StressCMCNCT03173209
Evaluating the Effectiveness of the Calm Moments Cards Program Implemented by School Personnel
A study testing professional development in Calm Moments Cards program in people with Stress and Child, Only, run by Cleveland State University.
Trial summary
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Stress, Child, Only
- What is being tested?
- professional development in Calm Moments Cards program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- No sites listed yet
- Study dates
- 17 Jan 2015to 13 Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- School personnel representing teachers, related service providers and para-educators working with elementary students in schools
Who cannot join
- School personnel who were informed of but declined to participate in the study
About this study
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.
Read the 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.
- Conditions
- Stress, Child, Only
- Being tested
- professional development in Calm Moments Cards program
- Keywords
- school
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
professional development in Calm Moments Cards programBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| school professional development | Other | 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. Receives: Behavioral: professional development in Calm Moments Cards program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in knowledge, beliefs, and actions regarding recognizing and reducing stress in children
20 questions using Likert Scale
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2017
- Study start17 Jan 2015
- Primary completion13 Oct 2016
- Study completion13 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- A one-group (N 93) mixed-methods design using a pretest-posttest survey and qualitative analysis of written reflections was used to explore the meaning and outcomes of the Calm Moments Cards program.
- Masking
- None (open label)
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cleveland State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Susan Bazyk, PhD, Principal investigator, Cleveland State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03173209
- Sponsor's protocol ID
- FY2016-49
- Acronym
- CMC
- Status last verified
- May 2017
- First submitted
- 30 May 2017
- Last updated
- 1 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effectiveness of the Calm Moments Cards Program Implemented by School Personnel
- ClinicalTrials.gov ID
- NCT03173209
- Acronym / sponsor ID
- CMC / FY2016-49
- Conditions
- Stress, Child, Only
- Keywords
- school
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Cleveland State UniversityUniversity, hospital or other
- Study start
- 17 Jan 2015 (actual)
- Primary completion
- 13 Oct 2016 (actual)
- Study completion
- 13 Oct 2016 (actual)
- First posted
- 1 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A one-group (N 93) mixed-methods design using a pretest-posttest survey and qualitative analysis of written reflections was used to explore the meaning and outcomes of the Calm Moments Cards program.
| Arm | Type | Receives |
|---|---|---|
| school professional development | Other | Behavioral: professional development in Calm Moments Cards programProfessional 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- School personnel representing teachers, related service providers and para-educators working with elementary students in schools
Key exclusion criteria (1 listed)
- School personnel who were informed of but declined to participate in the study
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 |
|---|---|---|
| professional development in Calm Moments Cards programProfessional 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. | Behavioural | school professional development |
Primary outcome
Change in knowledge, beliefs, and actions regarding recognizing and reducing stress in children
Time frame: 4 months
20 questions using Likert Scale
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2017.
- Calm Moments CardsLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Stress
RecruitingObservational study
Asprosin and miRNA Expression in Young Women With Metabolic Syndrome
Metabolic Syndrome, Insulin Resistance
Recruiting
The Effect of Using Nature Sounds and Virtual Reality During the Non-Stress Test
Pregnancy - Prenatal Testing
Not yet recruiting
A Mobile Informatics Solution to Assist Caregivers in Care Coordination and Monitoring Social Engagement
Memory Disorders, Mild Cognitive Impairment
Recruiting
Our Voices Matter: Intervention for Depression in Youth
Depressive Symptoms, Allostatic Load
RecruitingObservational study
Oxidative Stress and Inflammatory Biomarkers in Gaucher Disease
Gaucher Disease Type I, Oxidative Stress
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.
Susan Bazyk, PhD principal investigator
Cleveland State University
Questions about this trial
What is this clinical trial studying?
A study testing professional development in Calm Moments Cards program in people with Stress and Child, Only, run by Cleveland State University.
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 1 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 1 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in knowledge, beliefs, and actions regarding recognizing and reducing stress in children (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jun 2017.