Interpersonal Relations(EMCRR)NCT03170635
Refreshing Recess: Staff and Student Feedback Outcome Study (EMCRR)
A study testing Refreshing Recess program in people with Interpersonal Relations and Occupational Therapy, run by Cleveland State University.
Trial summary
A mixed methods design was used to explore the outcomes of a 6-week, occupational therapy-led Refreshing Recess program designed to build capacity of recess supervisors to create a positive recess experience so that all students can successfully participate in and enjoy active play and socialization with peers. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Interpersonal Relations, Occupational Therapy
- What is being tested?
- Refreshing Recess program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 485 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2013to 1 Mar 2014
- 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
- all kindergarten through 4th grade students in school where the Refreshing Recess program was offered based on principal approval
- all recess supervisors who supervised recess during program implementation
Who cannot join
- students who did not receive the school-sponsored Refreshing Recess program
About this study
Official title: The Refreshing Recess Program for Promoting Student Participation and Enjoyment: An Outcome Study
A mixed methods design was used to explore the outcomes of a 6-week, occupational therapy-led Refreshing Recess program designed to build capacity of recess supervisors to create a positive recess experience so that all students can successfully participate in and enjoy active play and socialization with peers.
Read the detailed description
A mixed methods design was used to explore the outcomes of a 6-week, occupational therapy-led Refreshing Recess program designed to build capacity of recess supervisors to create a positive mealtime environment so that all students can successfully participate in and enjoy recess and socialization with peers. Occupational therapy practitioners provide weekly information and coaching to recess supervisors and embed weekly activities into the recess experience (e.g. team building games, strategies for including students with disabilities, etc.).
- Conditions
- Interpersonal Relations, Occupational Therapy
- Being tested
- Refreshing Recess program
- Keywords
- recess, occupational therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Refreshing Recess programBehavioural
6-week program integrated into recess in order to build capacity of recess supervisors to foster active play and socialization so that all students enjoy recess and socialization with peers.
| Study group | Role | What they receive |
|---|---|---|
| 6 week Refreshing Recess program | Other | Education and coaching for recess supervisors to learn about how to promote positive social interaction and active play with all students during recess. Provision of play activities for students during recess that foster active play, teamwork, and inclusion of students with disabilities and/or social challenges. Receives: Behavioral: Refreshing Recess program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in students' participation and enjoyment of recess play and socialization
Visual analogue survey
Measured: pretest prior to the program implementation (10 minutes) and posttest 6 weeks later after program implementation (10 minutes)
Secondary outcomes (1)
Changes in recess supervisors knowledge, beliefs, and actions related to supervising recess
Likert scale survey
Measured: pre-survey prior to program implementation (10 min.) and post-survey following the 6 week program (10 min.)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2017
- Study start1 Mar 2013
- Primary completion1 Mar 2014
- Study completion1 Mar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interpersonal RelationsStudies 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The Refreshing Recess program was provided one day/week for 6 consecutive weeks.
- Masking
- None (open label)
- Enrolment
- 485 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cleveland State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Susan Bazyk, Cleveland State University
- Investigators
- Susan Bazyk, Principal investigator, Cleveland State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03170635
- Sponsor's protocol ID
- 29788-BAZ-HS
- Acronym
- (EMCRR)
- Status last verified
- May 2017
- First submitted
- 19 May 2017
- Last updated
- 31 May 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 31 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Refreshing Recess Program for Promoting Student Participation and Enjoyment: An Outcome Study
- ClinicalTrials.gov ID
- NCT03170635
- Acronym / sponsor ID
- (EMCRR) / 29788-BAZ-HS
- Conditions
- Interpersonal Relations, Occupational Therapy
- Keywords
- recess, occupational therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 485 participants (actual)
- Lead sponsor
- Cleveland State UniversityUniversity, hospital or other
- Study start
- 1 Mar 2013 (actual)
- Primary completion
- 1 Mar 2014 (actual)
- Study completion
- 1 Mar 2014 (actual)
- First posted
- 31 May 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.
A mixed methods design was used to explore the outcomes of a 6-week, occupational therapy-led Refreshing Recess program designed to build capacity of recess supervisors to create a positive recess experience so that all students can successfully participate in and enjoy active play and socialization with peers.
Detailed description
A mixed methods design was used to explore the outcomes of a 6-week, occupational therapy-led Refreshing Recess program designed to build capacity of recess supervisors to create a positive mealtime environment so that all students can successfully participate in and enjoy recess and socialization with peers. Occupational therapy practitioners provide weekly information and coaching to recess supervisors and embed weekly activities into the recess experience (e.g. team building games, strategies for including students with disabilities, etc.).
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The Refreshing Recess program was provided one day/week for 6 consecutive weeks.
| Arm | Type | Receives |
|---|---|---|
| 6 week Refreshing Recess program | Other | Behavioral: Refreshing Recess programEducation and coaching for recess supervisors to learn about how to promote positive social interaction and active play with all students during recess. Provision of play activities for students during recess that foster active play, teamwork, and inclusion of students with disabilities and/or social challenges. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- all kindergarten through 4th grade students in school where the Refreshing Recess program was offered based on principal approval
- all recess supervisors who supervised recess during program implementation
Key exclusion criteria (1 listed)
- students who did not receive the school-sponsored Refreshing Recess program
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 |
|---|---|---|
| Refreshing Recess program6-week program integrated into recess in order to build capacity of recess supervisors to foster active play and socialization so that all students enjoy recess and socialization with peers. | Behavioural | 6 week Refreshing Recess program |
Primary outcome
Changes in students' participation and enjoyment of recess play and socialization
Time frame: pretest prior to the program implementation (10 minutes) and posttest 6 weeks later after program implementation (10 minutes)
Visual analogue survey
1 secondary outcome
Changes in recess supervisors knowledge, beliefs, and actions related to supervising recess
Time frame: pre-survey prior to program implementation (10 min.) and post-survey following the 6 week program (10 min.)
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 31 May 2017.
- Individual participant dataSharing planned: No
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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 principal investigator
Cleveland State University
Questions about this trial
What is this clinical trial studying?
A study testing Refreshing Recess program in people with Interpersonal Relations and Occupational Therapy, 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 2 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 31 May 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?
Changes in students' participation and enjoyment of recess play and socialization (time frame: pretest prior to the program implementation (10 minutes) and posttest 6 weeks later after program implementation (10 minutes)). 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 31 May 2017.