Ignite Creation Date:
2024-05-06 @ 6:57 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05841680
Status:
RECRUITING
Last Update Posted:
2024-05-03
First Post:
2023-02-24
Brief Title:
A Single-Session Intervention for Families on Waitlists for Child Anxiety Treatment
Sponsor:
Florida International University
Organization:
Florida International University
Study Overview
Official Title:
A Single-Session Intervention for Families on Waitlists for Child Anxiety
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
aSSI
Brief 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 levels of anxiety The benefits of this SSI would include increasing accessibility and scalability of treatment for youth anxiety disorders Overall this study will provide critically needed data to advance resource efficient treatment options for youth anxiety disorders
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None