- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05039671
Feedback and Outcomes for Clinically Useful Student Services (FOCUSS)
October 11, 2023 updated by: Yale University
The purpose of the study is to examine the implementation outcomes (i.e., feasibility, appropriateness, acceptability, and fidelity) of MBC in school-based mental health treatment services.
The investigators plan to observe the effectiveness of MBC on student engagement and treatment outcomes as a secondary goal.
This pilot implementation-effectiveness trial is designed to inform a future, large-scale trial with more participants.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
A clustered, multiple-baseline design will be used to examine the impact of implementation support on clinicians' fidelity, use and ratings of MBC appropriateness, acceptability and fidelity.
Approximately 50 school-based mental health (SMH) clinicians will be recruited to participate from up to three school districts.
All clinicians will receive the same implementation supports; there is no random assignment to condition.
Following an initial control period of at least 1 month, school districts will start receiving implementation supports.
During the initial control period, baseline MBC use, attitudes, acceptability, feasibility and appropriateness (per clinician self-report) will be collected, as well as needs assessment data from clinician surveys to inform necessary adjustments to the implementation supports.
Baseline engagement and student outcomes will be collected after initial clinician training session.
MBC implementation outcomes (i.e., MBC use, attitudes, acceptability, appropriateness, and feasibility), engagement and student outcomes will be collected at 3-month and 6-month follow-up during intervention supports, plus a 9-month follow-up interval.
This allows clinicians in the two school districts to be compared to each other and to their own baseline.
The primary comparison is pre-post ratings of implementation outcomes for all N=50 clinicians.
The secondary comparisons are pre-post ratings of engagement and student outcomes, and between-agency differences.
Study Type
Interventional
Enrollment (Actual)
52
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Connecticut
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Stamford, Connecticut, United States, 06901
- Stamford Public Schools
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West Haven, Connecticut, United States, 06516
- West Haven Public Schools
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
To be eligible for inclusion in the study, a clinician must meet all of the following criteria:
- Female, male or other gender ≥18 years of age at the time of recruitment.
- Provide school-based individual and/or family mental health treatment in an elementary, middle or high school in a participating school district.
- Hold a professional license or certification in their state to provide mental health treatment OR be supervised by a licensed or certified mental health professional in their state.
- English-speaking.
- Ability to provide informed consent.
Exclusion Criteria:
- Clinicians who do not meet all inclusion criteria are excluded. There are no other exclusion criteria.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Measurement-based care
Clinicians will receive a 3-hour interactive MBC training followed by six months of post-training consultation.
Training and consultation will include how to collect, score, and use student- and parent-reported progress measures with students and families to inform collaborative progress monitoring and treatment decisions.
|
Clinicians will receive a 3-hour interactive MBC training followed by six months of post-training consultation.
Training and consultation will include how to collect, score, and use student- and parent-reported progress measures with students and families to inform collaborative progress monitoring and treatment decisions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in clinician acceptability of MBC
Time Frame: Baseline, post training, 3-month follow up, 6-month follow up, 9-month follow up
|
Change in clinician-reported Acceptability of Intervention Measure (e.g., a score of 5 = completely agree and is most favorable; possible scores range from 1-5)
|
Baseline, post training, 3-month follow up, 6-month follow up, 9-month follow up
|
Change in clinician appropriateness of MBC
Time Frame: Baseline, post training, 3-month follow up, 6-month follow up, 9-month follow up
|
Change in clinician-reported Intervention Appropriateness Measure (e.g., a score of 5 = completely agree and is most favorable; possible scores range from 1-5)
|
Baseline, post training, 3-month follow up, 6-month follow up, 9-month follow up
|
Change in clinician feasibility of MBC
Time Frame: Baseline, post training, 3-month follow up, 6-month follow up, 9-month follow up
|
Change in clinician-reported Feasibility of Intervention Measure (e.g., a score of 5 = completely agree and is most favorable; possible scores range from 1-5)
|
Baseline, post training, 3-month follow up, 6-month follow up, 9-month follow up
|
Change in clinician fidelity to MBC components
Time Frame: 3-month follow up, 9-month follow up
|
Retrospective coding of progress notes in clinical records for evidence of scoring, interpretation and feedback provided on the PCOMS measures (ORS and SRS).
A composite fidelity score will be calculated with higher fidelity scores being more favorable.
The fidelity rubric is still under development as this is a pilot study.
Possible scores range from 0-100%.
|
3-month follow up, 9-month follow up
|
Change in clinician use of MBC
Time Frame: Baseline, post training, 3-month follow up, 6-month follow up, 9-month follow up
|
Change in clinician-reported Current Assessment Practice Evaluation - Revised (e.g., a score of 100% across all items is most favorable).
Possible scores range from 0-100%.
|
Baseline, post training, 3-month follow up, 6-month follow up, 9-month follow up
|
Change in clinician acceptability of the PCOMS ORS and SRS
Time Frame: post training, 3-month follow up, 6-month follow up, 9-month follow up
|
Change in clinician-reported Usage Rating Profile - Assessment (e.g., a score of 6 = strongly agree and is most favorable; possible scores range from 1-6. )
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post training, 3-month follow up, 6-month follow up, 9-month follow up
|
Change in clinician attitudes toward standardized assessment
Time Frame: Baseline, post training, 3-month follow up, 6-month follow up, 9-month follow up
|
Change in clinician-reported Attitudes toward Standardized Assessment-Monitoring and Feedback Scale (e.g., a score of 5 = strongly agree across is most favorable; possible scores range from 1-5)
|
Baseline, post training, 3-month follow up, 6-month follow up, 9-month follow up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in child engagement
Time Frame: 3-month follow up, 9-month follow up
|
Change in the parent-reported Session Rating Scale (per chart review; where a score = 40 is most favorable and a score below 36 or less than 9 on any functioning domain should be discussed with the client).
Possible scores range from 0 to 40.
|
3-month follow up, 9-month follow up
|
Change in child functioning
Time Frame: 3-month follow up, 9-month follow up
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Change in the parent-reported Outcome Rating Scale (per chart review; where a score = 0 is most favorable and a score over 28 on a 0 to 40 scale is the clinical cutoff).
Possible scores range from 0 to 40.
|
3-month follow up, 9-month follow up
|
Change in parent engagement
Time Frame: Baseline, 3-month follow up, 6-month follow up, 9-month follow up
|
Change in parent-reported Therapeutic Alliance Scales for Caregivers and Parents (parent-reported to study staff over the phone, where 4 = very much true and is most favorable; possible scores range from 1-4)
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Baseline, 3-month follow up, 6-month follow up, 9-month follow up
|
Change in child emotional and behavioral symptoms
Time Frame: Baseline, 3-month follow up, 6-month follow up, 9-month follow up
|
Change in the Pediatric Symptom Checklist, 35-item version (PSC-35; parent-reported to study staff over the phone where a score of 0 = no symptoms and is most favorable).
Possible scores range from 0 to 70 and a score at or above 28 is the clinical cutoff for youth ages 6 to 16.
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Baseline, 3-month follow up, 6-month follow up, 9-month follow up
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Elizabeth H. Connors, PhD, Yale University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 17, 2021
Primary Completion (Actual)
August 31, 2023
Study Completion (Actual)
August 31, 2023
Study Registration Dates
First Submitted
August 26, 2021
First Submitted That Met QC Criteria
September 1, 2021
First Posted (Actual)
September 9, 2021
Study Record Updates
Last Update Posted (Actual)
October 12, 2023
Last Update Submitted That Met QC Criteria
October 11, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2000030199
- 1K08MH116119-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
IPD is not available to other researchers at this time, as this is a pilot study.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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