Improving Wellness for Young Men

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01650233
Recruitment Status : Completed
First Posted : July 26, 2012
Last Update Posted : January 18, 2018
Information provided by (Responsible Party):
Johns Hopkins University

July 20, 2012
July 26, 2012
January 18, 2018
August 2009
July 2010   (Final data collection date for primary outcome measure)
  • psychological symptoms [ Time Frame: 6 months ]
    Psychological symptoms assessed include anxiety, hostility, and depression.
  • coping [ Time Frame: 6 months ]
    Coping assessed includes rumination and typically positive and negative coping approaches.
Same as current
Complete list of historical versions of study NCT01650233 on Archive Site
  • Sleep [ Time Frame: 6 months ]
    Sleep was measured using diary and actigraphy.
  • stress [ Time Frame: 6 months ]
    Stress was measured using self-report and salivary cortisol.
Same as current
Behavior [ Time Frame: 6 months ]
Assessed by teacher-rated behavior ratings.
Same as current
Improving Wellness for Young Men
Improving Wellness for Young Men
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.
Not Provided
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Stress-exposed Urban Male Youth
Behavioral: Mindfulness-based stress reduction
  • 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.
    Intervention: Behavioral: Mindfulness-based stress reduction
Sibinga EM, Perry-Parrish C, Chung SE, Johnson SB, Smith M, Ellen JM. School-based mindfulness instruction for urban male youth: a small randomized controlled trial. Prev Med. 2013 Dec;57(6):799-801. doi: 10.1016/j.ypmed.2013.08.027. Epub 2013 Sep 9.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
July 2010
July 2010   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: Male
Child, Adult, Senior
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Johns Hopkins University
Johns Hopkins University
Not Provided
Not Provided
Johns Hopkins University
January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP