NCT03939208

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
850

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

April 24, 2019

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 6, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
Last Updated

May 6, 2019

Status Verified

May 1, 2019

Enrollment Period

3 years

First QC Date

April 24, 2019

Last Update Submit

May 2, 2019

Conditions

Keywords

children's mental healthschool mental healthevidence-based practice (EBP)academic success

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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 Outcomes (3)

  • Change in School Engagement

    Pre-intervention/baseline, post-intervention/2 months, 6-month follow-up

  • Youth Satisfaction with Services

    2-month follow-up after baseline

  • Therapeutic Alliance

    2-month follow-up after baseline

Study Arms (2)

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.

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.

Behavioral: SAU

Interventions

BRISCBEHAVIORAL
Intervention (BRISC) Group
SAUBEHAVIORAL
Services as Usual (SAU) Group

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \- SMH clinicians with previous BRISC exposure
  • Students
  • 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
  • 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
  • Biological parent or legal guardian
  • Must be English or Spanish speaking.
  • \- Parents who only speak any languages other than English or Spanish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington School Mental Health Assessment, Research, and Training (SMART) Center

Seattle, Washington, 98115, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants include students, parents, and clinicians. Students and parents are prevented from having knowledge of the interventions assigned. Clinicians are aware of their intervention assignment.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, School of Medicine: Psychiatry

Study Record Dates

First Submitted

April 24, 2019

First Posted

May 6, 2019

Study Start

July 1, 2016

Primary Completion

June 30, 2019

Study Completion

June 30, 2019

Last Updated

May 6, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations