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Trial record 8 of 53 for:    Developmental Disabilities | ( Map: Indiana, United States )

The CHICA Developmental Screening Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01351077
Recruitment Status : Completed
First Posted : May 10, 2011
Results First Posted : June 26, 2017
Last Update Posted : June 26, 2017
Sponsor:
Collaborator:
Agency for Healthcare Research and Quality (AHRQ)
Information provided by (Responsible Party):
Aaron Carroll, Indiana University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Health Services Research
Condition Developmental Delay
Intervention Other: CHICA DevScreen Module
Enrollment 360
Recruitment Details  
Pre-assignment Details  
Arm/Group Title CHICA DevScreen Module CHICA DevScreen Control
Hide Arm/Group Description

This arm will get the CHICA Developmental Screening Module

CHICA DevScreen Module: This module assists in the diagnosis and management of developmental screening

This arm will get CHICA without the developmental screening module
Period Title: Overall Study
Started 180 180
Completed 180 180
Not Completed 0 0
Arm/Group Title CHICA DevScreen Module CHICA DevScreen Control Total
Hide Arm/Group Description

This arm will get the CHICA Developmental Screening Module

CHICA DevScreen Module: This module assists in the diagnosis and management of developmental screening

This arm will get CHICA without the developmental screening module Total of all reporting groups
Overall Number of Baseline Participants 180 180 360
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 180 participants 180 participants 360 participants
19.8  (5.1) 23.7  (6.5) 21.8  (5.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 180 participants 180 participants 360 participants
Female
97
  53.9%
91
  50.6%
188
  52.2%
Male
83
  46.1%
89
  49.4%
172
  47.8%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 180 participants 180 participants 360 participants
Black
51
  28.3%
164
  91.1%
215
  59.7%
Hispanic
117
  65.0%
11
   6.1%
128
  35.6%
White/Asian
11
   6.1%
4
   2.2%
15
   4.2%
Other
1
   0.6%
1
   0.6%
2
   0.6%
Insurance  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 180 participants 180 participants 360 participants
Advantage/Commercial
8
   4.4%
6
   3.3%
14
   3.9%
Self-pay
12
   6.7%
2
   1.1%
14
   3.9%
Medicaid
160
  88.9%
171
  95.0%
331
  91.9%
1.Primary Outcome
Title Number of Children Screened for Developmental Delay
Hide Description [Not Specified]
Time Frame one year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CHICA DevScreen Module CHICA DevScreen Control
Hide Arm/Group Description:

This arm will get the CHICA Developmental Screening Module

CHICA DevScreen Module: This module assists in the diagnosis and management of developmental screening

This arm will get CHICA without the developmental screening module
Overall Number of Participants Analyzed 180 180
Measure Type: Count of Participants
Unit of Measure: Participants
153
  85.0%
44
  24.4%
2.Secondary Outcome
Title Age of Children Diagnosed With Developmental Delay
Hide Description [Not Specified]
Time Frame one year
Hide Outcome Measure Data
Hide Analysis Population Description
The denominator was only children diagnosed with developmental delay
Arm/Group Title CHICA DevScreen Module CHICA DevScreen Control
Hide Arm/Group Description:

This arm will get the CHICA Developmental Screening Module

CHICA DevScreen Module: This module assists in the diagnosis and management of developmental screening

This arm will get CHICA without the developmental screening module
Overall Number of Participants Analyzed 19 12
Mean (Standard Deviation)
Unit of Measure: months
19.8  (5.1) 23.8  (6.5)
3.Other Pre-specified Outcome
Title Number of Children With a Positive Screen
Hide Description [Not Specified]
Time Frame one year
Hide Outcome Measure Data
Hide Analysis Population Description
The denominator was number of children for whom a standard developmental screening tool was administered
Arm/Group Title CHICA DevScreen Module CHICA DevScreen Control
Hide Arm/Group Description:

This arm will get the CHICA Developmental Screening Module

CHICA DevScreen Module: This module assists in the diagnosis and management of developmental screening

This arm will get CHICA without the developmental screening module
Overall Number of Participants Analyzed 153 44
Measure Type: Count of Participants
Unit of Measure: Participants
30
  19.6%
8
  18.2%
4.Other Pre-specified Outcome
Title Number of Children Referred for Evaluation and Services When There Was a Positive Screening Result
Hide Description [Not Specified]
Time Frame one year
Hide Outcome Measure Data
Hide Analysis Population Description
The denominator was the number of children with a positive screen
Arm/Group Title CHICA DevScreen Module CHICA DevScreen Control
Hide Arm/Group Description:

This arm will get the CHICA Developmental Screening Module

CHICA DevScreen Module: This module assists in the diagnosis and management of developmental screening

This arm will get CHICA without the developmental screening module
Overall Number of Participants Analyzed 30 8
Measure Type: Count of Participants
Unit of Measure: Participants
22
  73.3%
4
  50.0%
5.Other Pre-specified Outcome
Title Number of Patients Whose Referred Evaluations and Services Were Completed
Hide Description [Not Specified]
Time Frame one year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CHICA DevScreen Module CHICA DevScreen Control
Hide Arm/Group Description:

This arm will get the CHICA Developmental Screening Module

CHICA DevScreen Module: This module assists in the diagnosis and management of developmental screening

This arm will get CHICA without the developmental screening module
Overall Number of Participants Analyzed 22 4
Measure Type: Count of Participants
Unit of Measure: Participants
12
  54.5%
1
  25.0%
Time Frame two years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title CHICA DevScreen Module CHICA DevScreen Control
Hide Arm/Group Description

This arm will get the CHICA Developmental Screening Module

CHICA DevScreen Module: This module assists in the diagnosis and management of developmental screening

This arm will get CHICA without the developmental screening module
All-Cause Mortality
CHICA DevScreen Module CHICA DevScreen Control
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
CHICA DevScreen Module CHICA DevScreen Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/180 (0.00%)   0/180 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
CHICA DevScreen Module CHICA DevScreen Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/180 (0.00%)   0/180 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Aaron E. Carroll, MD, MS
Organization: Indiana University School of Medicine
Phone: 3172789616
Responsible Party: Aaron Carroll, Indiana University
ClinicalTrials.gov Identifier: NCT01351077     History of Changes
Other Study ID Numbers: CHICA_DevScreen_Study
R01HS017939 ( U.S. AHRQ Grant/Contract )
First Submitted: May 9, 2011
First Posted: May 10, 2011
Results First Submitted: December 8, 2016
Results First Posted: June 26, 2017
Last Update Posted: June 26, 2017