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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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ 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.


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • Behavior [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.

  Eligibility

Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01650233

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

No publications provided

Responsible Party: Erica Sibinga, Assistant Professor, Pediatrics, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01650233     History of Changes
Other Study ID Numbers: NA_00028889
Study First Received: July 20, 2012
Last Updated: July 23, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 16, 2013