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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by Johns Hopkins University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 August 28, 2014