Improving Wellness for Young Men
1 other identifier
interventional
41
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2010
CompletedFirst Submitted
Initial submission to the registry
July 20, 2012
CompletedFirst Posted
Study publicly available on registry
July 26, 2012
CompletedJanuary 18, 2018
January 1, 2018
11 months
July 20, 2012
January 16, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
psychological symptoms
Psychological symptoms assessed include anxiety, hostility, and depression.
6 months
coping
Coping assessed includes rumination and typically positive and negative coping approaches.
6 months
Secondary Outcomes (2)
Sleep
6 months
stress
6 months
Other Outcomes (1)
Behavior
6 months
Study Arms (2)
Mindfulness-based stress reduction
EXPERIMENTALThe 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.
Healthy Topics
PLACEBO COMPARATORAn 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.
Interventions
Eligibility Criteria
You may qualify if:
- th or 8th graders at St. Ignatius Loyola Academy in 2009-2010 academic year.
- Parent/guardian consents
- Student assents
You may not qualify if:
- significant psychopathology
- significant developmental delay
- significant substance abuse with behavioral consequences
- significant behavioral problems
- foster care due to consent restrictions)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
St. Ignatius Loyola Academy
Baltimore, Maryland, United States
Related Publications (1)
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.
PMID: 24029559DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 20, 2012
First Posted
July 26, 2012
Study Start
August 1, 2009
Primary Completion
July 1, 2010
Study Completion
July 1, 2010
Last Updated
January 18, 2018
Record last verified: 2018-01