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Testing TRUST Depression Management Intervention (TRUST)

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ClinicalTrials.gov Identifier: NCT03599141
Recruitment Status : Recruiting
First Posted : July 25, 2018
Last Update Posted : December 21, 2018
Sponsor:
Collaborator:
National Institute on Minority Health and Health Disparities (NIMHD)
Information provided by (Responsible Party):
Heather K. Hardin, PhD, RN, Case Western Reserve University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Depression Quality of Life Behavioral: Trust-building Self-management Together Behavioral: Depression Management Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pilot RCT to Evaluate the Effects of a Trust-Building Depression Management Intervention on Moderate Depressive Symptoms in Low-Income Adolescents
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : August 31, 2019
Estimated Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Depression Management
8 weekly group sessions
Behavioral: Depression Management
Traditional depression self-management
Other Name: DM

Experimental: Trust-building Self-management Together
8 weekly group sessions
Behavioral: Trust-building Self-management Together
Trust building plus depression self-management
Other Name: TRUST




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


Secondary Outcome Measures :
  1. Youth Quality of Life scale [ Time Frame: From Baseline to 3 monhts and 6 months ]
    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.

  2. Adolescent Sleep Hygiene Scale [ Time Frame: From Baseline to 3 months and 6 months ]
    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.

  3. Adolescent Lifestyle Questionnaire Stress management subscale [ Time Frame: From Baseline to 3 months and 6 months ]
    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.

  4. Extent of Medication Non-Adherence scale (Medication adherence) [ Time Frame: From Baseline to 3 months and 6 months ]
    Change in total summed score on the Extent of Medication Non-Adherence scale. Higher scores indicate greater levels of nonadherence. Range is 3-15.

  5. Hill-Bone Compliance Scale (Appointment keeping) [ Time Frame: From Baseline to 3 months and 6 months ]
    Change in total summed score on Hill-Bone Compliance Scale. Range is 9-36, with lower scores indicating greater appointment keeping.



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Ages Eligible for Study:   14 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03599141


Contacts
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Contact: Heather K Hardin, PhD 216.368.5129 hkh10@case.edu

Locations
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United States, Ohio
Case Western Reserve University Recruiting
Cleveland, Ohio, United States, 44106
Contact: Heather K Hardin    216-368-5129    hkh10@case.edu   
Principal Investigator: Heather K Hardin, PhD         
Sponsors and Collaborators
Case Western Reserve University
National Institute on Minority Health and Health Disparities (NIMHD)

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Responsible Party: Heather K. Hardin, PhD, RN, Assistant Professor, Case Western Reserve University
ClinicalTrials.gov Identifier: NCT03599141     History of Changes
Other Study ID Numbers: 20180519
U54MD002265-11 ( U.S. NIH Grant/Contract )
First Posted: July 25, 2018    Key Record Dates
Last Update Posted: December 21, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified data will be shared for further analysis after main results are published.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Heather K. Hardin, PhD, RN, Case Western Reserve University:
adolescent
parent

Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders