Impacts of Cash Transfers on Child Neurodevelopment (Auxilio Brasil)

NCT05477901 | Recruiting

• 2 other identifiers: IRB #8245/Pro000773971R01MH128937-01
• Study Type: interventional
• Target: 450
• Locations: 2 countries
• Sites: 2

Brief 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.

Conditions

Inflammation; HPA; CBCL; Family Relations

Outcome Measures

Primary Outcomes (32)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• Biospecimen - Child hair sample

  Child hair samples to measure HPA activity (cortisol)

  Baseline

• Biospecimen - Changes in Child hair sample

  Child hair samples to measure HPA activity(cortisol)

  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.

  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.

  24 months

• Biospecimen - Blood Draw - CRP

  Primary immune measures will consist of IL-6 and CRP, consistent with prior research on inflammation and neurodevelopment.

  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.

  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.

  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.

  24 months

Secondary Outcomes (4)

• Food insecurity

  Baseline, 24 months

• Changes in Food insecurity

  24 months

• Home observation/environment

  Baseline

• Changes in Home observation/environment

  24 months

Study Arms (2)

Intervention

EXPERIMENTAL

High supplemental transfer: $40 a month

Other: Supplemental cash transfer

Control

NO INTERVENTION

Low supplemental transfer: $2 a month

Interventions

Supplemental cash transfer OTHER

Supplemental cash transfer ($40/month)

Intervention

Eligibility Criteria

• Age: 23 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• \. Mother and child do not reside in same household
• Child:
• Age 7-10 years old
• Intellectual Disability
• 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)

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (2)

New York State Psychiatric Institute

New York, New York, 10032, United States

NOT YET RECRUITING

UNIFESP

São Paulo, São Paulo, 04023, Brazil

RECRUITING

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Cristiane Duarte, PhD

  New York State Psychiatric Institute

  PRINCIPAL INVESTIGATOR

• Andrea Jackowsi, PhD

  Federal University of São Paulo

  PRINCIPAL INVESTIGATOR

• Jonathan Posner, MD

  Duke University

  PRINCIPAL INVESTIGATOR

• Tenneill Murray, MPH

  New York State Psychiatric Institute

  STUDY DIRECTOR

Central Study Contacts

Cristiane Duarte, PhD

CONTACT

646-774-5801; cristiane.duarte@nyspi.columbia.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ruane Professor for the Implementation of Science for Child and Adolescent mental Health (in Psychiatry) at CUMC

Model Details: 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

Study Record Dates

• First Submitted: July 15, 2022
• First Posted: July 28, 2022
• Study Start: May 28, 2025
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): January 31, 2029
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); BR (1)