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ACTIVE NOT RECRUITING

NCT04598230

PHASE3

Partners in Caring for Anxious Youth

Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago

View on ClinicalTrials.gov

Summary

Pediatric onset anxiety disorders (generalized anxiety, social anxiety, separation anxiety) are highly prevalent, and if untreated, are impairing into adolescence and adulthood. In the largest comparative efficacy study remission occurred in about 65% of children and adolescents treated with a combination of a selective serotonin reuptake inhibitors (SSRI) and cognitive behavioral therapy (CBT). In contrast, CBT without an SSRI achieved remission in 35% of children at 3 months and 45% at 6 months-a 30% and 20% difference, respectively. Despite the difference in remission rates, CBT alone is the preferred treatment of most patients and families. Lack of awareness of the significant difference in remission rates and concerns about medication side effects may drive patient and family preference even though SSRIs have a positive safety profile. Critiques of CBT in the above study suggest that CBT was not as effective as it could be due to short treatment duration, restricted family involvement and limited exposure sessions. Would the combination of CBT and an SSRI still be superior to CBT only, if CBT was of longer duration, and included more family involvement and exposure sessions? In the Partners in Care for Anxious Youth (PCAY) study, children and adolescents with an anxiety disorder ages 7-17 years followed in pediatric primary care clinics affiliated with three institution: Lurie Children's Hospital of Chicago, University of California Los Angeles and University of Cincinnati will be randomized to one of two treatment arms; either CBT only or CBT combined with an SSRI (either fluoxetine, sertraline, or escitalopram). CBT in PCAY will be 6 months in duration and include more family involvement, and more exposure opportunities than past trials. The 6-month acute treatment phase will be followed by 6 months of followup. The primary outcome will be anxiety symptom remission and reduction in impairment over 6 and 12-months.

Key Details

Gender

All

Age Range

7 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

468

Start Date

2021-02-09

Completion Date

2026-12-31

Last Updated

2025-02-18

Healthy Volunteers

Yes

Conditions

Anxiety, Separation Anxiety, Generalized Anxiety, Social

Interventions

BEHAVIORAL

Cognitive Behavioral Therapy (CBT)

Participants randomized to this arm will receive up to 20 sessions of evidence based cognitive behavioral therapy (CBT) of extended duration, with more exposure tasks and greater family involvement than has been studied in the past.

DRUG

Combination therapy (COMB)

Participants randomized to this arm will receive cognitive behavioral therapy comparable to that in the cognitive behavioral therapy arm, plus one of three selective serotonin reuptake inhibitors (SSRI) medications (fluoxetine, sertraline, escitalopram)

Inclusion Criteria 1. Ages 7-17 years (inclusive at time of consent/assent) 2. 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. 3. Stable/treated Attention Deficit Hyperactivity Disorder (ADHD), combined or hyperactive impulsive subtypes 4. An available primary caretaker with ongoing patient contact who is legally able to provide consent 5. 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: 1. Patients with the following lifetime psychiatric disorders: moderate to severe autism, bipolar disorder, schizophrenia, or schizoaffective disorder, history of intellectual disability 2. Primary Attention Deficit Hyperactivity Disorder (ADHD), combined or hyperactive impulsive subtypes 3. Major depressive disorder with greater severity than anxiety disorder requiring treatment not provided in PCAY 4. Obsessive Compulsive Disorder (OCD) only (no co-occurring SAD, SocAD or GAD) 5. 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). 6. Patients who are pregnant as indicated by a positive pregnancy test or are sexually active and not using effective birth control. 7. Patients who pose a significant and imminent risk to self or to others. 8. 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) 9. Patients or caregiver(s) who do not speak English or Spanish. All materials and treatments will be available in Spanish and English. 10. 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

Locations (3)

UCLA Semel Institute for Neuroscience and Human Behavior

Los Angeles, California, United States

Lurie Children's Hospital and Affiliated Pediatric Practices

Chicago, Illinois, United States

University of Cincinnati

Cincinnati, Ohio, United States