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Feedback and Outcomes for Clinically Useful Student Services (FOCUSS)

Feedback and Outcomes for Clinically Useful Student Services (FOCUSS)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05039671
Enrollment
92
Registered
2021-09-09
Start date
2021-08-17
Completion date
2023-08-31
Last updated
2024-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

School-based Mental Health Treatment Services

Keywords

measurement-based care (MBC)

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.

Interventions

BEHAVIORALMeasurement-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.

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
Yale University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Clinician Attitudes Toward Standardized AssessmentBaseline, 3-month follow up, 6-month follow up, 9-month follow upChange 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)
Change in Clinician Feasibility of MBCBaseline, post training, 3-month follow up, 6-month follow up, 9-month follow upChange 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 MBC9-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 MBCBaseline, post training, 3-month follow up, 6-month follow up, 9-month follow upChange 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 PCOMS3-month follow up, 6-month follow up, 9-month follow upChange 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 Acceptability of MBCBaseline, 3-month follow up, 6-month follow up, 9-month follow upChange 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 MBCBaseline, 3-month follow up, 6-month follow up, 9-month follow upChange in clinician-reported Intervention Appropriateness Measure (e.g., a score of 5 = completely agree and is most favorable; possible scores range from 1-5)

Secondary

MeasureTime frameDescription
Change in Parent EngagementBaseline, 3-month follow up, 6-month follow up, 9-month follow upData were not collected due to study design changes during the pandemic, which were approved by the Yale IRB and NIMH.
Change in Child Engagement3-month follow up, 9-month follow upData were not collected due to study design changes during the pandemic, which were approved by the Yale IRB and NIMH.
Change in Child Functioning3-month follow up, 9-month follow upData were not collected due to study design changes during the pandemic, which were approved by the Yale IRB and NIMH.
Change in Child Emotional and Behavioral SymptomsBaseline, 3-month follow up, 6-month follow up, 9-month follow upData were not collected due to study design changes during the pandemic, which were approved by the Yale IRB and NIMH.

Countries

United States

Participant flow

Recruitment details

Only clinicians were enrolled. Parents were not enrolled in the study. Clinicians were considered completed if they completed at least one baseline, 3-month follow up, 6-month follow up, or 9-month follow up survey.

Participants by arm

ArmCount
Measurement-based Care Year 1
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. 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. Year 1 is for academic school year 2021-2022
12
Measurement-based Care Year 2
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. 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. Year 2 is for academic school year 2022-2023.
57
Total69

Baseline characteristics

CharacteristicMeasurement-based Care Year 2Measurement-based Care Year 1Total
Age, Customized
Age
21-30
8 Participants2 Participants10 Participants
Age, Customized
Age
31-40
16 Participants5 Participants21 Participants
Age, Customized
Age
41-50
16 Participants3 Participants19 Participants
Age, Customized
Age
51-60
12 Participants2 Participants14 Participants
Age, Customized
Age
61 and over
5 Participants0 Participants5 Participants
Highest Degree Earned
Bachelors
1 Participants0 Participants1 Participants
Highest Degree Earned
Doctorate
1 Participants0 Participants1 Participants
Highest Degree Earned
Masters
55 Participants12 Participants67 Participants
Professional Discipline
Multiple
5 Participants0 Participants5 Participants
Professional Discipline
Other
1 Participants0 Participants1 Participants
Professional Discipline
Professional Counseling
1 Participants2 Participants3 Participants
Professional Discipline
School Psychology
6 Participants3 Participants9 Participants
Professional Discipline
Social Work
44 Participants7 Participants51 Participants
Race/Ethnicity, Customized
Race/Ethnicity
Asian or Asian American
1 Participants0 Participants1 Participants
Race/Ethnicity, Customized
Race/Ethnicity
Black or African American
3 Participants1 Participants4 Participants
Race/Ethnicity, Customized
Race/Ethnicity
Hispanic or Latino
9 Participants1 Participants10 Participants
Race/Ethnicity, Customized
Race/Ethnicity
Missing (Did not respond)
1 Participants0 Participants1 Participants
Race/Ethnicity, Customized
Race/Ethnicity
Multiple Races
1 Participants0 Participants1 Participants
Race/Ethnicity, Customized
Race/Ethnicity
Prefer not to answer
2 Participants1 Participants3 Participants
Race/Ethnicity, Customized
Race/Ethnicity
White or Caucasian
40 Participants9 Participants49 Participants
Sex/Gender, Customized
Gender
Female
51 Participants12 Participants63 Participants
Sex/Gender, Customized
Gender
Male
5 Participants0 Participants5 Participants
Sex/Gender, Customized
Gender
Other
1 Participants0 Participants1 Participants
Years in Mental Health16.43 years11.12 years13.78 years
Years in School13.45 years10.21 years11.83 years

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 130 / 79
other
Total, other adverse events
0 / 130 / 79
serious
Total, serious adverse events
0 / 130 / 79

Outcome results

Primary

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)

Time frame: Baseline, 3-month follow up, 6-month follow up, 9-month follow up

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
Measurement-based Care Year 1Change in Clinician Acceptability of MBC6-month4.64 score on a scaleStandard Deviation 0.63
Measurement-based Care Year 1Change in Clinician Acceptability of MBC9-month4.56 score on a scaleStandard Deviation 0.51
Measurement-based Care Year 1Change in Clinician Acceptability of MBC3-month4.54 score on a scaleStandard Deviation 0.51
Measurement-based Care Year 1Change in Clinician Acceptability of MBCBaseline3.96 score on a scaleStandard Deviation 0.65
Measurement-based Care Year 2Change in Clinician Acceptability of MBC3-month3.58 score on a scaleStandard Deviation 0.87
Measurement-based Care Year 2Change in Clinician Acceptability of MBCBaseline3.52 score on a scaleStandard Deviation 0.95
Measurement-based Care Year 2Change in Clinician Acceptability of MBC9-month3.76 score on a scaleStandard Deviation 0.75
Primary

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. )

Time frame: 3-month follow up, 6-month follow up, 9-month follow up

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
Measurement-based Care Year 1Change in Clinician Acceptability of the PCOMS3-Month4.62 score on a scaleStandard Deviation 0.51
Measurement-based Care Year 1Change in Clinician Acceptability of the PCOMS6-Month4.70 score on a scaleStandard Deviation 0.54
Measurement-based Care Year 1Change in Clinician Acceptability of the PCOMS9-Month4.38 score on a scaleStandard Deviation 0.59
Measurement-based Care Year 2Change in Clinician Acceptability of the PCOMS3-Month3.69 score on a scaleStandard Deviation 0.78
Measurement-based Care Year 2Change in Clinician Acceptability of the PCOMS9-Month3.95 score on a scaleStandard Deviation 0.7
Primary

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)

Time frame: Baseline, 3-month follow up, 6-month follow up, 9-month follow up

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
Measurement-based Care Year 1Change in Clinician Appropriateness of MBC6-month4.68 score on a scaleStandard Deviation 0.55
Measurement-based Care Year 1Change in Clinician Appropriateness of MBC9-month4.47 score on a scaleStandard Deviation 0.54
Measurement-based Care Year 1Change in Clinician Appropriateness of MBC3-month4.50 score on a scaleStandard Deviation 0.55
Measurement-based Care Year 1Change in Clinician Appropriateness of MBCBaseline4.13 score on a scaleStandard Deviation 0.79
Measurement-based Care Year 2Change in Clinician Appropriateness of MBC3-month3.52 score on a scaleStandard Deviation 0.99
Measurement-based Care Year 2Change in Clinician Appropriateness of MBCBaseline3.64 score on a scaleStandard Deviation 0.87
Measurement-based Care Year 2Change in Clinician Appropriateness of MBC9-month3.93 score on a scaleStandard Deviation 0.8
Primary

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)

Time frame: Baseline, 3-month follow up, 6-month follow up, 9-month follow up

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
Measurement-based Care Year 1Change in Clinician Attitudes Toward Standardized Assessment6-Month4.21 score on a scaleStandard Deviation 0.48
Measurement-based Care Year 1Change in Clinician Attitudes Toward Standardized Assessment9-Month3.98 score on a scaleStandard Deviation 0.57
Measurement-based Care Year 1Change in Clinician Attitudes Toward Standardized Assessment3-Month4.31 score on a scaleStandard Deviation 0.38
Measurement-based Care Year 1Change in Clinician Attitudes Toward Standardized AssessmentBaseline3.65 score on a scaleStandard Deviation 0.63
Measurement-based Care Year 2Change in Clinician Attitudes Toward Standardized Assessment3-Month3.36 score on a scaleStandard Deviation 0.7
Measurement-based Care Year 2Change in Clinician Attitudes Toward Standardized AssessmentBaseline3.33 score on a scaleStandard Deviation 0.59
Measurement-based Care Year 2Change in Clinician Attitudes Toward Standardized Assessment9-Month3.49 score on a scaleStandard Deviation 0.65
Primary

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)

Time frame: Baseline, post training, 3-month follow up, 6-month follow up, 9-month follow up

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
Measurement-based Care Year 1Change in Clinician Feasibility of MBC6-Month4.07 score on a scaleStandard Deviation 1.16
Measurement-based Care Year 1Change in Clinician Feasibility of MBC9-Month4.08 score on a scaleStandard Deviation 0.64
Measurement-based Care Year 1Change in Clinician Feasibility of MBC3-Month4.29 score on a scaleStandard Deviation 0.66
Measurement-based Care Year 1Change in Clinician Feasibility of MBCBaseline3.92 score on a scaleStandard Deviation 0.48
Measurement-based Care Year 2Change in Clinician Feasibility of MBC3-Month3.45 score on a scaleStandard Deviation 0.85
Measurement-based Care Year 2Change in Clinician Feasibility of MBCBaseline3.47 score on a scaleStandard Deviation 0.86
Measurement-based Care Year 2Change in Clinician Feasibility of MBC9-Month3.74 score on a scaleStandard Deviation 0.68
Primary

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%.

Time frame: 9-month follow up (end of school year; end of study period)

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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Measurement-based Care Year 1Change in Clinician Fidelity to MBC9 Participants
Measurement-based Care Year 2Change in Clinician Fidelity to MBC12 Participants
Primary

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%.

Time frame: Baseline, post training, 3-month follow up, 6-month follow up, 9-month follow up

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
Measurement-based Care Year 1Change in Clinician Use of MBC6-Month31.59 score on a scaleStandard Deviation 37.55
Measurement-based Care Year 1Change in Clinician Use of MBC9-Month21.29 score on a scaleStandard Deviation 23.21
Measurement-based Care Year 1Change in Clinician Use of MBC3-Month24.33 score on a scaleStandard Deviation 24.63
Measurement-based Care Year 1Change in Clinician Use of MBCBaseline2.23 score on a scaleStandard Deviation 4.52
Measurement-based Care Year 2Change in Clinician Use of MBC3-Month9.81 score on a scaleStandard Deviation 15.37
Measurement-based Care Year 2Change in Clinician Use of MBCBaseline19.60 score on a scaleStandard Deviation 17.15
Measurement-based Care Year 2Change in Clinician Use of MBC9-Month11.82 score on a scaleStandard Deviation 18.38
Secondary

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.

Time frame: Baseline, 3-month follow up, 6-month follow up, 9-month follow up

Population: Data were not collected due to study design changes during the pandemic, which were approved by the Yale IRB and NIMH.

Secondary

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.

Time frame: 3-month follow up, 9-month follow up

Population: Data were not collected due to study design changes during the pandemic, approved by the IRB and funder (NIMH).

Secondary

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.

Time frame: 3-month follow up, 9-month follow up

Population: Data were not collected due to study design changes during the pandemic, which were approved by the Yale IRB and NIMH.

Secondary

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.

Time frame: Baseline, 3-month follow up, 6-month follow up, 9-month follow up

Population: Data were not collected due to study design changes during the pandemic, which were approved by the Yale IRB and NIMH.

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026