Cash Transfers for Child Neurodevelopment

Recruiting at 1 trial location

Overseen By Cristiane Duarte, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: New York State Psychiatric Institute

Disqualifiers: Major Axis I disorder, MRI contradictions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

450 Participants Needed

Trial Summary

What is the purpose of 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.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Supplemental cash transfer for child neurodevelopment?

Research shows that cash transfer programs can improve child health and nutrition by providing financial support to families, which helps them access better food and healthcare. These programs have been associated with positive outcomes like improved child growth and reduced malnutrition in low- and middle-income countries. ^{1 2 3 4 5}

How does the treatment of supplemental cash transfer differ from other treatments for child neurodevelopment?

Supplemental cash transfers are unique because they provide financial support to families, which can improve child health and development by enhancing access to better nutrition, healthcare, and educational resources. Unlike traditional medical treatments, this approach addresses the socio-economic factors that can influence a child's development. ^{1 2 3 5 6}

Research Team

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

Principal Investigator

New York State Psychiatric Institute

Eligibility Criteria

This trial is for mothers aged 23-45 in Brazil with at least one child aged 7-10, already receiving Auxilio Brasil cash transfers. They must be able to give consent and have a willingness to participate along with their child.

Inclusion Criteria

Mother: Able to consent

Mother: Receiving AB cash transfers

I am a mother with a child aged 7-10.

Exclusion Criteria

Mother: Mother and child do not reside in the same household

Child: Does not reside in the same household as the mother

Child: ADHD and disruptive behavior disorders will not be exclusionary because of their high prevalence

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Initial assessments including MRI scans, biospecimen collection, and behavioral evaluations

1 month

1 visit (in-person)

Intervention

Families receive either high or low supplemental cash transfers for 24 months

24 months

Periodic assessments at 8, 16, and 24 months

Follow-up

Participants are monitored for changes in neurodevelopmental and mental health outcomes post-intervention

6 months

1 visit (in-person)

Treatment Details

Interventions

• Supplemental cash transfer

Trial Overview The study tests if giving extra money ($40 vs $2 per month) to families can protect children's brain development and mental health. It randomly assigns families to receive different amounts of cash for two years, then checks the effects on kids' stress levels and behavior.

Participant Groups

Group I: Intervention Experimental Treatment 1 Intervention

High supplemental transfer: $40 a month

Group II: Control Active Control 1 Intervention

Low supplemental transfer: $2 a month

Who Is Running the Clinical Trial?

New York State Psychiatric Institute

Lead Sponsor

Trials

481

Recruited

154,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

References

1. England pubmed.ncbi.nlm.nih.gov

Effects of unconditional cash transfers on the outcome of treatment for severe acute malnutrition (SAM): a cluster-randomised trial in the Democratic Republic of the Congo. [2022]

2. England pubmed.ncbi.nlm.nih.gov

More evidence on cash transfers and child nutritional outcomes: a systematic review and meta-analysis. [2022]

3. Brazil pubmed.ncbi.nlm.nih.gov

Impact of cash transfer programs on birth and child growth outcomes: systematic review. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of cash-plus programmes on early childhood outcomes compared to cash transfers alone: A systematic review and meta-analysis in low- and middle-income countries. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Child Support Grant access and receipt among 12-week-old infants in an urban township setting in South Africa. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Effect of Ecuador's cash transfer program (Bono de Desarrollo Humano) on child development in infants and toddlers: a randomized effectiveness trial. [2011]