Autism Spectrum DisorderNCT02445105
Mobilizing Community Systems to Engage Families in Early Autism Spectrum Disorder (ASD) Detection & Services
A study testing Autism Navigator Enhanced Practice and Family Engagement plus Autism Navigator in people with Autism Spectrum Disorder, run by Florida State University at 4 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Autism Navigator Enhanced Practice and Family Engagement plus Autism Navigator
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10,857 participants
- Where
- 4 sitesUnited States
- Study dates
- Dec 2015to Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Emory University
Atlanta, Georgia, 30329
Drexel University
Philadelphia, Pennsylvania, 19104
Florida State University
Tallahassee, Florida, 32303
Weill Cornell Medical College
White Plains, New York, 10605
About this study
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.
Read the 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.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Autism Navigator Enhanced Practice, Family Engagement plus Autism Navigator
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autism Navigator Enhanced PracticeBehavioural
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.
Family Engagement plus Autism NavigatorBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Autism Navigator Enhanced Practice | Active comparator | 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. Receives: Behavioral: Autism Navigator Enhanced Practice |
| Family Engagement plus Autism Navigator | Experimental | 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. Receives: Behavioral: Family Engagement plus Autism Navigator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of children screened by community service provider
This is a tally of the number of children screened by each provider and then summed.
Measured: 9 to 36 months of age
Child age at screening by community service provider
This is the age of the child at the time of screening in months.
Measured: 9 to 36 months of age
Child age at referral for evaluation by community service provider
This is the age that the child is referred by the provider for an evaluation in months.
Measured: 9 to 36 months of age
Child age at entry into intervention
This is the age that the child enters and begins early intervention in months.
Measured: 9 to 36 months of age
Secondary outcomes (6)
Child autism symptoms measured with the Autism Diagnostic Observation Schedule
Autism symptoms measured with the Autism Diagnostic Observation Schedule
Measured: when child is 27 and 36 months of age
Child developmental level measured with the Mullen Scales of Early Learning
Developmental level measured with the Mullen Scales of Early Learning
Measured: when child is 27 and 36 months of age
Child adaptive behavior measured with the Vineland Adaptive Behavior Scales
Adaptive behavior measured with the Vineland Adaptive Behavior Scales
Measured: when child is 27 and 36 months of age
Family measure of resources measured with Family Resource Scale completed by parent
Family Resource Scale completed by parent
Measured: when child is 27 and 36 months of age
Family measure of stress measured with Parenting Stress Index completed by parent
Parenting Stress Index completed by parent
Measured: when child is 27 and 36 months of age
Family measure of access to community activities measured with Home and Community Activities Survey completed by parent
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.
Measured: when child is 27 and 36 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2015 (estimated)
- Study startDec 2015
- Primary completionJun 2021
- Study completionJun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Florida State UniversityThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 10,857 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Collaborators
- Emory University, Weill Medical College of Cornell University, Drexel University, National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Amy M. Wetherby, Florida State University
- Investigators
- Amy M Wetherby, PhD, Principal investigator, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02445105
- Sponsor's protocol ID
- MH104423
- Other IDs
- 1R01MH104423-01
- Status last verified
- Jul 2022
- First submitted
- 1 Apr 2015
- Last updated
- 13 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobilizing Community Systems to Engage Families in Early Autism Spectrum Disorder (ASD) Detection & Services
- ClinicalTrials.gov ID
- NCT02445105
- Acronym / sponsor ID
- MH104423
- Conditions
- Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10,857 participants (actual)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Collaborators
- Emory University, Weill Medical College of Cornell University, Drexel University, National Institute of Mental Health (NIMH)
- Study start
- Dec 2015
- Primary completion
- Jun 2021 (actual)
- Study completion
- Jun 2021 (actual)
- First posted
- 15 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autism Navigator Enhanced Practice | Active comparator | Behavioral: Autism Navigator Enhanced PracticeA 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. |
| Family Engagement plus Autism Navigator | Experimental | Behavioral: Family Engagement plus Autism NavigatorA 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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:
- 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.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Autism Navigator Enhanced PracticeCommunity 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. | Behavioural | Autism Navigator Enhanced Practice |
| Family Engagement plus Autism NavigatorCommunity 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. | Behavioural | Family Engagement plus Autism Navigator |
Primary outcome
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.
Child age at screening by community service provider
Time frame: 9 to 36 months of age
This is the age of the child at the time of screening in months.
Child age at referral for evaluation by community service provider
Time frame: 9 to 36 months of age
This is the age that the child is referred by the provider for an evaluation in months.
Child age at entry into intervention
Time frame: 9 to 36 months of age
This is the age that the child enters and begins early intervention in months.
6 secondary outcomes
Child autism symptoms measured with the Autism Diagnostic Observation Schedule
Time frame: when child is 27 and 36 months of age
Child developmental level measured with the Mullen Scales of Early Learning
Time frame: when child is 27 and 36 months of age
Child adaptive behavior measured with the Vineland Adaptive Behavior Scales
Time frame: when child is 27 and 36 months of age
Family measure of resources measured with Family Resource Scale completed by parent
Time frame: when child is 27 and 36 months of age
Family measure of stress measured with Parenting Stress Index completed by parent
Time frame: when child is 27 and 36 months of age
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2022.
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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.
Amy M Wetherby, PhD principal investigator
Florida State University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autism Navigator Enhanced Practice and Family Engagement plus Autism Navigator in people with Autism Spectrum Disorder, run by Florida State University at 4 sites 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 5 inclusion and 0 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 13 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 by community service provider (time frame: 9 to 36 months of age). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jul 2022.