Active — Not RecruitingNot Applicable

Testing FIRST in Youth Outpatient Psychotherapy

United States212 participantsStarted 2021-09-27

Plain-language summary

The study will compare the impact FIRST (a transdiagnostic treatment built upon five empirically supported principles of change) versus usual care outpatient psychotherapy on youths' mental health outcomes and a candidate mechanism of change: regulation of negative emotions.

Who can participate

Age range7 Years – 15 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Child Behavior Checklist (CBCL; Achenbach & Rescorla, 2001) and Youth Self-Report (YSR; Achenbach & Rescorla, 2001)

Timeframe: Change from baseline to 18 months (quarterly at 0, 3, 6, 9, 12, and 18 months from 0 up to 78 weeks)

Behavior and Feelings Survey (BFS; Weisz et al., 2020)

Timeframe: Change from baseline through end of treatment (weekly from 0 up to 78 weeks)

Functional Top Problems Assessment (TPA; Weisz et al., 2011)

Timeframe: Change from baseline through end of treatment (weekly from 0 up to 78 weeks)

Trial details

NCT IDNCT04725721

SponsorHarvard University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-02

View on ClinicalTrials.gov More Anxiety trials

Who can participate

Age range7 Years – 15 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Child Behavior Checklist (CBCL; Achenbach & Rescorla, 2001) and Youth Self-Report (YSR; Achenbach & Rescorla, 2001)

Timeframe: Change from baseline to 18 months (quarterly at 0, 3, 6, 9, 12, and 18 months from 0 up to 78 weeks)

Behavior and Feelings Survey (BFS; Weisz et al., 2020)

Timeframe: Change from baseline through end of treatment (weekly from 0 up to 78 weeks)

Functional Top Problems Assessment (TPA; Weisz et al., 2011)

Timeframe: Change from baseline through end of treatment (weekly from 0 up to 78 weeks)