Inflammation Clinical Trial
Official title:
Mental Health and Bolsa Familia: A Mechanistically Focused Clinical Trial of a Cash Transfer Intervention on Child Brain, Behavior, and Mental Health
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.
Status | Not yet recruiting |
Enrollment | 450 |
Est. completion date | January 1, 2028 |
Est. primary completion date | December 1, 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 23 Years to 45 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Brazil | UNIFESP | São Paulo | SP |
United States | New York State Psychiatric Institute | New York | New York |
Lead Sponsor | Collaborator |
---|---|
New York State Psychiatric Institute | National Institute of Mental Health (NIMH) |
United States, Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | Biospecimen - Child hair sample | Child hair samples to measure HPA activity (cortisol) | Baseline | |
Primary | Biospecimen - Changes in Child hair sample | Child hair samples to measure HPA activity(cortisol) | 24 months | |
Primary | Biospecimen - Blood Draw - IL-6 | Primary immune measures will consist of IL-6 and CRP, consistent with prior research on inflammation and neurodevelopment. | Baseline | |
Primary | 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 | |
Primary | Biospecimen - Blood Draw - CRP | Primary immune measures will consist of IL-6 and CRP, consistent with prior research on inflammation and neurodevelopment. | Baseline | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | 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. | Baseline, 24 months | |
Secondary | 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. | 24 months | |
Secondary | 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. | Baseline | |
Secondary | 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. | 24 months |
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