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Improving Wellness for Young Men

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ClinicalTrials.gov Identifier: NCT01650233
Recruitment Status : Completed
First Posted : July 26, 2012
Last Update Posted : January 18, 2018
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Stress-exposed Urban Male Youth Behavioral: Mindfulness-based stress reduction

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Improving Wellness for Young Men
Study Start Date : August 2009
Primary Completion Date : July 2010
Study Completion Date : July 2010
Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. psychological symptoms [ Time Frame: 6 months ]
    Psychological symptoms assessed include anxiety, hostility, and depression.

  2. coping [ Time Frame: 6 months ]
    Coping assessed includes rumination and typically positive and negative coping approaches.


Secondary Outcome Measures :
  1. Sleep [ Time Frame: 6 months ]
    Sleep was measured using diary and actigraphy.

  2. stress [ Time Frame: 6 months ]
    Stress was measured using self-report and salivary cortisol.


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


Eligibility Criteria

Information from the National Library of Medicine

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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 Posted: July 26, 2012    Key Record Dates
Last Update Posted: January 18, 2018
Last Verified: January 2018