The CHICA Developmental Screening Study

NCT01351077 | Completed Results

• 2 other identifiers: CHICA_DevScreen_StudyR01HS017939
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

Brief Summary

The aims of this study are to (1) Expand and modify an existing computer-based decision support system (CHICA) to include the 2006 AAP developmental surveillance and screening algorithm; (2) Evaluate the effect of the CHICA system on the developmental surveillance and screening practices of four pediatric clinics; (3) Evaluate the effect of the CHICA system on referrals for developmental and medical evaluations as well as early developmental intervention/early childhood services for those children identified as having concerning developmental screening results; and (4) Develop a cohort of children with identified developmental disabilities that can be followed over time in order to look at the end results/effects of developmental screening

Conditions

Developmental Delay

Keywords

Developmental Delay

Outcome Measures

Primary Outcomes (1)

• Number of Children Screened for Developmental Delay

  one year

Secondary Outcomes (1)

• Age of Children Diagnosed With Developmental Delay

  one year

Other Outcomes (3)

• Number of Children With a Positive Screen

  one year

• Number of Children Referred for Evaluation and Services When There Was a Positive Screening Result

  one year

• Number of Patients Whose Referred Evaluations and Services Were Completed

  one year

Study Arms (2)

CHICA DevScreen Module

EXPERIMENTAL

This arm will get the CHICA Developmental Screening Module

Other: CHICA DevScreen Module

CHICA DevScreen Control

NO INTERVENTION

This arm will get CHICA without the developmental screening module

Interventions

CHICA DevScreen Module OTHER

This module assists in the diagnosis and management of developmental screening

CHICA DevScreen Module

Eligibility Criteria

• Age: 1 Day - 3 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• This study will involve the analysis of data collected in the care of children seen in four IUMG-PC pediatric clinics. For aim 2 of the study all children between the ages of 0 and 3 seen in the four study clinics will be eligible for and will be participants in the study.
• For aim 3 of the study, a child is eligible for participation if they are younger than 5 years of age, have a concerning developmental screening result, and are seen in one of the four clinics participating in this study. Additionally, these children cannot have a previous diagnosis of a developmental disorder and at least one of the child's parents must speak English.

You may not qualify if:

• For aim 3, having no parents who can speak English

Sponsors & Collaborators

• Indiana University: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (1)

Children's Health Services Research

Indianapolis, Indiana, 46202, United States

Location

Related Publications (1)

• Carroll AE, Bauer NS, Dugan TM, Anand V, Saha C, Downs SM. Use of a computerized decision aid for developmental surveillance and screening: a randomized clinical trial. JAMA Pediatr. 2014 Sep;168(9):815-21. doi: 10.1001/jamapediatrics.2014.464.

  PMID: 25022724 DERIVED

MeSH Terms

Conditions

Learning Disabilities

Condition Hierarchy (Ancestors)

Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Results Point of Contact

• Title: Aaron E. Carroll, MD, MS
• Organization: Indiana University School of Medicine

aaecarro@iu.edu

3172789616

Study Officials

• Aaron E Carroll, MD, MS

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof of Pediatrics

Study Record Dates

• First Submitted: May 9, 2011
• First Posted: May 10, 2011
• Study Start: May 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: June 26, 2017
• Results First Posted: June 26, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)