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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01311596
Other study ID # 101201
Secondary ID
Status Completed
Phase N/A
First received March 8, 2011
Last updated June 23, 2014
Start date February 2011
Est. completion date February 2011

Study information

Verified date June 2014
Source Akron Children's Hospital
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

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.

1. Use icons during triage/check in process to decrease time and increase patient compliance. Compare typical children to those with Autism/communication delay.

2. 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.


Recruitment information / eligibility

Status Completed
Enrollment 83
Est. completion date February 2011
Est. primary completion date February 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 4 Years to 18 Years
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Other:
Icons
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

Locations

Country Name City State
United States Akron Children's Hospital Akron Ohio

Sponsors (1)

Lead Sponsor Collaborator
Akron Children's Hospital

Country where clinical trial is conducted

United States, 

References & Publications (7)

Bondy A, Frost L. The Picture Exchange Communication System. Behav Modif. 2001 Oct;25(5):725-44. Review. — View Citation

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. — View Citation

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. — View Citation

Francis K. Autism interventions: a critical update. Dev Med Child Neurol. 2005 Jul;47(7):493-9. Review. — View Citation

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. — View Citation

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. — View Citation

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

Outcome

Type Measure Description Time frame Safety issue
Primary Icons improve understanding, transition and cooperation of the child with Autism/communication delay as measured by improved times for the obtainment of vital signs 4 weeks No
Secondary 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 4 weeks No
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