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Impacts of Cash Transfers on Child Neurodevelopment (Auxilio Brasil)

Primary Purpose

Inflammation, HPA, CBCL

Status
Not yet recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Supplemental cash transfer
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Inflammation

Eligibility Criteria

23 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

Mother:

Inclusion Criteria:

  1. Age 23-45 years old
  2. Receiving AB cash transfers
  3. Has at least one child ages 7-10 years old at time of recruitment
  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. IQ > 80

Exclusion Criterion

  1. Does not reside in same household as the mother
  2. Major Axis I disorder (e.g., Autism, Schizophrenia, Bipolar), ADHD and disruptive behavior disorders will not be exclusionary because of their high prevalence
  3. MRI contradictions

Sites / Locations

  • New York State Psychiatric Institute
  • UNIFESP

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

High supplemental transfer: $40 a month

Low supplemental transfer: $2 a month

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Child brain MRI scan
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
Child participants will undergo an MRI scan (~1 hour) to examine the function and connectivity of EF-related brain systems
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.
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.
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.
Biospecimen - Child hair sample
Child hair samples to measure HPA activity (cortisol)
Biospecimen - Changes in Child hair sample
Child hair samples to measure HPA activity(cortisol)
Biospecimen - Blood Draw - IL-6
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
Primary immune measures will consist of IL-6 and CRP, consistent with prior research on inflammation and neurodevelopment.
Biospecimen - Blood Draw - CRP
Primary immune measures will consist of IL-6 and CRP, consistent with prior research on inflammation and neurodevelopment.
Biospecimen - Blood Draw - Change in CRP
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)
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)
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.

Secondary Outcome Measures

Food insecurity
Mothers will be interviewed using the Brazilian adaptation of the Household Food insecurity. Scores range from 0-8. Higher scores mean more food insecurity.
Changes in Food insecurity
Mothers will be interviewed using the Brazilian adaptation of the Household Food insecurity. Scores range from 0-8. Higher scores mean more food insecurity.
Home observation/environment
The quality of the child's home environment will be assessed with the Home Observation Measurement of the Environment (HOME) Inventory. Scores range from 0 to 55. Higher scores mean more quality and quantity of stimulation and support available to child in the home.
Changes in Home observation/environment
The quality of the child's home environment will be assessed with the Home Observation Measurement of the Environment (HOME) Inventory. Scores range from 0 to 55. Higher scores mean more quality and quantity of stimulation and support available to child in the home.

Full Information

First Posted
July 15, 2022
Last Updated
September 26, 2023
Sponsor
New York State Psychiatric Institute
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT05477901
Brief Title
Impacts of Cash Transfers on Child Neurodevelopment (Auxilio Brasil)
Official Title
Mental Health and Bolsa Familia: A Mechanistically Focused Clinical Trial of a Cash Transfer Intervention on Child Brain, Behavior, and Mental Health
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 15, 2023 (Anticipated)
Primary Completion Date
December 1, 2027 (Anticipated)
Study Completion Date
January 1, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York State Psychiatric Institute
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed 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 inflammatory markers and HPA activity/cortisol. Hypothesis 2A (H2A) - Relative to low cash transfers, children of mothers who received high cash transfers will have lower pre vs-post RCT levels of pro-inflammatory markers (e.g., CRP, Il-6, TNF-a; from blood draws) and hair cortisol (HPA activity over past 2-3 months). Hypothesis 2B (H2B) - Inflammatory and HPA activity levels (H2A) will be lower in children with fewer new onset ACEs (i.e., new ACEs occurring during the 24-month RCT). H2C [Mediation] - The effects of high cash transfers on neurodevelopment (H1B) will be mediated by the impact of cash transfers on reducing new onset ACEs (H1A) and lower inflammation and HPA activity (H2A & H2B), while taking into account covariates and three additional pathways (see A.9 And C.6.3). Exploratory Aim: The investigators will explore (i) whether sex/gender of the children moderates the pathways in the above mediation model (H2C); and (ii) whether cash transfer-related effects - reducing new onset ACEs and symptoms (CBCL), and improved EF behavior - persist 6 months post-RCT. Impact: Designed to decrease inequalities, AB is one of the largest social interventions in the world, yet its impact on child mental health is unknown. Our strategy, rather than relying on prohibitively expensive multi-site designs, proposes to generate evidence about the impact of AB on child neurodevelopmental outcomes by focusing on specific, well-supported mechanisms that may underlie mental illness risk. Our findings will have strong implications for tailoring the impact of cash transfer policies to maximize child mental health gains.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation, HPA, CBCL, Family Relations

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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
Masking
None (Open Label)
Allocation
Randomized
Enrollment
450 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
High supplemental transfer: $40 a month
Arm Title
Control
Arm Type
No Intervention
Arm Description
Low supplemental transfer: $2 a month
Intervention Type
Other
Intervention Name(s)
Supplemental cash transfer
Intervention Description
Supplemental cash transfer ($40/month)
Primary Outcome Measure Information:
Title
Adverse Childhood Experiences (ACEs) - FHE
Description
Family History Epidemiologic screener is a 9-item (+subitems) checklist to asses child's ACEs, more checked items mean more ACEs.
Time Frame
Baseline
Title
Changes in Adverse Childhood Experiences (ACEs) - FHE
Description
Family History Epidemiologic screener is a 9-item (+subitems) checklist to asses child's ACEs, more checked items mean more ACEs.
Time Frame
8 months
Title
Changes in Adverse Childhood Experiences (ACEs) - FHE
Description
Family History Epidemiologic screener is a 9-item (+subitems) checklist to asses child's ACEs, more checked items mean more ACEs.
Time Frame
16 months
Title
Changes in Adverse Childhood Experiences (ACEs) - FHE
Description
Family History Epidemiologic screener is a 9-item (+subitems) checklist to asses child's ACEs, more checked items mean more ACEs.
Time Frame
24 months
Title
Changes in Adverse Childhood Experiences (ACEs) - FHE
Description
Family History Epidemiologic screener is a 9-item (+subitems) checklist to asses child's ACEs, more checked items mean more ACEs.
Time Frame
6 months post-RCT
Title
Adverse Childhood Experiences (ACEs) - CTC
Description
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.
Time Frame
Baseline
Title
Changes in Adverse Childhood Experiences (ACEs) - CTC
Description
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.
Time Frame
8 months
Title
Changes in Adverse Childhood Experiences (ACEs) - CTC
Description
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.
Time Frame
16 months
Title
Changes in Adverse Childhood Experiences (ACEs) - CTC
Description
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.
Time Frame
24 months
Title
Changes in Adverse Childhood Experiences (ACEs) - CTC
Description
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.
Time Frame
6 months-post RCT
Title
Child internalizing and externalizing symptoms
Description
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.
Time Frame
Baseline
Title
Changes in Child internalizing and externalizing symptoms
Description
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.
Time Frame
8 months
Title
Changes in Child internalizing and externalizing symptoms
Description
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.
Time Frame
16 months
Title
Changes in Child internalizing and externalizing symptoms
Description
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.
Time Frame
24 months
Title
Changes in Child internalizing and externalizing symptoms
Description
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.
Time Frame
6 months-post RCT
Title
Access to health care
Description
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.
Time Frame
Baseline
Title
Changes in Access to health care
Description
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.
Time Frame
8 months
Title
Changes in Access to health care
Description
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.
Time Frame
16 months
Title
Changes in Access to health care
Description
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.
Time Frame
24 months
Title
Child brain MRI scan
Description
Child participants will undergo an MRI scan (~1 hour) to examine the function and connectivity of EF-related brain systems
Time Frame
Baseline
Title
Changes in Child brain MRI scan
Description
Child participants will undergo an MRI scan (~1 hour) to examine the function and connectivity of EF-related brain systems
Time Frame
24 months
Title
Child Executive Function
Description
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.
Time Frame
Baseline
Title
Changes in Child Executive Function
Description
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.
Time Frame
24 months
Title
Changes in Child Executive Function
Description
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.
Time Frame
6 months-post RCT
Title
Biospecimen - Child hair sample
Description
Child hair samples to measure HPA activity (cortisol)
Time Frame
Baseline
Title
Biospecimen - Changes in Child hair sample
Description
Child hair samples to measure HPA activity(cortisol)
Time Frame
24 months
Title
Biospecimen - Blood Draw - IL-6
Description
Primary immune measures will consist of IL-6 and CRP, consistent with prior research on inflammation and neurodevelopment.
Time Frame
Baseline
Title
Biospecimen - Blood Draw - Change in IL-6
Description
Primary immune measures will consist of IL-6 and CRP, consistent with prior research on inflammation and neurodevelopment.
Time Frame
24 months
Title
Biospecimen - Blood Draw - CRP
Description
Primary immune measures will consist of IL-6 and CRP, consistent with prior research on inflammation and neurodevelopment.
Time Frame
Baseline
Title
Biospecimen - Blood Draw - Change in CRP
Description
Primary immune measures will consist of IL-6 and CRP, consistent with prior research on inflammation and neurodevelopment.
Time Frame
24 months
Title
Family Adaptability and Cohesion Evaluation Scale-III (FACES-III)
Description
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.
Time Frame
Baseline
Title
Change in Family Adaptability and Cohesion Evaluation Scale-III (FACES-III)
Description
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.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Food insecurity
Description
Mothers will be interviewed using the Brazilian adaptation of the Household Food insecurity. Scores range from 0-8. Higher scores mean more food insecurity.
Time Frame
Baseline, 24 months
Title
Changes in Food insecurity
Description
Mothers will be interviewed using the Brazilian adaptation of the Household Food insecurity. Scores range from 0-8. Higher scores mean more food insecurity.
Time Frame
24 months
Title
Home observation/environment
Description
The quality of the child's home environment will be assessed with the Home Observation Measurement of the Environment (HOME) Inventory. Scores range from 0 to 55. Higher scores mean more quality and quantity of stimulation and support available to child in the home.
Time Frame
Baseline
Title
Changes in Home observation/environment
Description
The quality of the child's home environment will be assessed with the Home Observation Measurement of the Environment (HOME) Inventory. Scores range from 0 to 55. Higher scores mean more quality and quantity of stimulation and support available to child in the home.
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
23 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Mother: Inclusion Criteria: Age 23-45 years old Receiving AB cash transfers Has at least one child ages 7-10 years old at time of recruitment Able to consent Exclusion Criteria: 1. Mother and child do not reside in same household Child: Inclusion Criterion Age 7-10 years old IQ > 80 Exclusion Criterion Does not reside in same household as the mother Major Axis I disorder (e.g., Autism, Schizophrenia, Bipolar), ADHD and disruptive behavior disorders will not be exclusionary because of their high prevalence MRI contradictions
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cristiane Duarte, PhD
Phone
646-774-5801
Email
cristiane.duarte@nyspi.columbia.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cristiane Duarte, PhD
Organizational Affiliation
New York State Psychiatric Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andrea Jackowsi, PhD
Organizational Affiliation
Federal University of São Paulo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jonathan Posner, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tenneill Murray, MPH
Organizational Affiliation
New York State Psychiatric Institute
Official's Role
Study Director
Facility Information:
Facility Name
New York State Psychiatric Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cristiane Duarte, PhD
Phone
646-774-5801
Email
Cristiane.Duarte@nyspi.columbia.edu
Facility Name
UNIFESP
City
São Paulo
State/Province
SP
ZIP/Postal Code
04023
Country
Brazil
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Jackowski, PhD
Email
andrea.jackowski@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Impacts of Cash Transfers on Child Neurodevelopment (Auxilio Brasil)

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