Clinical trial NCT05841680: A Single-Session Intervention for Families on Waitlists for Child Anxiety Treatment
Official title: A Single-Session Intervention for Families on Waitlists for Child Anxiety
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Anxiety Disorders
Lead sponsor: Florida International University
Sponsor class: OTHER
First posted: 2023-05-03
Enrollment: 65
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Screen for Child Anxiety Related Emotional Disorders - Parent Version at posttreatment
timeFrame: 1 week after first session
measure: Screen for Child Anxiety Related Emotional Disorders - Child Version at posttreatment
timeFrame: 1 week after first session
measure: Screen for Child Anxiety Related Emotional Disorders - Parent Version at Follow up
timeFrame: 4 weeks after first session
measure: Screen for Child Anxiety Related Emotional Disorders - Child Version at Follow-Up
timeFrame: 4 weeks after first session
Secondary outcomes:
measure: Screen for Child Anxiety Related Emotional Disorders - Child Version at Pre
timeFrame: first session
measure: Screen for Child Anxiety Related Emotional Disorders - Parent Version at Pre
timeFrame: first session
measure: Child Anxiety Impact Scale - Parent Version at Pre
timeFrame: first session
measure: Child Anxiety Impact Scale - Child Version at Pre
timeFrame: first session
measure: Child Anxiety Impact Scale - Parent Version at Posttreatment
timeFrame: 1 week after first session
measure: Child Anxiety Impact Scale - Child Version at Posttreatment
timeFrame: 1 week after first session
measure: Child Anxiety Impact Scale - Parent Version at Follow Up
timeFrame: 4 weeks after first session
measure: Child Anxiety Impact Scale - Child Version at Follow Up
timeFrame: 4 weeks after first session
measure: Family Accommodation Scale Anxiety - Parent Version at Pre
timeFrame: first session
measure: Family Accommodation Scale Anxiety - Child Version at Pre
timeFrame: first session
measure: Family Accommodation Scale Anxiety - Parent Version at Posttreatment
timeFrame: 1 week after first session
measure: Family Accommodation Scale Anxiety - Child Version at Posttreatment
timeFrame: 1 week after first session
measure: Family Accommodation Scale Anxiety - Parent Version at Follow Up
timeFrame: 4 weeks after first session
measure: Family Accommodation Scale Anxiety - Child Version at Follow Up
timeFrame: 4 weeks after first session
measure: Client Satisfaction Questionnaire - Parent Report at Posttreatment
timeFrame: 1 week after first session
measure: Client Satisfaction Questionnaire - Youth Report at Posttreatment
timeFrame: 1 week after first session
measure: Program Feedback Scale - Parent Report
timeFrame: 1 week after first session
measure: Program Feedback Scale - Youth Report
timeFrame: 1 week after first session
Other outcomes:
Locations:
city: Coral Gables
country: United States
facility: Florida International University
state: Florida
Study officials:
References: