We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Improving Wellness for Young Men

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01650233
First Posted: July 26, 2012
Last Update Posted: October 6, 2017
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.
Information provided by (Responsible Party):
Johns Hopkins University
  Purpose
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.

Condition Intervention
Stress-exposed Urban Male Youth Behavioral: Mindfulness-based stress reduction

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Improving Wellness for Young Men

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • Behavior [ Time Frame: 6 months ]
    Assessed by teacher-rated behavior ratings.


Enrollment: 41
Study Start Date: August 2009
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
Behavioral: Mindfulness-based stress reduction

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01650233


Locations
United States, Maryland
St. Ignatius Loyola Academy
Baltimore, Maryland, United States
Sponsors and Collaborators
Johns Hopkins University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01650233     History of Changes
Other Study ID Numbers: NA_00028889
First Submitted: July 20, 2012
First Posted: July 26, 2012
Last Update Posted: October 6, 2017
Last Verified: October 2017