N/A
N=59
A Single-Session Intervention for Families on Waitlists for Child Anxiety Treatment
Anxiety Disorders
Bottom Line
View on ClinicalTrials.gov: NCT05841680 ↗Enrolled (actual)
59
Serious AEs
0.0%
Results posted
Nov 2025
Primary outcome: Primary: Screen for Child Anxiety Related Emotional Disorders - Parent Version at Posttreatment — 35; 30 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- SSI Module (Behavioral)
- Age
- Pediatric · 7+ yrs
- Sex
- All
- Sponsor
- Florida International University
- Primary completion
- Jun 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Screen for Child Anxiety Related Emotional Disorders - Parent Version at Posttreatment |
35; 30 | — |
| PRIMARY Screen for Child Anxiety Related Emotional Disorders - Child Version at Posttreatment |
33; 23 | — |
| PRIMARY Screen for Child Anxiety Related Emotional Disorders - Parent Version at Follow up |
34; 26 | — |
| PRIMARY Screen for Child Anxiety Related Emotional Disorders - Child Version at Follow-Up |
31; 23 | — |
| SECONDARY Screen for Child Anxiety Related Emotional Disorders - Child Version at Pre |
36; 36 | — |
| SECONDARY Screen for Child Anxiety Related Emotional Disorders - Parent Version at Pre |
34; 37 | — |
| SECONDARY Child Anxiety Impact Scale - Parent Version at Pre |
28; 22 | — |
| SECONDARY Child Anxiety Impact Scale - Child Version at Pre |
24; 19 | — |
| SECONDARY Child Anxiety Impact Scale - Parent Version at Posttreatment |
27; 18 | — |
| SECONDARY Child Anxiety Impact Scale - Child Version at Posttreatment |
21; 17 | — |
| SECONDARY Child Anxiety Impact Scale - Parent Version at Follow Up |
25; 15 | — |
| SECONDARY Child Anxiety Impact Scale - Child Version at Follow Up |
18; 16 | — |
| SECONDARY Family Accommodation Scale Anxiety - Parent Version at Pre |
15; 13 | — |
| SECONDARY Family Accommodation Scale Anxiety - Child Version at Pre |
15; 14 | — |
| SECONDARY Family Accommodation Scale Anxiety - Parent Version at Posttreatment |
14; 11 | — |
| SECONDARY Family Accommodation Scale Anxiety - Child Version at Posttreatment |
11; 9 | — |
| SECONDARY Family Accommodation Scale Anxiety - Parent Version at Follow Up |
14; 11 | — |
| SECONDARY Family Accommodation Scale Anxiety - Child Version at Follow Up |
11; 8 | — |
| SECONDARY Client Satisfaction Questionnaire - Parent Report at Posttreatment |
29 | — |
| SECONDARY Client Satisfaction Questionnaire - Youth Report at Posttreatment |
29 | — |
| SECONDARY Program Feedback Scale - Parent Report |
34 | — |
| SECONDARY Program Feedback Scale - Youth Report |
29 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Be between ages 7 and 17 years
- Endorse clinically elevated anxiety symptoms on either parent or youth report, as indicated by a score > 25 on the Screen for Child Anxiety and Related Emotional Disorders-Child or Parent Versions (SCARED-C/P).
Exclusion Criteria
- Parent report of past diagnosis of Autism Spectrum Disorder, Intellectual Disability, Bipolar Disorder, Tourette's Disorder, Psychotic Disorders, or Substance Use Disorders
- Show high likelihood of hurting themselves or others
- Not having access/connectivity needed for telehealth video conferencing to complete the module.
Data sourced from ClinicalTrials.gov (NCT05841680). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.