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临床试验/NCT04725721
NCT04725721进行中(未招募)不适用

Testing FIRST in Youth Outpatient Psychotherapy

Harvard University4 个研究点 分布在 1 个国家目标入组 212 人开始时间: 2021年9月27日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
212
试验地点
4
主要终点
Child Behavior Checklist (CBCL; Achenbach & Rescorla, 2001) and Youth Self-Report (YSR; Achenbach & Rescorla, 2001)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
7 Years 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

FIRST

Experimental

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.

干预措施: FIRST (Behavioral)

Usual Care

Active Comparator

Treatment in the usual care (UC) condition will use the clinical procedures therapists consider appropriate and believe to be effective.

干预措施: Usual Care (Behavioral)

结局指标

主要结局

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

时间窗: 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)

时间窗: 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)

时间窗: 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.

次要结局

  • 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))
  • Coping Questionnaire (CQ; Crane & Kendall, 2020)(Change from baseline through end of treatment (weekly from 0 up to 78 weeks))
  • 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))
  • 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))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

John Weisz

Professor

Harvard University

研究点 (4)

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