Time frame: 24 months
Home observation/environment
Time frame: Baseline
Changes in Home observation/environment
Time frame: 24 months
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 23 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Cristiane Duarte, PhD principal investigator
New York State Psychiatric Institute
Andrea Jackowsi, PhD principal investigator
Federal University of São Paulo
Jonathan Posner, MD principal investigator
Duke University
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supplemental cash transfer in people with Inflammation and HPA, run by New York State Psychiatric Institute at 2 sites in 2 countries.
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 6 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Brazil. 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?
Contact Cristiane Duarte, PhD (646-774-5801, cristiane.duarte@nyspi.columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Childhood Experiences (ACEs) - FHE (time frame: Baseline). The study lists 32 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 23 Apr 2026.