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| ID | Type | Description | Link |
|---|---|---|---|
| 1K08MH116119-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Measurement-based care (MBC) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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) | 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) | 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%. | 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%. | Baseline, post training, 3-month follow up, 6-month follow up, 9-month follow up |
| Change in Clinician Acceptability of the PCOMS |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3-month follow up, 9-month follow up |
| Change in Child Functioning |
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Inclusion Criteria:
To be eligible for inclusion in the study, a clinician must meet all of the following criteria:
Exclusion Criteria:
- Clinicians who do not meet all inclusion criteria are excluded. There are no other exclusion criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth H. Connors, PhD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stamford Public Schools | Stamford | Connecticut | 06901 | United States | ||
| West Haven Public Schools |
IPD is not available to other researchers at this time, as this is a pilot study.
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Baseline demographics were only collected from participants that completed.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3-month follow up, 6-month follow up, 9-month follow up |
|
Approximately 9 months per participant.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Elizabeth Connors | Yale University | 12038150685 | elizabeth.connors@yale.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 1, 2022 | May 1, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 26, 2023 | May 2, 2024 | ICF_001.pdf |
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|
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 | 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 |
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 | 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 | 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 |
| West Haven |
| Connecticut |
| 06516 |
| United States |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex/Gender, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Professional Discipline | Count of Participants | Participants |
|
| Highest Degree Earned | Count of Participants | Participants |
|
| Years in Mental Health | Full range for Years in Mental Health refers to the observed range self-reported by clinician participants. "0" years refers to clinicians being in their very first year working in mental health during the study period. | Mean | Full Range | years |
|
| Years in School | Full range for Years in School refers to the observed range self-reported by clinician participants. "0" years refers to clinicians being in their very first year working in schools during the study period. | Mean | Full Range | years |
|
| OG001 | Measurement-based Care Year 2 | 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. |
|
|
| 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) | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3-month follow up, 6-month follow up, 9-month follow up |
|
|
|
| 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) | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, post training, 3-month follow up, 6-month follow up, 9-month follow up |
|
|
|
| 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%. | Some participants attrited or opted out before the end of the school year. | Posted | Count of Participants | Participants | 9-month follow up (end of school year; end of study period) |
|
|
|
| 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%. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, post training, 3-month follow up, 6-month follow up, 9-month follow up |
|
|
|
| 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. ) | 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. | Posted | Mean | Standard Deviation | score on a scale | 3-month follow up, 6-month follow up, 9-month follow up |
|
|
|
| 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) | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3-month follow up, 6-month follow up, 9-month follow up |
|
|
|
| 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. | Data were not collected due to study design changes during the pandemic, approved by the IRB and funder (NIMH). | Posted | 3-month follow up, 9-month follow up |
|
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| 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. | Data were not collected due to study design changes during the pandemic, which were approved by the Yale IRB and NIMH. | Posted | 3-month follow up, 9-month follow up |
|
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| 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. | Data were not collected due to study design changes during the pandemic, which were approved by the Yale IRB and NIMH. | Posted | Baseline, 3-month follow up, 6-month follow up, 9-month follow up |
|
|
| 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. | Data were not collected due to study design changes during the pandemic, which were approved by the Yale IRB and NIMH. | Posted | Baseline, 3-month follow up, 6-month follow up, 9-month follow up |
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| 0 |
| 13 |
| 0 |
| 13 |
| 0 |
| 13 |
| EG001 | 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. | 0 | 79 | 0 | 79 | 0 | 79 |
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