Mental Health and Bolsa Familia: A Mechanistically Focused Clinical Trial of a Cash Transfer Intervention on Child Brain, Behavior, and Mental Health
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 450
- 试验地点
- 2
- 主要终点
- Biospecimen - Blood Draw - CRP
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 23 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria:
- •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
排除标准
- •1. Mother and child do not reside in same household
- •Inclusion Criterion
- •Age 7-10 years old
- •Intellectual Disability
- •Exclusion Criterion
- •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)
研究组 & 干预措施
Control
Low supplemental transfer: $2 a month
Intervention
High supplemental transfer: $40 a month
干预措施: Supplemental cash transfer (Other)
结局指标
主要结局
Biospecimen - Blood Draw - CRP
时间窗: Baseline
Primary immune measures will consist of IL-6 and CRP, consistent with prior research on inflammation and neurodevelopment.
Changes in Adverse Childhood Experiences (ACEs) - FHE
时间窗: 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
时间窗: 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
时间窗: 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) - CTC
时间窗: 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
时间窗: 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
时间窗: 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 Child internalizing and externalizing symptoms
时间窗: 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
时间窗: 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
时间窗: 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 Access to health care
时间窗: 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
时间窗: 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 Child Executive Function
时间窗: 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.
Adverse Childhood Experiences (ACEs) - FHE
时间窗: Baseline
Family History Epidemiologic screener is a 9-item (+subitems) checklist to asses child's ACEs, more checked items mean more ACEs.
Access to health care
时间窗: 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
时间窗: 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.
Biospecimen - Changes in Child hair sample
时间窗: 24 months
Child hair samples to measure HPA activity(cortisol)
Changes in Adverse Childhood Experiences (ACEs) - FHE
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
Changes in Child brain MRI scan
时间窗: 24 months
Child participants will undergo an MRI scan (\~1 hour) to examine the function and connectivity of EF-related brain systems
Child brain MRI scan
时间窗: Baseline
Child participants will undergo an MRI scan (\~1 hour) to examine the function and connectivity of EF-related brain systems
Changes in Child Executive Function
时间窗: 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
时间窗: Baseline
Child hair samples to measure HPA activity (cortisol)
Biospecimen - Blood Draw - Change in CRP
时间窗: 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)
时间窗: 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.
Child Executive Function
时间窗: 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.
Biospecimen - Blood Draw - IL-6
时间窗: 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
时间窗: 24 months
Primary immune measures will consist of IL-6 and CRP, consistent with prior research on inflammation and neurodevelopment.
Change in Family Adaptability and Cohesion Evaluation Scale-III (FACES-III)
时间窗: 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.
次要结局
- Home observation/environment(Baseline)
- Food insecurity(Baseline, 24 months)
- Changes in Food insecurity(24 months)
- Changes in Home observation/environment(24 months)
研究者
Cristiane Duarte
Ruane Professor for the Implementation of Science for Child and Adolescent mental Health (in Psychiatry) at CUMC
New York State Psychiatric Institute