Improving Wellness for Young Men

Johns Hopkins University

Status: Completed

Conditions: Stress-exposed Urban Male Youth

Treatments: Behavioral: Mindfulness-based stress reduction

Study type: Interventional

Funder types: Other

Identifiers

NCT01650233

NA_00028889

Details and patient eligibility

About

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.

Enrollment: 41 patients

Sex: Male

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

41 participants in 2 patient groups, including a placebo group

Mindfulness-based stress reduction

Experimental group

Description:

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.

Treatment:

Behavioral: Mindfulness-based stress reduction

Healthy Topics

Placebo Comparator group

Description:

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.

Treatment:

Behavioral: Mindfulness-based stress reduction