NCT00661271

Brief Summary

Our uncontrolled study of mindfulness-based stress reduction (MBSR) for urban youth suggests benefits in mental health and quality of life outcomes. To evaluate further the specific effects of MBSR, we are conducting a small randomized controlled trial of the MBSR program compared with a health education program.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 15, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 18, 2008

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
6.3 years until next milestone

Results Posted

Study results publicly available

June 28, 2018

Completed
Last Updated

June 28, 2018

Status Verified

May 1, 2018

Enrollment Period

4.5 years

First QC Date

April 15, 2008

Results QC Date

July 7, 2015

Last Update Submit

May 31, 2018

Conditions

Stress, Psychological

Keywords

mindfulnessmeditationurban youthstress reductionadolescentStress reduction for urban youth

Outcome Measures

Primary Outcomes (1)

  • Mindful Attention and Awareness Scale (MAAS)

    * Mindful Attention and Awareness Scale (MAAS) - measures mindfulness with total score range of 1 - 6, where higher scores indicate greater mindfulness * Children's Response Style Questionnaire(CRSQ) - measures coping mechanisms along three subscales: rumination (range: 0-3), distraction (range: 0-3) and problem-solving (range: 0-3), where higher scores on any of the subscales indicates more frequent use of that type of coping mechanism * Aggression scale - uses total score to measure aggression with a range of 0-6, where higher scores indicated more aggressive behavior

    assessed at Baseline, 3 months follow-up, 4-6 months follow-up; scores at 4-6 month follow-up reported

Secondary Outcomes (1)

  • Quality of Life

    assessed at Baseline, 3 months follow-up, 4-6 months follow-up; scores at 4-6 month follow-up reported

Study Arms (2)

Mindfulness-Based Stress Reduction

EXPERIMENTAL

8-week mindfulness-based stress reduction program with one retreat session

Behavioral: Mindfulness-based stress reduction (MBSR)

Healthy Topics

ACTIVE COMPARATOR

8-week health education program with one retreat session - based on a health curriculum developed by McGraw/Hill

Behavioral: Healthy topics

Interventions

Mindfulness-based stress reduction (MBSR)BEHAVIORAL

8 weekly sessions with instruction designed to enhance mindfulness--mindful meditation, mindful yoga, and discussion of mindfulness practice, with one retreat session.

Also known as: MBSR
Mindfulness-Based Stress Reduction
Healthy topicsBEHAVIORAL

8 week health education program with one retreat session

Healthy Topics

Eligibility Criteria

Age14 Years - 22 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • year old youth who receive primary care at the Harriet Lane Clinic or Children's Hospital of Philadelphia.

You may not qualify if:

  • Significant developmental, behavioral, substance abuse, or psychiatric disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Johns Hopkins, Harriet Lane Clinic

Baltimore, Maryland, 21287, United States

Location

Children's Hospital of Philadelphia, Adolescent Initiative & Special Immunology Clinic

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (2)

  • Webb L, Perry-Parrish C, Ellen J, Sibinga E. Mindfulness instruction for HIV-infected youth: a randomized controlled trial. AIDS Care. 2018 Jun;30(6):688-695. doi: 10.1080/09540121.2017.1394434. Epub 2017 Oct 25.

    PMID: 29067834RESULT

  • Sibinga EM, Perry-Parrish C, Thorpe K, Mika M, Ellen JM. A small mixed-method RCT of mindfulness instruction for urban youth. Explore (NY). 2014 May-Jun;10(3):180-6. doi: 10.1016/j.explore.2014.02.006. Epub 2014 Feb 25.

    PMID: 24767265DERIVED

MeSH Terms

Conditions

Stress, Psychological

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

MindfulnessCognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Limitations and Caveats

Participant attrition during the study period limited post-intervention data for analysis, although attrition was balanced by study arm, maintaining the balance across study arms.

Results Point of Contact

Title
Erica Sibinga
Organization
Johns Hopkins School of Medicine
esibinga@jhmi.edu
410-550-4134

Study Officials

  • Erica M Sibinga, MD, MHS

    Johns Hopkins School of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2008

First Posted

April 18, 2008

Study Start

September 1, 2007

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

June 28, 2018

Results First Posted

June 28, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations

US(2)