Testing FIRST in Youth Outpatient Psychotherapy

  • STATUS
    Recruiting
  • End date
    Feb 25, 2026
  • participants needed
    212
  • sponsor
    Harvard University
Updated on 25 October 2021
anxiety
depressed mood
psychotherapy

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.

Description

Children and adolescents (herein "youths") treated in outpatient mental health care span a broad range of problems and disorders, with substantial comorbidity, and their most pressing problems and treatment needs may shift during treatment. These challenges may be addressed by treatment that is flexible and transdiagnostic (i.e., applicable to multiple mental health problems and disorders). A recent transdiagnostic treatment, FIRST, created in collaboration with community practitioners and intervention scientists, uses a principle-based approach to support efficient learning and implementation by clinicians. FIRST is built upon five empirically supported principles of change (e.g., calming, problem solving), each applicable to treatment of depression, anxiety/OCD, trauma, and misconduct. Three open benchmarking trials of FIRST, using low-cost clinician training and group consultation, have shown steep slopes of clinical improvement in youths treated in outpatient clinics.

This randomized controlled effectiveness trial will provide a more definitive test of FIRST, an initial investigation of a candidate mechanism of change, and tests of therapist characteristics that may predict and moderate implementation of evidence-based practices. The sample will be ethnically and economically diverse youths, ages 7-15, from four community clinics-two in greater Boston MA, two in greater Austin TX-all referred by their families and all showing elevated depression, anxiety/OCD, post-traumatic stress, or conduct problems. Clinicians within each clinic will be randomly assigned to learn and use FIRST or to employ Usual Care (UC), and youths will be randomized to treatment by FIRST or UC clinicians. Clinical outcomes will include change on standardized measures of mental health and on severity of the specific problems identified as most important by each youth and each caregiver at baseline. Study measures will include a proposed mechanism-regulation of negative emotions- thought to be responsive to treatment and responsible for changes in mental health. Analyses will assess whether treatment with FIRST impacts regulation, and whether improved regulation accounts for outcomes of FIRST treatment relative to UC. Finally, the study will investigate whether clinicians' baseline knowledge of, attitudes toward, and motivation to use evidence-based practices predicts or moderates their implementation of such practices in psychotherapy. The study will thus provide the first randomized trial of this new practice-adapted transdiagnostic treatment, plus an inquiry into the process through which it may work and therapist factors that may strengthen or weaken implementation.

Details
Condition Generalized Anxiety Disorder (GAD), Anxiety Disorders, Wounds - qualifier, Problem Behavior, traumatic injury, miserable, Anxiety Disorders (Pediatric), Behavior Problems, depressed mood, depressive disorders, Endogenous depression, Anxiety, Depression (Treatment-Resistant), Depression (Adult and Geriatric), traumatic disorder, Depressed, Wounds, Behavioral Changes, anxiety disorder, Behavior Problem, behavioral problems, Depression (Major/Severe), Trauma, Behavioural Problems, Depression (Adolescent), Anxiety Symptoms, behavioral disturbances, ANXIETY NEUROSIS, depressive disorder, abnormal behavior, anxious, Generalized Anxiety Disorder (GAD - Pediatric), Depression (Pediatric), Depression
Treatment Usual Care, FIRST
Clinical Study IdentifierNCT04725721
SponsorHarvard University
Last Modified on25 October 2021

Eligibility

Yes No Not Sure

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
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