Emotional/Behavioral FunctionBRISCNCT03939208
Efficacy of a Brief Intervention for School Clinicians (BRISC)
A study testing BRISC and SAU in people with Emotional/Behavioral Function and Academic Performance, run by University of Washington at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 14 years and olderHealthy volunteers can take part
- Conditions the study is for
- Emotional/Behavioral Function, Academic Performance
- What is being tested?
- BRISC and SAU
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 850 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2016to 30 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 14 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
- 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
Show all 9Show fewer
- If student is under 18 years old, a parent or legal guardian must consent for the student to participate
- Biological parent or legal guardian
- Must be English or Spanish speaking.
Who cannot join
- SMH clinicians with previous BRISC exposure
- Students
- 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
- Parents who only speak any languages other than English or Spanish
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Washington School Mental Health Assessment, Research, and Training (SMART) Center
Seattle, Washington, 98115
About this study
Official title: Efficacy of a Brief Intervention Strategy for School Mental Health Clinicians (BRISC)
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.
Read the detailed 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:
- 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.
- 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.
- 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.
- To examine the impact of BRISC on treatment efficiency, in terms of trajectory of student change in outcomes over time.
- 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.
- 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).
- Being tested
- BRISC, SAU
- Keywords
- children's mental health, school mental health, evidence-based practice (EBP), academic success
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BRISCBehavioural
SAUBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Intervention (BRISC) Group | Experimental | Clinicians randomly assigned to BRISC will implement a flexible intervention that, over four sessions, aims to assess and engage student clients, and identify and address student identified difficulties that are distressing and impacting academic performance/behavior, social, and overall functioning. BRISC uses an explicit, problem-solving structure and a range of techniques common to evidence-based practices (EBP) tailored to the identified needs of the student. Receives: Behavioral: BRISC |
| Services as Usual (SAU) Group | Active comparator | Clinicians in the SAU condition will use a diverse array of "treatment as usual" strategies over four sessions that may include some directive, skill-building techniques common in EBPs, but, given findings from pilot studies and studies of mental health services "as usual" in community and school settings, are likely to be provided at an overall lower rate, and at lower intensity, than in BRISC or other EBP. Receives: Behavioral: SAU |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pre-intervention/baseline, 2-week follow-up, post-intervention/2 months, 4-month follow-up, 6-month follow-up
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.
Measured: Pre-intervention/baseline, post-intervention/2 months, 6-month follow-up
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.
Measured: Pre-intervention/baseline, post-intervention/2 months, 6-month follow-up
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.
Measured: Pre-intervention/baseline, post-intervention/2 months, 6-month follow-up
Secondary outcomes (3)
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.
Measured: Pre-intervention/baseline, post-intervention/2 months, 6-month follow-up
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.
Measured: 2-month follow-up after baseline
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.
Measured: 2-month follow-up after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2019
- Study start1 Jul 2016
- Primary completion30 Jun 2019 (estimated)
- Study completion30 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emotional/Behavioral FunctionStudies 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.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 850 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of Education Sciences
- Responsible party
- Principal investigator, Eric Bruns, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03939208
- Sponsor's protocol ID
- 52229
- Other IDs
- R305A160111
- Acronym
- BRISC
- Status last verified
- May 2019
- First submitted
- 24 Apr 2019
- Last updated
- 6 May 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Brief Intervention Strategy for School Mental Health Clinicians (BRISC)
- ClinicalTrials.gov ID
- NCT03939208
- Acronym / sponsor ID
- BRISC / 52229
- Keywords
- children's mental health, school mental health, evidence-based practice (EBP), academic success
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 850 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Institute of Education Sciences
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 30 Jun 2019 (estimated)
- Study completion
- 30 Jun 2019 (estimated)
- First posted
- 6 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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:
- 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.
- 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.
- 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.
- To examine the impact of BRISC on treatment efficiency, in terms of trajectory of student change in outcomes over time.
- 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.
- 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).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention (BRISC) Group | Experimental | Behavioral: BRISCClinicians randomly assigned to BRISC will implement a flexible intervention that, over four sessions, aims to assess and engage student clients, and identify and address student identified difficulties that are distressing and impacting academic performance/behavior, social, and overall functioning. BRISC uses an explicit, problem-solving structure and a range of techniques common to evidence-based practices (EBP) tailored to the identified needs of the student. |
| Services as Usual (SAU) Group | Active comparator | Behavioral: SAUClinicians in the SAU condition will use a diverse array of "treatment as usual" strategies over four sessions that may include some directive, skill-building techniques common in EBPs, but, given findings from pilot studies and studies of mental health services "as usual" in community and school settings, are likely to be provided at an overall lower rate, and at lower intensity, than in BRISC or other EBP. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- 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
- 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
Key exclusion criteria (7 listed)
- SMH clinicians with previous BRISC exposure
- Students
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BRISC | Behavioural | Intervention (BRISC) Group |
| SAU | Behavioural | Services as Usual (SAU) Group |
Primary outcome
Change in Internal and External Symptoms
Time frame: Pre-intervention/baseline, 2-week follow-up, post-intervention/2 months, 4-month follow-up, 6-month follow-up
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.
Change in Symptoms of Depression
Time frame: Pre-intervention/baseline, post-intervention/2 months, 6-month follow-up
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.
Change in Symptoms of Anxiety
Time frame: Pre-intervention/baseline, post-intervention/2 months, 6-month follow-up
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.
Change in Overall Mental Health Function
Time frame: Pre-intervention/baseline, post-intervention/2 months, 6-month follow-up
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.
3 secondary outcomes
Change in School Engagement
Time frame: Pre-intervention/baseline, post-intervention/2 months, 6-month follow-up
Youth Satisfaction with Services
Time frame: 2-month follow-up after baseline
Therapeutic Alliance
Time frame: 2-month follow-up after baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BRISC and SAU in people with Emotional/Behavioral Function and Academic Performance, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Internal and External Symptoms (time frame: Pre-intervention/baseline, 2-week follow-up, post-intervention/2 months, 4-month follow-up, 6-month follow-up). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2019.