NCT01311596

Brief 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. 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
83

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 8, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 9, 2011

Completed
Last Updated

June 24, 2014

Status Verified

June 1, 2014

Enrollment Period

Same day

First QC Date

March 8, 2011

Last Update Submit

June 23, 2014

Conditions

Keywords

icons in clinic or office for patients with Autism

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • 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

Study Arms (2)

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

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

Other: Icons

Interventions

IconsOTHER

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

Also known as: Picture Exchange communication system (PECS)
Icons

Eligibility Criteria

Age4 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Children who are established patients, 4-18 years old, and present to the NeuroDevelopmental Science Center for a follow-up office visit during the study period, since a diagnosis will be available at the time of the study (patients in the lab study may be new patients if they have a diagnosis at the time their lab work is prescribed). The NeuroDevelopmental Science Center at Akron Children's Hospital provides nearly 25,000 visits annually to children and youth affected by neurological, developmental, and behavioral disorders. This includes children with autism, intellectual disabilities, physical disabilities, learning disabilities, epilepsy and other neurological conditions.

You may qualify if:

  • established patients with a documented diagnosis
  • 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

You may not qualify if:

  • \<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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Akron Children's Hospital

Akron, Ohio, 44308, United States

Location

Related Publications (7)

  • Bondy A, Frost L. The Picture Exchange Communication System. Behav Modif. 2001 Oct;25(5):725-44. doi: 10.1177/0145445501255004.

    PMID: 11573337BACKGROUND
  • 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.

    PMID: 12365736BACKGROUND
  • 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.

    PMID: 18519500BACKGROUND
  • Francis K. Autism interventions: a critical update. Dev Med Child Neurol. 2005 Jul;47(7):493-9. doi: 10.1017/s0012162205000952.

    PMID: 15991872BACKGROUND
  • 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.

    PMID: 15449515BACKGROUND
  • 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.

    PMID: 14516062BACKGROUND
  • 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

    BACKGROUND

MeSH Terms

Conditions

Autistic Disorder

Condition Hierarchy (Ancestors)

Autism Spectrum DisorderChild Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2011

First Posted

March 9, 2011

Study Start

February 1, 2011

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

June 24, 2014

Record last verified: 2014-06

Locations