- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03718845
A Mind-Body Medicine Curriculum for Peer Counselors
August 26, 2022 updated by: James S. Gordon, M.D., The Center for Mind-Body Medicine
Evaluation of a Mind-Body Medicine Curriculum for High School Peer Counselors
This study will evaluate a Mind-Body Medicine curriculum for high school peer counselors in order to answer the following research questions:
- Will peer counselor participation in the Mind-Body Medicine curriculum increase their sense of self-regulation, responsibility, social competence, and empathy; decrease anxiety; and increase hope?
- What are the experiences of peer support counselors participating in the Mind-Body Medicine curriculum?
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The study will be done at the Marjory Stoneman Douglas High School.
The research will use a mixed-methods design by collecting both quantitative and qualitative data.
The quantitative data will be in the form of standardized research instruments and the qualitative data will be gathered through focus group interviews with the peer-counselors.
Study Type
Observational
Enrollment (Actual)
124
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
-
-
Florida
-
Parkland, Florida, United States, 33076
- Marjory Stoneman Douglas High School
-
-
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
15 years to 18 years (ADULT, CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
High school students who are participating in the Peer Counseling Program at Marjory Stoneman Douglas High School
Description
Inclusion Criteria:
• All high school students who are participating in the Peer Counseling Program at Marjory Stoneman Douglas High School
Exclusion Criteria:
• None (as long as the students meet the inclusion criteria)
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Peer Counselors
Mind-Body Medicine Curriculum
|
The Mind-Body Medicine curriculum consists of presentations on different mind-body techniques as well as the research supporting the use of these techniques.The mind-body technique is then practiced in a supportive small group setting.
Mind-body techniques will include guided imagery, relaxation techniques, several forms of meditation, autogenic training and biofeedback.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in State-Trait Anxiety Inventory (STAI) scores
Time Frame: baseline, approximately 2 months, approximately 8 months
|
The State-Trait Anxiety Inventory has two subscales: State Anxiety and Trait Anxiety.
Each has a minimum score of 20 and a maximum score of 80. Higher scores indicate more anxiety which is a worse outcome.
|
baseline, approximately 2 months, approximately 8 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in the Social Emotional Assets and Resilience Scales for Adolescents (SEARS-A)
Time Frame: baseline, approximately 2 months, approximately 8 months
|
The Social Emotional Assets and Resilience Scales for Adolescents (SEARS-A) has a total score and four subscales.
The score ranges are as follows: Total Score 0-105; Self-Regulation 0-24; Social Competence 0-30; Empathy 0-33; Responsibility 0-18.
Lower scores indicate a worse outcome.
Subscales are summed to obtain the total score.
|
baseline, approximately 2 months, approximately 8 months
|
Change in the Adult Hope Scale
Time Frame: baseline, approximately 2 months, approximately 8 months
|
The Adult Hope Scale has a total score and 2 subscales.
The score ranges are as follows: Total Score 8-24; Agency subscale 4-32; Pathways subscale 4-32.
Lower scores indicate a worse outcome.
Subscales are summed to obtain the total score.
|
baseline, approximately 2 months, approximately 8 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Focus Group Interviews
Time Frame: baseline, approximately 2 months, approximately 6 months, and approximately 8 months
|
Focus group interviews will be held with approximately 3 groups of 8 students to obtain information about the experiences of peer support counselors participating in the Mind-Body Medicine curriculum.
|
baseline, approximately 2 months, approximately 6 months, and approximately 8 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
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.
Helpful Links
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 (ACTUAL)
October 22, 2018
Primary Completion (ACTUAL)
June 30, 2019
Study Completion (ACTUAL)
June 30, 2019
Study Registration Dates
First Submitted
October 8, 2018
First Submitted That Met QC Criteria
October 23, 2018
First Posted (ACTUAL)
October 25, 2018
Study Record Updates
Last Update Posted (ACTUAL)
August 31, 2022
Last Update Submitted That Met QC Criteria
August 26, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
Clinical Trials on Anxiety
-
AstraZenecaCompletedAnxiety Disorders | Anxiety | Anxiety Neuroses | Anxiety StatesUnited States
-
Prisma Health-UpstateCompletedAnxiety | Anxiety, Separation | Separation Anxiety | Anxiety Generalized
-
Ann & Robert H Lurie Children's Hospital of ChicagoUniversity of California, Los Angeles; University of CincinnatiRecruitingAnxiety, Separation | Anxiety, Social | Anxiety, GeneralizedUnited States
-
Yale UniversityNational Institute of Mental Health (NIMH)Active, not recruitingGeneralized Anxiety Disorder | Anxiety Disorder of Childhood | Separation Anxiety Disorder of Childhood | Social Anxiety Disorder of ChildhoodUnited States
-
Nazife Begüm KARANCompletedDental Anxiety | Sedative; Anxiety DisorderTurkey
-
Eli Lilly and CompanyCompletedAnxiety Neuroses | Anxiety States, Neurotic | Neuroses, AnxietyUnited States, Mexico, South Africa
-
Loyola UniversityCompletedAnxiety | Anxiety State | Procedural AnxietyUnited States
-
West University of TimisoaraUnknownAnxiety Disorder/Anxiety StateRomania
-
Consciousness and Healing InitiativeNot yet recruitingAnxiety | Anxiety State | Mental Health Issue | Anxiety Generalized
-
University of MichiganBrain & Behavior Research FoundationRecruitingGeneralized Anxiety Disorder | Anxiety | Social Anxiety Disorder | Panic DisorderUnited States
Clinical Trials on Mind-Body Medicine Curriculum
-
Rush University Medical CenterCompleted
-
Mercy Medical CenterCompleted
-
The Center for Mind-Body MedicineSimon Family FoundationEnrolling by invitation
-
Universität Duisburg-EssenRobert Bosch Medical CenterRecruiting
-
Universität Duisburg-EssenCompletedQuality of Life | Breast Cancer | Chemotherapy | Acupuncture | Mind-Body-MedicineGermany
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingGlioblastoma | Malignant Glioma | WHO Grade III Glioma | Metastatic Malignant Neoplasm in the Brain | Low Grade Glioma | PartnerUnited States
-
Universität Duisburg-EssenCompleted
-
Carmel Medical CenterRecruitingWellbeing of Healthcare Providersin Frontline COVID-19 DepartmentsIsrael
-
Weill Medical College of Cornell UniversityCompletedPediatric Residents Rotating in Pediatric OncologyUnited States
-
Beth Israel Deaconess Medical CenterCompletedChronic Pain | Chronic Pain SyndromeUnited States