AzTrials
AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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
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

Other trials in United States

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.

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 groups in NCT03333629
Study groupRoleWhat they receive
Enhanced early detectionExperimentalProviders will receive training to administer enhanced early detection strategies.
Receives: Behavioral: Enhanced early detection
Usual careNo interventionProviders 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.

  1. 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

  2. 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)
  1. Adaptive Functioning

    Vineland Adaptive Behavior Scales-3

    Measured: Immediately post-treatment, 48 m, 60 m; 45 minutes

  2. ASD Symptoms - secondary measure1

    Autism Diagnostic Observation Schedule, Second Edition (ADOS-2)

    Measured: 48 m, 60 m; 45 minutes

  3. Kindergarten Readiness

    Developmental Indicators for the Assessment of Learning-4

    Measured: 60 m; 45 minutes

  4. 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

  5. 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

  6. 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

  7. ASD symptoms - secondary measure2

    PDD Behavior Inventory

    Measured: Immediately post-treatment, 48 m, 60 m; 20 minutes

  8. ASD symptoms - secondary measure3

    BOSCC

    Measured: 48 m, 60 m; 10 minutes

  9. 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.

  1. First posted7 Nov 2017
  2. Study start29 Nov 2017
  3. Primary completion6 Sep 2023
  4. Study completion30 Jun 2024

Resources

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)
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 39454668
  • McClure 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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in