Specifying and Treating Anxiety in Autism Research
Public ClinicalTrials.gov record NCT03279471. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Specifying and Treating the Anxiety Phenotype in Autism Spectrum Disorder
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
In the Specifying and Treating the Anxiety Phenotype in Autism Spectrum Disorder (STAAR) study, we conducted a16-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 involved 2-3 half day telehealth visits for behavioral and medical assessments, 1-2 lab visits for safety testing, and 1-2 optional fMRI (functional magnetic resonance imaging) visits for participants before the pandemic made this impossible. The study provided 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 was conducted and participants in the placebo group were given the option to participate in an additional study phase with the study treatment of their choice. Study participation could be done remotely through the use of telehealth and local labs, meaning that visits to the University of California (UC) Davis MIND Institute were not required for most participants. Several changes were made to the original protocol after the initiation of the COVID-19 Pandemic in mid-March of 2020. While the IRB of UCDMC deemed our study to be essential and permitted us to continue both psychosocial CBT therapy and medication administration, they required that: 1. Assessment measures that had been implemented in person, be switched to online or Zoom administration. 2. It also became impossible to administer the Autism Diagnostic Observation Scale (ADOS) in a valid manner. We then used the Childhood Autism Rating Scale (CARS-2) as the basis for qualification for the study. 3. We were no longer able to see participants in person so Cognitive Behavior Therapy visits were moved to an online format. 4. Similarly, medication visits were conducted over Zoom unless it was necessary to have the participant come into our clinic such as in the initial assessment or for safety concerns. 5. In the Medication Arm, we partnered with Quest Labs to enable participants to receive their safety monitoring blood tests in the community. 6. Unfortunately, it became extremely difficult to recruit patients willing to be scanned so we halted the fMRI component of the study.
Study identification
- NCT ID
- NCT03279471
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 65 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 8 Years to 14 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 1, 2017 (Actual)
- Primary completion
- Feb 22, 2023 (Actual)
- Completion
- Feb 22, 2023 (Actual)
- Last update posted
- Sep 23, 2026
2017 – 2023
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UC Davis MIND Institute | Sacramento | California | 95817 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03279471, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 23, 2026 · Synced Oct 28, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03279471 live on ClinicalTrials.gov.