Autism Spectrum DisorderPhase 4NCT03333629
Promoting Positive Outcomes for Individuals With ASD: Linking Early Detection, Treatment, and Long-term Outcomes
A Phase 4 study testing Enhanced early detection in people with Autism Spectrum Disorder, run by Drexel University at 3 sites in United States.
Trial summary
Autism spectrum disorder (ASD) is defined by impaired social engagement and social communication, and repetitive, restricted, or stereotyped behaviors and interests. The average age of diagnosis in the US is after the fourth birthday. Read more about this study
- Who is it for?
- Ages 16 to 58 months
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Enhanced early detection
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,087 participants
- Where
- 3 sitesUnited States
- Study dates
- 29 Nov 2017to 30 Jun 2024
- Phase
- Phase 4
- 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 16 to 58 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- child attended 18 m visiting at participating pediatric practice
- legal guardian is fluent in English or Spanish
Who cannot join
- child has severe sensory or motor deficit that precludes completing standardized evaluation
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Drexel University
Philadelphia, Pennsylvania, 19104
University of California, Davis
Sacramento, California, 95817
University of Connecticut
Storrs, Connecticut, 06269
About this study
Official title: Connecting the Dots: An RCT Integrating Standardized ASD Screening, High-Quality Treatment, and Long-Term Outcomes
Autism spectrum disorder (ASD) is defined by impaired social engagement and social communication, and repetitive, restricted, or stereotyped behaviors and interests. The average age of diagnosis in the US is after the fourth birthday. However, children who start ASD-specific early intervention have better outcomes than children start later. The current study will address a gap identified by the US Prevention Services Task Force, namely that children detected through screening respond positively to early intervention. This study will directly relate early detection strategies to early intervention, and measure the impact of age of intervention onset on outcomes when children are entering kindergarten. Local pediatric providers will be randomized to provide either usual care, or to an experimental condition in which autism early detection strategies are enhanced through the addition of specific procedures. Across all sites, 8,000 children will be recruited through their participating pediatric practice. Qualifying children will receive up to one year of early intensive behavioral intervention, after getting an ASD diagnosis. Primary outcome measures will include children's cognitive functioning and ASD symptom severity, which will be measured at multiple time points. The investigators predict that this study will inform early detection strategies which will result in improving children's social and cognitive functioning, mitigating lifespan disability, reducing societal costs, and improving personal well-being and productivity of individuals with ASD.
Read the detailed description
Autism spectrum disorder (ASD) is a serious neurodevelopmental disorder defined by impaired social engagement and social communication, in addition to the presence of repetitive, restricted, or stereotyped behaviors and interests. Although many cases of ASD can be detected when children are less than two years old, the average age of diagnosis in the US is still after the fourth birthday. However, evidence demonstrates that children who start ASD-specific early intervention have better outcomes than children who do not start treatment until later ages. In 2006 and 2007, American Academy of Pediatrics recommended three early detection approaches to improve identification of children at risk for ASD: ongoing developmental surveillance at every well-child check-up, routine broad developmental screening at three infant/toddler ages, and ASD-specific screening at two toddler ages. When these early detection strategies are used with all children attending well-child check-ups, the age of ASD detection is lower, and children who are diagnosed have the opportunity to start ASD-specific early intervention at younger ages than if they had not been detected. Yet in 2016, the US Preventive Services Task Force (USPSTF) indicated that current evidence is insufficient to recommend universal ASD screening, given the lack of experimental studies demonstrating positive outcomes for treated children that are detected through screening. The current study will address this gap. This study will directly relate early detection strategies to early intervention, and measure the impact of age of intervention onset on outcomes when children are entering kindergarten. The study will be conducted by investigators from three sites: Drexel University; the University of California, Davis; and the University of Connecticut. Local pediatric providers will be enrolled in the study, and their practices will be randomized to provide either usual care, or to an experimental condition in which autism early detection strategies are enhanced through the addition of specific procedures. Children attending well-child visits at participating practices will then be enrolled. Across all sites, 8,000 children will be recruited through their participating pediatric practice. As part of the study, qualifying children will receive up to one year of early intensive behavioral intervention, using an evidence-based manualized treatment. Primary outcome measures will include children's cognitive functioning and ASD symptom severity, which will be measured at multiple time points. Exploratory outcomes will include children's adaptive functioning, kindergarten readiness, and social reciprocity, as measured by experimental eye tracking and parent-child interaction ratings. This study also will examine the impact of the screening intervention on physician attitudes and on parent empowerment and stress. Finally, investigators will examine potential moderators of outcomes, to determine whether initial symptom severity, cognitive ability, or socioeconomic status affects children's long-term outcomes. The investigators predict that this study will inform early detection strategies which will result in improving children's social and cognitive functioning, mitigating lifespan disability, reducing societal costs, and improving personal well-being and productivity of individuals with ASD.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Enhanced early detection
- Keywords
- Autistic Disorder, Early Detection, Early Intervention
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced early detectionBehavioural
standardized screening
| Study group | Role | What they receive |
|---|---|---|
| Enhanced early detection | Experimental | Providers will receive training to administer enhanced early detection strategies. Receives: Behavioral: Enhanced early detection |
| Usual care | No intervention | Providers will not change their early detection strategies, but will be monitored. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ASD Symptom Severity
ASD symptom severity will be measured with the Brief Observation of Social Communication Change (BOSCC)
Measured: Change from pre-treatment to immediately post-treatment; 10 minutes
Change in Cognitive Functioning
Cognitive functioning will be measured by the Mullen Scales of Early Learning (MSEL).
Measured: Change from pre-treatment to immediately post-treatment; 60 minutes
Secondary outcomes (9)
Adaptive Functioning
Vineland Adaptive Behavior Scales-3
Measured: Immediately post-treatment, 48 m, 60 m; 45 minutes
ASD Symptoms - secondary measure1
Autism Diagnostic Observation Schedule, Second Edition (ADOS-2)
Measured: 48 m, 60 m; 45 minutes
Kindergarten Readiness
Developmental Indicators for the Assessment of Learning-4
Measured: 60 m; 45 minutes
Social Engagement
Eye tracking paradigms will assess aspects of social engagement (i.e., social orienting, motivation, and cognition)
Measured: Immediately post-treatment, 48 m, 60 m; 15 minutes
Long-term change in Cognitive Functioning
Cognitive functioning will be measured by the Mullen Scales of Early Learning (MSEL)
Measured: 48 m, 60 m; 60 minutes
Parent-Child Social Engagement
Parent-child social engagement will be measured with the Joint Engagement Rating Inventory, which is applied to video recordings of the Communication Play Protocol.
Measured: Immediately post-treatment, 48 m, 60 m; 15 minutes
ASD symptoms - secondary measure2
PDD Behavior Inventory
Measured: Immediately post-treatment, 48 m, 60 m; 20 minutes
ASD symptoms - secondary measure3
BOSCC
Measured: 48 m, 60 m; 10 minutes
Long-term change in Cognitive Functioning (alternative)
and for children who reach ceiling on the MSEL, we will use the Differential Differential Abilities Scales-II (DAS-II) will be used for children too advanced for Outcome 7
Measured: 48 m, 60 m; 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2017
- Study start29 Nov 2017
- Primary completion6 Sep 2023
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies 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 4
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 2,087 participants (actual)
Sponsor and investigators
- Lead sponsor
- Drexel University
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Davis, University of Connecticut
- Responsible party
- Principal investigator, Diana Robins, Drexel University
- Investigators
- Diana Robins, PhD, Principal investigator, Drexel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03333629
- Sponsor's protocol ID
- R01MH115715
- Status last verified
- Aug 2024
- First submitted
- 8 Sep 2017
- Last updated
- 16 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be uploaded to the National Database for Autism Research (NDAR) semi-annually
Publications
Vivanti G, Algur Y, Ryan V, McClure LA, Fein D, Stahmer AC, Wieckowski AT, Robins DL. The Impact of Using Standardized Autism Screening on Referral to Specialist Evaluation for Young Children on the Autism Spectrum: A Cluster-Randomized Controlled Trial. J Am Acad Child Adolesc Psychiatry. 2025 Jun;64(6):686-698. doi: 10.1016/j.jaac.2024.08.502. Epub 2024 Oct 15.
PubMed 39454668McClure LA, Lee NL, Sand K, Vivanti G, Fein D, Stahmer A, Robins DL. Connecting the Dots: a cluster-randomized clinical trial integrating standardized autism spectrum disorders screening, high-quality treatment, and long-term outcomes. Trials. 2021 May 2;22(1):319. doi: 10.1186/s13063-021-05286-6.
PubMed 33934719
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Connecting the Dots: An RCT Integrating Standardized ASD Screening, High-Quality Treatment, and Long-Term Outcomes
- ClinicalTrials.gov ID
- NCT03333629
- Acronym / sponsor ID
- R01MH115715
- Conditions
- Autism Spectrum Disorder
- Keywords
- Autistic Disorder, Early Detection, Early Intervention
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,087 participants (actual)
- Lead sponsor
- Drexel UniversityUniversity, hospital or other
- Collaborators
- University of California, Davis, University of Connecticut
- Study start
- 29 Nov 2017 (actual)
- Primary completion
- 6 Sep 2023 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 7 Nov 2017 (actual)
- 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.
Autism spectrum disorder (ASD) is defined by impaired social engagement and social communication, and repetitive, restricted, or stereotyped behaviors and interests. The average age of diagnosis in the US is after the fourth birthday. However, children who start ASD-specific early intervention have better outcomes than children start later. The current study will address a gap identified by the US Prevention Services Task Force, namely that children detected through screening respond positively to early intervention. This study will directly relate early detection strategies to early intervention, and measure the impact of age of intervention onset on outcomes when children are entering kindergarten. Local pediatric providers will be randomized to provide either usual care, or to an experimental condition in which autism early detection strategies are enhanced through the addition of specific procedures. Across all sites, 8,000 children will be recruited through their participating pediatric practice. Qualifying children will receive up to one year of early intensive behavioral intervention, after getting an ASD diagnosis. Primary outcome measures will include children's cognitive functioning and ASD symptom severity, which will be measured at multiple time points. The investigators predict that this study will inform early detection strategies which will result in improving children's social and cognitive functioning, mitigating lifespan disability, reducing societal costs, and improving personal well-being and productivity of individuals with ASD.
Detailed description
Autism spectrum disorder (ASD) is a serious neurodevelopmental disorder defined by impaired social engagement and social communication, in addition to the presence of repetitive, restricted, or stereotyped behaviors and interests. Although many cases of ASD can be detected when children are less than two years old, the average age of diagnosis in the US is still after the fourth birthday. However, evidence demonstrates that children who start ASD-specific early intervention have better outcomes than children who do not start treatment until later ages. In 2006 and 2007, American Academy of Pediatrics recommended three early detection approaches to improve identification of children at risk for ASD: ongoing developmental surveillance at every well-child check-up, routine broad developmental screening at three infant/toddler ages, and ASD-specific screening at two toddler ages. When these early detection strategies are used with all children attending well-child check-ups, the age of ASD detection is lower, and children who are diagnosed have the opportunity to start ASD-specific early intervention at younger ages than if they had not been detected. Yet in 2016, the US Preventive Services Task Force (USPSTF) indicated that current evidence is insufficient to recommend universal ASD screening, given the lack of experimental studies demonstrating positive outcomes for treated children that are detected through screening. The current study will address this gap. This study will directly relate early detection strategies to early intervention, and measure the impact of age of intervention onset on outcomes when children are entering kindergarten. The study will be conducted by investigators from three sites: Drexel University; the University of California, Davis; and the University of Connecticut. Local pediatric providers will be enrolled in the study, and their practices will be randomized to provide either usual care, or to an experimental condition in which autism early detection strategies are enhanced through the addition of specific procedures. Children attending well-child visits at participating practices will then be enrolled. Across all sites, 8,000 children will be recruited through their participating pediatric practice. As part of the study, qualifying children will receive up to one year of early intensive behavioral intervention, using an evidence-based manualized treatment. Primary outcome measures will include children's cognitive functioning and ASD symptom severity, which will be measured at multiple time points. Exploratory outcomes will include children's adaptive functioning, kindergarten readiness, and social reciprocity, as measured by experimental eye tracking and parent-child interaction ratings. This study also will examine the impact of the screening intervention on physician attitudes and on parent empowerment and stress. Finally, investigators will examine potential moderators of outcomes, to determine whether initial symptom severity, cognitive ability, or socioeconomic status affects children's long-term outcomes. The investigators predict that this study will inform early detection strategies which will result in improving children's social and cognitive functioning, mitigating lifespan disability, reducing societal costs, and improving personal well-being and productivity of individuals with ASD.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced early detection | Experimental | Behavioral: Enhanced early detectionProviders will receive training to administer enhanced early detection strategies. |
| Usual care | No intervention | –Providers will not change their early detection strategies, but will be monitored. |
Who may qualify
- Ages
- 16 to 58 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- child attended 18 m visiting at participating pediatric practice
- legal guardian is fluent in English or Spanish
Key exclusion criteria (1 listed)
- child has severe sensory or motor deficit that precludes completing standardized evaluation
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 |
|---|---|---|
| Enhanced early detectionstandardized screening | Behavioural | Enhanced early detection |
Primary outcome
Change in ASD Symptom Severity
Time frame: Change from pre-treatment to immediately post-treatment; 10 minutes
ASD symptom severity will be measured with the Brief Observation of Social Communication Change (BOSCC)
Change in Cognitive Functioning
Time frame: Change from pre-treatment to immediately post-treatment; 60 minutes
Cognitive functioning will be measured by the Mullen Scales of Early Learning (MSEL).
9 secondary outcomes
Adaptive Functioning
Time frame: Immediately post-treatment, 48 m, 60 m; 45 minutes
ASD Symptoms - secondary measure1
Time frame: 48 m, 60 m; 45 minutes
Kindergarten Readiness
Time frame: 60 m; 45 minutes
Social Engagement
Time frame: Immediately post-treatment, 48 m, 60 m; 15 minutes
Long-term change in Cognitive Functioning
Time frame: 48 m, 60 m; 60 minutes
Parent-Child Social Engagement
Time frame: Immediately post-treatment, 48 m, 60 m; 15 minutes
ASD symptoms - secondary measure2
Time frame: Immediately post-treatment, 48 m, 60 m; 20 minutes
ASD symptoms - secondary measure3
Time frame: 48 m, 60 m; 10 minutes
Long-term change in Cognitive Functioning (alternative)
Time frame: 48 m, 60 m; 60 minutes
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 16 Aug 2024.
- Derived from this study: PubMed 39454668Vivanti G, Algur Y, Ryan V, McClure LA, Fein D, Stahmer AC, Wieckowski AT, Robins DL. The Impact of Using Standardized Autism Screening on Referral to Specialist Evaluation for Young Children on the Autism Spectrum: A Cluster-Randomized Controlled Trial. J Am Acad Child Adolesc Psychiatry. 2025 Jun;64(6):686-698. doi: 10.1016/j.jaac.2024.08.502. Epub 2024 Oct 15.
- Derived from this study: PubMed 33934719McClure LA, Lee NL, Sand K, Vivanti G, Fein D, Stahmer A, Robins DL. Connecting the Dots: a cluster-randomized clinical trial integrating standardized autism spectrum disorders screening, high-quality treatment, and long-term outcomes. Trials. 2021 May 2;22(1):319. doi: 10.1186/s13063-021-05286-6.
- Individual participant dataSharing planned: Yes. Data will be uploaded to the National Database for Autism Research (NDAR) semi-annually
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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.
Diana Robins, PhD principal investigator
Drexel University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Enhanced early detection in people with Autism Spectrum Disorder, run by Drexel University at 3 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 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 16 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in ASD Symptom Severity (time frame: Change from pre-treatment to immediately post-treatment; 10 minutes). The study lists 2 primary outcomes in all. 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 NCT03333629, which also lists 2 linked publications.
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 16 Aug 2024.