Collaborative Redesign of Implementation Strategies for the Brief Intervention for School Clinicians

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 13 years and older
• All sexes
• No healthy volunteers
• Child, Adult, Older adult

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

About this study

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

Conditions

Anxiety Disorders, Depressive Symptoms, Mental Health Issue

Being tested

Unadapted Brief Intervention for School Clinicians (BRISC; BR-O), Brief Intervention for School Clinicians (BRISC) with Implementation Strategies Adapted for School-Employed Practitioners (BR-A)

Keywords

School Mental Health

Medical subject headings

Anxiety Disorders, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

  BRISC is a four-session, individual engagement, assessment, brief intervention and triage strategy for youth age 13-18. BRISC provides a research-based approach to improving structure, efficiency, and effectiveness of school mental health via five elements: (1) Stepped care/tiered structure; (2) Culturally-informed engagement and motivation strategies;(3) Systematic problem-solving framework; (4) Modularized common elements approach; and (5) Structured assessment and monitoring.BRISC is hypothesized to operate on specific mechanisms that influence improvements in efficiency and clinical outcomes.

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

  BR-A is a version of the Brief Intervention for School Clinicians with implementation strategies (IS) adapted for delivery by in the education sector by school-employed practitioners. Although IS modifications will be determined by Study 1 activities, we anticipate that BR-A may include changes to training pacing or format (e.g., asynchronous e-learning modules and videos); adaptations to format/content of consultation; and/ or addition of other ISs to enhance skills development (e.g., development of a learning collaborative) and/or overcome organizational or system barriers (e.g., educational outreach, changes to regulations). Core components of BRISC will be retained in the BR-A condition.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Implementation Strategy Usability Scale (ISUS)

   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.

   Measured: Post-training, End of Year 1

2. Participant Responsiveness Scale (PRS)

   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.

   Measured: Post-training, End of Year 1

3. Intervention Appropriateness Measure (IAM)

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

   Measured: Baseline, 3 months, 6 months

4. Adoption

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

   Measured: Baseline, 3 months, 6 months

5. Reach

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

   Measured: Baseline, 3 months, 6 months

6. Youth Top Problems (YTP)

   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).

   Measured: Baseline, 3 months, 6 months

7. Therapeutic Alliance Scale for Adolescents (TASA)

   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.

   Measured: Baseline, 3 months, 6 months

8. Treatment Completion/Triage

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

   Measured: End of study

9. Patient Health Questionnaire (PHQ-8 for Adolescent)

   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.

   Measured: Baseline, 3 months, 6 months

10. Generalized Anxiety Disorder-7 scale (GAD-7)

    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.

    Measured: Baseline, 3 months, 6 months

11. Columbia Impairment Scale (CIS)

    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.

    Measured: Baseline, 3 months, 6 months

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

    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).

    Measured: Baseline, 3 months, 6 months

13. Academic Progress Self-Report

    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.

    Measured: Baseline, 3 months, 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted13 May 2025
2. Study start30 May 2025 (estimated)
3. Primary completion1 Mar 2028 (estimated)
4. Study completion1 Mar 2028 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Anxiety DisordersStudies of the same condition, open and under way.
• More trials run by University of WashingtonThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.