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Partners in Caring for Anxious Youth

Study acronym: PCAY
StatusActive, Not Recruiting
PhasePhase 3
Started
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Record History

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  1. Minor Study completion date: Dec 31, 2026 to Dec 1, 2026v8
  2. Notable Primary completion date: Dec 30, 2024 to Aug 31, 2025
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Apr 1, 2025 to Dec 31, 2026
    • Site details revised at 3 of 3 sites
    v7
  3. Notable Primary completion date: Oct 1, 2023 to Dec 30, 2024
    • Study completion date: Apr 1, 2024 to Apr 1, 2025
    v6
  4. Minor Study sites: 1 to 3v5
  5. Minor Re-verified, no change to tracked fieldsv4
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  1. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jan 1, 2021 to Feb 9, 2021
    • Site details revised
    v3
  2. Notable Start date: Nov 1, 2020 to Jan 1, 2021
    • Primary completion date: Dec 1, 2023 to Oct 1, 2023
    • Study completion date: Jan 31, 2024 to Apr 1, 2024
    • Eligibility criteria expanded, about 143 words
    v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04598230
Lead Sponsor Ann & Robert H Lurie Children's Hospital of Chicago
Collaborators: University of Cincinnati, University of California, Los Angeles
Conditions
(from sponsor)
Anxiety, Separation, Anxiety, Generalized, Anxiety, Social
Related terms Anxiety Disorders, Anxiety, Separation, Generalized Anxiety Disorder
Enrollment 468 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov