Clinical trial NCT04725721: Testing FIRST in Youth Outpatient Psychotherapy
Official title: Testing FIRST in Youth Outpatient Psychotherapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anxiety
Depression
Trauma
Behavior Problem
Keywords: anxiety
depression
trauma
behavior problems
youth
mental health
emotion regulation
Lead sponsor: Harvard University
Sponsor class: OTHER
Collaborators: name: University of Texas at Austin
First posted: 2021-01-27
Enrollment: 212
Sex: ALL
Minimum age (years): 7
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

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

Primary outcomes:
measure: 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)
measure: Behavior and Feelings Survey (BFS; Weisz et al., 2020)
timeFrame: Change from baseline through end of treatment (weekly from 0 up to 78 weeks)
measure: Functional Top Problems Assessment (TPA; Weisz et al., 2011)
timeFrame: Change from baseline through end of treatment (weekly from 0 up to 78 weeks)
Secondary outcomes:
measure: Positive and Negative Affect Schedule Short Form (PANAS-C/P-SF; Laurent et al., 1999; Ebesutani et al., 2011)
timeFrame: Change from baseline through end of treatment (weekly from 0 up to 78 weeks)
measure: Coping Questionnaire (CQ; Crane & Kendall, 2020)
timeFrame: Change from baseline through end of treatment (weekly from 0 up to 78 weeks)
measure: Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID parent version; Sheehan et al., 2010)
timeFrame: Change from baseline (0 months) to end of treatment (up to 78 weeks)
measure: UCLA PTSD Reaction Index (PTSDRI; Steinberg et al., 2004)
timeFrame: Baseline for entire sample; quarterly (3, 6, 9, 12, and 18 months) for up to 18 months for those with elevated baseline PTS symptoms (from 0 up to 78 weeks)
Other outcomes:
measure: Evidence-Based Practice Attitudes Scale (EBPAS-15; Aarons, 2004)
timeFrame: Baseline
measure: Evidence-Based Treatment Intentions (EBTI; Williams, 2015)
timeFrame: Baseline
measure: Knowledge of Evidence Based Services Questionnaire (KEBS-Q; Stumpf et al., 2009)
timeFrame: Baseline, post-training (approx 2 weeks after training)
measure: Therapeutic Alliance Scale for Children and Caregivers/Parents(TASC-r; Shirk et al., 2011; TASCP; Accurso et al., 2013)
timeFrame: Monthly beginning after first session through end of treatment (every 4 weeks from 0 up to 78 weeks)
measure: Therapy Process Observational Coding System-Alliance Scale (TPOCS-A; McLeod & Weisz, 2005)
timeFrame: Assessed throughout treatment via observational coding (ongoing from 0 up to 78 weeks)
measure: Therapist Satisfaction Index (TSI; Chorpita et al., 2015)
timeFrame: Immediately after treatment
measure: Parent and Child Satisfaction Scales (PCSS)
timeFrame: At first quarterly assessment after treatment ends (up to 78 weeks)
measure: Therapist Integrity in Evidence-Based Interventions (TIEBI; Jensen et al., 2004)
timeFrame: Assessed throughout treatment via observational coding (ongoing from 0 up to 78 weeks)
measure: Engagement of families in treatment
timeFrame: Post-treatment (up to 78 weeks)
measure: Perceptions of Supervisory Support Scale (PSSS; Fukui et al., 2014)
timeFrame: Post-treatment (up to 78 weeks)
measure: TCU Organizational Readiness for Change (TCU-ORC; Organizational Climate Scale; Institute of Behavioral Research, 2009)
timeFrame: Baseline
Locations:
city: Cambridge
country: United States
facility: Harvard University
state: Massachusetts
city: Austin
country: United States
facility: University of Texas at Austin
state: Texas
Study officials:
References:
citation: Cho E, Bearman SK, Woo R, Weisz JR, Hawley KM. A Second and Third Look at FIRST: Testing Adaptations of A Principle-Guided Youth Psychotherapy. J Clin Child Adolesc Psychol. 2021 Nov-Dec;50(6):919-932. doi: 10.1080/15374416.2020.1796678. Epub 2020 Aug 7.
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