Testing FIRST in Youth Outpatient Psychotherapy

Depression Clinical Trial

Official title: Testing FIRST in Youth Outpatient Psychotherapy

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 FIRST or UC. 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. ;

Related Conditions & MeSH terms

• Anxiety
• Behavior Problem
• Depression
• Problem Behavior
• Trauma

• NCT number: NCT04725721
• Study type: Interventional
• Source: Harvard University
• Contact: Olivia Petersen, B.A.
• Phone: (617) 495-3832
• Email: opetersen@fas.harvard.edu
• Status: Recruiting
• Phase: N/A
• Start date: September 27, 2021
• Completion date: February 2026