Specifying and Treating Anxiety in Autism Research (STAAR) Study
About the STAAR Study
At least 50 percent of children with autism spectrum disorder (ASD) exhibit clinically significant anxiety symptoms. These are associated with increased social deficits, depression, irritability, and stereotyped and self-injurious behaviors. While it is clear that anxiety represents a substantial problem for those with ASD, there are important issues that need to be clarified before effective treatment becomes widespread. This project of the ACE will explore better ways to detect anxiety in children with ASD and determine whether cognitive behavioral therapy or medication can better alleviate their symptoms.
Participation in the study begins with 3-4 half day visits for behavioral and cognitive testing. These visits are conducted remotely, unless the family prefers to come to the MIND Institute in Sacramento. There is an in-person laboratory visit that can be completed either at the MIND Institute or at multiple laboratory locations throughout California. This study also includes an optional MRI which takes place at the Imaging Research Center in Sacramento. After these visits, your eligibility for the study will be determined. If your child qualifies, he or she will be randomly assigned to a treatment group. There are two treatment groups: 1) treatment with a program of cognitive behavioral therapy, or 2) treatment with the medication sertraline (commonly referred to as a selective serotonin reuptake inhibitor or SSRI). Within the medication group, some participants will receive a placebo medication. More information about these options can be found below. You will be asked to participate in weekly remote appointments with your child for 16 weeks during the course of treatment. At the end of this treatment, we will ask your child to repeat behavioral testing and the optional MRI done at the start of the study to see if there have been any changes. You will also be asked to participate in follow-up visits to see how your child is doing after the treatment is complete.
About The Treatments
Cognitive-Behavioral Therapy (CBT) is a well researched, problem-solving, goal-directed therapy that examines and treats the relationships between thoughts, feelings, and behaviors that are maintaining the anxious feelings. The basic philosophy behind CBT is that if you change the way you think about anxiety-provoking situations, you can change the way you feel about them and thus reduce your overall anxiety. Many studies have shown that CBT can be effective in persons with ASD and anxiety. But very few have tried this technique in children with autism and intellectual disability. The CBT we will provide in the STAAR study is intended specifically for individuals with ASD and can be adapted for those with mild levels of intellectual disability. If placed in the CBT group, you and your child will participate remotely in weekly 1 1/2 hour therapy sessions for 16 weeks, using a special type of CBT called the Behavioral Interventions for Anxiety in Children with Autism (BIACA) program. BIACA is a therapy curriculum which has been specifically adapted and designed for children with ASD. All BIACA treatment will be administered by well-trained and well-supervised psychologists.
Medication (Sertraline & Pill Placebo)
Sertraline is an SSRI antidepressant medication that may be used to help with anxiety and/or autism symptoms. A placebo will look the same as the sertraline pill but will not contain any active medication ingredient. A placebo group is used to ensure that any changes that are observed are due to the medication and not just to involvement in the study. If placed in the medication group, your child will be randomly assigned to take either sertraline or the placebo daily for 16 weeks. A medical doctor (MD) will start the medication at a low dose to minimize possible side effects, and the dose will gradually be increased over the course of the study. The medication should be taken daily, and will be provided through the UC Davis Pharmacy. You will be asked to keep a medication log documenting when you give the daily medication, including any skipped doses. The study team will monitor your child throughout the course of the 16 weeks through a combination of clinic visits and/or phone or video calls. If your child experiences any side effects from the medication, the MD will make adjustments to help eliminate them.
Which treatment will my child get? Can I choose?
In this study, we will work hard to ensure that all people evaluating you and your child do not know the type of treatment you are receiving. This means that the treatment you get will be chosen by chance, like flipping a coin. Neither you, nor the study MD will choose what treatment you get. You will have an equal chance of being given each treatment (CBT, sertraline, or placebo). We use this “blinding” procedure so that neither you nor the MD can influence the results of the study. At the end of the study participants in the placebo group are informed of their study assignment and offered the opportunity to participate in a follow-up phase where they can choose their study treatment, either CBT or sertraline.
We have put together the following materials to help you and your child understand and prepare for the components of this study:
About the STAAR Study- Social Story (PDF) »
About the STAAR Study- Social Story Discussion Points (PDF) »
Welcome to the MIND - Social Story (PDF) »
STAAR- Imaging Social Story (PDF) »
Phlebotomy Information (PDF) »
If you would like more information or to enroll your child, please contact our Recruitment Coordinator: