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NCT05039671

Feedback and Outcomes for Clinically Useful Student Services (FOCUSS)

Completed NA Results posted Last updated 14 August 2024
What this trial tests

NA trial testing Measurement-based care (MBC) in School-based Mental Health Treatment Services in 92 participants. Completed in 31 August 2023.

Timeline
17 August 2021
Primary endpoint
31 August 2023
31 August 2023

Quick facts

Lead sponsorYale University
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposehealth services research
Enrollment92
Start date17 August 2021
Primary completion31 August 2023
Estimated completion31 August 2023
Sites2 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Yale University

Who can join

18 and older, any sex, with School-based Mental Health Treatment Services. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Clinician Acceptability of MBC Primary · 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
GroupValue95% CI
Measurement-based Care Year 13.96± 0.65
Measurement-based Care Year 23.52± 0.95
3-month
GroupValue95% CI
Measurement-based Care Year 14.54± 0.51
Measurement-based Care Year 23.58± 0.87
6-month
GroupValue95% CI
Measurement-based Care Year 14.64± 0.63
9-month
GroupValue95% CI
Measurement-based Care Year 14.56± 0.51
Measurement-based Care Year 23.76± 0.75
Change in Clinician Appropriateness of MBC Primary · 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
GroupValue95% CI
Measurement-based Care Year 14.13± 0.79
Measurement-based Care Year 23.64± 0.87
3-month
GroupValue95% CI
Measurement-based Care Year 14.50± 0.55
Measurement-based Care Year 23.52± 0.99
6-month
GroupValue95% CI
Measurement-based Care Year 14.68± 0.55
9-month
GroupValue95% CI
Measurement-based Care Year 14.47± 0.54
Measurement-based Care Year 23.93± 0.8
Change in Clinician Feasibility of MBC Primary · 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
GroupValue95% CI
Measurement-based Care Year 13.92± 0.48
Measurement-based Care Year 23.47± 0.86
3-Month
GroupValue95% CI
Measurement-based Care Year 14.29± 0.66
Measurement-based Care Year 23.45± 0.85
6-Month
GroupValue95% CI
Measurement-based Care Year 14.07± 1.16
9-Month
GroupValue95% CI
Measurement-based Care Year 14.08± 0.64
Measurement-based Care Year 23.74± 0.68
Change in Clinician Fidelity to MBC Primary · 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%.

GroupValue95% CI
Measurement-based Care Year 19
Measurement-based Care Year 212
Change in Clinician Use of MBC Primary · 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
GroupValue95% CI
Measurement-based Care Year 12.23± 4.52
Measurement-based Care Year 219.60± 17.15
3-Month
GroupValue95% CI
Measurement-based Care Year 124.33± 24.63
Measurement-based Care Year 29.81± 15.37
6-Month
GroupValue95% CI
Measurement-based Care Year 131.59± 37.55
9-Month
GroupValue95% CI
Measurement-based Care Year 121.29± 23.21
Measurement-based Care Year 211.82± 18.38
Change in Clinician Acceptability of the PCOMS Primary · 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
GroupValue95% CI
Measurement-based Care Year 14.62± 0.51
Measurement-based Care Year 23.69± 0.78
6-Month
GroupValue95% CI
Measurement-based Care Year 14.70± 0.54
9-Month
GroupValue95% CI
Measurement-based Care Year 14.38± 0.59
Measurement-based Care Year 23.95± 0.70
Change in Clinician Attitudes Toward Standardized Assessment Primary · 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
GroupValue95% CI
Measurement-based Care Year 13.65± 0.63
Measurement-based Care Year 23.33± 0.59
3-Month
GroupValue95% CI
Measurement-based Care Year 14.31± 0.38
Measurement-based Care Year 23.36± 0.70
6-Month
GroupValue95% CI
Measurement-based Care Year 14.21± 0.48
9-Month
GroupValue95% CI
Measurement-based Care Year 13.98± 0.57
Measurement-based Care Year 23.49± 0.65

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing