STAAR study is now recruiting children 8-14 years old for clinical trial
Parents can get customized therapy for their child from the Institute’s trained experts without leaving home. It’s part of a clinical trial called the Specifying and Treating Anxiety in Autism Research, or STAAR Study. And it has now expanded to offer online, telehealth study treatment appointments.
It compares the effectiveness of two treatments in children ages 8-14: the medication sertraline and individualized cognitive behavioral therapy (CBT). CBT is a well-researched, problem-solving, goal-directed therapy that examines and treats the relationships between thoughts and behaviors that are maintaining the anxious feelings.
“Most of it can be done from your couch,” said Marjorie Solomon, professor of psychiatry and behavioral sciences, who’s leading the trial. Solomon, a MIND Institute faculty member, said that when COVID-19 forced the cancellation of in-person research appointments, she and her team saw an opportunity.
“The online model is really exciting because it can be delivered so much more broadly to people who don’t live near the MIND Institute. We can serve people in Stockton, in Orange County and all over California. It really increases access,” she said.
At least 50 percent of children with autism exhibit clinically significant anxiety symptoms.
“If your child has anxiety, that has a negative impact on so many aspects of their life: academically, socially, eventually career-wise. Anxiety has a really profound effect on well-being, and children that are anxious aren’t happy, so we really want to correct that,” said Solomon.
Medication vs. therapy
Children enrolled in STAAR will be randomly assigned to either receive the medication sertraline (or a placebo) or CBT for 16 weeks. They’ll also be asked to get some lab work completed, which can be done at many locations throughout the state, as well as offered an optional MRI scan, which is done at the UC Davis Imaging Research Center in Sacramento. There is no cost to take part in the study.
Sertraline is an antidepressant, known as a selective serotonin reuptake inhibitor, and it may be used to help with symptoms of anxiety or autism. Some trial participants will take sertraline daily, and others will be given a placebo as a control.
Others will be assigned CBT. Participants and their parents will take part in 1.5-hour, interactive therapy sessions via a videoconferencing program on a tablet, phone or computer. The sessions will be administered by psychologists well-trained in CBT.
“Surprisingly, there aren’t really any big studies of either CBT or sertraline in this population, and we are the first single study to compare the two,” Solomon noted.
— Marjorie Solomon
When their treatment in the study ends, participants in the placebo group are offered the option of either CBT or sertraline.
“It’s state-of-the-art, comprehensive assessment and treatment, and now, you can do it from the safety of your own home – it’s a great opportunity,” said Solomon.
The MIND Institute is currently recruiting children with autism and anxiety, ages 8-14, to take part in the STAAR study. Information about STARR can be found here, or you can email email@example.com or call 916-703-0119.
The UC Davis MIND Institute in Sacramento, Calif. was founded in 1998 as a unique interdisciplinary research center where families, community leaders, researchers, clinicians and volunteers work together toward a common goal: researching causes, treatments and potential prevention of neurodevelopmental disorders. The institute has major research efforts in autism, fragile X syndrome, chromosome 22q11.2 deletion syndrome, attention-deficit/hyperactivity disorder (ADHD) and Down syndrome. More information about the institute and its Distinguished Lecturer Series, including previous presentations in this series, is available on the Web at mindinstitute.ucdavis.edu.