Feedback and Outcomes for Clinically Useful Student Services (FOCUSS)

Not Applicable

Completed

• Conditions: School-based Mental Health Treatment Services
• Interventions: Behavioral: Measurement-based care (MBC)

• Registration Number: NCT05039671
• Lead Sponsor: Yale University

Brief Summary

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2021-08-17
• Study First Submitted: 2021-08-26
• Study First Submitted QC: 2021-09-01
• Study First Posted: 2021-09-09
• Primary Completion: 2023-08-31
• Study Completion: 2023-08-31
• Results First Submitted: 2024-05-03
• Status Verified: 2024-07
• Results First Submitted QC: 2024-07-23
• Last Update Submitted: 2024-07-23
• Results First Posted: 2024-08-14
• Last Update Posted: 2024-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

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.

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Exclusion Criteria

• Clinicians who do not meet all inclusion criteria are excluded. There are no other exclusion criteria.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Measurement-based care	Measurement-based care (MBC)	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.

Primary Outcome Measures

Name	Time	Method
Change in Clinician Acceptability of MBC	Baseline, 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)
Change in Clinician Fidelity to MBC	9-month follow up (end of school year; end of study period)	Monthly fidelity monitoring of ORS measures entered in the online system as evidence of administration with student or parent respondents. A count of participants meeting the established fidelity threshold of 2 or more ORS measures will be calculated each month. Possible scores range from 0-100%.
Change in Clinician Attitudes Toward Standardized Assessment	Baseline, 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)
Change in Clinician Appropriateness of MBC	Baseline, 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)
Change in Clinician Acceptability of the PCOMS	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. )
Change in Clinician Feasibility of MBC	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)
Change in Clinician Use of MBC	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%.

Secondary Outcome Measures

Name	Time	Method
Change in Child Functioning	3-month follow up, 9-month follow up	Data were not collected due to study design changes during the pandemic, which were approved by the Yale IRB and NIMH.
Change in Child Engagement	3-month follow up, 9-month follow up	Data were not collected due to study design changes during the pandemic, which were approved by the Yale IRB and NIMH.
Change in Parent Engagement	Baseline, 3-month follow up, 6-month follow up, 9-month follow up	Data were not collected due to study design changes during the pandemic, which were approved by the Yale IRB and NIMH.
Change in Child Emotional and Behavioral Symptoms	Baseline, 3-month follow up, 6-month follow up, 9-month follow up	Data were not collected due to study design changes during the pandemic, which were approved by the Yale IRB and NIMH.

Trial Locations

Locations (2)

Stamford Public Schools; 🇺🇸 Stamford, Connecticut, United States

West Haven Public Schools; 🇺🇸 West Haven, Connecticut, United States