Feedback and Outcomes for Clinically Useful Student Services (FOCUSS)

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

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): 92
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Stamford, Connecticut, United States, 06901
      • Stamford Public Schools
    • West Haven, Connecticut, United States, 06516
      • West Haven Public Schools

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Clinician Acceptability of MBC	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, 3-month follow up, 6-month follow up, 9-month follow up
Change in Clinician Appropriateness of MBC	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, 3-month follow up, 6-month follow up, 9-month follow up
Change in Clinician Feasibility of MBC	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	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%.	9-month follow up (end of school year; end of study period)
Change in Clinician Use of MBC	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	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. )	3-month follow up, 6-month follow up, 9-month follow up
Change in Clinician Attitudes Toward Standardized Assessment	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, 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	Data were not collected due to study design changes during the pandemic, which were approved by the Yale IRB and NIMH.	3-month follow up, 9-month follow up
Change in Child Functioning	Data were not collected due to study design changes during the pandemic, which were approved by the Yale IRB and NIMH.	3-month follow up, 9-month follow up
Change in Parent Engagement	Data were not collected due to study design changes during the pandemic, which were approved by the Yale IRB and NIMH.	Baseline, 3-month follow up, 6-month follow up, 9-month follow up
Change in Child Emotional and Behavioral Symptoms	Data were not collected due to study design changes during the pandemic, which were approved by the Yale IRB and NIMH.	Baseline, 3-month follow up, 6-month follow up, 9-month follow up

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Elizabeth H. Connors, PhD, Yale University

Study record dates

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): August 14, 2024
• Last Update Submitted That Met QC Criteria: July 23, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: measurement-based care (MBC)
• 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