Impacts of Cash Transfers on Child Neurodevelopment (Auxilio Brasil)

Condition(s) studied

Investigational drug(s) / intervention(s)

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

Study 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.

Eligibility

Primary outcome measure(s)

• Adverse Childhood Experiences (ACEs) - FHE — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — Baseline
  Child hair samples to measure HPA activity (cortisol)
• Biospecimen - Changes in Child hair sample — 24 months
  Child hair samples to measure HPA activity(cortisol)
• Biospecimen - Blood Draw - IL-6 — 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 — 24 months
  Primary immune measures will consist of IL-6 and CRP, consistent with prior research on inflammation and neurodevelopment.
• Biospecimen - Blood Draw - CRP — 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 — 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) — 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) — 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.

Trial sites (2)

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