NCT01708291

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 4, 2012

Completed
27 days until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 16, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

November 23, 2015

Completed
Last Updated

November 23, 2015

Status Verified

October 1, 2015

Enrollment Period

6 months

First QC Date

September 4, 2012

Results QC Date

September 21, 2015

Last Update Submit

October 20, 2015

Conditions

Stress

Keywords

youthStressmindfulnessfoster carestress reductionhigh risk teens

Outcome Measures

Primary Outcomes (1)

  • Number of Participants Reporting Pediatric Symptoms as Assessed by the Pediatric Symptom Checklist-17 (PSC-17)

    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

Study Arms (2)

Mindfulness Based Stress reduction

ACTIVE COMPARATOR

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

No Mindfulness based intervention

PLACEBO COMPARATOR

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

Behavioral: only pre and post evaluation measures

Interventions

Mindfulness based stress reductionBEHAVIORAL

an 8 week group intervention to teach mindfulness skills

Mindfulness Based Stress reduction
only pre and post evaluation measuresBEHAVIORAL
No Mindfulness based intervention

Eligibility Criteria

Age14 Years - 21 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • severe developmental delay
  • non English speaking, not in age range

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

Related Publications (3)

  • 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.

    PMID: 21502256BACKGROUND

  • 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.

    PMID: 21683668BACKGROUND

  • 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.

    PMID: 26256140DERIVED

MeSH Terms

Interventions

Mindfulness-Based Stress Reduction

Intervention Hierarchy (Ancestors)

MindfulnessCognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Results Point of Contact

Title
Sandra Jee
Organization
University of Rochester
sandra_jee@urmc.rochester.edu
585-273-4657

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Pediatrics, Principal Investigator

Study Record Dates

First Submitted

September 4, 2012

First Posted

October 16, 2012

Study Start

October 1, 2012

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

November 23, 2015

Results First Posted

November 23, 2015

Record last verified: 2015-10

Locations

US(1)