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NCT05841680 · ClinicalTrials.gov registry record · NA
A Single-Session Intervention for Families on Waitlists for Child Anxiety Treatment
A NA study of Anxiety Disorders, sponsored by Florida International University.
- Completed
- Registry status
- NA
- Development phase
- 59
- Enrollment target
- 1
- Study location
NCT05841680 is a NA study of Anxiety Disorders that has completed, run by Florida International University. The registered enrollment target is 59 participants, below the 1,139-participant average among 84 other Anxiety Disorders trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05841680, a NA study of Anxiety Disorders, has completed, sponsored by Florida International University.
- COMPLETED
- Registry status
- NA
- Development phase
- 59 participants
- Enrollment target
- 1
- Study location
Study Summary
Lengthy wait times to access treatment for youth anxiety disorders is a critical issue. To help address this issue, investigators will pursue the following aims in N = 65 families on waitlists for outpatient youth anxiety psychosocial treatment. Aim 1 Pilot Phase: Develop and pilot a single session intervention (SSI) tailored for families on waitlists for outpatient psychosocial treatment for youth anxiety disorders. Investigators will pilot the single session intervention (SSI) with N = 5 families and use cognitive response interviewing to obtain data from parents and children, ensuring the content is understandable and accessible. The SSI will include psychoeducation on the cognitive behavioral conceptualization of anxiety, introduction to self-regulation strategies to manage physiological manifestations of anxiety, and cognitive restructuring of anxiogenic thoughts. The SSI will also involve parents and present strategies on how parents can support their children in managing anxious feelings and thoughts. Investigators will refine the SSI based on these data. Following the Pilot Phase, investigators will enroll an additional N = 60 families and randomize them to either the SSI (n = 30) or waitlist control (n = 30). Aim 2 Test Phase Acceptability, and Satisfaction: Examine acceptability of the refined SSI, as well as satisfaction with the SSI. Investigators hypothesize that users will find the module to be acceptable and will report high satisfaction. Aim 3 Test Phase Anxiety Outcomes: Demonstrate reductions in youth anxiety symptom severity. Investigators hypothesize that anxiety symptom severity and impairment will be significantly lower among youth who receive the refined SSI relative to youth on waitlist control. The main risk or discomfort from this research is that participants might feel uncomfortable answering questions about their behavior and feelings. Another possible risk is breach of confidentiality that could identify a participant as having elevated
Conditions Studied
Interventions
- BEHAVIORAL SSI Module
Study Locations (1)
Florida
- Florida International University - Coral Gables
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 59 participants |
| Start Date | 2023-02-10 |
| Est. Completion | 2025-10-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05841680
The ClinicalTrials.gov registry entry for NCT05841680 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 59 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,139-participant average among 84 other Anxiety Disorders trials with a reported enrollment target (95% lower). The listed sponsor is Florida International University, which has 89 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Anxiety Disorders appearing as the primary indexed condition, and to 1 intervention - of which SSI Module is the first listed.
NCT05841680 reports 1 study location spanning 1 distinct geographic area - top geographies include Florida.
Frequently Asked Questions
What is clinical trial NCT05841680 about?
NCT05841680 is a clinical study titled "A Single-Session Intervention for Families on Waitlists for Child Anxiety Treatment". Lengthy wait times to access treatment for youth anxiety disorders is a critical issue. To help address this issue, investigators will pursue the following aims in N = 65 families on waitlists for outpatient youth anxiety psychosocial treatment. Aim 1 Pilot Phase: Develop and pilot a single session ...
What is the current status of trial NCT05841680?
This trial is currently completed. It is a NA study. The enrollment target is 59 participants. The study started on 2023-02-10. Estimated completion is 2025-10-01.
What conditions does trial NCT05841680 study?
This clinical trial studies the following conditions: Anxiety Disorders.
What interventions are being tested in trial NCT05841680?
The interventions under investigation include: SSI Module (BEHAVIORAL).
Who is sponsoring clinical trial NCT05841680?
This trial is sponsored by Florida International University, which has 89 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05841680 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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