NCT03575429Completed
Autism Adaptive Community-based Treatment to Improve Outcomes Using Navigators (ACTION) Network
Source: ClinicalTrials.gov · Last updated 16 May 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 81 (actual)
- First submitted
- 15 Jun 2018
- Start date
- 1 Aug 2019
- Primary completion date
- 31 Jan 2024
- Lead sponsor
- Florida State University
- Diseases
- Autism
- NCT number
- NCT03575429
What you commit to
- Study type: Interventional
- Participants enrolled: 81
- From 1 Aug 2019 to the primary completion date, 31 Jan 2024
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Child is already receiving early intervention services
Other
- Parent/caregiver declines to participate in the study
- Child does not screen positive for autism on the ESAC and/or SORF
- Child is over 24 months old
Who the study is looking for
- Positive screen for autism by community provider in a primary care setting
- Child is between 12 and 24 months old
- Parent completes the Smart Early Screening for Autism and Communication Disorders (ESAC)
- Parent participates in the home observation to complete the Systematic Observation of Red Flags (SORF) of ASD
- Positive autism screen on the SORF
- Lives in the designated study region in Florida and Massachusetts
Age in the registry: 12 months to 24 months · Sex: All · Accepts healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Boston Medical Center Corporation Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| University of Miami Coordinator of this site? Confirm its status | Coral Gables | United States | Unknown status |
| Florida State University Autism Institute Coordinator of this site? Confirm its status | Tallahassee | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.