Other Specified Personal Exposures and History Presenting Hazards to HealthSPARKNCT01291225
Safe Play Areas for Ross County Kids Project
A study testing Playground renovation and development and Educational campaign in people with Other Specified Personal Exposures and History Presenting Hazards to Health and Knowledge, Attitudes, Practice, run by Nationwide Children's Hospital at 1 site in United States.
Trial summary
Specific Aim 1 - In collaboration with partners in Ross County, renovate and develop playgrounds in Chillicothe. Specific Aim 2 - In collaboration with partners in Ross County, promote safe play and play areas for children on farms. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Other Specified Personal Exposures and History Presenting Hazards to Health, Knowledge, Attitudes, Practice, Fall Involving Playground Equipment, Occurrence on Farm
- What is being tested?
- Playground renovation and development and Educational campaign
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 311 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to Jun 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For playgrounds
- must be seen at Adena Medical Center or Pickaway Pediatrics
- must be the parent of a child younger than 6 years of age
- must live in Chillicothe (if recruited at Adena) or Circleville (if recruited at Pickaway Peds)
- must be English speaking
- must be at least 18 years old
Show all 12Show fewer
- For farms
- must self-identify as living on a farm
- must have a child younger than 6 years of age
- must live in Ross county or Pickaway county
- must be English speaking
- must be at least 18 years old
Who cannot join
- Participants can only enroll in one study at a time
Trial locations and contacts
1 site in 1 country.
United States1 site
The Research Institute at Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
Specific Aim 1 - In collaboration with partners in Ross County, renovate and develop playgrounds in Chillicothe.
Specific Aim 2 - In collaboration with partners in Ross County, promote safe play and play areas for children on farms.
Read the detailed description
Injury is the leading cause of mortality and morbidity among children in the United States. Because children spend much of their time playing, it is important that they have safe play environments where they can challenge themselves and develop physically, mentally, and socially. The SPARK Project will focus its intervention in Ross County, Ohio, an area with more than 930 farms. Prior to this project, relatively little has been done to promote the prevention of injuries to children who live and play on farms.
The specific aims of this project are as follows:
- In collaboration with partners in Ross County, renovate and develop playgrounds in Chillicothe, Ohio.
- In collaboration with partners in Ross County, promote safe play areas for children on farms.
The SPARK Project will employ a multi-faceted approach to injury prevention, centered on community partnership and collaboration. Utilizing methodology that was successfully developed and implemented as part of the Community Action for Playground Safety (CAPS) Program in Columbus, the SPARK Project will combine both active and passive injury prevention strategies to reduce playground and play-related farm injuries to children in Ross County.
- Conditions
- Other Specified Personal Exposures and History Presenting Hazards to Health, Knowledge, Attitudes, Practice, Fall Involving Playground Equipment, Occurrence on Farm
- Being tested
- Playground renovation and development, Educational campaign
- Keywords
- playgrounds, farms, injury prevention, safety knowledge, attitudes and practices, safe play, rural
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Playground renovation and developmentOther
Playgrounds in Chillicothe will be renovated based on priorities determined by audits.
Educational campaignBehavioural
Educational materials will be developed and distributed in Ross County.
| Study group | Role | What they receive |
|---|---|---|
| Playground | Other | The playground arm of the study will consist of playground audits and KAP surveys about playground safety in both Chillicothe and Circleville, Ohio.
The intervention is Playground Safety Renovations and Development. Receives: Other: Playground renovation and development; Behavioral: Educational campaign |
| Farms | Other | The Farm Arm will consist of farm audits with safety checklists and KAP surveys about farm safety. The intervention is a Safety Educational Campaign. Receives: Behavioral: Educational campaign |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Playground Hazards
The investigators hypothesize that the decrease in the number of identified playground hazards (comparing each playground to itself from the year 1 baseline survey to the year 3 follow-up survey utilizing a playground hazards checklist) will be significantly greater for the intervention playgrounds compared with non-intervention playgrounds in Circleville, Pickaway Co. The percentage increase in the number of playgrounds with adequate safety surfacing will be used as a proxy for playground hazardousness.
Measured: Year 1 baseline to year 3 follow-up
Secondary outcomes (1)
Playground and Farm Safety Knowledge, Attitudes and Practices Composite Scores
The investigators hypothesize that the improvement in the playground safety Knowledge, Attitudes, and Practices (KAP) survey composite scores and farm audits from the baseline in year 1 to the follow-up in year 3 will be significantly greater for parents residing in Ross County than for parents in the non-intervention counties (Morrow and Pickaway).The playground safety KAP survey consisted of 7 items and individuals could receive a summed score of 0-7, with a score of 7 indicating mastery of the material.
Measured: Year 1 baseline to Year 3 follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Other Specified Personal Exposures and History Presenting Hazards to HealthStudies of the same condition, open and under way.
- More trials run by Nationwide Children's HospitalThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 311 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nationwide Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ohio State University
- Responsible party
- Principal investigator, Gary A. Smith, Nationwide Children's Hospital
- Investigators
- Gary A Smith, MD, DrPH, Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01291225
- Sponsor's protocol ID
- IRB10-00368
- Acronym
- SPARK
- Status last verified
- Mar 2016
- First submitted
- 7 Feb 2011
- Last updated
- 1 Apr 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safe Play Areas for Ross County Kids Project
- ClinicalTrials.gov ID
- NCT01291225
- Acronym / sponsor ID
- SPARK / IRB10-00368
- Conditions
- Other Specified Personal Exposures and History Presenting Hazards to Health, Knowledge, Attitudes, Practice, Fall Involving Playground Equipment, Occurrence on Farm
- Keywords
- playgrounds, farms, injury prevention, safety knowledge, attitudes and practices, safe play, rural
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 311 participants (actual)
- Lead sponsor
- Nationwide Children's HospitalUniversity, hospital or other
- Collaborators
- Ohio State University
- Study start
- Feb 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 8 Feb 2011 (estimated)
- Results
- Posted 1 Apr 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Specific Aim 1 - In collaboration with partners in Ross County, renovate and develop playgrounds in Chillicothe.
Specific Aim 2 - In collaboration with partners in Ross County, promote safe play and play areas for children on farms.
Detailed description
Injury is the leading cause of mortality and morbidity among children in the United States. Because children spend much of their time playing, it is important that they have safe play environments where they can challenge themselves and develop physically, mentally, and socially. The SPARK Project will focus its intervention in Ross County, Ohio, an area with more than 930 farms. Prior to this project, relatively little has been done to promote the prevention of injuries to children who live and play on farms.
The specific aims of this project are as follows:
- In collaboration with partners in Ross County, renovate and develop playgrounds in Chillicothe, Ohio.
- In collaboration with partners in Ross County, promote safe play areas for children on farms.
The SPARK Project will employ a multi-faceted approach to injury prevention, centered on community partnership and collaboration. Utilizing methodology that was successfully developed and implemented as part of the Community Action for Playground Safety (CAPS) Program in Columbus, the SPARK Project will combine both active and passive injury prevention strategies to reduce playground and play-related farm injuries to children in Ross County.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Playground | Other | Other: Playground renovation and development, Behavioral: Educational campaignThe playground arm of the study will consist of playground audits and KAP surveys about playground safety in both Chillicothe and Circleville, Ohio. The intervention is Playground Safety Renovations and Development. |
| Farms | Other | Behavioral: Educational campaignThe Farm Arm will consist of farm audits with safety checklists and KAP surveys about farm safety. The intervention is a Safety Educational Campaign. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- For playgrounds
- For farms
Key exclusion criteria (1 listed)
- Participants can only enroll in one study at a time
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 |
|---|---|---|
| Playground renovation and developmentPlaygrounds in Chillicothe will be renovated based on priorities determined by audits. | Other | Playground |
| Educational campaignEducational materials will be developed and distributed in Ross County. | Behavioural | Farms, Playground |
Primary outcome
Change in Playground Hazards
Time frame: Year 1 baseline to year 3 follow-up
The investigators hypothesize that the decrease in the number of identified playground hazards (comparing each playground to itself from the year 1 baseline survey to the year 3 follow-up survey utilizing a playground hazards checklist) will be significantly greater for the intervention playgrounds compared with non-intervention playgrounds in Circleville, Pickaway Co. The percentage increase in the number of playgrounds with adequate safety surfacing will be used as a proxy for playground hazardousness.
1 secondary outcome
Playground and Farm Safety Knowledge, Attitudes and Practices Composite Scores
Time frame: Year 1 baseline to Year 3 follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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.
Gary A Smith, MD, DrPH principal investigator
Nationwide Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Playground renovation and development and Educational campaign in people with Other Specified Personal Exposures and History Presenting Hazards to Health and Knowledge, Attitudes, Practice, run by Nationwide Children's Hospital at 1 site in United States.
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 12 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 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 1 Apr 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Playground Hazards (time frame: Year 1 baseline to year 3 follow-up). 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 Apr 2016.