Mindfulness-based Stress Reduction for Urban Youth

This study has been completed.

Sponsor:

Collaborator:

National Center for Complementary and Integrative Health (NCCIH)

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

History of Changes

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

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

National Center for Complementary and Integrative Health (NCCIH)

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):

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.


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 March 03, 2015

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