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Partners in Caring for Anxious Youth
NCT04598230 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- BEHAVIORAL Cognitive Behavioral Therapy (CBT)
- DRUG Combination therapy (COMB)
Study Locations (3)
California
- UCLA Semel Institute for Neuroscience and Human Behavior — Los Angeles
Illinois
- Lurie Children's Hospital and Affiliated Pediatric Practices — Chicago
Ohio
- University of Cincinnati — Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 468 participants |
| Start Date | 2021-02-09 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04598230
The ClinicalTrials.gov registry entry for NCT04598230 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 468 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ann & Robert H Lurie Children's Hospital of Chicago, which has 69 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Anxiety, Separation appearing as the primary indexed condition, and to 2 interventions — of which Cognitive Behavioral Therapy (CBT) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04598230 reports 3 study locations spanning 3 distinct geographic areas — top geographies include California, Illinois, Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04598230 about?
NCT04598230 is a clinical study titled "Partners in Caring for Anxious Youth". 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 combi...
What is the current status of trial NCT04598230?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 468 participants. The study started on 2021-02-09. Estimated completion is 2026-12-31.
What conditions does trial NCT04598230 study?
This clinical trial studies the following conditions: Anxiety, Separation, Anxiety, Generalized, Anxiety, Social. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04598230?
The interventions under investigation include: Cognitive Behavioral Therapy (CBT) (BEHAVIORAL), Combination therapy (COMB) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04598230?
This trial is sponsored by Ann & Robert H Lurie Children's Hospital of Chicago, which has 69 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04598230 being conducted?
This trial has 3 study locations across California, Illinois, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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