- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01311596
Show Me to Help Me
This cohort observation, randomized controlled trial is intended to provide data that icons and non-verbal communication improve communication and cooperation with children with Autism/communication delay and aid in the transition to an unfamiliar environment. It would lay the foundation for future studies and practices of using icons and pictures for the whole office visit to enhance communication between the patient and physician/nurse/medical staff and cooperation of the patient.
- Use icons during triage/check in process to decrease time and increase patient compliance. Compare typical children to those with Autism/communication delay.
- Use icons during blood draw to improve communication with patients, to help with patient understanding, and increase patient cooperation and decrease noise and length of procedure.
Study Overview
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Ohio
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Akron, Ohio, United States, 44308
- Akron Children's Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- established patients with a documented diagnosis
- 4-18 years old
- present to the NeuroDevelopmental Center during the study period
- Lab study: given prescription for lab work that will be following the visit or the next day in the Locust outpatient lab
Exclusion Criteria:
- <4 years old or >18 years old
- new patient
- diagnosis not documented
- Lab study: lab work will be drawn at another lab or more than 1 day later
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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No icons
Clinic - Children who are established patients, 4-18 years old, and presented to the NeuroDevelopmental Science Center for a follow-up office visit during the first 2 weeks of the study period Lab -Patients 4-18 years old with a documented diagnosis who were seen in the NeuroDevelopmental Science Center and were given a prescription for lab work during the first 2 weeks of the study period |
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Icons
Clinic - Children who are established patients, 4-18 years old, and presented to the NeuroDevelopmental Science Center for a follow-up office visit during the last 2 weeks of the study period Lab - Patients 4-18 years old with a documented diagnosis who were seen in the NeuroDevelopmental Science Center and were given a prescription for lab work during the last 2 weeks of the study period |
Clinic- patients first shown picture icons of the steps of taking vital signs Lab - patients first shown picture icons of the steps of a blood draw procedure
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Icons improve understanding, transition and cooperation of the child with Autism/communication delay as measured by improved times for the obtainment of vital signs
Time Frame: 4 weeks
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4 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Icons improve understanding and cooperation of the child with Autism/communication delay as measured by improved times of lab draws, success of lab draws, and decreased noise level
Time Frame: 4 weeks
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4 weeks
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Ganz JB, Simpson RL. Effects on communicative requesting and speech development of the Picture Exchange Communication System in children with characteristics of autism. J Autism Dev Disord. 2004 Aug;34(4):395-409. doi: 10.1023/b:jadd.0000037416.59095.d7.
- Charlop-Christy MH, Carpenter M, Le L, LeBlanc LA, Kellet K. Using the picture exchange communication system (PECS) with children with autism: assessment of PECS acquisition, speech, social-communicative behavior, and problem behavior. J Appl Behav Anal. 2002 Fall;35(3):213-31. doi: 10.1901/jaba.2002.35-213.
- Bondy A, Frost L. The Picture Exchange Communication System. Behav Modif. 2001 Oct;25(5):725-44. doi: 10.1177/0145445501255004.
- Desch LW, Gaebler-Spira D; Council on Children With Disabilities. Prescribing assistive-technology systems: focus on children with impaired communication. Pediatrics. 2008 Jun;121(6):1271-80. doi: 10.1542/peds.2008-0695.
- Francis K. Autism interventions: a critical update. Dev Med Child Neurol. 2005 Jul;47(7):493-9. doi: 10.1017/s0012162205000952.
- Magiati I, Howlin P. A pilot evaluation study of the Picture Exchange Communication System (PECS) for children with autistic spectrum disorders. Autism. 2003 Sep;7(3):297-320. doi: 10.1177/1362361303007003006.
- Sulzer-Azaroff B, Hoffman AO, et al. The Picture Exchange Communication System (PECS): What Do the Data Say? Focus on Autism and Other Developmental Disabilities. 209;24(2):89-103
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 101201
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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