Impacts of Cash Transfers on Child Neurodevelopment (Auxilio Brasil)

Inflammation Clinical Trial

Official title:

Mental Health and Bolsa Familia: A Mechanistically Focused Clinical Trial of a Cash Transfer Intervention on Child Brain, Behavior, and Mental Health

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05477901
• Other study ID #: IRB #8245
• Secondary ID: 1R01MH128937-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: January 1, 2028

Study information

• Verified date: March 2024
• Source: New York State Psychiatric Institute
• Contact: Cristiane Duarte, PhD
• Phone: 646-774-5801
• Email: cristiane.duarte[@]nyspi.columbia.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 450
• Est. completion date: January 1, 2028
• Est. primary completion date: December 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 23 Years to 45 Years

Eligibility

Mother:

Inclusion Criteria:

1. Age 23-45 years old

2. Receiving AB cash transfers

3. Has at least one child ages 7-10 years old at time of recruitment

4. Able to consent

Exclusion Criteria:

1. Mother and child do not reside in same household

Child:

Inclusion Criterion

1. Age 7-10 years old

2. IQ > 80

Exclusion Criterion

1. Does not reside in same household as the mother

2. Major Axis I disorder (e.g., Autism, Schizophrenia, Bipolar), ADHD and disruptive behavior disorders will not be exclusionary because of their high prevalence

3. MRI contradictions

Related Conditions & MeSH terms

• Family Relations
• Inflammation

Intervention

Other:
• Supplemental cash transfer
Supplemental cash transfer ($40/month)

Locations

Country	Name	City	State
Brazil	UNIFESP	São Paulo	SP
United States	New York State Psychiatric Institute	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York State Psychiatric Institute	National Institute of Mental Health (NIMH)

Countries where clinical trial is conducted

United States,  Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline
Primary	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.	8 months
Primary	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.	16 months
Primary	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.	24 months
Primary	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.	6 months post-RCT
Primary	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.	Baseline
Primary	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.	8 months
Primary	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.	16 months
Primary	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.	24 months
Primary	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.	6 months-post RCT
Primary	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.	Baseline
Primary	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.	8 months
Primary	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.	16 months
Primary	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.	24 months
Primary	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.	6 months-post RCT
Primary	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.	Baseline
Primary	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.	8 months
Primary	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.	16 months
Primary	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.	24 months
Primary	Child brain MRI scan	Child participants will undergo an MRI scan (~1 hour) to examine the function and connectivity of EF-related brain systems	Baseline
Primary	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	24 months
Primary	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.	Baseline
Primary	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.	24 months
Primary	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.	6 months-post RCT
Primary	Biospecimen - Child hair sample	Child hair samples to measure HPA activity (cortisol)	Baseline
Primary	Biospecimen - Changes in Child hair sample	Child hair samples to measure HPA activity(cortisol)	24 months
Primary	Biospecimen - Blood Draw - IL-6	Primary immune measures will consist of IL-6 and CRP, consistent with prior research on inflammation and neurodevelopment.	Baseline
Primary	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.	24 months
Primary	Biospecimen - Blood Draw - CRP	Primary immune measures will consist of IL-6 and CRP, consistent with prior research on inflammation and neurodevelopment.	Baseline
Primary	Biospecimen - Blood Draw - Change in CRP	Primary immune measures will consist of IL-6 and CRP, consistent with prior research on inflammation and neurodevelopment.	24 months
Primary	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.	Baseline
Primary	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.	24 months
Secondary	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.	Baseline, 24 months
Secondary	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.	24 months
Secondary	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.	Baseline
Secondary	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.	24 months