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

NCT ID: NCT01708291

Last Updated: 2015-11-23

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2013-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Stress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Mindfulness based stress reduction

Intervention Type BEHAVIORAL

an 8 week group intervention to teach mindfulness skills

No Mindfulness based intervention

completing only re- and post-evaluation measures on the first and last sessions

Group Type PLACEBO_COMPARATOR

only pre and post evaluation measures

Intervention Type BEHAVIORAL

Interventions

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Mindfulness based stress reduction

an 8 week group intervention to teach mindfulness skills

Intervention Type BEHAVIORAL

only pre and post evaluation measures

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

14 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Rochester

OTHER

Sponsor Role lead

Responsible Party

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Sandra Jee

Associate Professor of Pediatrics, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Rochester

Rochester, New York, United States

Site Status

Countries

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United States

References

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Jee SH, Szilagyi M, Conn AM, Nilsen W, Toth S, Baldwin CD, Szilagyi PG. Validating office-based screening for psychosocial strengths and difficulties among youths in foster care. Pediatrics. 2011 May;127(5):904-10. doi: 10.1542/peds.2010-1350. Epub 2011 Apr 18.

Reference Type BACKGROUND
PMID: 21502256 (View on PubMed)

Jee SH, Halterman JS, Szilagyi M, Conn AM, Alpert-Gillis L, Szilagyi PG. Use of a brief standardized screening instrument in a primary care setting to enhance detection of social-emotional problems among youth in foster care. Acad Pediatr. 2011 Sep-Oct;11(5):409-13. doi: 10.1016/j.acap.2011.03.001. Epub 2011 Jun 17.

Reference Type BACKGROUND
PMID: 21683668 (View on PubMed)

Jee SH, Couderc JP, Swanson D, Gallegos A, Hilliard C, Blumkin A, Cunningham K, Heinert S. A pilot randomized trial teaching mindfulness-based stress reduction to traumatized youth in foster care. Complement Ther Clin Pract. 2015 Aug;21(3):201-9. doi: 10.1016/j.ctcp.2015.06.007. Epub 2015 Jun 20.

Reference Type DERIVED
PMID: 26256140 (View on PubMed)

Other Identifiers

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PMA 2-12213

Identifier Type: -

Identifier Source: org_study_id