Testing TRUST Depression Management Intervention

Study Overview
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Brief Summary
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This study evaluates the effectiveness of a novel depression management intervention in adolescents with depression. Half of participants will receive a traditional depression management intervention, wile the other half will receive the novel depression management intervention.

Official Title
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Pilot RCT to Evaluate the Effects of a Trust-Building Depression Management Intervention on Moderate Depressive Symptoms in Low-Income Adolescents

Conditions
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Depression, Quality of Life

Intervention / Treatment
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* Behavioral: Trust-building Self-management Together
* Behavioral: Depression Management


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Lives in the Cleveland metro area Ages 14-17 years old Reports moderate depressive symptoms Able to read, speak, and understand the English language Exclusion Criteria: Current suicide risk Diagnosis with bipolar disorder, schizophrenia, or a personality disorder Severe behavioral problems that preclude group participation (as reported by parent) Family plans to move from the region within 6 months

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Depression Management<br>8 weekly group sessions | Behavioral: Depression Management<br>* Traditional depression self-management<br>* Other names: DM;|
| Experimental: Trust-building Self-management Together<br>8 weekly group sessions | Behavioral: Trust-building Self-management Together<br>* Trust building plus depression self-management<br>* Other names: TRUST;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Health Questionnaire-9 (PHQ-9) [Depressive symptoms] | Change in total summed score on PHQ-9. Higher scores indicate greater depressive symptoms. Range is 0-27. | From Baseline to 3 months and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Youth Quality of Life scale | Change in total summed and transformed score on the Youth Quality of Life scale. The response scale ranges from 0 = not at all to 10 = a great deal or completely. The scores are summed and then transformed to a 0 to 100 scale, with a higher score representing a higher quality of life. | From Baseline to 3 monhts and 6 months | 
| Adolescent Sleep Hygiene Scale | Change in mean score of all items in each subscale of the Adolescent Sleep Hygiene Scale. Higher scores indicate better sleep hygiene. Range is 1-6. | From Baseline to 3 months and 6 months | 
| Adolescent Lifestyle Questionnaire Stress management subscale | Change in total summed score on stress management sub-scale of the Adolescent Lifestyle Questionnaire. Higher scores indicate better stress management. Range is 4-20. | From Baseline to 3 months and 6 months | 
| Extent of Medication Non-Adherence scale (Medication adherence) | Change in total summed score on the Extent of Medication Non-Adherence scale. Higher scores indicate greater levels of nonadherence. Range is 3-15. | From Baseline to 3 months and 6 months | 
| Hill-Bone Compliance Scale (Appointment keeping) | Change in total summed score on Hill-Bone Compliance Scale. Range is 9-36, with lower scores indicating greater appointment keeping. | From Baseline to 3 months and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adolescent, parent