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NCT04505488: ASPEN
Efficacy of the ASPEN Intervention Program in Low-Resource Communities
NA trial testing ASD Screening Parent ENgagement Intervention Program (ASPEN) in Autism Spectrum Disorder in 320 participants. Participants enrolled and being followed up; not accepting new ones.
28 February 2026
Quick facts
| Lead sponsor | University of Texas at Austin |
|---|---|
| Phase | NA |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 320 |
| Start date | 7 July 2020 |
| Primary completion | 28 February 2026 |
| Estimated completion | 31 May 2026 |
| Sites | 1 location across United States |
Drugs / interventions tested
- ASD Screening Parent ENgagement Intervention Program (ASPEN)
Conditions studied
- Autism Spectrum Disorder — all drugs for Autism Spectrum Disorder →
Sponsor
University of Texas at Austin
Who can join
Adults 18 Months to 6, any sex, with Autism Spectrum Disorder. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04505488
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other University of Texas at Austin trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04505488 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Texas at Austin
- Last refreshed: 27 January 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04505488.
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