Improving Wellness for Young Men

NCT ID: NCT01650233

Last Updated: 2018-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2010-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Stress-exposed Urban Male Youth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Mindfulness-based stress reduction

Intervention Type BEHAVIORAL

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.

Group Type PLACEBO_COMPARATOR

Mindfulness-based stress reduction

Intervention Type BEHAVIORAL

Interventions

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Mindfulness-based stress reduction

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 7th or 8th graders at St. Ignatius Loyola Academy in 2009-2010 academic year.
* Parent/guardian consents
* Student assents

Exclusion Criteria

* significant psychopathology
* significant developmental delay
* significant substance abuse with behavioral consequences
* significant behavioral problems
* foster care due to consent restrictions)
Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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St. Ignatius Loyola Academy

Baltimore, Maryland, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 24029559 (View on PubMed)

Other Identifiers

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NA_00028889

Identifier Type: -

Identifier Source: org_study_id

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