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

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ClinicalTrials.gov Identifier: NCT01708291
Recruitment Status : Completed
First Posted : October 16, 2012
Results First Posted : November 23, 2015
Last Update Posted : November 23, 2015
Sponsor:
Information provided by (Responsible Party):
Sandra Jee, University of Rochester

Brief Summary:
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 or disease Intervention/treatment Phase
Stress Behavioral: Mindfulness based stress reduction Behavioral: only pre and post evaluation measures Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Study Start Date : October 2012
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Number of Participants Reporting Pediatric Symptoms as Assessed by the Pediatric Symptom Checklist-17 (PSC-17) [ Time Frame: Baseline and week 10 ]
    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.



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Ages Eligible for Study:   14 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01708291


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