NCT01612897

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
368

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2009

Longer than P75 for not_applicable

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

September 1, 2009

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

June 4, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 6, 2012

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

March 24, 2015

Status Verified

March 1, 2015

Enrollment Period

4.8 years

First QC Date

June 4, 2012

Last Update Submit

March 23, 2015

Conditions

Keywords

autismwell child carescreeningcomputerreminders

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Are appropriate diagnostic studies conducted among children who screen positive for autism.

    Up to 4 years

Study Arms (2)

Computer based reminders to MD

EXPERIMENTAL

Children in this arm attend a clinic that is randomly assigned to receive physician alerts to screen appropriate children for autism.

Other: Computer based care reminders

Usual care arm

NO INTERVENTION

Children in this are receive usual care from a clinic randomly chosen to serve as a control.

Interventions

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

Computer based reminders to MD

Eligibility Criteria

Age17 Months - 4 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wishard (Eskenazi) Healthcare clinics

Indianapolis, Indiana, 46202, United States

Location

Related Publications (1)

  • Downs SM, Bauer NS, Saha C, Ofner S, Carroll AE. Effect of a Computer-Based Decision Support Intervention on Autism Spectrum Disorder Screening in Pediatric Primary Care Clinics: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2019 Dec 2;2(12):e1917676. doi: 10.1001/jamanetworkopen.2019.17676.

MeSH Terms

Conditions

Autistic Disorder

Condition Hierarchy (Ancestors)

Autism Spectrum DisorderChild Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2012

First Posted

June 6, 2012

Study Start

September 1, 2009

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

March 24, 2015

Record last verified: 2015-03

Locations