About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

Supplemental cash transfer
Other intervention
Supplemental cash transfer ($40/month)

Treatment groups

450 Participants

are divided into 2 treatment groups

Group A: InterventionExperimental treatment 1 intervention

Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame

Baseline

2

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.

Time frame

8 months

3

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.

Time frame

16 months

4

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.

Time frame

24 months

Secondary outcomes

1

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.

Time frame

Baseline, 24 months

2

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.

Time frame

24 months

3

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.

Time frame

Baseline

4

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.

Time frame

24 months

Impacts of Cash Transfers on Child Neurodevelopment (Auxilio Brasil)

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts