- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03173209
Evaluating the Effectiveness of the Calm Moments Cards Program Implemented by School Personnel (CMC)
May 30, 2017 updated by: Cleveland State University
We explored the meaning and outcomes of a 4-month program designed to build capacity of school personnel in implementing evidence-based strategies for reducing stress and promoting mental well-being among students in school settings.
A one-group (N 93) mixed-methods design using a pretest-posttest survey and qualitative analysis of their written reactions was used to explore the meaning and outcomes of the Calm Moments Cards program.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
In order to explore the effectiveness of the Calm Moments Cards program on school personnel's ability to recognize signs of stress and the implementation of embedded strategies to reduce stress and enhance emotional well-being, we conduct a mixed-methods research study using pretest-posttest surveys (assessing knowledge, beliefs, and actions) and qualitative analysis of written reflections about the meaning and use of the Calm Moments Cards.
The focus of the intervention is on prevention of stress and anxiety based on situational stressors (e.g.
taking a test, completing an assignment) so that students can focus on and succeed in doing their schoolwork.
Occupational therapy practitioners oriented school personnel to the signs of stress and the use of the 17 Calm Moments Cards using a 1 hour inservice.
This was followed by informal coaching to foster implementation.
Study Type
Interventional
Enrollment (Actual)
93
Phase
- Not Applicable
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- School personnel representing teachers, related service providers and para-educators working with elementary students in schools
Exclusion Criteria:
- School personnel who were informed of but declined to participate in the study
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
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: school professional development
Professional development in Calm Moments Cards program.
Occupational therapists used lecture and coaching to educate school personnel on signs of stress and how to embed evidence based strategies (cognitive behavioral, mindfulness, and sensory) throughout the school day to reduce stress and enhance emotional well-being in students using the Calm Moments Cards program.
|
Professional development (lecture and coaching)was used in combination with informal coaching by occupational therapy practitioners to educate school personnel on signs of stress and how to embed evidence based strategies (cognitive behavioral, mindfulness, and sensory) throughout the school day to reduce stress and enhance emotional well-being in students using the Calm Moments Cards program.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in knowledge, beliefs, and actions regarding recognizing and reducing stress in children
Time Frame: 4 months
|
20 questions using Likert Scale
|
4 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Susan Bazyk, PhD, Cleveland State University
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)
January 17, 2015
Primary Completion (Actual)
October 13, 2016
Study Completion (Actual)
October 13, 2016
Study Registration Dates
First Submitted
May 30, 2017
First Submitted That Met QC Criteria
May 30, 2017
First Posted (Actual)
June 1, 2017
Study Record Updates
Last Update Posted (Actual)
June 1, 2017
Last Update Submitted That Met QC Criteria
May 30, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- FY2016-49
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Study Data/Documents
-
intervention materials
Information identifier: Calm Moments Cards programInformation comments: Calm Moments Cards program
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.
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