Efficacy of a Brief Intervention for School Clinicians (BRISC)

Academic Performance Clinical Trial

— BRISC  

Official title:

Efficacy of a Brief Intervention Strategy for School Mental Health Clinicians (BRISC)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03939208
• Other study ID #: 52229
• Secondary ID: R305A160111
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 1, 2016
• Est. completion date: June 30, 2019

Study information

• Verified date: May 2019
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Research shows that the majority of all mental health (MH) treatment for children is delivered in schools. Unfortunately, however, school mental health (SMH) providers rarely use evidence-based approaches and are often poorly integrated into the school context. Given the high (>20%) and increasing rates of MH disorders among children and youth, MH clinicians working in schools need effective and efficient ways to address student emotional and behavioral problems. The Brief Intervention Strategy for School Clinicians (BRISC) is a four-session, flexible, and research-informed "Tier 2" intervention tailored to high school students and designed to fit the school context. Findings from initial research funded by an IES Development and Innovation grant, including a small (n=66) comparison study, indicate positive, small to large sized effects (ES = .30- 1.33) in favor of BRISC for MH impairment, emotional symptoms, therapeutic alliance, coping skills, and client satisfaction. Moreover, even though the majority of students who were referred to BRISC were in the clinical range for functional impairment due to MH problems, over 50% were able to step down to lower levels of intervention after four sessions of BRISC, demonstrating promise for efficiency and reach. Given potential for public health impact, the purpose of the current study is to further examine the efficacy of BRISC by assessing its impact on mental health and academic outcomes - as well as feasibility, acceptability, and efficiency - in a larger, multi-site trial.

Description:

Fostering emotional and behavioral well-being is critical to school success, and research shows that over 70% of all mental health treatment for children is delivered in schools. Thus, school mental health (SMH) services are a fundamental component of our nation's strategy to ensure academic and life success of our children and youth. Unfortunately, SMH providers rarely use evidence-based approaches and are often poorly integrated into the school context. SMH providers carry large caseloads, experience time constraints, and serve youth with a broad array of needs. For SMH to live up to its potential, individuals who provide SMH treatment must be equipped with effective and efficient ways to address student emotional and behavioral needs.

The purpose of this project is to conduct a multi-site randomized controlled trial (RCT) of the Brief Intervention Strategy for School Clinicians (BRISC). BRISC is a fully developed, manualized intervention strategy for use by professionals working individually with high school students experiencing mental health symptoms or other emotional and behavioral stressors that negatively affect their ability to succeed academically. With funding from an IES Development and Innovation grant (R305A120128), BRISC was developed as a brief, evidence-based, and flexible "Tier 2" intervention designed to fit the high school context. Findings from a small (N=66) comparison study indicate positive, small to large sized effects (ES = .30 - 1.33) in favor of BRISC over SMH services as usual (SAU) for a range of short and longer-term outcomes (see Section A9). The study also found high clinician fidelity to BRISC, increased clinician use of evidence-based strategies, high ratings of feasibility, and very low ratings of research burden. Moreover, even though the majority of students who were referred to BRISC were in the clinical range for functional impairment due to MH problems, over 50% were able to step down to lower levels of intervention after four sessions of BRISC, demonstrating promise for efficiency and reach. The current study aims to further examine the efficacy of BRISC, the mediators and moderators that may further influence its development, and to illuminate how and under what conditions BRISC is effective. A cluster randomized design has been used to assign 52 schools in Washington, Minnesota, and Maryland to BRISC or SAU (520 students total; 260 per group).

This efficacy project has six research aims:

1. To test the effects of BRISC on hypothesized short-term service outcomes such as clinician use of evidence-based strategies and standardized assessment data, therapeutic alliance, student service satisfaction, retention in services, and service referrals.

2. To test the effects of BRISC on hypothesized short-term student outcomes, such as problem-solving, coping skills, school engagement, school attendance, and homework completion.

3. To test the effects of BRISC on longer-term outcomes such as MH symptoms, emotional/behavioral functioning, peer/family relations, discipline problems at school, and academic performance.

4. To examine the impact of BRISC on treatment efficiency, in terms of trajectory of student change in outcomes over time.

5. To confirm that BRISC is perceived as an appropriate, feasible, and acceptable intervention for use by SMH clinicians working in a diverse array of high schools.

6. To examine hypothesized moderators and mediators of outcomes, including service factors (e.g., fidelity, service dosage/duration, clinician orientation, receipt of other services), student factors (e.g., age, gender, problem type and severity), and proximal outcomes (e.g., problem-solving skills, coping strategies, school engagement).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 850
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years and older

Eligibility

Clinicians

Inclusion Criteria:

• SMH clinicians from a MH provider agency dedicated at .50 FTE to MH treatment (to ensure adequate integration in the school and students for the study) OR school counselors who are employed by the school district

• SMH clinicians or school counselors not currently receiving support to implement another specific intervention model

• Master's or Ph.D.-level mental health counselors

Exclusion Criteria:

• SMH clinicians with previous BRISC exposure

Students

Inclusion Criteria:

• Students must be age 14-21 years and enrolled in high school

• Students who are seeking or referred to services for the first time in the current school year, to minimize confusion about for which service episode measures should be completed

• English must be the first or primary language of the students

• If student is under 18 years old, a parent or legal guardian must consent for the student to participate

Exclusion Criteria:

• Students receiving Special Education services due to cognitive disability, due to inappropriateness of BRISC for youth with these disorders

• Students in foster care, due to challenges in obtaining consent to participate from public child welfare systems who serve as guardians

• Students who present currently in a crisis situation (defer to clinician's clinical judgment)

Parents/Guardians

Inclusion Criteria:

• Biological parent or legal guardian

• Must be English or Spanish speaking.

Exclusion Criteria:

• Parents who only speak any languages other than English or Spanish

Related Conditions & MeSH terms

• Academic Performance
• Emotional/Behavioral Function

Intervention

Behavioral:
• BRISC

• SAU

Locations

Country	Name	City	State
United States	University of Washington School Mental Health Assessment, Research, and Training (SMART) Center	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	Institute of Education Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Internal and External Symptoms	The Brief Problem Checklist (BPC) is a youth/parent 12-item questionnaire adapted from items on the CBCL (Child Behavior Checklist) and YSR (Youth Self Report) designed to assess internalizing and externalizing behaviors with items measured on 0-2 scale. Subscale and total scores are mean scores of items with a range of 0-2. Higher scores reflect less favorable outcomes.	Pre-intervention/baseline, 2-week follow-up, post-intervention/2 months, 4-month follow-up, 6-month follow-up
Primary	Change in Symptoms of Depression	The Patient Health Questionnaire (PHQ-9) is a widely-used, brief 9-item scale that queries about the presence depressive disorder symptoms with items on a 0-3 scale. Total scores are summed scores of items with a range of 0-27. Higher scores reflect more severe levels of depression.	Pre-intervention/baseline, post-intervention/2 months, 6-month follow-up
Primary	Change in Symptoms of Anxiety	The Generalized Anxiety Disorder scale (GAD-7) is a widely-used, brief 7-item scale that queries about anxiety symptoms with items on a 0-3 scale. Total scores are summed scores of items with a range of 0-21. Higher scores reflect more severe levels of anxiety.	Pre-intervention/baseline, post-intervention/2 months, 6-month follow-up
Primary	Change in Overall Mental Health Function	The Columbia Impairment Scale (CIS) is a 13-item scale that measures adolescents' level of adaptive functioning with items on a 0-4 scale. Total scores are summed scores of items with a range of 0-52. Higher scores reflect less favorable outcomes.	Pre-intervention/baseline, post-intervention/2 months, 6-month follow-up
Secondary	Change in School Engagement	The Student Engagement Instrument (SEI) is a widely-used 35-item instrument that assesses engagement, a malleable determinant of high school success, with items on a scale of 0-3. SEI yields scores on six factors: teacher-student relationships, control and relevance of school work, peer support for learning, future aspirations and goals, family, support for learning, and extrinsic reward. Subscale and total scores are averaged scores of items with a range of 0-3. Higher scores reflect better outcomes.	Pre-intervention/baseline, post-intervention/2 months, 6-month follow-up
Secondary	Youth Satisfaction with Services	The Multidimensional Adolescent Satisfaction Scale (MASS) is a 21-item measure of client satisfaction with the services they receive from their mental health provider. The MASS includes four factors: counselor qualities, meeting needs, effectiveness, and counselor conflict. Items are on a 1-4 scale. Subscale and total scores are averaged scores of items with a range of 0-4. Higher scores reflect higher satisfaction with services.	2-month follow-up after baseline
Secondary	Therapeutic Alliance	The Therapeutic Alliance Scale for Adolescents (TASA) is a widely used, 12-item scale designed to measure the working alliance between clinicians and their adolescent clients with items on a 1-6 scale. The scale covers three domains: bond, goals, and tasks. Subscale and total scores are averaged scores of items with a range of 1-6. Higher scores reflect better alliance.	2-month follow-up after baseline