HEALTHY (Health Education Adolescent Leadership Training to Help Youth) Leaders

This study has been completed.
Information provided by (Responsible Party):
Sandra Jee, University of Rochester Identifier:
First received: September 4, 2012
Last updated: October 20, 2015
Last verified: October 2015
This project will measure baseline stress among a group of youth in foster and kinship care. The investigators will implement a pilot program to target stress reduction by using an evidence-based group therapy technique teaching mindfulness skills. The investigators hypothesize that the mindfulness skills will help youth to reduce stress, which will be measured using psychological and physiological techniques.

Condition Intervention
Behavioral: Mindfulness based stress reduction
Behavioral: only pre and post evaluation measures

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Prevention

Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • Number of Participants Reporting Pediatric Symptoms as Assessed by the Pediatric Symptom Checklist-17 (PSC-17) [ Time Frame: Baseline and week 10 ] [ Designated as safety issue: No ]
    Self Administered questionnaire to assess level of stress at baseline and week 10. PSC-17 is a one page behavioral assessment tool that can be completed in <5 minutes and can assess the sub-domains of attention, externalizing problem and internalizing problems. Attention, externalizing and Internalizing domains are each scored on a scale from 0 (best) to 10 (worst), where a score >= 7 indicates stress.

Enrollment: 45
Study Start Date: October 2012
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Mindfulness Based Stress reduction
attending 10 weekly sessions and comprised of an eight week mindfulness intervention program, and completing pre- and postevaluation measures on the first and last sessions
Behavioral: Mindfulness based stress reduction
an 8 week group intervention to teach mindfulness skills
Placebo Comparator: No Mindfulness based intervention
completing only re- and post-evaluation measures on the first and last sessions
Behavioral: only pre and post evaluation measures


Ages Eligible for Study:   14 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • ages 14-21 years at time of intervention being offered, offered to youth in out of home care (e.g. foster and kinship care)

Exclusion Criteria:

  • severe developmental delay
  • non English speaking, not in age range
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01708291

United States, New York
University of Rochester
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
  More Information

Responsible Party: Sandra Jee, Associate Professor of Pediatrics, Principal Investigator, University of Rochester Identifier: NCT01708291     History of Changes
Other Study ID Numbers: PMA 2-12213
Study First Received: September 4, 2012
Results First Received: September 21, 2015
Last Updated: October 20, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by University of Rochester:
foster care
stress reduction
high risk teens processed this record on November 27, 2015