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Efficacy of the ASPEN Intervention Program in Low-Resource Communities
NCT04505488 · View on ClinicalTrials.gov ↗
Study Summary
The ASD Screening and Parent ENgagement (ASPEN) program is a culturally adapted, parent-mediated intervention program. The ASPEN program is tailored to address social communication and behavioral difficulties that young children with developmental delays may experience in early childhood. The ASPEN Program includes 12 sessions where parents are provided with psychoeducation about self-care, child development, and evidence-based strategies. Coaching is also provided to train parents on using evidence-based strategies within the home setting. The ASPEN program is delivered by a student clinician and a peer leader. We hypothesize that coaching strategies delivered by the clinician will lead to primary family caregivers learning evidence-based strategies and this will result in improved child outcomes. We hypothesize that education and family support delivered by peer leaders will help primary family caregivers learn social support strategies and this will lead to improved parent outcomes.
Conditions Studied
Interventions
- BEHAVIORAL ASD Screening Parent ENgagement Intervention Program (ASPEN)
Study Locations (1)
Texas
- University of Texas at Austin — Austin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 320 participants |
| Start Date | 2020-07-07 |
| Est. Completion | 2026-05-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04505488
The ClinicalTrials.gov registry entry for NCT04505488 describes a study currently listed as active not 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 320 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Texas at Austin, which has 225 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 Spectrum Disorder appearing as the primary indexed condition, and to 1 intervention — of which ASD Screening Parent ENgagement Intervention Program (ASPEN) 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: NCT04505488 reports 1 study location spanning 1 distinct geographic area — top geographies include Texas. 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 NCT04505488 about?
NCT04505488 is a clinical study titled "Efficacy of the ASPEN Intervention Program in Low-Resource Communities". The ASD Screening and Parent ENgagement (ASPEN) program is a culturally adapted, parent-mediated intervention program. The ASPEN program is tailored to address social communication and behavioral difficulties that young children with developmental delays may experience in early childhood. The ASPEN ...
What is the current status of trial NCT04505488?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 320 participants. The study started on 2020-07-07. Estimated completion is 2026-05-31.
What conditions does trial NCT04505488 study?
This clinical trial studies the following conditions: Autism Spectrum Disorder. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04505488?
The interventions under investigation include: ASD Screening Parent ENgagement Intervention Program (ASPEN) (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04505488?
This trial is sponsored by University of Texas at Austin, which has 225 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04505488 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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