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Mindfulness-based Stress Reduction for Urban Youth

Primary Purpose

Stress, Psychological

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness-based stress reduction (MBSR)
Healthy topics
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress, Psychological focused on measuring mindfulness, meditation, urban youth, stress reduction, adolescent, Stress reduction for urban youth

Eligibility Criteria

14 Years - 22 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 14-22 year old youth who receive primary care at the Harriet Lane Clinic or Children's Hospital of Philadelphia.

Exclusion Criteria:

  • Significant developmental, behavioral, substance abuse, or psychiatric disorders

Sites / Locations

  • Johns Hopkins, Harriet Lane Clinic
  • Children's Hospital of Philadelphia, Adolescent Initiative & Special Immunology Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mindfulness-Based Stress Reduction

Healthy Topics

Arm Description

8-week mindfulness-based stress reduction program with one retreat session

8-week health education program with one retreat session - based on a health curriculum developed by McGraw/Hill

Outcomes

Primary Outcome Measures

Mindful Attention and Awareness Scale (MAAS)
Mindful Attention and Awareness Scale (MAAS) - measures mindfulness with total score range of 1 - 6, where higher scores indicate greater mindfulness Children's Response Style Questionnaire(CRSQ) - measures coping mechanisms along three subscales: rumination (range: 0-3), distraction (range: 0-3) and problem-solving (range: 0-3), where higher scores on any of the subscales indicates more frequent use of that type of coping mechanism Aggression scale - uses total score to measure aggression with a range of 0-6, where higher scores indicated more aggressive behavior

Secondary Outcome Measures

Quality of Life
Life satisfaction was measured with the HIV Quality of Life (QOL) measure, which included three subscales: life satisfaction (range: 1-5), illness burden (range: 1-5) and illness anxiety (range: 1-5). For life satisfaction, higher scores indicated higher satisfaction, and for the other two subscales greater scores indicated more issues with illness burden and illness anxiety.

Full Information

First Posted
April 15, 2008
Last Updated
May 31, 2018
Sponsor
Johns Hopkins University
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT00661271
Brief Title
Mindfulness-based Stress Reduction for Urban Youth
Official Title
Mindfulness-based Stress Reduction for Urban Youth
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Our uncontrolled study of mindfulness-based stress reduction (MBSR) for urban youth suggests benefits in mental health and quality of life outcomes. To evaluate further the specific effects of MBSR, we are conducting a small randomized controlled trial of the MBSR program compared with a health education program.
Detailed Description
A randomized controlled trial will be conducted at two urban clinic sites. HIV-positive youth between the ages of 14 and 22 will be recruited and randomized into either an eight-week (with one retreat session) Mindfulness-Based Stress Reduction (MBSR) course (intervention) or an eight-week (with one retreat session) Healthy Topics (HT) course (active control). Measures of psychological functioning, coping, and life satisfaction will take place at baseline, immediately post-program, and 3-months post program. Medical data, including Cluster of Differentiation 4 (CD4) and viral load counts, will also be collected at the three data collection time points.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Psychological
Keywords
mindfulness, meditation, urban youth, stress reduction, adolescent, Stress reduction for urban youth

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
96 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness-Based Stress Reduction
Arm Type
Experimental
Arm Description
8-week mindfulness-based stress reduction program with one retreat session
Arm Title
Healthy Topics
Arm Type
Active Comparator
Arm Description
8-week health education program with one retreat session - based on a health curriculum developed by McGraw/Hill
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-based stress reduction (MBSR)
Other Intervention Name(s)
MBSR
Intervention Description
8 weekly sessions with instruction designed to enhance mindfulness--mindful meditation, mindful yoga, and discussion of mindfulness practice, with one retreat session.
Intervention Type
Behavioral
Intervention Name(s)
Healthy topics
Intervention Description
8 week health education program with one retreat session
Primary Outcome Measure Information:
Title
Mindful Attention and Awareness Scale (MAAS)
Description
Mindful Attention and Awareness Scale (MAAS) - measures mindfulness with total score range of 1 - 6, where higher scores indicate greater mindfulness Children's Response Style Questionnaire(CRSQ) - measures coping mechanisms along three subscales: rumination (range: 0-3), distraction (range: 0-3) and problem-solving (range: 0-3), where higher scores on any of the subscales indicates more frequent use of that type of coping mechanism Aggression scale - uses total score to measure aggression with a range of 0-6, where higher scores indicated more aggressive behavior
Time Frame
assessed at Baseline, 3 months follow-up, 4-6 months follow-up; scores at 4-6 month follow-up reported
Secondary Outcome Measure Information:
Title
Quality of Life
Description
Life satisfaction was measured with the HIV Quality of Life (QOL) measure, which included three subscales: life satisfaction (range: 1-5), illness burden (range: 1-5) and illness anxiety (range: 1-5). For life satisfaction, higher scores indicated higher satisfaction, and for the other two subscales greater scores indicated more issues with illness burden and illness anxiety.
Time Frame
assessed at Baseline, 3 months follow-up, 4-6 months follow-up; scores at 4-6 month follow-up reported

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 14-22 year old youth who receive primary care at the Harriet Lane Clinic or Children's Hospital of Philadelphia. Exclusion Criteria: Significant developmental, behavioral, substance abuse, or psychiatric disorders
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erica M Sibinga, MD, MHS
Organizational Affiliation
Johns Hopkins School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins, Harriet Lane Clinic
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Children's Hospital of Philadelphia, Adolescent Initiative & Special Immunology Clinic
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29067834
Citation
Webb L, Perry-Parrish C, Ellen J, Sibinga E. Mindfulness instruction for HIV-infected youth: a randomized controlled trial. AIDS Care. 2018 Jun;30(6):688-695. doi: 10.1080/09540121.2017.1394434. Epub 2017 Oct 25.
Results Reference
result
PubMed Identifier
24767265
Citation
Sibinga EM, Perry-Parrish C, Thorpe K, Mika M, Ellen JM. A small mixed-method RCT of mindfulness instruction for urban youth. Explore (NY). 2014 May-Jun;10(3):180-6. doi: 10.1016/j.explore.2014.02.006. Epub 2014 Feb 25.
Results Reference
derived

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Mindfulness-based Stress Reduction for Urban Youth

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