AutismNCT01311596
Show Me to Help Me
An observational study of Autism, run by Akron Children's Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 4 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism
- What is being tested?
- Icons
- How many people
- 83 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to Feb 2011
- Phase
- Observational
- 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 4 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- 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
Who cannot join
- <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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Autism
- Being tested
- Icons
- Keywords
- icons in clinic or office for patients with Autism
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IconsOther
Also called Picture Exchange communication system (PECS)
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Icons |
What is being measured
The primary outcome is the main question the study is designed to answer.
Icons improve understanding, transition and cooperation of the child with Autism/communication delay as measured by improved times for the obtainment of vital signs
Measured: 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
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2011 (estimated)
- Study startFeb 2011
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for AutismStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akron Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01311596
- Sponsor's protocol ID
- 101201
- Status last verified
- Jun 2014
- First submitted
- 8 Mar 2011
- Last updated
- 24 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Bondy A, Frost L. The Picture Exchange Communication System. Behav Modif. 2001 Oct;25(5):725-44. doi: 10.1177/0145445501255004.
PubMed 11573337Charlop-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.
PubMed 12365736Desch 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.
PubMed 18519500Francis K. Autism interventions: a critical update. Dev Med Child Neurol. 2005 Jul;47(7):493-9. doi: 10.1017/s0012162205000952.
PubMed 15991872Ganz 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.
PubMed 15449515Magiati 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.
PubMed 14516062Sulzer-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 at a glance
From the registry record, last updated by the sponsor on 24 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Show Me to Help Me
- ClinicalTrials.gov ID
- NCT01311596
- Acronym / sponsor ID
- 101201
- Conditions
- Autism
- Keywords
- icons in clinic or office for patients with Autism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Akron Children's HospitalUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 9 Mar 2011 (estimated)
- 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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Other: IconsClinic - 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 |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- <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
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 |
|---|---|---|
| IconsAlso: Picture Exchange communication system (PECS)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 | Icons |
Primary outcome
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
1 secondary outcome
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
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 24 Jun 2014.
- Background: PubMed 11573337Bondy A, Frost L. The Picture Exchange Communication System. Behav Modif. 2001 Oct;25(5):725-44. doi: 10.1177/0145445501255004.
- Background: PubMed 12365736Charlop-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.
- Background: PubMed 18519500Desch 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.
- Background: PubMed 15991872Francis K. Autism interventions: a critical update. Dev Med Child Neurol. 2005 Jul;47(7):493-9. doi: 10.1017/s0012162205000952.
- Background: PubMed 15449515Ganz 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.
- Background: PubMed 14516062Magiati 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.
- BackgroundSulzer-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
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism, run by Akron 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 4 inclusion and 4 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 24 Jun 2014. 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?
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?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01311596, which also lists 7 linked publications.
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 24 Jun 2014.