Partners in Caring for Anxious Youth (PCAY)
Anxiety, Separation, Anxiety, Generalized, Anxiety, Social
About this trial
This is an interventional treatment trial for Anxiety, Separation focused on measuring anxiety disorders, child, adolescent, pediatric, cognitive behavioral therapy, selective serotonin reuptake inhibitor, antidepressant medication
Eligibility Criteria
Inclusion Criteria
- Ages 7-17 years (inclusive at time of consent/assent)
- Primary Diagnostic and Statistical Manual, 5th Edition (DSM-5) diagnosis of separation anxiety disorder (SAD), and/or generalized anxiety disorder (GAD), and/or social anxiety disorder (SocAD) as determined by self-reported structured interview (MINI-KID) and confirmation by a study clinician.
- Stable/treated Attention Deficit Hyperactivity Disorder (ADHD), combined or hyperactive impulsive subtypes
- An available primary caretaker with ongoing patient contact who is legally able to provide consent
- Medically cleared by a pediatric clinician including a negative urine pregnancy test for females of child-bearing age. Furthermore, female patients must agree to abstain from sexual activity or to use a reliable method of birth control as determined by pediatric clinician during the study.
Exclusion Criteria:
- Patients with the following lifetime psychiatric disorders: moderate to severe autism, bipolar disorder, schizophrenia, or schizoaffective disorder, history of intellectual disability
- Primary Attention Deficit Hyperactivity Disorder (ADHD), combined or hyperactive impulsive subtypes
- Major depressive disorder with greater severity than anxiety disorder requiring treatment not provided in PCAY
- Obsessive Compulsive Disorder (OCD) only (no co-occurring SAD, SocAD or GAD)
- Patients with a major medical illness that would interfere with participation in the study (e.g., complex, and evolving medical treatments, or require frequent hospitalizations).
- Patients who are pregnant as indicated by a positive pregnancy test or are sexually active and not using effective birth control.
- Patients who pose a significant and imminent risk to self or to others.
Patients who experienced minimal or no change an adequate dose of evidenced-based medication treatment or CBT for their anxiety disorder.
(See medication and CBT exclusions below)
- Patients or caregiver(s) who do not speak English or Spanish. All materials and treatments will be available in Spanish and English.
- Children and adolescents with complex psychiatric needs that cannot be managed in primary care and community settings as determined by study local Principal Investigator (PI) and provider teams.
Medication Exclusions
Fluoxetine
- 20 mg for at least 6 of 10 weeks in children <12 year
- 40 mg for at least 6 of 10 weeks in adolescents >12 years
Sertraline
- 100 for at least 6 of 10 weeks in children <12 years
- 150 for at least 6 of 10 weeks in adolescents >12 years
Citalopram
- 20 mg for at least 6 of 10 weeks in children >12 years
- 30 mg for at least 6 of 10 weeks adolescent > 12 years
Escitalopram
- 10 mg for at least 6 of 10 weeks in children <12 years
- 20 mg for at least 6 of 10 weeks in adolescent >12 years
Fluvoxamine
- 150 mg for at least 6 of 10 weeks in children <12 years
- 200 mg for at least 6 of 10 weeks in children < 12 year
CBT Exclusions
Failed a previous trial of verified CBT for anxiety disorders within the previous year judged adequate by ≥12 exposure-based CBT sessions
Sites / Locations
- UCLA Semel Institute for Neuroscience and Human BehaviorRecruiting
- Lurie Children's Hospital and Affiliated Pediatric PracticesRecruiting
- University of Cincinnati
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Combination therapy (COMB)
Cognitive behavioral therapy (CBT)
Participants randomized to this arm will receive cognitive behavioral therapy and one of three study medications (fluoxetine, sertraline, or escitalopram).
Participants randomized to this arm will receive cognitive behavioral therapy (CBT) only