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NCT03279471 · ClinicalTrials.gov registry record · Phase 2
Specifying and Treating Anxiety in Autism Research
A Phase 2 study of Anxiety and Autism Spectrum Disorder, sponsored by University of California, Davis.
- Completed
- Registry status
- Phase 2
- Development phase
- 68
- Enrollment target
- 1
- Study location
NCT03279471: Completed Phase 2 study of Anxiety and Autism Spectrum Disorder, sponsored by University of California, Davis.
NCT03279471 is a Phase 2 study of Anxiety and Autism Spectrum Disorder that has completed, run by University of California, Davis. The registered enrollment target is 68 participants, below the 440-participant average among 364 other Anxiety trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03279471, a Phase 2 study of Anxiety and Autism Spectrum Disorder, has completed, sponsored by University of California, Davis.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 68 participants
- Enrollment target
- 1
- Study location
Study Summary
The Specifying and Treating the Anxiety Phenotype in Autism Spectrum Disorder (STAAR) study aims to better characterize the sub-group of children and preadolescents with ASD that exhibit clinically significant anxiety by conducting a 16-week randomized comparative treatment trial of the Behavioral Intervention for Anxiety in Children with Autism (BIACA), the medication sertraline, and placebo in youth with ASD ages 8-14 years old. The study involves 2-3 half day telehealth visits for behavioral and medical assessments, 1-2 lab visits for safety testing, and 1-2 optional fMRI visits. The study provides 16-weeks of anxiety treatment involving weekly BIACA therapy either in-person or through telehealth, or medical check-up visits either at the UC Davis MIND Institute or via telehealth. After study completion a 3 month follow up call is conducted and participants in the placebo group are given the option to participate in an additional study phase with the study treatment of their choice. Study participation can be done remotely through the use of telehealth and local labs, visits to the UC Davis MIND Institute are not required for most participants.
Primary Outcome
The Pediatric Anxiety Rating Scale (PARS) is a clinician-rated scale assessing anxiety symptoms and the associated severity and impairment in children over the past week. The PARS will be used to assess both immediately pre- and post-treatment anxiety, as well as at a 3 month post-treatment follow-up.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Sertraline
- BEHAVIORAL CBT/BIACA
Study Locations (1)
California
- UC Davis MIND Institute - Sacramento
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 68 participants |
| Start Date | 2017-10-01 |
| Est. Completion | 2023-02-22 |
| Phase | Phase 2 |
What the finished NCT03279471 record still lists
NCT03279471 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 68 participants, a relatively small participant target, below the 440-participant average among 364 other Anxiety trials with a reported enrollment target (85% lower).
The record links to 2 conditions, with Anxiety appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT03279471 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT03279471 about?
NCT03279471 is a clinical study titled "Specifying and Treating Anxiety in Autism Research". The Specifying and Treating the Anxiety Phenotype in Autism Spectrum Disorder (STAAR) study aims to better characterize the sub-group of children and preadolescents with ASD that exhibit clinically significant anxiety by conducting a 16-week randomized comparative treatment trial of the Behavioral I...
What is the current status of trial NCT03279471?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 68 participants. The study started on 2017-10-01. Estimated completion is 2023-02-22.
What conditions does trial NCT03279471 study?
This clinical trial studies the following conditions: Anxiety, Autism Spectrum Disorder.
What interventions are being tested in trial NCT03279471?
The interventions under investigation include: Placebo (DRUG), Sertraline (DRUG), CBT/BIACA (BEHAVIORAL).
Who is sponsoring clinical trial NCT03279471?
This trial is sponsored by University of California, Davis, which has 657 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03279471 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03279471's enrollment target sits among peer trials
68 218th of 364 higher than 145 of 364 other Anxiety trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Anxiety trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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