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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01612897
Other study ID # R01HS018453
Secondary ID
Status Completed
Phase N/A
First received June 4, 2012
Last updated March 23, 2015
Start date September 2009
Est. completion date July 2014

Study information

Verified date March 2015
Source Indiana University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The investigators hypothesize that children seen in a clinic that uses a compute based system known as CHICA, which reminds pediatricians to screen at defined time point for autism, will be screened more consistently for autism and receive more timely diagnostic a treatment services.


Description:

To be eligible for this trial, participants must receive their care at one of four primary care clinics in Indianapolis where the CHICA system is used.


Recruitment information / eligibility

Status Completed
Enrollment 368
Est. completion date July 2014
Est. primary completion date July 2014
Accepts healthy volunteers No
Gender Both
Age group 17 Months to 4 Years
Eligibility Inclusion Criteria:

- Previously healthy children receiving routine care in one of four clinics in Indianapolis who participate in this study.

Exclusion Criteria:

- Previously known autism spectrum disorders or other causes of developmental delay

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Screening


Related Conditions & MeSH terms


Intervention

Other:
Computer based care reminders
Physicians in the intervention clinic will receive computer generated reminders to screen for autism among children of appropriate age visiting the clinic.

Locations

Country Name City State
United States Wishard (Eskenazi) Healthcare clinics Indianapolis Indiana

Sponsors (1)

Lead Sponsor Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Structure autism screening instrument administered Physicians are reminded by the computer system to screen children under 3 years of age for autism with a structured screening instrument. Chart abstraction is used to document whether or not the screening occurred. Up to 4 years No
Secondary Are appropriate diagnostic studies conducted among children who screen positive for autism. Among children who a suspected of having autism, chart abstraction and interviews are done to determine if the child received appropriate diagnostic and studies. Up to 4 years No
See also
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