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Recruiting Not applicable NCT05477901

Impacts of Cash Transfers on Child Neurodevelopment (Auxilio Brasil)

No applicable phase (e.g. observational)
Conditions: Inflammation HPA CBCL Family Relations

Sponsor: New York State Psychiatric Institute

trial.available_in: БГ
Overview
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 inflamma
Who can participate
Mother: Inclusion Criteria: 1. Age 23-45 years old 2. Receiving AB cash transfers 3. Has at least two or more children ages 7- 10 years old at time of recruitment (up to 4 children per family) 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. Intellectual Disability Exclusion Criterion 1. Does not reside in same household as the mother 2. Major Axis I disorder (e.g., Autism, Schizophrenia, Bipolar) 3. Severe Disability 4. MRI contradictions (index child only)
Interventions
Supplemental cash transfer
OTHER
Locations 2
Brazil (1)
UNIFESP
São Paulo , São Paulo
United States (1)
New York State Psychiatric Institute
New York , New York
NOT_YET_RECRUITING
Technical details
Status
Recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
23 Years
Maximum age
45 Years
Healthy volunteers
No
Start date
28.05.2025
Completion date
31.01.2029
Registry ID
NCT05477901
Source
clinicaltrials.gov
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