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Clinical Trials/NCT06968949
NCT06968949Not yet recruitingNot Applicable

Collaborative Redesign of Implementation Strategies for the Brief Intervention for School Clinicians (BRISC)

University of Washington0 sites60 target enrollmentStarted: May 30, 2025Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
60
Primary Endpoint
Implementation Strategy Usability Scale (ISUS)

Study Overview

Brief Summary

Schools are the most common venue for youth mental health services, but school mental health (SMH) typically does not use evidence-based clinical interventions (CI), common elements of effective mental health, or effective implementation strategies. To address this gap, a multidisciplinary team developed the Brief Intervention for School Clinicians (BRISC), a four-session engagement, brief intervention, and triage strategy targeting a range of mental health (e.g., anxiety, depression, past trauma) and other problems (academic, peer, family). BRISC outperformed SMH usual care on engagement, treatment completion, and youth self-reported problem severity. Although there are many evidence-based SMH strategies such as BRISC, integration into practice is poor because accompanying implementation strategies are often absent, poorly defined, or insufficiently tailored to the education context.

Detailed Description

The investigators will evaluate the impact of original BRISC (BR-O) implementation versus adapted BRISC (BR-A) implementation for students referred to SMH on mental health outcomes (i.e., student top problems, anxiety, depression, mental health functioning). The investigators hypothesize:

H-1: In both BR-O and BR-A, more students will experience clinical improvement on mental health outcomes (i.e., top problems, anxiety, depression, mental health functioning) than deteriorate or remain unchanged.

H-2: BR-A will demonstrate noninferiority to BR-O on mental health outcomes.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
13 Years to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Clinician participants: Counselors will be included if they (a) provide school-based services; (b) have not previously received formal training in BRISC; and (c) are not actively receiving support to implement another intervention.
  • •Youth participants: Students must meet eligibility criteria for BRISC including (a) being in grades 9-12 and 13 years or older (b) receiving school mental health services

Exclusion Criteria

  • •Anyone not meeting inclusion criteria.

Arms & Interventions

Unadapted Brief Intervention for School Clinicians (BRISC; BR-O)

Active Comparator

Participants in this arm will receive unadapted Brief Intervention for School Clinicians (BRISC), a four-session engagement, brief intervention, and triage strategy targeting a range of mental health (e.g., anxiety, depression, past trauma) and other problems (academic, peer, family).

Intervention: Unadapted Brief Intervention for School Clinicians (BRISC; BR-O) (Behavioral)

BRISC with Implementation Strategies Adapted for School Practitioners (BR-A)

Experimental

Participants in this arm will Brief Intervention for School Clinicians (BRISC) with implementation strategies adapted for school-employed practitioners (BR-A).

Intervention: Brief Intervention for School Clinicians (BRISC) with Implementation Strategies Adapted for School-Employed Practitioners (BR-A) (Behavioral)

Outcomes

Primary Outcomes

Implementation Strategy Usability Scale (ISUS)

Time Frame: Post-training, End of Year 1

Usability will be evaluated with the 10-item Implementation Strategy Usability Scale (ISUS), which is based closely on the well-validated System Usability Scale. Ratings are on a 1 to 5 scale and yield a total score from 0 to 100. Half the items are reverse scored; higher total scores reflect greater usability. The ISUS has good inter-item consistency (a = .83) and sensitivity. Research has also demonstrated that the original version of the ISUS (the SUS) functions similarly - and yields similar scores - for adults and youth.

Participant Responsiveness Scale (PRS)

Time Frame: Post-training, End of Year 1

Engagement will be measured using the Participant Responsiveness Scale (PRS), an adapted version of the 12-item Patient Responsiveness Scale tailored to be developmentally appropriate for children aged 8 and above as well as adults. The PRS measures two factors, Participation and Enthusiasm. The original Patient Responsiveness Scale has demonstrated strong reliability (a = .86) and construct validity.

Intervention Appropriateness Measure (IAM)

Time Frame: Baseline, 3 months, 6 months

The Intervention Appropriateness Measure (IAM) is a rigorously developed, pragmatic instrument with strong good internal consistency (a = .87) and test-retest reliability (a = .87).

Adoption

Time Frame: Baseline, 3 months, 6 months

Adoption is operationalized as the initiation of a clinician first BR-0 or BR-A session at any point during study participation.

Reach

Time Frame: Baseline, 3 months, 6 months

Reach will be calculated using adoption data as the percentage of clinicians caseloads receiving BR-O or BR-A.

Youth Top Problems (YTP)

Time Frame: Baseline, 3 months, 6 months

The Youth Top Problems (YTP) assessment is an assessment in which youth and caregivers are asked to list the problems they were most concerned about. Upon completion of the list, respondents are asked to assign a severity rating for each problem by answering the questions: how big of a problem is this for you? (0 = not at all to 10 = very, very much). Respondents are then asked to identify which of the problems listed is the biggest problem right now? Which one is the most important to work on? Then the second and third most important until 3 top problems are identified. The YTP shows excellent concurrence with standardized assessments (Kappa ranging from .78 to .91), while also adding specificity for treatment targets (41% of caregivers-, and 79% of youth-identified top problems were not identified by an item amongst elevated standardized assessment subscales).

Therapeutic Alliance Scale for Adolescents (TASA)

Time Frame: Baseline, 3 months, 6 months

Therapeutic Alliance Scale for Adolescents (TASA) is a widely used rating scale designed to measure the working alliance between clinicians and their adolescent clients. Youth and Counselor forms will be used. Both include 12 seven-point Likert Scale items covering three domains: bond, goals, and tasks.

Treatment Completion/Triage

Time Frame: End of study

A measure of treatment efficiency, records will be reviewed of treatment disposition after 4 sessions, as well as triage to school/community services/supports.

Patient Health Questionnaire (PHQ-8 for Adolescent)

Time Frame: Baseline, 3 months, 6 months

The Patient Health Questionnaire is one of the most used short depression measures. We will use the Adolescent adopted version of the PHQ-8, which removes the 9th item regarding suicide, which is commonly done in research settings where follow-up may be delayed; this has only minor effect on scoring and does not impact scoring interpretations. The PHQ features 8 items on a four-point scale (0=not at all, 1=several days, 2=more than half the days, 3=nearly everyday) with cutpoints for 5, 10, 15, and 20 representing mild, moderate, moderately severe, and severe levels of depressive symptoms. Four original validation studies were conducted on nearly 10,000 patients, and there have been multiple meta-analyses. Scores have been found valid, with sensitivity of 88% and specificity of 88% for a cutpoint of 10 has been found for Major Depressive Disorders.

Generalized Anxiety Disorder-7 scale (GAD-7)

Time Frame: Baseline, 3 months, 6 months

Generalized Anxiety Disorder-7 scale (GAD-7) is a brief scale that queries about anxiety symptoms. Normative data for the GAD-7 included a large sample of adolescents aged 14-25 years (n = 634) that concluded the measure demonstrated age invariance, reliability, and internal consistency.

Columbia Impairment Scale (CIS)

Time Frame: Baseline, 3 months, 6 months

The Columbia Impairment Scale (CIS) is a 13-item scale that measures adolescents level of adaptive functioning. The scale was used in the NIMH Methods for the Epidemiology of Child and Adolescent Mental Disorders (MECA) study and showed good reliability and validity. It is also correlated with other indicators of psychological distress and with standardized clinician ratings.

Quality of Life in Neurological Disorders Social Relations scale (Neuro-QOL)

Time Frame: Baseline, 3 months, 6 months

The Quality of Life in Neurological Disorders Social Relations scale (Neuro-QOL) is a widely used 8-item measure of functioning in usual social roles, activities, and responsibilities. Factor analyses and Item Response Theory analyses have ensured broad information parameters without differential item functioning by demographics. Scale scores have been validated and normed on thousands of participants in the US general and clinical inpatient and outpatient settings, presenting with a variety of problem areas. Scores provide a T score with a mean of 50 and SD of 10, aligned with a variety of norming samples. An example item stem is : In the past 7 days I am able to do all of my regular family activities. Response options are on a scale of 1 to 5(1=never, 2=rarely, 3=sometimes, 4=often, 5=always).

Academic Progress Self-Report

Time Frame: Baseline, 3 months, 6 months

Academic Progress Self-Report is a form successfully employed in other studies of school-based services by the research team to gauge academic success in areas such as homework completion, attendance, tardies, disciplinary action, and praise or discipline from school staff.

Secondary Outcomes

  • BRISC External Rating Tool (BECT)(Baseline, 3 months, 6 months)
  • Framework for Modifications and Adaptations of Evidence-Based Interventions(Baseline, 3 months, 6 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Eric Bruns

Professor, School of Medicine: Psychiatry

University of Washington

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