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NCT03575429
Autism Adaptive Community-based Treatment to Improve Outcomes Using Navigators (ACTION) Network
NA trial testing Engagement Intervention in Autism Spectrum Disorder in 81 participants. Completed in 30 April 2024.
31 January 2024
Quick facts
| Lead sponsor | Florida State University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | sequential |
| Masking | double |
| Primary purpose | health services research |
| Enrollment | 81 |
| Start date | 1 August 2019 |
| Primary completion | 31 January 2024 |
| Estimated completion | 30 April 2024 |
| Sites | 3 locations across United States |
Drugs / interventions tested
- Engagement Intervention
- Engagement + Coaching Intervention
Conditions studied
- Autism Spectrum Disorder — all drugs for Autism Spectrum Disorder →
Sponsor
Florida State University
Who can join
Adults 12 Months to 24 Months, any sex, with Autism Spectrum Disorder. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The Autism Adaptive Community-based Treatment to Improve Outcomes Using Navigators (ACTION) Network-a new interdisciplinary network of 6 institutions-will blend clinical effectiveness and implementation research designs to study individual and combined effects of 2 evidence-based interventions in real world settings. The first is to engage families to access resources and support when they first learn their child has signs of ASD using an evidence-based intervention that integrates motivational interviewing and problem-solving education (MI+PSE). The second is to coach families to embed evidence-based intervention strategies for toddlers with ASD in everyday activities using the Early Social Interaction (ESI) model. In Phase 1, investigators will compare the effectiveness of adaptive interventions that use MI+PSE with and without ESI on parent and child outcomes in 3 sites in Florida and Massachusetts using a 2-stage Sequential Multiple Assignment Randomized Trial (SMART) design. In Phase 2, investigators will construct an adaptive intervention to optimize the effects and study the feasibility of implementation in new sites in California. This research network can build the capacity of community-based systems to provide earlier and widespread access to cost-efficient, community-viable treatment and be ready for immediate and rapid implementation across the US.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Defining the core components of Family Navigation for autism spectrum disorder.
Broder-Fingert S, Stadnick NA, Hickey E, Goupil J, et al · · 2020 · cited 37× · PMID 31311287 · DOI 10.1177/1362361319864079
Verify or expand the search:
- PubMed search for NCT03575429
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT03575429 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Florida State University
- Last refreshed: 16 May 2024
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/NCT03575429.
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