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

July 20, 2012
July 23, 2012
August 2009
July 2010   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01650233 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Behavior [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
41
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)
Male
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01650233
NA_00028889
No
Erica Sibinga, Johns Hopkins University
Johns Hopkins University
Not Provided
Not Provided
Johns Hopkins University
July 2012

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