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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: Completed NA study of Anxiety Disorders, sponsored by Florida International University.

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. According to ClinicalTrials.gov, the official US trial registry.

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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

Primary Outcome

Posttreatment parent rating of youth anxiety symptom severity over the past week. The name of the measure is the Screen for Child Anxiety Related Emotional Disorders - Parent Version (SCARED-P). The SCARED-P is a parent rated measure of the severity of youths' anxiety symptoms. Total scores on the SCARED-P range from 0 to 82, with higher scores representing more severe anxiety.

Conditions Studied

Interventions

  • BEHAVIORAL SSI Module

Study Locations (1)

Florida

  • Florida International University - Coral Gables

Trial Details

FieldValue
Enrollment Target 59 participants
Start Date 2023-02-10
Est. Completion 2025-10-01
Phase NA
Florida International University

89 total trials

What the finished NCT05841680 record still lists

NCT05841680 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 59 participants, a relatively small participant target, below the 1,139-participant average among 84 other Anxiety Disorders trials with a reported enrollment target (95% lower).

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 a single indexed study location in 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.

Similar trials for Anxiety Disorders

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.

Where NCT05841680's enrollment target sits among peer trials

59 64th of 84 higher than 21 of 84 other Anxiety Disorders trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Anxiety Disorders trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05841680, the US trial registry maintained by the National Library of Medicine. NCT05841680 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.