- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT05041517
Brief Online Training (BOLT) for Routine Outcome Monitoring
Studienübersicht
Status
Intervention / Behandlung
Detaillierte Beschreibung
In the US, although roughly one in five children experiences a mental health problem severe enough to warrant diagnosis and intervention, most lack access to needed services. Schools offer opportunities to improve service access, but school mental health clinicians are unlikely to deliver high-quality evidence-based practices (EBP). Multiple barriers interfere with clinicians receiving adequate training and support for EBP, including limited time and scarce training resources. The goal of this project is to improve school-based services by developing and testing an online training and consultation system to facilitate the use of measurement-based care (MBC). MBC is the target intervention because it is an EBP with extensive empirical support for its ability to improve mental health service outcomes and is a feasible and cost-effective option.
The larger study was conducted in phases to address study aims (this clinical trial record reflects Aim 3/Phase 5):
- AIM 1: Phases 1 and 2. Develop the Brief On-Line Training (BOLT) for Measurement-Based Care training through prototyping and continuous user testing. The goal is to optimize BOLT's impact on system usability and clinician gains in MBC knowledge and attitudes.
- AIM 2: Phases 3 and 4. Develop the BOLT post-training consultation procedures to optimize effective consultation.
- AIM 3: Phase 5. Test BOLT by conducting a randomized controlled pilot trial of the full BOLT training/consultation package to test (1) its impact on MBC knowledge, attitudes, and use; (2) the impact of varying degrees of consultation dosage on weekly assessments of MBC use; and (3) moderators and mechanisms of impact: (a) system usability, (b) clinician knowledge and attitudes gain, (c) experience of collaboration, and (d) responsiveness of consultation.
During the final year (i.e., phase 5), participants include a sample of 75 clinicians, recruited from national email listservs in order to most closely approximate how clinicians tend to discover and engage in online training opportunities. Participants complete an initial online survey about their use of MBC in practice and are randomly assigned to participate in one of two study conditions: the BOLT condition (training and consultation) or a Control condition (no training and no consultation). Participants in the BOLT condition complete a self-paced Brief Online Training (BOLT) for Measurement-Based Care (MBC), are asked to begin to use MBC with their caseloads, and are then randomly assigned to one of three different consultation groups receiving 2 weeks, 4 weeks or 8 weeks of consultation. Participation in a consultation group includes participating in biweekly group phone consultations and posting weekly assignments on an online consultation discussion board about their use of MBC in practice. Participants in all BOLT groups and the Control condition complete weekly online surveys for the full 32 weeks of data collection.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
-
-
Washington
-
Seattle, Washington, Vereinigte Staaten, 98115
- University of Washington
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Between 22-80 years of age
- Employed as a School-Based Mental Health provider
- Must routinely provide individual-level interventions or therapy to students and spend >50% of their time providing services in schools
Exclusion Criteria:
- Being younger than 22 or older than 80
- Not being employed as a School-Based Mental Health provider
- Don't provide individual-level interventions or therapy to students nor spend >50% of their time providing services in schools.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Versorgungsforschung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Kein Eingriff: Kontrolle
Kein Eingriff
|
|
Experimental: BOLT + 1 PTC
BOLT Training + 1 PTC Call
|
BOLT is a Brief Online Training (BOLT) for Measurement-Based Care (MBC).
Participants in the BOLT condition were subsequently randomized into varying amounts of post-training consultation (PTC).
|
Experimental: BOLT + 2 PTC
BOLT Training + 2 PTC Calls
|
BOLT is a Brief Online Training (BOLT) for Measurement-Based Care (MBC).
Participants in the BOLT condition were subsequently randomized into varying amounts of post-training consultation (PTC).
|
Experimental: BOLT + 4 PTC
BOLT Training + 4 PTC Calls
|
BOLT is a Brief Online Training (BOLT) for Measurement-Based Care (MBC).
Participants in the BOLT condition were subsequently randomized into varying amounts of post-training consultation (PTC).
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Current Assessment Practice Evaluation - Revised (CAPER) - Change of use of MBC
Zeitfenster: Baseline, Weeks 2-32
|
The CAPER includes the original four-item CAPE measure plus three new items to assess use of individualized assessment.
It assesses clinician self-reported use of the full range of MBC practices including administration of individualized/standardized assessments at different points during treatment, client feedback on assessment results, and using assessment results to inform treatment.
All items are scored on a 1-4 scale, with anchors signifying percent of clients they used the practice with: 1 = None (0%), 2 = Some (1-39%), 3 = Half (40-60%), 4 = Most (61-100%).
|
Baseline, Weeks 2-32
|
Monitoring & Feedback Attitudes Scale (MFAS) - Change of attitudes about MBC use
Zeitfenster: Baseline, Weeks: 2,4,6,8,10,16,20,24,28,32
|
The purpose of this measure is to collect information on attitudes on routine progress monitoring (or measurement-based care).
Monitoring and Feedback Attitudes Scale (MFA; Jensen-Doss, Becker, Smith, Lyon, Lewis, Stanick, & Hawley, 2018) responses range from 1 ("Strongly Disagree") to 5 ("Strongly Agree").
The MFA has two subscales: (1) Benefit (i.e., facilitating collaboration with clients) and (2) Harm (i.e., harmful for therapeutic alliance, misuse by administrators).
|
Baseline, Weeks: 2,4,6,8,10,16,20,24,28,32
|
MBC Knowledge Questionnaire (MBCKQ) - Change of knowledge about MBC
Zeitfenster: Baseline, Weeks: 2,4,6,8,10,16,20,24,28,32
|
The purpose of this questionnaire is to measure MBC knowledge.
The 28-item, multiple-choice MBCKQ was iteratively developed based on the key content and learning objectives of the MBC training modules.
|
Baseline, Weeks: 2,4,6,8,10,16,20,24,28,32
|
Routine-Outcome Monitoring Skill - Change of skill of MBC use
Zeitfenster: Baseline, Weeks: 2,4,6,8,10,16,20,24,28,32
|
The purpose of this measure is to collect information on clinician familiarity and use of routine outcome monitoring (both individualized and standardized assessment tools).
Items address selection of clients for administration as well as tool selection, administration, scoring, interpretation, integration into treatment, feedback, and progress monitoring.
In previous samples, the scale had good internal consistency (Cronbach's α = .85).
Responses are ratings about skill level and practice, ranging from 1 (''Minimal'') to 5 (''Advanced'').
Items are averaged to create a total assessment skill score.
|
Baseline, Weeks: 2,4,6,8,10,16,20,24,28,32
|
Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Andere Studien-ID-Nummern
- 52550
- R34MH109605 (US NIH Stipendium/Vertrag)
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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