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| ID | Type | Description | Link |
|---|---|---|---|
| U54MD002265-11 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
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This study evaluates the effectiveness of a novel depression self-management intervention in adolescents with depression.
Half of participants will receive a traditional depression self-management intervention, while the other half will receive the novel depression self-management intervention. In an exploratory, pilot 2-group randomized controlled trial (RCT), 16 adolescents were followed over 6 months. Data were collected at baseline, 3 months, and 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Depression Management | Active Comparator | 8 weekly group sessions |
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| Trust-building Self-management Together | Experimental | 8 weekly group sessions |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trust-building Self-management Together | Behavioral | Trust building plus depression self-management |
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| Measure | Description | Time Frame |
|---|---|---|
| Patient Health Questionnaire-8 Adolescent | The Patient Health Questionnaire-8 (PHQ-8) Adolescent has 8 items scored on a 4 point Likert scale summed for a total score ranging from 0-24. Higher scores indicate greater levels of depressive symptoms with a score of 10 indicating a moderate level of depressive symptoms. The population mean = 5.6 (SD = 1.0). | 3 months and 6 months post baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Youth Quality of Life Scale | The Youth Quality of Life Instrument-Short Form has 15 items measured on a 10 point Likert scale that are summed and t-scored, with higher scores indicating greater QoL. This is a continuously distributed scale without clinical cutoff scores. The quality of life mean t-score in the youth without depression (M= 81.0, SD= 11.7) is greater than the mean t-score in youth diagnosed with depression (M= 58.6, SD= 14.2). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Case Western Reserve University | Cleveland | Ohio | 44106 | United States |
De-identified data will be shared for further analysis after main results are published.
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All consented participants were assigned arms.
We recruited in the community using flyers in Cleveland, Ohio from 2018-2020.
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| ID | Title | Description |
|---|---|---|
| FG000 | Depression Management | 8 weekly group sessions Depression Management: Traditional depression self-management |
| FG001 | Trust-building Self-management Together | 8 weekly group sessions Trust-building Self-management Together: Trust building plus depression self-management |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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All participants who completed the baseline questionnaire
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| ID | Title | Description |
|---|---|---|
| BG000 | Depression Management | 8 weekly group sessions Depression Management: Traditional depression self-management |
| BG001 | Trust-building Self-management Together | 8 weekly group sessions Trust-building Self-management Together: Trust building plus depression self-management |
| 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, Categorical | 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 | Patient Health Questionnaire-8 Adolescent | The Patient Health Questionnaire-8 (PHQ-8) Adolescent has 8 items scored on a 4 point Likert scale summed for a total score ranging from 0-24. Higher scores indicate greater levels of depressive symptoms with a score of 10 indicating a moderate level of depressive symptoms. The population mean = 5.6 (SD = 1.0). | Using intent-to-treat principles, all participants were included in the analysis. However, four participants were lost to follow up at 6 months post baseline. | Posted | Mean | Standard Deviation | units on a scale | 3 months and 6 months post baseline |
|
Entire course of study (Baseline, 3 months, 6 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 | Depression Management | 8 weekly group sessions Depression Management: Traditional depression self-management |
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This is a small feasibility study; therefore, these results may not be generalizable.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Heather K. Hardin | Indiana University | 317.274.5966 | hhardin@iu.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 | Oct 13, 2022 | Aug 31, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| Depression Management | Behavioral | Traditional depression self-management |
|
| 3 and 6 months post baseline |
| Adolescent Sleep Hygiene Scale | The Adolescent Sleep Hygiene Scale-revised has 8 subscales with 24 items scored on a 6 point Likert scale. Each subscale total is the mean of the items contained within. The mean of the subscale scores indicates the overall sleep score, with higher scores indicating greater sleep hygiene. The range is 1-6, with poor sleep hygiene indicated by the lowest quintile scores, which is ≤ 3.8 and good sleep hygiene is indicated by the highest quintile score, which is ≥ 4.9. | 3 and 6 months post baseline |
| Stress Management | The Adolescent Lifestyle Questionnaire Stress Management Subscale has four items on a 5 point Likert scale that are summed for a total score. The range is 5-20. Higher scores indicate greater stress management behavior. This is a continuously distributed scale without clinical cutoff scores. The population mean = 13.0 (SD = 3.6). | 3 and 6 months post baseline |
| Medication Adherence | The Extent of Non-Adherence Scale has 3 items measured on a 5-point Likert scale. A total score reflecting non-adherence is calculated by the mean of item responses, with a range of 1-5. Higher scores indicate greater levels of non-adherence and lower scores indicate greater adherence. The population mean = 1.8 (SD = 1.0). | 3 and 6 months post baseline |
| Appointment Keeping | The Hill-Bone Compliance Appointment Keeping Scale has 3 items measured on a four-point Likert scale. One item is reverse scored and then the three items are summed, resulting in a score ranging from 3-12. This is a continuously distributed scale without clinical cutoff scores. Lower scores indicate greater appointment keeping (M = 5.27 ± 0.93). | 3 and 6 months post baseline |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Depressive Symptoms | The Patient Health Questionnaire-8 (PHQ-8) Adolescent has 8 items scored on a 4 point Likert scale summed for a total score ranging from 0-24. Higher scores indicate greater levels of depressive symptoms with a score of 10-14 indicating a moderate level of depressive symptoms. The population mean = 5.6 (SD = 1.0). | Mean | Standard Deviation | units on a scale |
|
| Quality of Life | The Youth Quality of Life Instrument-Short Form has 15 items measured on a 10 point Likert scale that are summed and t-scored, with higher scores indicating greater quality of life. This is a continuously distributed scale without clinical cutoff scores. The quality of life mean t-score in the population of youth without depression (M= 81.0, SD= 11.7) is greater than the mean t-score in the population of youth diagnosed with depression (M= 58.6, SD= 14.2). | Mean | Standard Deviation | T-score |
|
| Sleep | The Adolescent Sleep Hygiene Scale-revised has 8 subscales with 24 items scored on a 6 point Likert scale. Each subscale total is the mean of the items contained within. The mean of the subscale scores indicates the overall sleep score, with higher scores indicating greater sleep hygiene. The range is 1-6, with poor sleep hygiene indicated by the lowest quintile scores, which is ≤ 3.8 and good sleep hygiene is indicated by the highest quintile score, which is ≥ 4.9. | Mean | Standard Deviation | units on a scale |
|
| Stress management | The Adolescent Lifestyle Questionnaire Stress Management Subscale has four items on a 5 point Likert scale that are summed for a total score. The range is 5-20. Higher scores indicate greater stress management behavior. This is a continuously distributed scale without clinical cutoff scores. The population mean = 13.0 (SD = 3.6). | Mean | Standard Deviation | units on a scale |
|
| Medication adherence | The Extent of Non-Adherence Scale has 3 items measured on a 5-point Likert scale. A total score reflecting non-adherence is calculated by the mean of item responses. This is a continuously distributed scale without clinical cutoff scores and the range is 1-5. Greater scores indicate greater levels of non-adherence. The population mean = 1.8 (SD = 1.0). | Mean | Standard Deviation | units on a scale |
|
| Appointment keeping | The Hill-Bone Compliance Appointment Keeping Scale has 3 items measured on a four-point Likert scale. One item is reverse scored and then the three items are summed, resulting in a score ranging from 3-12. This is a continuously distributed scale without clinical cutoff scores. Lower scores indicate greater appointment keeping (M = 5.27 ± 0.93). | Mean | Standard Deviation | units on a scale |
|
8 weekly group sessions with self-management content and parent relationship building content |
|
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| Secondary | Youth Quality of Life Scale | The Youth Quality of Life Instrument-Short Form has 15 items measured on a 10 point Likert scale that are summed and t-scored, with higher scores indicating greater QoL. This is a continuously distributed scale without clinical cutoff scores. The quality of life mean t-score in the youth without depression (M= 81.0, SD= 11.7) is greater than the mean t-score in youth diagnosed with depression (M= 58.6, SD= 14.2). | Using intent-to-treat principles, all participants were included in the analysis. However, four participants were lost to follow up at 6 months post baseline. | Posted | Mean | Standard Deviation | units on a scale | 3 and 6 months post baseline |
|
|
|
| Secondary | Adolescent Sleep Hygiene Scale | The Adolescent Sleep Hygiene Scale-revised has 8 subscales with 24 items scored on a 6 point Likert scale. Each subscale total is the mean of the items contained within. The mean of the subscale scores indicates the overall sleep score, with higher scores indicating greater sleep hygiene. The range is 1-6, with poor sleep hygiene indicated by the lowest quintile scores, which is ≤ 3.8 and good sleep hygiene is indicated by the highest quintile score, which is ≥ 4.9. | Using intent-to-treat principles, all participants were included in the analysis. However, four participants were lost to follow up at 6 months post baseline. | Posted | Mean | Standard Deviation | units on a scale | 3 and 6 months post baseline |
|
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|
| Secondary | Stress Management | The Adolescent Lifestyle Questionnaire Stress Management Subscale has four items on a 5 point Likert scale that are summed for a total score. The range is 5-20. Higher scores indicate greater stress management behavior. This is a continuously distributed scale without clinical cutoff scores. The population mean = 13.0 (SD = 3.6). | Using intent-to-treat principles, all participants were included in the analysis. However, four participants were lost to follow up at 6 months post baseline. | Posted | Mean | Standard Deviation | units on a scale | 3 and 6 months post baseline |
|
|
|
| Secondary | Medication Adherence | The Extent of Non-Adherence Scale has 3 items measured on a 5-point Likert scale. A total score reflecting non-adherence is calculated by the mean of item responses, with a range of 1-5. Higher scores indicate greater levels of non-adherence and lower scores indicate greater adherence. The population mean = 1.8 (SD = 1.0). | Using intent-to-treat principles, all participants were included in the analysis. However, four participants were lost to follow up at 6 months post baseline. | Posted | Mean | Standard Deviation | units on a scale | 3 and 6 months post baseline |
|
|
|
| Secondary | Appointment Keeping | The Hill-Bone Compliance Appointment Keeping Scale has 3 items measured on a four-point Likert scale. One item is reverse scored and then the three items are summed, resulting in a score ranging from 3-12. This is a continuously distributed scale without clinical cutoff scores. Lower scores indicate greater appointment keeping (M = 5.27 ± 0.93). | Using intent-to-treat principles, all participants were included in the analysis. However, four participants were lost to follow up at 6 months post baseline. | Posted | Mean | Standard Deviation | units on a scale | 3 and 6 months post baseline |
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| 0 |
| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | Trust-building Self-management Together | 8 weekly group sessions Trust-building Self-management Together: Trust building plus depression self-management | 0 | 8 | 0 | 8 | 0 | 8 |
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| 6 months post baseline |
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| 6 months post baseline |
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| 6 months post baseline |
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| 6 months post baseline |
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| 6 months post baseline |
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