Testing FIRST in Youth Outpatient Psychotherapy

Not Applicable

Recruiting

• Conditions: Behavior Problem; Depression; Trauma; Anxiety
• Interventions: Behavioral: Usual Care; Behavioral: FIRST

• Registration Number: NCT04725721
• Lead Sponsor: Harvard University

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.

Study Timeline

• Study First Submitted: 2021-01-10
• Study First Submitted QC: 2021-01-23
• Study First Posted: 2021-01-27
• Study Start: 2021-09-27
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-08
• Last Update Posted: 2024-10-10
• Primary Completion: 2026-02
• Study Completion: 2026-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 212

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual Care	Usual Care	Treatment in the usual care (UC) condition will use the clinical procedures therapists consider appropriate and believe to be effective.
FIRST	FIRST	FIRST is built upon five empirically supported principles of change (ESPCs-i.e., feeling calm, increasing motivation, repairing thoughts, solving problems, trying the opposite). Each principle can be applied to treatment of problems spanning depression, anxiety (including OCD and PTS), and conduct problems-thus encompassing a majority of the youths seen in outpatient care. Its design addresses breadth of problem coverage, youth comorbidity, and flux in youth treatment needs during episodes of care. It is used in conjunction with performance feedback via a web-based tracking system that gives clinicians weekly data on youth treatment response. FIRST has treatment and training efficiency, and efficient clinician skill-building is supported by group consultation.

Primary Outcome Measures

Name	Time	Method
Child Behavior Checklist (CBCL; Achenbach & Rescorla, 2001) and Youth Self-Report (YSR; Achenbach & Rescorla, 2001)	Change from baseline to 18 months (quarterly at 0, 3, 6, 9, 12, and 18 months from 0 up to 78 weeks)	The CBCL is a parent-report checklist with 113 youth problem items, each rated on a 0-1-2 scale (0 = not true, 1 = somewhat/sometimes true, 2 = very often true). The YSR is a corresponding 112-item youth-report checklist measure. From both the CBCL and the YSR, T-scores, adjusted for age and gender, Internalizing, Externalizing, and Total Problems scales will be used for outcome assessment. Higher scores represent more severe problems, with borderline and clinical cutoffs at T = 60 and T = 63, respectively. Evidence of CBCL/YSR validity and reliability is strong and extensive.
Behavior and Feelings Survey (BFS; Weisz et al., 2020)	Change from baseline through end of treatment (weekly from 0 up to 78 weeks)	The 12-item BFS is a measure of internalizing (6 items), externalizing (6 items), and total problems, developed via four studies, three with samples of clinically referred youths aged 7-15 and their caregivers. Both youth and caregiver forms showed robust factor structure, internal consistency, test-retest reliability, convergent and discriminant validity in relation to three well-established symptom measures (including CBCL and YSR), and slopes of change indicating efficacy in monitoring treatment progress during therapy. Items are rated on a scale from 0 (not a problem) to 4 (a very big problem). Internalizing and externalizing scale scores range from 0 to 24 and total problems from 0 to 48 (with higher scores indicating greater problem severity).
Functional Top Problems Assessment (TPA; Weisz et al., 2011)	Change from baseline through end of treatment (weekly from 0 up to 78 weeks)	The TPA assesses youth and caregiver severity ratings (from 0 = not a problem to 4 = a very big problem) for the functional top three problems the youth and caregiver independently identified as most important to them, in separate baseline interviews. Psychometric analyses have shown strong test-retest reliability, convergent and discriminant validity for the TPA in relation to standardized measures, and sensitivity to change during treatment.

Secondary Outcome Measures

Name	Time	Method
Positive and Negative Affect Schedule Short Form (PANAS-C/P-SF; Laurent et al., 1999; Ebesutani et al., 2011)	Change from baseline through end of treatment (weekly from 0 up to 78 weeks)	Derived from the original Positive and Negative Affect Schedule, the brief 10-item PANAS includes 5 adjectives for positive affect (joyful, cheerful, happy, lively, proud) and 5 for negative affect (miserable, mad, afraid, scared, sad), on which youth and their parents report the extent to which they felt each on a 5- point Likert scale from 1 (very slightly or not at all) to 5 (extremely). Evidence of convergent and divergent validity of both the positive and negative affect scale scores with reports of anxiety and depressive symptoms has been found as well as good internal consistency of both scales. The 10-item version has shown similar validity and reliability properties and superior measurement properties as compared to the 27-item version. Total positive and negative affect scale scores range from 5 to 25, such that higher scores reflect stronger endorsement of positive or negative mood states.
Coping Questionnaire (CQ; Crane & Kendall, 2020)	Change from baseline through end of treatment (weekly from 0 up to 78 weeks)	The CQ was developed in the context of the youth anxiety treatment research to assess youth and caregiver ratings of the youths' ability to regulate the emotional arousal associated with anxiety disorders. The CQ procedure is both idiographic (each youth and each caregiver identifies three situations that make the youth most upset) and standardized (each youth and each caregiver then rates, for each situation, the youth's ability "to make yourself (or himself/herself) feel less upset" on a 1 to 7 Likert scale). This simple measure, tested with a sample of 442 7-17 year-olds, showed good evidence of internal consistency, convergent and divergent validity in relation to measures of psychopathology and functioning, and criterion validity in its association with clinical severity ratings of the youths' principle diagnosis on a standardized diagnostic interview.
Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID parent version; Sheehan et al., 2010)	Change from baseline (0 months) to end of treatment (up to 78 weeks)	The parent version of the MINI-KID is a structured diagnostic interview for DSM-IV and ICD-10 youth psychiatric disorders. It has been shown to provide efficient and highly reliable and valid diagnoses.
UCLA PTSD Reaction Index (PTSDRI; Steinberg et al., 2004)	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)	The PTSDRI has been widely used to assess PTS symptoms in children and teens. Various studies have shown good evidence of internal consistency, test-retest reliability, and validity relative to both degree of exposure to traumas and to PTSD diagnoses on standardized interviews.

Trial Locations

Locations (2)

Harvard University; 🇺🇸 Cambridge, Massachusetts, United States

University of Texas at Austin; 🇺🇸 Austin, Texas, United States