Mindfulness-based Stress Reduction for Urban Youth

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Erica Sibinga, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00661271
First received: April 15, 2008
Last updated: July 18, 2012
Last verified: March 2011
  Purpose

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.


Condition Intervention Phase
Stress Reduction
Behavioral: Mindfulness-based stress reduction (MBSR)
Behavioral: Healthy topics
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Mindfulness-based Stress Reduction for Urban Youth

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • mental health outcomes [ Time Frame: post group ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • quality of life [ Time Frame: post group ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: September 2007
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
8 week mindfulness-based stress reduction program
Behavioral: Mindfulness-based stress reduction (MBSR)
8 weekly sessions with instruction designed to enhance mindfulness--mindful meditation, mindful yoga, and discussion of mindfulness practice.
Other Name: MBSR
Active Comparator: B
Health education group--8 weekly sessions of age-appropriate health topics.
Behavioral: Healthy topics
8 week health education program

  Eligibility

Ages Eligible for Study:   14 Years to 22 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00661271

Locations
United States, Maryland
Johns Hopkins, Harriet Lane Clinic
Baltimore, Maryland, United States, 21287
United States, Pennsylvania
Children's Hospital of Philadelphia, Adolescent Initiative & Special Immunology Clinic
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Erica M Sibinga, MD, MHS Johns Hopkins School of Medicine
  More Information

No publications provided

Responsible Party: Erica Sibinga, Assistant Professor, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00661271     History of Changes
Other Study ID Numbers: NA_00002064, R21AT005209
Study First Received: April 15, 2008
Last Updated: July 18, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
mindfulness
meditation
urban youth
stress reduction
adolescent
Stress reduction for urban youth

ClinicalTrials.gov processed this record on April 17, 2014