School-based Mental Health Treatment ServicesNCT05039671

Feedback and Outcomes for Clinically Useful Student Services (FOCUSS)

A study testing Measurement-based care (MBC) in people with School-based Mental Health Treatment Services, run by Yale University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: School-based Mental Health Treatment Services
What is being tested?: Measurement-based care (MBC)
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 92 participants
Where: 2 sitesUnited States
Study dates: 17 Aug 2021to 31 Aug 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Stamford Public Schools
Stamford, Connecticut, 06901
West Haven Public Schools
West Haven, Connecticut, 06516

Other trials in United States

About this study

Read the 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.

Conditions: School-based Mental Health Treatment Services
Being tested: Measurement-based care (MBC)
Keywords: measurement-based care (MBC)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Measurement-based care (MBC)Behavioural
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.

Study groups in NCT05039671
Study group	Role	What they receive
Measurement-based care	Experimental	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. Receives: Behavioral: Measurement-based care (MBC)

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
Measured: 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)
Measured: 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)
Measured: 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%.
Measured: 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%.
Measured: 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. )
Measured: 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)
Measured: Baseline, 3-month follow up, 6-month follow up, 9-month follow up

Secondary outcomes (4)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 3-month follow up, 6-month follow up, 9-month follow up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Aug 202131 Aug 2023

First posted9 Sep 2021
Study start17 Aug 2021
Primary completion31 Aug 2023
Study completion31 Aug 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for School-based Mental Health Treatment ServicesStudies of the same condition, open and under way.
More trials run by Yale UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 92 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05039671
Sponsor's protocol ID: 2000030199
Other IDs: 1K08MH116119-01A1
Status last verified: Jul 2024
First submitted: 26 Aug 2021
Last updated: 14 Aug 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: IPD is not available to other researchers at this time, as this is a pilot study.

Study at a glance

From the registry record, last updated by the sponsor on 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Feedback and Outcomes for Clinically Useful Student Services (FOCUSS)
ClinicalTrials.gov ID: NCT05039671
Acronym / sponsor ID: 2000030199
Conditions: School-based Mental Health Treatment Services
Keywords: measurement-based care (MBC)
Study type: Interventional
Recruitment status: Completed
Enrolment: 92 participants (actual)
Lead sponsor: Yale UniversityUniversity, hospital or other
Collaborators: National Institute of Mental Health (NIMH)
Study start: 17 Aug 2021 (actual)
Primary completion: 31 Aug 2023 (actual)
Study completion: 31 Aug 2023 (actual)
First posted: 9 Sep 2021 (actual)
Results: Posted 14 Aug 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Measurement-based care	Experimental	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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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.	Behavioural	Measurement-based care

Primary outcome

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)
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)
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)
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%.
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%.
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. )
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)

4 secondary outcomes

Change in Child Engagement
Time frame: 3-month follow up, 9-month follow up
Change in Child Functioning
Time frame: 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 Child Emotional and Behavioral Symptoms
Time frame: Baseline, 3-month follow up, 6-month follow up, 9-month follow up

Results and safety

Results posted to the registry on 14 Aug 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Measurement-based Care Year 1	13	12
Measurement-based Care Year 2	79	57

Primary outcome: Change in Clinician Acceptability of MBC

Time frame: Baseline, 3-month follow up, 6-month follow up, 9-month follow up. Mean (Standard Deviation). Unit: score on a scale

Measure	Measurement-based Care Year 1 n = 12	Measurement-based Care Year 2 n = 57
Baseline	3.96 (0.65)	3.52 (0.95)
3-month	4.54 (0.51)	3.58 (0.87)
6-month	4.64 (0.63)	–
9-month	4.56 (0.51)	3.76 (0.75)

Population analysed: Not all participants were asked to complete each survey that was administered across the study time period. However, the number analyzed varies based on actual survey completion results, which varies by time point.

Primary outcome: Change in Clinician Appropriateness of MBC

Time frame: Baseline, 3-month follow up, 6-month follow up, 9-month follow up. Mean (Standard Deviation). Unit: score on a scale

Measure	Measurement-based Care Year 1 n = 12	Measurement-based Care Year 2 n = 57
Baseline	4.13 (0.79)	3.64 (0.87)
3-month	4.50 (0.55)	3.52 (0.99)
6-month	4.68 (0.55)	–
9-month	4.47 (0.54)	3.93 (0.8)

Primary outcome: Change in Clinician Feasibility of MBC

Time frame: Baseline, post training, 3-month follow up, 6-month follow up, 9-month follow up. Mean (Standard Deviation). Unit: score on a scale

Measure	Measurement-based Care Year 1 n = 12	Measurement-based Care Year 2 n = 57
Baseline	3.92 (0.48)	3.47 (0.86)
3-Month	4.29 (0.66)	3.45 (0.85)
6-Month	4.07 (1.16)	–
9-Month	4.08 (0.64)	3.74 (0.68)

Primary outcome: Change in Clinician Fidelity to MBC

Time frame: 9-month follow up (end of school year; end of study period). Count of participants. Unit: Participants

Measure	Measurement-based Care Year 1 n = 10	Measurement-based Care Year 2 n = 31
Value	9	12

Population analysed: Some participants attrited or opted out before the end of the school year.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Approximately 9 months per participant.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Measurement-based Care Year 1	0 of 13 (0%)	0 of 13 (0%)	0 of 13
Measurement-based Care Year 2	0 of 79 (0%)	0 of 79 (0%)	0 of 79

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. IPD is not available to other researchers at this time, as this is a pilot study.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Elizabeth H. Connors, PhD principal investigator

Yale University

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Measurement-based care (MBC) in people with School-based Mental Health Treatment Services, run by Yale University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Clinician Acceptability of MBC (time frame: Baseline, 3-month follow up, 6-month follow up, 9-month follow up). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05039671.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2024.