Clinical trial NCT00661271: Mindfulness-based Stress Reduction for Urban Youth
Official title: Mindfulness-based Stress Reduction for Urban Youth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress, Psychological
Keywords: mindfulness
meditation
urban youth
stress reduction
adolescent
Stress reduction for urban youth
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2008-04-18
Enrollment: 96
Sex: ALL
Minimum age (years): 14
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: A randomized controlled trial will be conducted at two urban clinic sites. HIV-positive youth between the ages of 14 and 22 will be recruited and randomized into either an eight-week (with one retreat session) Mindfulness-Based Stress Reduction (MBSR) course (intervention) or an eight-week (with one retreat session) Healthy Topics (HT) course (active control). Measures of psychological functioning, coping, and life satisfaction will take place at baseline, immediately post-program, and 3-months post program. Medical data, including Cluster of Differentiation 4 (CD4) and viral load counts, will also be collected at the three data collection time points.

Eligibility criteria: Inclusion Criteria:

* 14-22 year old youth who receive primary care at the Harriet Lane Clinic or Children's Hospital of Philadelphia.

Exclusion Criteria:

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

Primary outcomes:
measure: Mindful Attention and Awareness Scale (MAAS)
timeFrame: assessed at Baseline, 3 months follow-up, 4-6 months follow-up; scores at 4-6 month follow-up reported
Secondary outcomes:
measure: Quality of Life
timeFrame: assessed at Baseline, 3 months follow-up, 4-6 months follow-up; scores at 4-6 month follow-up reported
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins, Harriet Lane Clinic
state: Maryland
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia, Adolescent Initiative & Special Immunology Clinic
state: Pennsylvania
Study officials:
affiliation: Johns Hopkins School of Medicine
name: Erica M Sibinga, MD, MHS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.