Supplemental cash transfer for Inflammation

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
UNIFESP, São Paulo, Brazil
Inflammation+3 More
Supplemental cash transfer - Other
Eligibility
18 - 65
All Sexes
What conditions do you have?
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Study Summary

This trial will test whether giving cash to families of school-age children protects them from adversities and improves neurodevelopment. In this trial, supplemental cash transfer will be used to treat inflammation. No patients will receive a placebo. This is because supplemental cash transfer has previously been approved by the FDA for a different condition.

Eligible Conditions

  • Relations, Family
  • HPA
  • Inflammation
  • CBCL

Treatment Effectiveness

Study Objectives

20 Primary · 4 Secondary · Reporting Duration: 24 months

24 months
Biospecimen - Blood Draw - Change in CRP
Biospecimen - Blood Draw - Change in IL-6
Biospecimen - Changes in Child hair sample
Change in Family Adaptability and Cohesion Evaluation Scale-III (FACES-III)
Changes in Access to health care
Changes in Child brain MRI scan
Changes in Food insecurity
Changes in Home observation/environment
6 months post-RCT
Changes in Adverse Childhood Experiences (ACEs) - FHE
6 months-post RCT
Changes in Adverse Childhood Experiences (ACEs) - CTC
Changes in Child Executive Function
Changes in Child internalizing and externalizing symptoms
Baseline
Access to health care
Adverse Childhood Experiences (ACEs) - CTC
Adverse Childhood Experiences (ACEs) - FHE
Biospecimen - Blood Draw - CRP
Biospecimen - Blood Draw - IL-6
Biospecimen - Child hair sample
Child Executive Function
Child brain MRI scan
Child internalizing and externalizing symptoms
Family Adaptability and Cohesion Evaluation Scale-III (FACES-III)
Home observation/environment
Baseline, 24 months
Food insecurity

Trial Safety

Trial Design

2 Treatment Groups

Control
1 of 2
Intervention
1 of 2
Active Control
Experimental Treatment

450 Total Participants · 2 Treatment Groups

Primary Treatment: Supplemental cash transfer · No Placebo Group · N/A

Intervention
Other
Experimental Group · 1 Intervention: Supplemental cash transfer · Intervention Types: Other
ControlNoIntervention Group · 1 Intervention: Control · Intervention Types:

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 24 months
Closest Location: New York State Psychiatric Institute · New York, NY
Photo of New York 1Photo of New York 2Photo of New York 3
2001First Recorded Clinical Trial
1 TrialsResearching Inflammation
213 CompletedClinical Trials

Who is running the clinical trial?

National Institute of Mental Health (NIMH)NIH
2,492 Previous Clinical Trials
1,765,965 Total Patients Enrolled
11 Trials studying Inflammation
772 Patients Enrolled for Inflammation
New York State Psychiatric InstituteLead Sponsor
453 Previous Clinical Trials
135,548 Total Patients Enrolled
4 Trials studying Inflammation
567 Patients Enrolled for Inflammation
Cristiane Duarte, PhDPrincipal InvestigatorNew York State Psychiatric Institute
1 Previous Clinical Trials
40 Total Patients Enrolled
Andrea Jackowsi, PhDPrincipal InvestigatorFederal University of São Paulo
Jonathan Posner, MDPrincipal InvestigatorDuke University
1 Previous Clinical Trials
38 Total Patients Enrolled

Eligibility Criteria

Age 18 - 65 · All Participants · 4 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.