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Testing TRUST Depression Management Intervention (TRUST)

Primary Purpose

Depression, Quality of Life

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Trust-building Self-management Together
Depression Management
Sponsored by
Case Western Reserve University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring adolescent, parent

Eligibility Criteria

14 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Case Western Reserve UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Depression Management

Trust-building Self-management Together

Arm Description

8 weekly group sessions

8 weekly group sessions

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.

Full Information

First Posted
June 5, 2018
Last Updated
February 8, 2022
Sponsor
Case Western Reserve University
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)
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1. Study Identification

Unique Protocol Identification Number
NCT03599141
Brief Title
Testing TRUST Depression Management Intervention
Acronym
TRUST
Official Title
Pilot RCT to Evaluate the Effects of a Trust-Building Depression Management Intervention on Moderate Depressive Symptoms in Low-Income Adolescents
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
April 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Case Western Reserve University
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Quality of Life
Keywords
adolescent, parent

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Depression Management
Arm Type
Active Comparator
Arm Description
8 weekly group sessions
Arm Title
Trust-building Self-management Together
Arm Type
Experimental
Arm Description
8 weekly group sessions
Intervention Type
Behavioral
Intervention Name(s)
Trust-building Self-management Together
Other Intervention Name(s)
TRUST
Intervention Description
Trust building plus depression self-management
Intervention Type
Behavioral
Intervention Name(s)
Depression Management
Other Intervention Name(s)
DM
Intervention Description
Traditional depression self-management
Primary Outcome Measure Information:
Title
Patient Health Questionnaire-9 (PHQ-9) [Depressive symptoms]
Description
Change in total summed score on PHQ-9. Higher scores indicate greater depressive symptoms. Range is 0-27.
Time Frame
From Baseline to 3 months and 6 months
Secondary Outcome Measure Information:
Title
Youth Quality of Life scale
Description
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.
Time Frame
From Baseline to 3 monhts and 6 months
Title
Adolescent Sleep Hygiene Scale
Description
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.
Time Frame
From Baseline to 3 months and 6 months
Title
Adolescent Lifestyle Questionnaire Stress management subscale
Description
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.
Time Frame
From Baseline to 3 months and 6 months
Title
Extent of Medication Non-Adherence scale (Medication adherence)
Description
Change in total summed score on the Extent of Medication Non-Adherence scale. Higher scores indicate greater levels of nonadherence. Range is 3-15.
Time Frame
From Baseline to 3 months and 6 months
Title
Hill-Bone Compliance Scale (Appointment keeping)
Description
Change in total summed score on Hill-Bone Compliance Scale. Range is 9-36, with lower scores indicating greater appointment keeping.
Time Frame
From Baseline to 3 months and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Heather K Hardin, PhD
Phone
216.368.5129
Email
hkh10@case.edu
Facility Information:
Facility Name
Case Western Reserve University
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heather K Hardin
Phone
216-368-5129
Email
hkh10@case.edu
First Name & Middle Initial & Last Name & Degree
Heather K Hardin, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified data will be shared for further analysis after main results are published.

Learn more about this trial

Testing TRUST Depression Management Intervention

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