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CompletedNCT01351077Updated Jun 26, 2017Results posted

The CHICA Developmental Screening Study

An interventional study of CHICA DevScreen Module in Developmental Delay, sponsored by Indiana University. Completed at 1 site in United States. Open to participants aged 1 Day to 3 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-06-26.

Sponsored by Indiana University · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
360
Allocation
Randomized
Ages
1 Day to 3 Years
Sex
All
01

Study 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

Read the detailed description

Between 12 and 16% of children in the United States have a developmental disability. Research has demonstrated that early intervention programs are not only essential for improved outcomes in these children, but also cost-effective. As a result, there has been a push within the pediatric medical community to identify children with developmental delays or disabilities as early as possible. Currently, most pediatric primary care providers do not use standardized methods for developmental surveillance and screening. Instead they rely on intuition and clinical judgment which has been shown to have limitations when compared with standardized screening methods. Researchers and physician organizations such as the AAP have called on pediatric primary care providers to institute a standardized approach for the identification of developmental delays that includes both developmental surveillance and screening. In fact, the AAP recently published an algorithm for developmental surveillance and screening within a primary care setting. Physicians, however, cite several barriers to the implementation of these recommendations within their practices, including lack of time, lack of office staff, inadequate reimbursement, and language barriers.

The investigators have developed a novel computer decision support system (CDSS) for implementing clinical guidelines and algorithms within pediatric practices called CHICA. The investigators believe that this CDSS has the potential to address the barriers cited in previous studies as obstacles specific to the implementation of developmental surveillance and screening within primary care practices. CDSS will allow for developmental surveillance and screening to fit within the workflow of a busy pediatric practice without requiring an additional investment of time on the part of the physician and without requiring additional office staff.

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

02

Conditions studied

  • Developmental Delay

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Keywords

  • Developmental Delay
03

In context

Learning Disabilities

150 studies on the registry are indexed under Learning Disabilities; 51 are open to participants now.

This study's enrollment of 360 is above the median of 60 across 101 interventional studies indexed under Learning Disabilities.

Browse Learning Disabilities studies →

Lead sponsor

Indiana University is the lead sponsor of 982 studies on the registry; 199 are open to participants now.

Of its 148 completed or terminated interventional studies of FDA-regulated products, 117 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Day to 3 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • For aim 3, having no parents who can speak English
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
360 participants (actual)

Study arms

  • Experimental
    CHICA DevScreen Module

    This arm will get the CHICA Developmental Screening Module

    Other: CHICA DevScreen Module

  • No intervention
    CHICA DevScreen Control

    This arm will get CHICA without the developmental screening module

Interventions

  • OtherCHICA DevScreen Module

    This module assists in the diagnosis and management of developmental screening

06

What researchers measure

Primary outcomes

  1. Number of Children Screened for Developmental Delay

    Time frame: one year

Secondary outcomes

  1. Age of Children Diagnosed With Developmental Delay

    Time frame: one year

Other outcomes

  1. Number of Children With a Positive Screen

    Time frame: one year

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

    Time frame: one year

  3. Number of Patients Whose Referred Evaluations and Services Were Completed

    Time frame: one year

07

Results

Posted Jun 26, 2017

Participant flow

Participant flow — Overall Study
MilestoneCHICA DevScreen ModuleCHICA DevScreen Control
Started180180
Completed180180
Not completed00

Outcome measures

PrimaryNumber of Children Screened for Developmental Delay
Time frame:
one year
Reported as:
Count of participants · Participants
Number of Children Screened for Developmental Delay
ParticipantsCHICA DevScreen ModuleCHICA DevScreen Control
Number of Children Screened for Developmental Delay15344
SecondaryAge of Children Diagnosed With Developmental Delay
Time frame:
one year
Reported as:
Mean · months
Age of Children Diagnosed With Developmental Delay
monthsCHICA DevScreen ModuleCHICA DevScreen Control
Age of Children Diagnosed With Developmental Delay19.8 ± 5.123.8 ± 6.5
Other pre-specifiedNumber of Children With a Positive Screen
Time frame:
one year
Reported as:
Count of participants · Participants
Number of Children With a Positive Screen
ParticipantsCHICA DevScreen ModuleCHICA DevScreen Control
Number of Children With a Positive Screen308
Other pre-specifiedNumber of Children Referred for Evaluation and Services When There Was a Positive Screening Result
Time frame:
one year
Reported as:
Count of participants · Participants
Number of Children Referred for Evaluation and Services When There Was a Positive Screening Result
ParticipantsCHICA DevScreen ModuleCHICA DevScreen Control
Number of Children Referred for Evaluation and Services When There Was a Positive Screening Result224
Other pre-specifiedNumber of Patients Whose Referred Evaluations and Services Were Completed
Time frame:
one year
Reported as:
Count of participants · Participants
Number of Patients Whose Referred Evaluations and Services Were Completed
ParticipantsCHICA DevScreen ModuleCHICA DevScreen Control
Number of Patients Whose Referred Evaluations and Services Were Completed121

Adverse events

Collected over two years. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
CHICA DevScreen Module—0/180 (0%)0/180 (0%)
CHICA DevScreen Control—0/180 (0%)0/180 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(months)CHICA DevScreen ModuleCHICA DevScreen ControlTotal
Mean19.8 ± 5.123.7 ± 6.521.8 ± 5.8
Sex: Female, Male
Sex: Female, Male(Participants)CHICA DevScreen ModuleCHICA DevScreen ControlTotal
Female9791188
Male8389172
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)CHICA DevScreen ModuleCHICA DevScreen ControlTotal
Black51164215
Hispanic11711128
White/Asian11415
Other112
Insurance
Insurance(Participants)CHICA DevScreen ModuleCHICA DevScreen ControlTotal
Advantage/Commercial8614
Self-pay12214
Medicaid160171331
08

Study locations

1 site
  • Children's Health Services Research
    Indianapolis, Indiana 46202, United States
09

References and documents

Publications

  • 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. PubMed 25022724 ↗

Individual participant data

Plan to share: No

10

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of May 2011, a primary completion of Dec 2012 and a completion of Dec 2012. It does not say whether these dates are actual or estimated.

Results were first posted in Jun 2017, 4 years 6 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
May 9, 2011
First posted
May 10, 2011
Start
May 2011
Primary completionActual
Dec 2012
CompletionActual
Dec 2012
Results first posted
Jun 26, 2017
Last update
Jun 26, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 26, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01351077
Lead sponsor
Indiana University
Collaborators
Agency for Healthcare Research and Quality (AHRQ)
Responsible party
Aaron Carroll (Assoc. Prof of Pediatrics, Indiana University) — Principal investigator
First posted
May 10, 2011
Start date
May 2011
Primary completion
Dec 2012
Completion
Dec 2012
Results posted
Jun 26, 2017
Last update
Jun 26, 2017

Study contacts

Aaron E Carroll, MD, MS
principal investigator · Indiana University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.

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