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

October 20, 2015 updated by: Sandra Jee, University of Rochester
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Rochester, New York, United States, 14642
        • University of Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and week 10

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rochester

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

September 4, 2012

First Submitted That Met QC Criteria

October 15, 2012

First Posted (Estimate)

October 16, 2012

Study Record Updates

Last Update Posted (Estimate)

November 23, 2015

Last Update Submitted That Met QC Criteria

October 20, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PMA 2-12213

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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