Developmental DelayNCT01351077
The CHICA Developmental Screening Study
A study testing CHICA DevScreen Module in people with Developmental Delay, run by Indiana University at 1 site in United States.
Trial 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)… Read more about this study
- Who is it for?
- Ages 1 day to 3 yearsHealthy volunteers can take part
- Conditions the study is for
- Developmental Delay
- What is being tested?
- CHICA DevScreen Module
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Dec 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 3 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- For aim 3, having no parents who can speak English
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Health Services Research
Indianapolis, Indiana, 46202
About this study
Official title: A Study to Determine if CHICA Can Improve Developmental Screening
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
- Conditions
- Developmental Delay
- Being tested
- CHICA DevScreen Module
- Keywords
- Developmental Delay
- Medical subject headings
- Learning Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHICA DevScreen ModuleOther
This module assists in the diagnosis and management of developmental screening
| Study group | Role | What they receive |
|---|---|---|
| CHICA DevScreen Module | Experimental | This arm will get the CHICA Developmental Screening Module Receives: Other: CHICA DevScreen Module |
| CHICA DevScreen Control | No intervention | This arm will get CHICA without the developmental screening module |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Children Screened for Developmental Delay
Measured: one year
Secondary outcomes (1)
Age of Children Diagnosed With Developmental Delay
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2011 (estimated)
- Study startMay 2011
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Developmental DelayStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Principal investigator, Aaron Carroll, Indiana University
- Investigators
- Aaron E Carroll, MD, MS, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01351077
- Sponsor's protocol ID
- CHICA_DevScreen_Study
- Other IDs
- R01HS017939
- Status last verified
- Apr 2017
- First submitted
- 9 May 2011
- Last updated
- 26 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Determine if CHICA Can Improve Developmental Screening
- ClinicalTrials.gov ID
- NCT01351077
- Acronym / sponsor ID
- CHICA_DevScreen_Study
- Conditions
- Developmental Delay
- Keywords
- Developmental Delay
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- May 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 10 May 2011 (estimated)
- Results
- Posted 26 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CHICA DevScreen Module | Experimental | Other: CHICA DevScreen ModuleThis arm will get the CHICA Developmental Screening Module |
| CHICA DevScreen Control | No intervention | –This arm will get CHICA without the developmental screening module |
Who may qualify
- Ages
- 1 day to 3 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- For aim 3, having no parents who can speak English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CHICA DevScreen ModuleThis module assists in the diagnosis and management of developmental screening | Other | CHICA DevScreen Module |
Primary outcome
Number of Children Screened for Developmental Delay
Time frame: one year
1 secondary outcome
Age of Children Diagnosed With Developmental Delay
Time frame: one year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25022724Carroll 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aaron E Carroll, MD, MS principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CHICA DevScreen Module in people with Developmental Delay, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Children Screened for Developmental Delay (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01351077, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2017.