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Behavioral Intervention

Single-Session Intervention for Child Anxiety (aSSI Trial)

N/A
Recruiting
Research Sponsored by Florida International University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 week after first session
Awards & highlights
No Placebo-Only Group

Summary

This trial will study if a single session intervention can help reduce anxiety in youth on waitlists for treatment, with the aim of increasing accessibility & scalability of treatment for youth anxiety.

Who is the study for?
This trial is for families with children aged 7-17 who are on waitlists for anxiety treatment and show significant anxiety symptoms, as reported by parents or the children themselves using a specific questionnaire (SCARED-C/P).
What is being tested?
The study tests a single session intervention (SSI) module designed to educate about anxiety and teach self-regulation and cognitive restructuring techniques. It includes parental guidance on supporting their anxious child. Families will be randomly assigned to either receive this SSI or remain on the waitlist.
What are the potential side effects?
Possible discomforts include feeling uneasy discussing personal feelings and behaviors during research activities, along with the risk of confidentiality breaches potentially revealing participants' identities as individuals experiencing high levels of anxiety.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~first session
This trial's timeline: 3 weeks for screening, Varies for treatment, and first session for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Screen for Child Anxiety Related Emotional Disorders - Child Version at Follow-Up
Screen for Child Anxiety Related Emotional Disorders - Child Version at posttreatment
Screen for Child Anxiety Related Emotional Disorders - Parent Version at Follow up
+1 more
Secondary study objectives
Child Anxiety Impact Scale - Child Version at Follow Up
Child Anxiety Impact Scale - Child Version at Posttreatment
Child Anxiety Impact Scale - Child Version at Pre
+15 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: Single Session Intervention ReceiversActive Control1 Intervention
Participants complete pre then receive the SSI module. Then they complete post and follow-up questionnaires.
Group II: Waitlist ControlActive Control1 Intervention
Participants complete pre, post, and follow-up questionnaires. They have the option to view the SSI module after completing follow-up questionnaires.

Find a Location

Who is running the clinical trial?

Florida International UniversityLead Sponsor
106 Previous Clinical Trials
18,875 Total Patients Enrolled

Media Library

SSI Module (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05841680 — N/A
Generalized Anxiety Disorder Research Study Groups: Single Session Intervention Receivers, Waitlist Control
Generalized Anxiety Disorder Clinical Trial 2023: SSI Module Highlights & Side Effects. Trial Name: NCT05841680 — N/A
SSI Module (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05841680 — N/A
~0 spots leftby Dec 2024
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