Comparing a new therapy approach to standard outpatient care for youth mental health
Testing FIRST in Youth Outpatient Psychotherapy
This study is testing a new therapy for kids and teens with mental health challenges to see if it works better than regular outpatient care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 212 (estimated) |
| Ages | 7 Years to 15 Years |
| Sex | All |
| Sponsor | Harvard University Academic / other |
| Locations | 2 sites (Cambridge, Massachusetts and 1 other locations) |
| Trial ID | NCT04725721 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of FIRST, a transdiagnostic treatment designed for children and adolescents facing various mental health challenges, compared to usual outpatient psychotherapy. The approach focuses on five empirically supported principles of change that can address issues like anxiety, depression, trauma, and behavior problems. By utilizing a randomized controlled trial design, the study will assess mental health outcomes and explore mechanisms of change, particularly the regulation of negative emotions. Participants will include ethnically and economically diverse youths aged 7-15 from community clinics in Boston and Austin, all referred by their families for elevated mental health concerns.
Who should consider this trial
Good fit: Ideal candidates are youths aged 7-15 with clinically relevant anxiety, depression, or behavior problems.
Not a fit: Patients currently at risk for suicide or with specific disorders like eating disorders or autism may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for youths struggling with multiple mental health issues.
How similar studies have performed: Previous trials of the FIRST approach have shown promising results, indicating potential for success in this larger effectiveness trial.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Cambridge, Massachusetts and 1 other locations
- Harvard University — Cambridge, Massachusetts, United States (Recruiting)
- University of Texas at Austin — Austin, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Olivia Petersen, B.A.
- Email: opetersen@fas.harvard.edu
- Phone: (617) 495-3832
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.