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| ID | Type | Description | Link |
|---|---|---|---|
| R34MH118316 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Vanderbilt University | OTHER |
| National Institute of Mental Health (NIMH) | NIH |
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The purpose of this study is to compare two clinical approaches to youth mental health care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Unidimensional Measurement-Based Care | Experimental | Youth and caregivers will complete a symptom rating scale every session. Clinicians will receive feedback reports summarizing these data, including alerts indicating if the youth is on track for positive treatment outcomes. These feedback reports will be used to support clinical decision-making. |
|
| Multidimensional Measurement-Based Care | Experimental | Youth and caregivers will complete battery of questionnaires covering multiple process and outcome domains every session. Clinicians will receive feedback reports summarizing these data, including alerts indicating if the youth is on track for positive treatment outcomes. These feedback reports will be used to support clinical decision-making. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Unidimensional Measurement-Based Care | Behavioral | Youth and caregivers will complete a symptom rating scale every session. Clinicians will receive feedback reports summarizing these data, including alerts indicating if the youth is on track for positive treatment outcomes. These feedback reports will be used to support clinical decision-making. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in The Ohio Scales Problem Severity Scale Youth Report | A youth-report measure of youth symptoms ranging from 0 to 100, with higher scores indicating higher general mental health symptoms. | baseline, 12 weeks |
| Change in The Ohio Scales Problem Severity Scale Caregiver Report | A caregiver-report measure of youth symptoms ranging from 0 to 100, with higher scores indicating higher general mental health symptoms. | baseline, 12 weeks |
| Change in The Ohio Scales Problem Functioning Scale Youth Report | A youth-report measure of youth functioning in a variety of areas of daily living ranging from 0 to 80, with higher scores indicating better functioning. | baseline, 12 weeks |
| Change in The Ohio Scales Problem Functioning Scale Caregiver Report | A caregiver-report measure of youth functioning in a variety of areas of daily living ranging from 0 to 80, with higher scores indicating better functioning. | baseline, 12 weeks |
| Change in Symptoms & Functioning Severity Scale- Youth Report | A youth-report measure of youth mental health symptoms. Scores are reported as a total score, ranging from 33 to 86, with higher scores indicating higher symptoms. | baseline, up to 18 months |
| Change in Symptoms & Functioning Severity Scale- Caregiver Report | A caregiver-report measure of youth mental health symptoms. Scores are reported as a total score, ranging from 30 to 82, with higher scores indicating higher symptoms. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susan Douglas, Ph.D. | Vanderbilt University | Principal Investigator |
| Amanda Jensen-Doss, Ph.D. | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Health Connect America | Nashville | Tennessee | 37217 | United States |
Study data will be shared via the National Institute of Mental Health Data Archive (NDA).
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Data will be shared according to the NDA timelines.
Data access will be according to the NDA guidelines.
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All data reflect adolescent characteristics. Caregivers were not participants in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Unidimensional Measurement-Based Care | Youth and caregivers will complete a symptom rating scale every session. Clinicians will receive feedback reports summarizing these data, including alerts indicating if the youth is on track for positive treatment outcomes. These feedback reports will be used to support clinical decision-making. Unidimensional Measurement-Based Care: Youth and caregivers will complete a symptom rating scale every session. Clinicians will receive feedback reports summarizing these data, including alerts indicating if the youth is on track for positive treatment outcomes. These feedback reports will be used to support clinical decision-making. |
| FG001 | Multidimensional Measurement-Based Care | Youth and caregivers will complete battery of questionnaires covering multiple process and outcome domains every session. Clinicians will receive feedback reports summarizing these data, including alerts indicating if the youth is on track for positive treatment outcomes. These feedback reports will be used to support clinical decision-making. Multidimensional Measurement-Based Care: Youth and caregivers will complete battery of questionnaires covering multiple process and outcome domains every session. Clinicians will receive feedback reports summarizing these data, including alerts indicating if the youth is on track for positive treatment outcomes. These feedback reports will be used to support clinical decision-making. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Unidimensional Measurement-Based Care | Youth and caregivers will complete a symptom rating scale every session. Clinicians will receive feedback reports summarizing these data, including alerts indicating if the youth is on track for positive treatment outcomes. These feedback reports will be used to support clinical decision-making. Unidimensional Measurement-Based Care: Youth and caregivers will complete a symptom rating scale every session. Clinicians will receive feedback reports summarizing these data, including alerts indicating if the youth is on track for positive treatment outcomes. These feedback reports will be used to support clinical decision-making. |
| 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, Continuous | Mean |
| 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 The Ohio Scales Problem Severity Scale Youth Report | A youth-report measure of youth symptoms ranging from 0 to 100, with higher scores indicating higher general mental health symptoms. | This measure was only administered to participants who consented to completing additional research measures. Many of these were then lost to follow-up. | Posted | Mean | Standard Deviation | score on a scale | baseline, 12 weeks |
|
Up to 18 months
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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 | Unidimensional Measurement-Based Care | Youth and caregivers will complete a symptom rating scale every session. Clinicians will receive feedback reports summarizing these data, including alerts indicating if the youth is on track for positive treatment outcomes. These feedback reports will be used to support clinical decision-making. Unidimensional Measurement-Based Care: Youth and caregivers will complete a symptom rating scale every session. Clinicians will receive feedback reports summarizing these data, including alerts indicating if the youth is on track for positive treatment outcomes. These feedback reports will be used to support clinical decision-making. |
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The purpose of this trial was to pilot study procedures for a fully-powered trial. The procedures for recruiting and retaining research subsample participants were not successful, leading to a small number of participants with available data on the Ohio Scales outcome measures.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amanda Jensen-Doss | University of Miami | 3052848332 | ajensendoss@miami.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 | May 20, 2024 | May 21, 2024 | Prot_SAP_000.pdf |
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|
| Multidimensional Measurement-Based Care | Behavioral | Youth and caregivers will complete battery of questionnaires covering multiple process and outcome domains every session. Clinicians will receive feedback reports summarizing these data, including alerts indicating if the youth is on track for positive treatment outcomes. These feedback reports will be used to support clinical decision-making. |
|
| baseline, up to 18 months |
| BG001 | Multidimensional Measurement-Based Care | Youth and caregivers will complete battery of questionnaires covering multiple process and outcome domains every session. Clinicians will receive feedback reports summarizing these data, including alerts indicating if the youth is on track for positive treatment outcomes. These feedback reports will be used to support clinical decision-making. Multidimensional Measurement-Based Care: Youth and caregivers will complete battery of questionnaires covering multiple process and outcome domains every session. Clinicians will receive feedback reports summarizing these data, including alerts indicating if the youth is on track for positive treatment outcomes. These feedback reports will be used to support clinical decision-making. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| The Ohio Scales Problem Severity Scale Youth Report | A youth-report measure of youth symptoms ranging from 0 to 100, with higher scores indicating higher general mental health symptoms. | This measure was only administered to participants who consented to completing additional research measures. | Mean | Standard Deviation | scores on a scale |
|
| The Ohio Scales Problem Severity Scale Caregiver Report | A caregiver-report measure of youth symptoms ranging from 0 to 100, with higher scores indicating higher general mental health symptoms. | This measure was only administered to participants who consented to completing additional research measures. | Mean | Standard Deviation | scores on a scale |
|
| The Ohio Scales Problem Functioning Scale Youth Report | A youth-report measure of youth functioning in a variety of areas of daily living ranging from 0 to 80, with higher scores indicating better functioning. | This measure was only administered to participants who consented to completing additional research measures. | Mean | Standard Deviation | scores on a scale |
|
| The Ohio Scales Problem Functioning Scale Caregiver Report | A caregiver-report measure of youth functioning in a variety of areas of daily living ranging from 0 to 80, with higher scores indicating better functioning. | This measure was only administered to participants who consented to completing additional research measures. | Mean | Standard Deviation | scores on a scale |
|
| Symptoms & Functioning Severity Scale- Youth Report | A youth-report measure of youth mental health symptoms. Scores are reported as a total score, ranging from 33 to 86, with higher scores indicating higher symptoms. | Not all randomized participants went on to complete the measurement-based care measures. | Mean | Standard Deviation | scores on a scale |
|
| Symptoms & Functioning Severity Scale- Caregiver Report | A caregiver-report measure of youth mental health symptoms. Scores are reported as a total score, ranging from 30 to 82, with higher scores indicating higher symptoms. | Not all youth who were randomized to condition had caregivers who participated in treatment. Not all youth who were randomized to condition had caregivers who completed measurement-based care measures. | Mean | Standard Deviation | scores on a scale |
|
| OG001 | Multidimensional Measurement-Based Care | Youth and caregivers will complete battery of questionnaires covering multiple process and outcome domains every session. Clinicians will receive feedback reports summarizing these data, including alerts indicating if the youth is on track for positive treatment outcomes. These feedback reports will be used to support clinical decision-making. Multidimensional Measurement-Based Care: Youth and caregivers will complete battery of questionnaires covering multiple process and outcome domains every session. Clinicians will receive feedback reports summarizing these data, including alerts indicating if the youth is on track for positive treatment outcomes. These feedback reports will be used to support clinical decision-making. |
|
|
|
| Primary | Change in The Ohio Scales Problem Severity Scale Caregiver Report | A caregiver-report measure of youth symptoms ranging from 0 to 100, with higher scores indicating higher general mental health symptoms. | This measure was only administered to participants who consented to completing additional research measures. Many of these were then lost to follow-up. | Posted | Mean | Standard Deviation | score on a scale | baseline, 12 weeks |
|
|
|
|
| Primary | Change in The Ohio Scales Problem Functioning Scale Youth Report | A youth-report measure of youth functioning in a variety of areas of daily living ranging from 0 to 80, with higher scores indicating better functioning. | This measure was only administered to participants who consented to completing additional research measures. Many of these were then lost to follow-up. | Posted | Mean | Standard Deviation | score on a scale | baseline, 12 weeks |
|
|
|
|
| Primary | Change in The Ohio Scales Problem Functioning Scale Caregiver Report | A caregiver-report measure of youth functioning in a variety of areas of daily living ranging from 0 to 80, with higher scores indicating better functioning. | This measure was only administered to participants who consented to completing additional research measures. Many of these were then lost to follow-up. | Posted | Mean | Standard Deviation | score on a scale | baseline, 12 weeks |
|
|
|
|
| Primary | Change in Symptoms & Functioning Severity Scale- Youth Report | A youth-report measure of youth mental health symptoms. Scores are reported as a total score, ranging from 33 to 86, with higher scores indicating higher symptoms. | We analyzed youth who completed at least two sets of measures. | Posted | Mean | Standard Deviation | score on a scale | baseline, up to 18 months |
|
|
|
|
| Primary | Change in Symptoms & Functioning Severity Scale- Caregiver Report | A caregiver-report measure of youth mental health symptoms. Scores are reported as a total score, ranging from 30 to 82, with higher scores indicating higher symptoms. | We analyzed data from caregivers who completed at least two sets of measures. | Posted | Mean | Standard Deviation | score on a scale | baseline, up to 18 months |
|
|
|
|
| 0 |
| 637 |
| 0 |
| 637 |
| 0 |
| 637 |
| EG001 | Multidimensional Measurement-Based Care | Youth and caregivers will complete battery of questionnaires covering multiple process and outcome domains every session. Clinicians will receive feedback reports summarizing these data, including alerts indicating if the youth is on track for positive treatment outcomes. These feedback reports will be used to support clinical decision-making. Multidimensional Measurement-Based Care: Youth and caregivers will complete battery of questionnaires covering multiple process and outcome domains every session. Clinicians will receive feedback reports summarizing these data, including alerts indicating if the youth is on track for positive treatment outcomes. These feedback reports will be used to support clinical decision-making. | 0 | 624 | 0 | 624 | 0 | 624 |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
|
| More than one race |
|
| Unknown or Not Reported |
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