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

• Sponsor: University of Rochester (Other)
• Overall Status: Completed
• CT.gov ID: NCT01708291
• Collaborator: (none)
• Enrollment: 45
• Location: 1
• Arms: 2
• Duration (Months): 6
• Patients Per Site Per Month: 7.5

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 45 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Study Start Date: Oct 1, 2012
• Actual Primary Completion Date: Apr 1, 2013
• Actual Study Completion Date: Apr 1, 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 14 Years to 21 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	University of Rochester	Rochester	New York	United States	14642

Sponsors and Collaborators

• University of Rochester

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.

• Responsible Party: Sandra Jee, Associate Professor of Pediatrics, Principal Investigator, University of Rochester
• ClinicalTrials.gov Identifier: NCT01708291
• Other Study ID Numbers: PMA 2-12213
• First Posted: Oct 16, 2012
• Last Update Posted: Nov 23, 2015
• Last Verified: Oct 1, 2015

• Keywords provided by Sandra Jee, Associate Professor of Pediatrics, Principal Investigator, University of Rochester: youth; Stress; mindfulness; foster care; stress reduction; high risk teens

Study Results

Participant Flow

Pre-assignment Detail	3 participants were not included in the study due to fighting.

Arm/Group Title	Mindfulness Based Stress Reduction	No Mindfulness Based Stress Reduction
Arm/Group Description	Will complete 10 weekly sessions and comprised of an 8 week mindfulness intervention program and completing pre- and post-evaluation measures on the first and last sessions.	Will complete pre and post evaluation measures on the first and last sessions with no weekly sessions or mindfulness intervention program.
Period Title: Overall Study
STARTED	21	21
COMPLETED	19	20
NOT COMPLETED	2	1

Baseline Characteristics

Arm/Group Title	Mindfulness Based Stress Reduction	No Mindfulness Based Stress Reduction	Total
Arm/Group Description	Will complete 10 weekly sessions and comprised of an 8 week mindfulness intervention program and completing pre- and post-evaluation measures on the first and last sessions.	Will complete pre and post evaluation measures on the first and last sessions with no weekly sessions or mindfulness intervention program.	Total of all reporting groups
Overall Participants	21	21	42
Age, Customized (participants) [Number]
14 to 17	17 81%	5 23.8%	22 52.4%
18 to 21	4 19%	16 76.2%	20 47.6%
Sex: Female, Male (Count of Participants)
Female	10 47.6%	9 42.9%	19 45.2%
Male	11 52.4%	12 57.1%	23 54.8%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	16 76.2%	15 71.4%	31 73.8%
White	5 23.8%	2 9.5%	7 16.7%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	4 19%	4 9.5%
Region of Enrollment (participants) [Number]
United States	21 100%	21 100%	42 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants Reporting Pediatric Symptoms as Assessed by the Pediatric Symptom Checklist-17 (PSC-17)
Description	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.
Time Frame	Baseline and week 10

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Mindfulness Based Stress Reduction	No Mindfulness Based Stress Reduction
Arm/Group Description	Will complete 10 weekly sessions and comprised of an 8 week mindfulness intervention program and completing pre- and post-evaluation measures on the first and last sessions.	Will complete pre and post evaluation measures on the first and last sessions with no weekly sessions or mindfulness intervention program.
Measure Participants	21	21
week 0-attention	3 14.3%	2 9.5%
week 0-external	4 19%	3 14.3%
week 0-internal	4 19%	8 38.1%
week 10-attention	3 14.3%	4 19%
week 10-external	3 14.3%	3 14.3%
week 10-internal	6 28.6%	11 52.4%

Adverse Events

Arm/Group Title	Mindfulness Based Stress Reduction		No Mindfulness Based Stress Reduction
Arm/Group Description	Will complete 10 weekly sessions and comprised of an 8 week mindfulness intervention program and completing pre- and post-evaluation measures on the first and last sessions.		Will complete pre and post evaluation measures on the first and last sessions with no weekly sessions or mindfulness intervention program.
All Cause Mortality
	Mindfulness Based Stress Reduction		No Mindfulness Based Stress Reduction
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Mindfulness Based Stress Reduction		No Mindfulness Based Stress Reduction
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/21 (0%)		0/21 (0%)
Other (Not Including Serious) Adverse Events
	Mindfulness Based Stress Reduction		No Mindfulness Based Stress Reduction
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/21 (0%)		0/21 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.