- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02445105
Mobilizing Community Systems to Engage Families in Early Autism Spectrum Disorder (ASD) Detection & Services
July 11, 2022 updated by: Amy M. Wetherby, Florida State University
This multisite study will compare the effectiveness of universal screening by 3 community service systems using Autism Navigator, a highly interactive web platform that includes an automated screening tool, information about autism for families, and a professional development course on the early signs of autism and effective evidence-based practice with extensive video footage to rapidly build the capacity for early detection.
The investigators will also conduct a multisite pragmatic randomized clinical trial to test the effectiveness of an evidence-based Family Engagement Intervention compared to Autism Navigator Enhanced Practice implemented by the 3 community service systems with children who have a positive autism screen to increase the number of children who are screened, referred for evaluation, receive a diagnosis, and receive community-based EI between 18-27 months of age.
This study will impact family engagement in community screening and diagnosis by demonstrating the effectiveness of brief manualized engagement interventions.
Findings will advance science by providing researchers with a method for recruiting a community sample, allowing for research at younger ages, which could accelerate science.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The American Academy of Pediatrics recommends screening all children for autism spectrum disorder (ASD) at 18 and 24 months because research indicates that earlier intervention maximizes children's outcomes.
The earliest signs of ASD are delays in social communication milestones that appear in the first 2 years and yet most children are not diagnosed until 4-5 years of age.
Underserved families are identified even later and significantly underrepresented in intervention research.
It is vitally important to mobilize community service systems to impact family engagement throughout the process of screening, evaluation, and early intervention (EI) and to support linkages to public community-based EI in order to address health disparities.
This collaborative investigation of 4 universities aims to document the effectiveness of an online automated universal screen for communication delay and autism initially at 18 months of age and decision rule for referral to an ASD evaluation, and to study an evidence-based intervention to increase family engagement and expedite receipt of screening, diagnosis, eligibility for EI, and EI services.
The study will focus on the youngest age when ASD can be detected reliably, which is 18 months, and compare the effectiveness of screening and referral by 3 different community service systems: 1) primary care including private and public health care agencies and federally qualified health centers; 2) federal programs such as Women, Infants, and Children (WIC) Food and Nutrition Service and Early Head Start; and 3) the National Black Church Initiative (NBCI).
Using the Autism Navigator web-based platform the investigators will expand their capacity for universal ASD screening and referral for diagnosis and determining eligibility by EI providers through the public Individuals with Disabilities Education Act (IDEA) Part C system for children birth to 3 years of age.
Innovative web-based technology will be integrated at multiple levels- as the basis for an interactive professional development course to enable these community service systems to efficiently learn about autism and implement a universal broadband and autism-specific screening with seamless automation that links to electronic health records and provides families with web-based tools about autism.
This multidisciplinary research team will conduct a multisite pragmatic randomized clinical trial to test the effectiveness of an evidence-based Family Engagement Intervention plus Autism Navigator compared to Autism Navigator Enhanced Practice alone.
The investigators will also conduct an exploratory study to test strategies to improve uptake of evidence-based intervention by community-based EI providers through the Part C system.
This protocol has the potential to lower the age of screening for ASD to 18 months, which will have important implications for earlier access to intervention and improving ASD service systems and be ready for immediate and rapid implementation in community settings across the US.
Findings will advance science by providing researchers with a method for recruiting a population-based sample, allowing for research at younger ages, which could accelerate genetic, neuroscience, and intervention research, and lead to transformative changes to community healthcare delivery.
Study Type
Interventional
Enrollment (Actual)
10857
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Florida
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Tallahassee, Florida, United States, 32303
- Florida State University
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Georgia
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Atlanta, Georgia, United States, 30329
- Emory University
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New York
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White Plains, New York, United States, 10605
- Weill Cornell Medical College
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Drexel University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
Community service providers will be recruited from the specific catchment areas of the 4 sites in Florida, Georgia, New York, and Pennsylvania from 3 different community service systems:
- primary care including private, public, and military health care agencies and federally qualified health centers;
- federal programs including Women, Infants, and Children (WIC) Food and Nutrition Service, Early Head Start, and other social programs supporting low-income families; and
- the National Black Church Initiative (NBCI) and other religious networks serving minorities.
- Children are screened between 9 and 18 months of age by these community service providers who have agreed to be in this study and their families.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Autism Navigator Enhanced Practice
A 6-hour training will be provided to community service providers with the Autism Navigator for Primary Care professional development course and use of a web-based platform that includes an automated communication and autism screening and monthly electronic monitoring.
|
Community service providers will receive training in Autism Navigator for Primary Care, a 6-hour online professional development course with extensive video illustration of the early signs of autism in toddlers, collaborating with families, developmental milestones, screening and referral practices, and early intervention basics.
This web-based platform includes an automated screening for communication delay and autism, an automated monthly electronic monitoring, and digital tools for families to address practical obstacles to screening toddlers 9-18 months of age and referral to early intervention.
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Experimental: Family Engagement plus Autism Navigator
A 6-hour training will be provided to community service providers on the use of Motivational Interviewing, an evidence-based counseling method to improve engagement of families who are ambivalent about screening or intervention for their toddler, in addition to Autism Navigator Enhanced Practice.
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Community service providers will receive a 6-hour training on the use of Motivational Interviewing, an evidence-based counseling method to improve engagement of families who are ambivalent about screening or intervention for their toddler.
Community service providers will also receive a 6-hour training with the Autism Navigator for Primary Care professional development course and use of the web-based platform that includes an automated communication and autism screening and monthly electronic monitoring to address practical obstacles to screening toddlers 9-18 months of age and referral to early intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of children screened by community service provider
Time Frame: 9 to 36 months of age
|
This is a tally of the number of children screened by each provider and then summed.
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9 to 36 months of age
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Child age at screening by community service provider
Time Frame: 9 to 36 months of age
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This is the age of the child at the time of screening in months.
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9 to 36 months of age
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Child age at referral for evaluation by community service provider
Time Frame: 9 to 36 months of age
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This is the age that the child is referred by the provider for an evaluation in months.
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9 to 36 months of age
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Child age at entry into intervention
Time Frame: 9 to 36 months of age
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This is the age that the child enters and begins early intervention in months.
|
9 to 36 months of age
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Child autism symptoms measured with the Autism Diagnostic Observation Schedule
Time Frame: when child is 27 and 36 months of age
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Autism symptoms measured with the Autism Diagnostic Observation Schedule
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when child is 27 and 36 months of age
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Child developmental level measured with the Mullen Scales of Early Learning
Time Frame: when child is 27 and 36 months of age
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Developmental level measured with the Mullen Scales of Early Learning
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when child is 27 and 36 months of age
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Child adaptive behavior measured with the Vineland Adaptive Behavior Scales
Time Frame: when child is 27 and 36 months of age
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Adaptive behavior measured with the Vineland Adaptive Behavior Scales
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when child is 27 and 36 months of age
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Family measure of resources measured with Family Resource Scale completed by parent
Time Frame: when child is 27 and 36 months of age
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Family Resource Scale completed by parent
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when child is 27 and 36 months of age
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Family measure of stress measured with Parenting Stress Index completed by parent
Time Frame: when child is 27 and 36 months of age
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Parenting Stress Index completed by parent
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when child is 27 and 36 months of age
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Family measure of access to community activities measured with Home and Community Activities Survey completed by parent
Time Frame: when child is 27 and 36 months of age
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Home and Community Activities Survey completed by parent to rate how often the parent and child participate in 30 different activities and how important each activity is.
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when child is 27 and 36 months of age
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Amy M Wetherby, PhD, Florida State University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2015
Primary Completion (Actual)
June 1, 2021
Study Completion (Actual)
June 1, 2021
Study Registration Dates
First Submitted
April 1, 2015
First Submitted That Met QC Criteria
May 14, 2015
First Posted (Estimate)
May 15, 2015
Study Record Updates
Last Update Posted (Actual)
July 13, 2022
Last Update Submitted That Met QC Criteria
July 11, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MH104423
- 1R01MH104423-01 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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