Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04598230 · ClinicalTrials.gov registry record · Phase 3
Partners in Caring for Anxious Youth
A Phase 3 study of Anxiety, Separation and Anxiety Generalized, sponsored by Ann & Robert H Lurie Children's Hospital of Chicago.
- Active
- Registry status
- Phase 3
- Development phase
- 468
- Enrollment target
- 3
- Study locations
NCT04598230 is a Phase 3 study of Anxiety, Separation and Anxiety Generalized that is active but no longer recruiting, run by Ann & Robert H Lurie Children's Hospital of Chicago. The registered enrollment target is 468 participants. The trial reports 3 study locations across 3 states.
The verdict
NCT04598230, a Phase 3 study of Anxiety, Separation and Anxiety Generalized, is active but no longer recruiting, sponsored by Ann & Robert H Lurie Children's Hospital of Chicago.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 468 participants
- Enrollment target
- 3
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 3. 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 159 total studies on file at ClinicalTrials.gov.
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.
NCT04598230 reports 3 study locations spanning 3 distinct geographic areas - top geographies include California, Illinois, Ohio.
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.
What interventions are being tested in trial NCT04598230?
The interventions under investigation include: Cognitive Behavioral Therapy (CBT) (BEHAVIORAL), Combination therapy (COMB) (DRUG).
Who is sponsoring clinical trial NCT04598230?
This trial is sponsored by Ann & Robert H Lurie Children's Hospital of Chicago, which has 159 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Anxiety, Separation
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.