NCT03718845

Brief Summary

This study will evaluate a Mind-Body Medicine curriculum for high school peer counselors in order to answer the following research questions:

  1. 1.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?
  2. 2.What are the experiences of peer support counselors participating in the Mind-Body Medicine curriculum?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
124

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2018

Shorter than P25 for all trials

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

October 8, 2018

Completed
14 days until next milestone

Study Start

First participant enrolled

October 22, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 25, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
Last Updated

August 31, 2022

Status Verified

August 1, 2022

Enrollment Period

8 months

First QC Date

October 8, 2018

Last Update Submit

August 26, 2022

Conditions

Keywords

EmpathyHope

Outcome Measures

Primary Outcomes (1)

  • Change in State-Trait Anxiety Inventory (STAI) scores

    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 Outcomes (2)

  • Change in the Social Emotional Assets and Resilience Scales for Adolescents (SEARS-A)

    baseline, approximately 2 months, approximately 8 months

  • Change in the Adult Hope Scale

    baseline, approximately 2 months, approximately 8 months

Other Outcomes (1)

  • Focus Group Interviews

    baseline, approximately 2 months, approximately 6 months, and approximately 8 months

Study Arms (1)

Peer Counselors

Mind-Body Medicine Curriculum

Behavioral: Mind-Body Medicine Curriculum

Interventions

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.

Also known as: Mind-Body Skills Groups
Peer Counselors

Eligibility Criteria

Age15 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

High school students who are participating in the Peer Counseling Program at Marjory Stoneman Douglas High School

You may qualify if:

  • All high school students who are participating in the Peer Counseling Program at Marjory Stoneman Douglas High School

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marjory Stoneman Douglas High School

Parkland, Florida, 33076, United States

Location

Related Links

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • James S Gordon, MD

    The Center for Mind-Body Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Founder and Director

Study Record Dates

First Submitted

October 8, 2018

First Posted

October 25, 2018

Study Start

October 22, 2018

Primary Completion

June 30, 2019

Study Completion

June 30, 2019

Last Updated

August 31, 2022

Record last verified: 2022-08

Locations