Feedback and Outcomes for Clinically Useful Student Services (FOCUSS)

July 23, 2024 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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
92

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Clinician Acceptability of MBC
Time Frame: 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)
Baseline, 3-month follow up, 6-month follow up, 9-month follow up
Change in Clinician Appropriateness of MBC
Time Frame: 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)
Baseline, 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
Time Frame: 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%.
9-month follow up (end of school year; end of study period)
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
Time Frame: 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. )
3-month follow up, 6-month follow up, 9-month follow up
Change in Clinician Attitudes Toward Standardized Assessment
Time Frame: 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)
Baseline, 3-month follow up, 6-month follow up, 9-month follow up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Child Engagement
Time Frame: 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.
3-month follow up, 9-month follow up
Change in Child Functioning
Time Frame: 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.
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
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
Time Frame: 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.
Baseline, 3-month follow up, 6-month follow up, 9-month follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yale University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Mental Health (NIMH)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 17, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 26, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 1, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 9, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 14, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 23, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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