A first-of-its-kind clinical trial led by Children’s Hospital Los Angeles has found that no single approach to treating pediatric anxiety is clearly superior over time, although youth characteristics and sequencing of the treatments influence treatment response.
The initial findings from the Sequential Multiple Assignment Randomized Trial (SMART) Study for Pediatric Anxiety represent a major set of discoveries and offer important guidance for clinical providers choosing among cognitive behavioral therapy (CBT), medication, or their combination for children and adolescents.
The ongoing multicenter study is funded by the Patient-Centered Outcomes Research Institute (PCORI). The results cover the 24-week trial and were published in the American Journal of Psychiatry- Opens in a new window.
“What we’re learning is that there isn’t a single best treatment for pediatric anxiety,” says Bradley Peterson, MD, Chief of Psychiatry and Co-Director of the Behavioral Health Institute at CHLA, who is leading the study along with Clinical Psychologist Amy E. West, PhD, ABPP, Associate Director of Education, Research, and Mentorship in the Department of Psychology, and Director of the Clinical Child and Pediatric Psychology Internship. “Families and clinicians have options, and those choices can be guided by what’s accessible and what works best for the individual child.”
An epidemic of anxiety
The study was launched to address a fundamental gap in how clinicians treat pediatric anxiety: There is little clear evidence on which approach works best over time. That’s particularly problematic because the condition is widespread among youth.
“At least 20% of kids have a diagnosable anxiety disorder by age 18,” Dr. Peterson says. “We are in an epidemic of anxiety.”
Dr. West points out that this epidemic has grown worse in recent years. “We are currently in the midst of a significant pediatric mental health crisis, driven prominently by increasing rates of anxiety over the past two decades,” she says.
Currently, most children with anxiety are started on either CBT or medication. If they don’t fully improve after several months, clinicians and families must decide whether to continue that treatment or add another.
The SMART study is the first to directly compare CBT and medication—and their sequencing—in a diverse, real-world population. Researchers examined the effectiveness of CBT and a common antidepressant, as well as how outcomes differ depending on which treatment patients start with and whether a second approach is added later.
Previous studies have explored treatment strategies, but most have focused on children from higher socioeconomic backgrounds with few co-occurring conditions.
“Our trial is a real-world effectiveness study, involving kids from all socioeconomic levels and racial and ethnic groups,” Dr. Peterson says. “Participants also had many of the co-occurring challenges that typically accompany anxiety, like depression, school difficulties, or substance use.”
No single ‘best’ approach
The single-blind randomized controlled trial enrolled 316 youth ages 8 to 17 from Los Angeles County. All participants had severe anxiety, high levels of socioeconomic disadvantage, and co-occurring conditions.
The trial was split into two 12-week stages. In the first stage, participants were treated either with the antidepressant fluoxetine or with CBT. In the second stage, they either continued their initial treatment or received a combination of both approaches. Investigators tracked anxiety levels throughout the trial using a standardized screening tool.
Results showed only subtle differences between approaches:
- Starting with CBT had a slight advantage over starting with fluoxetine, though researchers emphasize that this does not mean starting with medication is a bad or ineffective strategy.
- Non-Hispanic white youth benefited more from using fluoxetine throughout the full trial, while minority youth saw greater improvement when shifted to combination therapy.
- For patients who started with CBT, adding fluoxetine after 12 weeks increased the likelihood of improvement.
Overall, symptom reduction was similar between CBT, fluoxetine, combination treatment, and different sequencing strategies. The findings suggest that families and clinicians can choose among these options based on preference and access, rather than relying on a single “best” approach.
“The good news is that, in general, the treatments appear to be similarly effective in reducing anxiety so treatment choice can depend on family preference, accessibility, and other individual or contextual factors,” Dr. West explains.
Dr. Peterson says the study
could help inform updates to clinical guidelines, which recommend starting with CBT before considering medication. “It’s perfectly reasonable to begin with medication if that’s what is accessible and is what works for the patient,” he notes.
Next steps
Researchers have also gathered follow-up data from the study participants for a full year, and PCORI has provided additional funding to continue following the participants for another six years.
Dr. West hopes to further analyze the effectiveness and quality of CBT delivery among the uniquely varied patient population over this period.
“While CBT is the most effective psychosocial treatment for pediatric anxiety, the effectiveness of CBT is dependent on how well it is delivered,” she explains. “Data from this study will help us better understand the quality of CBT when it’s delivered in real-world practice settings by clinicians with variable levels of experience to highly complex patients.”
Dr. Peterson is curious to see how long symptoms continue to improve for patients over the next six years.
“We’re already seeing that symptom improvement continues for a full year after completion of the 6-month trial,” he notes. “It takes time for anxiety symptoms to improve, regardless of which treatment you begin with. We want to see how long that progress continues, when it starts to level off, and whether it reduces the emergence of depression, substance use, and other problems later.”
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