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Search / Trial NCT04725721

Testing FIRST in Youth Outpatient Psychotherapy

Launched by HARVARD UNIVERSITY · Jan 23, 2021

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Anxiety Depression Trauma Behavior Problems Youth Mental Health Emotion Regulation

ClinConnect Summary

This clinical trial is studying a new treatment called FIRST, which stands for "Focused Interventions for Stressful Transitions," to see how it helps young people with mental health issues like anxiety, depression, trauma, and behavior problems. FIRST is designed to work on common emotional challenges and is being compared to regular therapy to determine which is more effective in improving mental health and managing negative emotions.

The trial is looking for children and teenagers aged 7 to 15 who show signs of anxiety, depression, or other behavioral issues. To participate, they need to speak English and have scores that indicate they are experiencing significant mental health challenges. However, those with serious issues like current suicide risk, certain eating disorders, or other specific diagnoses won’t be eligible. Participants will receive either the FIRST treatment or usual care and will be monitored to see how their mental health improves over time. This is a great opportunity for eligible youths to receive support while contributing to important research in mental health treatments.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • ages 7.0-15.9 years
  • at least one clinically-relevant CBCL subscale score indicating borderline/clinical-range anxiety, depression, conduct problems, or post-traumatic stress
  • English fluency indicated by taking all school classes in English
  • Exclusion Criteria:
  • current suicide risk, operationalized as active suicidal ideation or a history of suicide attempt or inpatient hospitalization for suicide risk within the last 3 months
  • presence of an eating disorder, schizophrenia spectrum disorder, autism spectrum disorder, or intellectual disability requiring special class placement in school
  • referral for ADHD if specifically and exclusively to address inattentiveness and/or hyperactivity-impulsivity

About Harvard University

Harvard University, a prestigious Ivy League institution, is a leading sponsor of clinical trials, dedicated to advancing medical research and improving patient outcomes. With a strong emphasis on innovation and interdisciplinary collaboration, Harvard leverages its world-class faculty, cutting-edge facilities, and extensive resources to conduct rigorous clinical studies across various fields, including medicine, public health, and biomedical sciences. The university is committed to adhering to the highest ethical standards and regulatory guidelines, ensuring the safety and well-being of participants while contributing valuable insights to the global healthcare community. Through its clinical research initiatives, Harvard aims to translate scientific discoveries into effective treatments and preventive strategies that address pressing health challenges.

Locations

Cambridge, Massachusetts, United States

Austin, Texas, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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