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Impacts of Cash Transfers on Child Neurodevelopment (Auxilio Brasil)

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Notable Primary completion date: Dec 1, 2027 to Jun 30, 2028
    • Study completion date: Jan 1, 2028 to Jan 31, 2029
    • Start date: May 17, 2025 to May 28, 2025
    v20
  2. Notable Trial status: Not Yet Recruiting to Recruiting
    • Site details revised at 2 of 2 sites
    • Eligibility criteria shortened, about 1 word
    v19
  3. Minor Start date: May 19, 2025 to May 17, 2025
    • Site contacts updated at 1 of 2 sites
    v18
  4. Notable Start date: Apr 1, 2025 to May 19, 2025v17
  5. Notable Start date: Feb 1, 2025 to Apr 1, 2025v16
Show 14 earlier versionsHide 14 earlier versions
  1. Notable Start date: Oct 1, 2024 to Feb 1, 2025v15
  2. Notable Start date: Jun 1, 2024 to Oct 1, 2024v14
  3. Notable Start date: Jan 31, 2024 to Jun 1, 2024v13
  4. Notable Start date: Dec 15, 2023 to Jan 31, 2024v12
  5. Notable Start date: Oct 15, 2023 to Dec 15, 2023v11
  6. Notable Start date: Sep 15, 2023 to Oct 15, 2023v10
  7. Notable Start date: Aug 1, 2023 to Sep 15, 2023v9
  8. Minor Re-verified, no change to tracked fieldsv8
  9. Notable Start date: Jun 1, 2023 to Aug 1, 2023v7
  10. Notable Start date: Apr 1, 2023 to Jun 1, 2023v6
  11. Minor Re-verified, no change to tracked fieldsv5
  12. Notable Start date: Feb 1, 2023 to Apr 1, 2023v4
  13. Notable Start date: Jan 1, 2023 to Feb 1, 2023v3
  14. Notable Primary completion date: Aug 1, 2026 to Dec 1, 2027v2 Show 4 more changesShow less
    • Start date: Sep 1, 2022 to Jan 1, 2023
    • Trial status: Recruiting to Not Yet Recruiting
    • Study completion date: Dec 1, 2027 to Jan 1, 2028
    • Site details revised at 2 of 2 sites
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05477901
Lead Sponsor New York State Psychiatric Institute
Collaborators: National Institute of Mental Health (NIMH)
Conditions
(from sponsor)
Inflammation, HPA, CBCL, Family Relations
Related terms Inflammation
Enrollment 450 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov