Clinical trial NCT05039671: Feedback and Outcomes for Clinically Useful Student Services (FOCUSS)
Official title: Feedback and Outcomes for Clinically Useful Student Services (FOCUSS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: School-based Mental Health Treatment Services
Keywords: measurement-based care (MBC)
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2021-09-09
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Clinician Acceptability of MBC
timeFrame: Baseline, 3-month follow up, 6-month follow up, 9-month follow up
measure: Change in Clinician Appropriateness of MBC
timeFrame: Baseline, 3-month follow up, 6-month follow up, 9-month follow up
measure: Change in Clinician Feasibility of MBC
timeFrame: Baseline, post training, 3-month follow up, 6-month follow up, 9-month follow up
measure: Change in Clinician Fidelity to MBC
timeFrame: 9-month follow up (end of school year; end of study period)
measure: Change in Clinician Use of MBC
timeFrame: Baseline, post training, 3-month follow up, 6-month follow up, 9-month follow up
measure: Change in Clinician Acceptability of the PCOMS
timeFrame: 3-month follow up, 6-month follow up, 9-month follow up
measure: Change in Clinician Attitudes Toward Standardized Assessment
timeFrame: Baseline, 3-month follow up, 6-month follow up, 9-month follow up
Secondary outcomes:
measure: Change in Child Engagement
timeFrame: 3-month follow up, 9-month follow up
measure: Change in Child Functioning
timeFrame: 3-month follow up, 9-month follow up
measure: Change in Parent Engagement
timeFrame: Baseline, 3-month follow up, 6-month follow up, 9-month follow up
measure: Change in Child Emotional and Behavioral Symptoms
timeFrame: Baseline, 3-month follow up, 6-month follow up, 9-month follow up
Other outcomes:
Locations:
city: Stamford
country: United States
facility: Stamford Public Schools
state: Connecticut
city: West Haven
country: United States
facility: West Haven Public Schools
state: Connecticut
Study officials:
affiliation: Yale University
name: Elizabeth H. Connors, PhD
role: PRINCIPAL_INVESTIGATOR
References: