- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03939208
Efficacy of a Brief Intervention for School Clinicians (BRISC) (BRISC)
Efficacy of a Brief Intervention Strategy for School Mental Health Clinicians (BRISC)
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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).
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Washington
-
Seattle, Washington, Forente stater, 98115
- University of Washington School Mental Health Assessment, Research, and Training (SMART) Center
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Intervention (BRISC) Group
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.
|
|
Aktiv komparator: Services as Usual (SAU) Group
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Change in Internal and External Symptoms
Tidsramme: 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.
|
Pre-intervention/baseline, 2-week follow-up, post-intervention/2 months, 4-month follow-up, 6-month follow-up
|
Change in Symptoms of Depression
Tidsramme: 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.
|
Pre-intervention/baseline, post-intervention/2 months, 6-month follow-up
|
Change in Symptoms of Anxiety
Tidsramme: 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.
|
Pre-intervention/baseline, post-intervention/2 months, 6-month follow-up
|
Change in Overall Mental Health Function
Tidsramme: 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.
|
Pre-intervention/baseline, post-intervention/2 months, 6-month follow-up
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Change in School Engagement
Tidsramme: Pre-intervention/baseline, post-intervention/2 months, 6-month follow-up
|
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
|
Youth Satisfaction with Services
Tidsramme: 2-month follow-up after baseline
|
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
|
Therapeutic Alliance
Tidsramme: 2-month follow-up after baseline
|
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
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- 52229
- R305A160111 (Annet stipend/finansieringsnummer: Institute of Education Sciences)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på Emotional/Behavioral Function
-
Incyte CorporationTilgjengeligSTAT1 Gain-of-Function sykdom
-
Massachusetts General HospitalTilbaketrukketADHD | Executive Function Deficits (EFD-er)
-
University of MalayaPåmelding etter invitasjonTannlege angst | Behavioral ManagementIrak
-
Centro de Estudos em Medicina ComportamentalFullført
-
The University of Hong KongQueen Elizabeth Hospital, Hong KongAvsluttet
-
Massachusetts General HospitalThe American Professional Society of ADHD and Related Disorders (APSARD)FullførtAttention Deficit Hyperactivity Disorder (ADHD) | Executive Function Deficits (EFD)Forente stater
-
Thammasat UniversityNational Research Council of ThailandFullførtBarn med spastisk diplegi, mellom 2 og 10 år | Gross Motor Function Classification System (GMFCS) nivå I, II og IIIThailand