Improving Wellness for Young Men

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Erica Sibinga, Johns Hopkins University

ClinicalTrials.gov Identifier:

NCT01650233

First received: July 20, 2012

Last updated: July 23, 2012

Last verified: July 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	July 20, 2012
Last Updated Date	July 23, 2012
Start Date ^ICMJE	August 2009
Primary Completion Date	July 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: July 23, 2012)	psychological symptoms [ Time Frame: 6 months ] [ Designated as safety issue: No ] Psychological symptoms assessed include anxiety, hostility, and depression. coping [ Time Frame: 6 months ] [ Designated as safety issue: No ] Coping assessed includes rumination and typically positive and negative coping approaches.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01650233 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: July 23, 2012)	Sleep [ Time Frame: 6 months ] [ Designated as safety issue: No ] Sleep was measured using diary and actigraphy. stress [ Time Frame: 6 months ] [ Designated as safety issue: No ] Stress was measured using self-report and salivary cortisol.
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE (submitted: July 23, 2012)	Behavior [ Time Frame: 6 months ] [ Designated as safety issue: No ] Assessed by teacher-rated behavior ratings.
Original Other Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	Improving Wellness for Young Men
Official Title ^ICMJE	Improving Wellness for Young Men
Brief Summary	This study assesses the impact of a mindfulness-based stress reduction program compared with a health education program for urban middle-school male youth on outcomes of psychological symptoms, coping, stress, sleep, and behavior.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Condition ^ICMJE	Stress-exposed Urban Male Youth
Intervention ^ICMJE	Behavioral: Mindfulness-based stress reduction
Study Arm (s)	Experimental: Mindfulness-based stress reduction The mindfulness-based stress reduction (MBSR) program was previously adapted for urban youth and here further adapted to 12 weekly 50-minute classes for use in school. Intervention: Behavioral: Mindfulness-based stress reduction Placebo Comparator: Healthy Topics An age-appropriate health education curriculum was used as a non-specific group comparison for the MBSR program to control for the effects of: positive adult instruction, interactive peer group instruction, learning new material, group size and location, time, and attention.
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	41
Completion Date	July 2010
Primary Completion Date	July 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: 7th or 8th graders at St. Ignatius Loyola Academy in 2009-2010 academic year. Parent/guardian consents Student assents Exclusion Criteria (as assessed by school staff): significant psychopathology significant developmental delay significant substance abuse with behavioral consequences significant behavioral problems foster care due to consent restrictions)
Gender	Male
Ages	Not Provided
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01650233
Other Study ID Numbers ^ICMJE	NA_00028889
Has Data Monitoring Committee	No
Responsible Party	Erica Sibinga, Johns Hopkins University
Study Sponsor ^ICMJE	Johns Hopkins University
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Johns Hopkins University
Verification Date	July 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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