Anxiety disorders affect more than 20 percent of youth, often interfering with self-esteem, confidence, family relationships, friendships, or school performance. Although psychological and medication therapies are helpful to many patients, not all patients respond to a given therapy, and those who do respond frequently relapse later. Treatment of a child who has an anxiety disorder begins with the question of which treatment to begin first: psychological or medication therapy. Few studies, however, have compared these two treatments directly, leaving patients, parents, and clinicians without scientific evidence for which treatment is likely to be most helpful. Another question is what to do when the initial treatment is not as helpful as desired: Should the initial single treatment be intensified, or should the other treatment be added to the first, producing a combined psychological and medication therapy? No studies have been performed to answer this second question. Another consideration is which child characteristics might influence the answer to these two questions. For example, does a child’s age, ethnicity, previous treatment history, co-occurring problems, severity of anxiety, or stress influence which treatment or sequence of treatments is most likely to help? We hope to answer these questions by enrolling 404 youth, ages 8 to 17, who are predominantly underserved ethnic minorities, into a study using a SMART (Sequential Multiple Assignment Randomized Trial) design. The main portion of the 24-week-long study will be divided into two stages.
Stage 1, which will last 12 weeks, will randomize youth to receive either cognitive behavioral therapy (CBT) alone or the medication fluoxetine alone. We will directly compare how well these treatments help symptoms. If the initial treatment in stage 1 fails to fully remove anxiety symptoms, then in stage 2 we will randomize the child a second time to receive, over the next 12 weeks, either
- intensification of the initial treatment from stage 1 or
- the other treatment in addition to the first (i.e., combining CBT and fluoxetine).
Stage 2 answers the second question above, and will tell us whether one of the four possible treatment sequences (CBT->optimized CBT, CBT->medication, medication->optimized medication, or medication->CBT) is better than the others. We will follow children for 12 months, after they complete this 24-week SMART study, to see how long treatment effects last. Finally, we will assess whether patient characteristics influence which of the initial treatments and which of the four treatment sequences is most helpful, to inform the third component above. The lived experiences and expertise of patients, caregivers, clinicians, and other healthcare stakeholders are playing a vital role in ensuring that this research is patient centered, relevant, and useful. They have been full partners in formulating the research questions, informing the design, and selecting the procedures and measures for this study. They, along with the patients and families participating in this study, will continue as full partners in execution of the study, reporting challenges, brainstorming solutions, sharing successes, discussing/interpreting findings, and assisting with dissemination.
*All proposed projects, including requested budgets and project periods, are approved subject to a programmatic and budget review by PCORI staff and the negotiation of a formal award contract.