Mental Health IssueNCT05041517
Brief Online Training (BOLT) for Routine Outcome Monitoring
A study testing BOLT + PTC in people with Mental Health Issue and Adoption of Measurement-Based Care (MBC), run by University of Washington at 1 site in United States.
Trial summary
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 (also known and referenced in original grant as routine outcome monitoring). Read more about this study
- Who is it for?
- Ages 22 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health Issue, Adoption of Measurement-Based Care (MBC)
- What is being tested?
- BOLT + PTC
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Feb 2017to 31 Dec 2020
- 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 22 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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 (also known and referenced in original grant as routine outcome monitoring). Measurement-based care (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. Following the iterative development of the BOLT training and consultation package (phases 1-4), the investigators will conduct a randomized control pilot trial (phase 5) to test the (1) impact of the package on MBC knowledge, attitudes and use, (2) impact of varying degrees of consultation dosage on weekly assessments of MBC use, and (3) moderators and mechanisms of impact.
Read the detailed description
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.
- Being tested
- BOLT + PTC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BOLT + PTCBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | No intervention |
| BOLT + 1 PTC | Experimental | BOLT Training + 1 PTC Call Receives: Behavioral: BOLT + PTC |
| BOLT + 2 PTC | Experimental | BOLT Training + 2 PTC Calls Receives: Behavioral: BOLT + PTC |
| BOLT + 4 PTC | Experimental | BOLT Training + 4 PTC Calls Receives: Behavioral: BOLT + PTC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Current Assessment Practice Evaluation - Revised (CAPER) - Change of use of MBC
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%).
Measured: Baseline, Weeks 2-32
Monitoring & Feedback Attitudes Scale (MFAS) - Change of attitudes about MBC use
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).
Measured: Baseline, Weeks: 2,4,6,8,10,16,20,24,28,32
MBC Knowledge Questionnaire (MBCKQ) - Change of knowledge about MBC
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.
Measured: Baseline, Weeks: 2,4,6,8,10,16,20,24,28,32
Routine-Outcome Monitoring Skill - Change of skill of MBC use
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.
Measured: Baseline, Weeks: 2,4,6,8,10,16,20,24,28,32
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2021
- Study start16 Feb 2017
- Primary completion16 Jul 2019
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental Health IssueStudies 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
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Aaron Lyon, University of Washington
- Investigators
- Aaron Lyon, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05041517
- Sponsor's protocol ID
- 52550
- Other IDs
- R34MH109605
- Status last verified
- Sep 2021
- First submitted
- 26 Aug 2021
- Last updated
- 13 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lyon AR, Liu FF, Connors EH, King KM, Coifman JI, Cook H, McRee E, Ludwig K, Law A, Dorsey S, McCauley E. How low can you go? Examining the effects of brief online training and post-training consultation dose on implementation mechanisms and outcomes for measurement-based care. Implement Sci Commun. 2022 Jul 22;3(1):79. doi: 10.1186/s43058-022-00325-y.
PubMed 35869500
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Online Training (BOLT) for Routine Outcome Monitoring
- ClinicalTrials.gov ID
- NCT05041517
- Acronym / sponsor ID
- 52550
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 16 Feb 2017 (actual)
- Primary completion
- 16 Jul 2019 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 13 Sep 2021 (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.
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 (also known and referenced in original grant as routine outcome monitoring). Measurement-based care (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. Following the iterative development of the BOLT training and consultation package (phases 1-4), the investigators will conduct a randomized control pilot trial (phase 5) to test the (1) impact of the package on MBC knowledge, attitudes and use, (2) impact of varying degrees of consultation dosage on weekly assessments of MBC use, and (3) moderators and mechanisms of impact.
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –No intervention |
| BOLT + 1 PTC | Experimental | Behavioral: BOLT + PTCBOLT Training + 1 PTC Call |
| BOLT + 2 PTC | Experimental | Behavioral: BOLT + PTCBOLT Training + 2 PTC Calls |
| BOLT + 4 PTC | Experimental | Behavioral: BOLT + PTCBOLT Training + 4 PTC Calls |
Who may qualify
- Ages
- 22 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| BOLT + PTCBOLT 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). | Behavioural | BOLT + 1 PTC, BOLT + 2 PTC, BOLT + 4 PTC |
Primary outcome
Current Assessment Practice Evaluation - Revised (CAPER) - Change of use of MBC
Time frame: 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%).
Monitoring & Feedback Attitudes Scale (MFAS) - Change of attitudes about MBC use
Time frame: 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).
MBC Knowledge Questionnaire (MBCKQ) - Change of knowledge about MBC
Time frame: 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.
Routine-Outcome Monitoring Skill - Change of skill of MBC use
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2021.
- Derived from this study: PubMed 35869500Lyon AR, Liu FF, Connors EH, King KM, Coifman JI, Cook H, McRee E, Ludwig K, Law A, Dorsey S, McCauley E. How low can you go? Examining the effects of brief online training and post-training consultation dose on implementation mechanisms and outcomes for measurement-based care. Implement Sci Commun. 2022 Jul 22;3(1):79. doi: 10.1186/s43058-022-00325-y.
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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.
Aaron Lyon, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BOLT + PTC in people with Mental Health Issue and Adoption of Measurement-Based Care (MBC), 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 13 Sep 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Current Assessment Practice Evaluation - Revised (CAPER) - Change of use of MBC (time frame: Baseline, Weeks 2-32). 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?
On the ClinicalTrials.gov record for NCT05041517, which also lists 1 linked publication.
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 13 Sep 2021.