RECRUITING

Impacts of Cash Transfers on Child Neurodevelopment (Auxilio Brasil)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-05-17
Study Completion:2028-01-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05477901

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:23 Years to 45 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Age 23-45 years old
  2. 2. Receiving AB cash transfers
  3. 3. Has at least two or more children ages 7- 10 years old at time of recruitment (up to 4 children per family)
  4. 4. Able to consent
  1. 1. Mother and child do not reside in same household
  2. 1. Age 7-10 years old
  3. 2. Intellectual Disability
  4. 1. Does not reside in same household as the mother
  5. 2. Major Axis I disorder (e.g., Autism, Schizophrenia, Bipolar)
  6. 3. Severe Disability
  7. 4. MRI contradictions (index child only)

Contacts and Locations

Study Contact

Cristiane Duarte, PhD
CONTACT
646-774-5801
cristiane.duarte@nyspi.columbia.edu

Principal Investigator

Cristiane Duarte, PhD
PRINCIPAL_INVESTIGATOR
New York State Psychiatric Institute
Andrea Jackowsi, PhD
PRINCIPAL_INVESTIGATOR
Federal University of São Paulo
Jonathan Posner, MD
PRINCIPAL_INVESTIGATOR
Duke University
Tenneill Murray, MPH
STUDY_DIRECTOR
New York State Psychiatric Institute

Study Locations (Sites)

New York State Psychiatric Institute
New York, New York, 10032
United States

Collaborators and Investigators

Sponsor: New York State Psychiatric Institute

  • Cristiane Duarte, PhD, PRINCIPAL_INVESTIGATOR, New York State Psychiatric Institute
  • Andrea Jackowsi, PhD, PRINCIPAL_INVESTIGATOR, Federal University of São Paulo
  • Jonathan Posner, MD, PRINCIPAL_INVESTIGATOR, Duke University
  • Tenneill Murray, MPH, STUDY_DIRECTOR, New York State Psychiatric Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-17
Study Completion Date2028-01-01

Study Record Updates

Study Start Date2025-05-17
Study Completion Date2028-01-01

Terms related to this study

Additional Relevant MeSH Terms

  • Inflammation
  • HPA
  • CBCL
  • Family Relations