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"Opt-In" Early Intervention Program for Children Waiting to Receive an Autism Diagnosis
NCT07081724 · View on ClinicalTrials.gov ↗
Study Summary
A growing body of literature documents the benefits of parent-mediated interventions for autism starting early in life . However, the median age of diagnosis in the US continues to be 49 months. Even following formal diagnosis, services often do not begin for another 9 months on average. Such harmful delays in accessing autism-specific early interventions are potentially avoidable, as caregivers of children later diagnosed with autism identify concerns about their child's development by 13 months on average - including difficulties that can be successfully addressed through evidence-based intervention practices. Wait times to receive a formal diagnosis of autism are such a significant barrier that they have been referred to as a "crisis" in the field, with parents reporting an average wait time of 1.2 years in the US. The current proposal focuses on circumventing the roadblock of delayed access to diagnosis and intervention by empowering caregivers to address their children's needs before a diagnosis is established. This will be accomplished through the implementation and evaluation of the "Online Parent Training in Early Behavioral Intervention (OPT-In-Early)", a self-directed online resource for caregivers of autistic children which will be made available during their enrollment in waitlists for a diagnostic evaluation. Key features of OPT-In-Early include: (a) a comprehensive scope (i.e., multiple developmental domains are addressed), (b) a focus on evidence-based Naturalistic Developmental Behavioral Intervention strategies, (c) a combination of required and optional modules, so that caregivers can focus on areas most relevant to their child's needs, and (d) access to online materials designed for self-directed implementation, as well as access to remote consultation with a clinician for advice, clarification and support (including on selection of appropriate modules). Following an alternative approach to the current "parental concerns - then enrollment in wai
Conditions Studied
Interventions
- BEHAVIORAL Online Parent Training in Early Behavioral Intervention (OPT-In-Early)
Study Locations (1)
Pennsylvania
- A.J. Drexel Autism Institute — Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2025-08-25 |
| Est. Completion | 2029-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07081724
The ClinicalTrials.gov registry entry for NCT07081724 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Drexel University, which has 65 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Autism appearing as the primary indexed condition, and to 1 intervention — of which Online Parent Training in Early Behavioral Intervention (OPT-In-Early) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT07081724 reports 1 study location spanning 1 distinct geographic area — top geographies include Pennsylvania. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT07081724 about?
NCT07081724 is a clinical study titled ""Opt-In" Early Intervention Program for Children Waiting to Receive an Autism Diagnosis". A growing body of literature documents the benefits of parent-mediated interventions for autism starting early in life . However, the median age of diagnosis in the US continues to be 49 months. Even following formal diagnosis, services often do not begin for another 9 months on average. Such harmfu...
What is the current status of trial NCT07081724?
This trial is currently recruiting. It is a NA study. The enrollment target is 120 participants. The study started on 2025-08-25. Estimated completion is 2029-12.
What conditions does trial NCT07081724 study?
This clinical trial studies the following conditions: Autism. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT07081724?
The interventions under investigation include: Online Parent Training in Early Behavioral Intervention (OPT-In-Early) (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07081724?
This trial is sponsored by Drexel University, which has 65 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT07081724 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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