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
  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
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, see Learn About Clinical Studies.

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 by Johns Hopkins University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 September 16, 2014