StressHEALTHYNCT01708291
HEALTHY (Health Education Adolescent Leadership Training to Help Youth) Leaders
A study testing Mindfulness based stress reduction and only pre and post evaluation measures in people with Stress, run by University of Rochester at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress
- What is being tested?
- Mindfulness based stress reduction and only pre and post evaluation measures
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Apr 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- ages 14-21 years at time of intervention being offered, offered to youth in out of home care (e.g. foster and kinship care)
Who cannot join
- severe developmental delay
- non English speaking, not in age range
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Stress
- Being tested
- Mindfulness based stress reduction, only pre and post evaluation measures
- Keywords
- youth, Stress, mindfulness, foster care, stress reduction, high risk teens
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness based stress reductionBehavioural
an 8 week group intervention to teach mindfulness skills
only pre and post evaluation measuresBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Mindfulness based stress reduction |
| No Mindfulness based intervention | Placebo comparator | completing only re- and post-evaluation measures on the first and last sessions Receives: Behavioral: only pre and post evaluation measures |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandra Jee, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01708291
- Sponsor's protocol ID
- PMA 2-12213
- Acronym
- HEALTHY
- Status last verified
- Oct 2015
- First submitted
- 4 Sep 2012
- Last updated
- 23 Nov 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 21502256Jee 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.
PubMed 21683668Jee 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.
PubMed 26256140
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HEALTHY (Health Education Adolescent Leadership Training to Help Youth) Leaders
- ClinicalTrials.gov ID
- NCT01708291
- Acronym / sponsor ID
- HEALTHY / PMA 2-12213
- Conditions
- Stress
- Keywords
- youth, Stress, mindfulness, foster care, stress reduction, high risk teens
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 16 Oct 2012 (estimated)
- Results
- Posted 23 Nov 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Based Stress reduction | Active comparator | Behavioral: Mindfulness based stress reductionattending 10 weekly sessions and comprised of an eight week mindfulness intervention program, and completing pre- and postevaluation measures on the first and last sessions |
| No Mindfulness based intervention | Placebo comparator | Behavioral: only pre and post evaluation measurescompleting only re- and post-evaluation measures on the first and last sessions |
Who may qualify
- Ages
- 14 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- ages 14-21 years at time of intervention being offered, offered to youth in out of home care (e.g. foster and kinship care)
Key exclusion criteria (2 listed)
- severe developmental delay
- non English speaking, not in age range
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness based stress reductionan 8 week group intervention to teach mindfulness skills | Behavioural | Mindfulness Based Stress reduction |
| only pre and post evaluation measures | Behavioural | No Mindfulness based intervention |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21502256Jee 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.
- Background: PubMed 21683668Jee 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.
- Derived from this study: PubMed 26256140Jee 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.
Related trials for Stress
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruitingObservational study
Periodontal Status and Biomarkers in MASLD
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness based stress reduction and only pre and post evaluation measures in people with Stress, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Nov 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Reporting Pediatric Symptoms as Assessed by the Pediatric Symptom Checklist-17 (PSC-17) (time frame: Baseline and week 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01708291, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2015.