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

This study is currently recruiting participants.
Verified October 2012 by University of Rochester
Sponsor:
Information provided by (Responsible Party):
Sandra Jee, University of Rochester
ClinicalTrials.gov Identifier:
NCT01708291
First received: September 4, 2012
Last updated: October 15, 2012
Last verified: October 2012
History of Changes
  Purpose

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
Stress
 Behavioral: Mindfulness based stress reduction

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

Resource links provided by NLM:

MedlinePlus related topics: Anxiety
U.S. FDA Resources

Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • State Trait Anxiety Inventory [ Time Frame: Baseline and Post Intervention (upon conclusion of groups at 10 weeks) ] [ Designated as safety issue: No ]
    Self Administered questionnaire to assess level of stress


Secondary Outcome Measures:
  • Pediatric Symptom Checklist [ Time Frame: Baseline and Post Intervention (upon conclusion of groups at 10 weeks) ] [ Designated as safety issue: No ]
    To use a social emotional screening tool before and after intervention


Other Outcome Measures:
  • Child and Adolescent Mindfulness Measure [ Time Frame: baseline and post intervention (at conclusion of group at 10 weeks) ] [ Designated as safety issue: No ]
    To use a mindfulness measure before and after intervention

  • Guidelines for Adolescent Preventive Services [ Time Frame: baseline and post intervention (at conclusion of groups at 10 weeks) ] [ Designated as safety issue: No ]
    to assess risk behaviors and health measures at baseline and post intervention


Estimated Enrollment: 40
Study Start Date: October 2012
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Mindfulness Based Stress reduction
Will complete 10 week stress reduction program
 Behavioral: Mindfulness based stress reduction
an 8 week group intervention to teach mindfulness skills

  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01708291

Contacts
Contact: Sandra H Jee, MD MPH 585-273-4657 Sandra_Jee@urmc.rochester.edu
Contact: Sara Heinert, MPH Sara_Heinert@urmc.rochester.edu

Locations
United States, New York
University of Rochester Recruiting
Rochester, New York, United States, 14642
Contact: Sandra Jee, MD MPH     585-273-4657     Sandra_Jee@urmc.rochester.edu    
Sponsors and Collaborators
University of Rochester
  More Information

Publications:

Responsible Party: Sandra Jee, Associate Professor of Pediatrics, Principal Investigator, University of Rochester
ClinicalTrials.gov Identifier: NCT01708291     History of Changes
Other Study ID Numbers: PMA 2-12213
Study First Received: September 4, 2012
Last Updated: October 15, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Rochester:
youth
Stress
mindfulness
 foster care
stress reduction
high risk teens

ClinicalTrials.gov processed this record on May 22, 2013