A Single-Session Intervention for Families on Waitlists for Child Anxiety Treatment

Anxiety Disorders Clinical Trial

— aSSI  

Official title:

A Single-Session Intervention for Families on Waitlists for Child Anxiety

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05841680
• Other study ID #: IRB-23-0040
• Status: Recruiting
• Phase: N/A
• Start date: February 10, 2023
• Est. completion date: August 1, 2025

Study information

• Verified date: May 2024
• Source: Florida International University
• Contact: Jeremy Pettit, Ph.D.
• Phone: 305-348-1671
• Email: jpettit[@]fiu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 65
• Est. completion date: August 1, 2025
• Est. primary completion date: August 9, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety Disorders

Intervention

Behavioral:
• SSI Module
Single Session Intervention (SSI) module for youth with anxiety disorders and their parents. The SSI module 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 module will also involve parents and present strategies on how parents can support their children in managing anxious feelings and thoughts.

Locations

Country	Name	City	State
United States	Florida International University	Coral Gables	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Florida International University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Screen for Child Anxiety Related Emotional Disorders - Parent Version at posttreatment	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.	1 week after first session
Primary	Screen for Child Anxiety Related Emotional Disorders - Child Version at posttreatment	Posttreatment child rating of youth anxiety symptom severity over the past week. The name of the measure is the Screen for Child Anxiety Related Emotional Disorders - Child Version (SCARED-C). The SCARED-C is a child rated measure of the severity of youths' anxiety symptoms. Total scores on the SCARED-C range from 0 to 82, with higher scores representing more severe anxiety.	1 week after first session
Primary	Screen for Child Anxiety Related Emotional Disorders - Parent Version at Follow up	Follow up parent rating of youth anxiety symptom severity over the past 3 weeks. 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.	4 weeks after first session
Primary	Screen for Child Anxiety Related Emotional Disorders - Child Version at Follow-Up	Follow up child rating of youth anxiety symptom severity over the past 3 weeks. The name of the measure is the Screen for Child Anxiety Related Emotional Disorders - Child Version (SCARED-C). The SCARED-C is a child rated measure of the severity of youths' anxiety symptoms. Total scores on the SCARED-C range from 0 to 82, with higher scores representing more severe anxiety.	4 weeks after first session
Secondary	Screen for Child Anxiety Related Emotional Disorders - Child Version at Pre	Child rating of youth anxiety symptom severity over the past month. The name of the measure is the Screen for Child Anxiety Related Emotional Disorders - Child Version (SCARED-C). The SCARED-C is a child rated measure of the severity of youths' anxiety symptoms. Total scores on the SCARED-C range from 0 to 82, with higher scores representing more severe anxiety.	first session
Secondary	Screen for Child Anxiety Related Emotional Disorders - Parent Version at Pre	Parent rating of youth anxiety symptom severity over the past month. 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.	first session
Secondary	Child Anxiety Impact Scale - Parent Version at Pre	Brief parent-report measure of anxiety-related functional impairment over the past month. The name of the measure is the Child Anxiety Impact Scale-Parent Version (CAIS-P). The CAIS-P is a parent rated measure of anxiety-related functional impairment. Total scores on the CAIS-P range from 0 to 81, with higher scores representing more functional impairment.	first session
Secondary	Child Anxiety Impact Scale - Child Version at Pre	Brief youth-report measure of anxiety-related functional impairment over the past month. The name of the measure is the Child Anxiety Impact Scale-Child/Adolescent Version (CAIS-C). The CAIS-C is a parent rated measure of anxiety-related functional impairment. Total scores on the CAIS-C range from 0 to 81, with higher scores representing more functional impairment.	first session
Secondary	Child Anxiety Impact Scale - Parent Version at Posttreatment	Brief parent-report measure of anxiety-related functional impairment over the past week. The name of the measure is the Child Anxiety Impact Scale-Parent Version (CAIS-P). The CAIS-P is a parent rated measure of anxiety-related functional impairment. Total scores on the CAIS-P range from 0 to 81, with higher scores representing more functional impairment.	1 week after first session
Secondary	Child Anxiety Impact Scale - Child Version at Posttreatment	Brief youth-report measure of anxiety-related functional impairment over the past week. The name of the measure is the Child Anxiety Impact Scale-Child/Adolescent Version (CAIS-C). The CAIS-C is a parent rated measure of anxiety-related functional impairment. Total scores on the CAIS-C range from 0 to 81, with higher scores representing more functional impairment.	1 week after first session
Secondary	Child Anxiety Impact Scale - Parent Version at Follow Up	Brief parent-report measure of anxiety-related functional impairment over the past 3 weeks. The name of the measure is the Child Anxiety Impact Scale-Parent Version (CAIS-P). The CAIS-P is a parent rated measure of anxiety-related functional impairment. Total scores on the CAIS-P range from 0 to 81, with higher scores representing more functional impairment.	4 weeks after first session
Secondary	Child Anxiety Impact Scale - Child Version at Follow Up	Brief youth-report measure of anxiety-related functional impairment over the past 3 weeks. The name of the measure is the Child Anxiety Impact Scale-Child/Adolescent Version (CAIS-C). The CAIS-C is a parent rated measure of anxiety-related functional impairment. Total scores on the CAIS-C range from 0 to 81, with higher scores representing more functional impairment.	4 weeks after first session
Secondary	Family Accommodation Scale Anxiety - Parent Version at Pre	Parent-report measure of the frequency with which parents participate in their child's anxiety-related behaviors (e.g., assisting avoidance, providing reassurance) and modification of family routines because of child anxiety over the past month. The name of the measure is the Family Accommodation Scale Anxiety - Parent Version (FASA-P). The FASA-P is a measure of parental accommodation. Total scores on the FASA-C range from 0 to 36, with higher scores representing more parental accommodation.	first session
Secondary	Family Accommodation Scale Anxiety - Child Version at Pre	Youth-report measure of the frequency with which parents participate in their child's anxiety-related behaviors (e.g., assisting avoidance, providing reassurance) and modification of family routines because of child anxiety over the past month. The name of the measure is the Family Accommodation Scale Anxiety - Child Version (FASA-C). The FASA-C is a measure of parental accommodation. Total scores on the FASA-C range from 0 to 36, with higher scores representing more parental accommodation.	first session
Secondary	Family Accommodation Scale Anxiety - Parent Version at Posttreatment	Parent-report measure of the frequency with which parents participate in their child's anxiety-related behaviors (e.g., assisting avoidance, providing reassurance) and modification of family routines because of child anxiety over the past week. The name of the measure is the Family Accommodation Scale Anxiety - Parent Version (FASA-P). The FASA-P is a measure of parental accommodation. Total scores on the FASA-C range from 0 to 36, with higher scores representing more parental accommodation.	1 week after first session
Secondary	Family Accommodation Scale Anxiety - Child Version at Posttreatment	Youth-report measure of the frequency with which parents participate in their child's anxiety-related behaviors (e.g., assisting avoidance, providing reassurance) and modification of family routines because of child anxiety over the past week. The name of the measure is the Family Accommodation Scale Anxiety - Child Version (FASA-C). The FASA-C is a measure of parental accommodation. Total scores on the FASA-C range from 0 to 36, with higher scores representing more parental accommodation.	1 week after first session
Secondary	Family Accommodation Scale Anxiety - Parent Version at Follow Up	Parent-report measure of the frequency with which parents participate in their child's anxiety-related behaviors (e.g., assisting avoidance, providing reassurance) and modification of family routines because of child anxiety over the past 3 weeks. The name of the measure is the Family Accommodation Scale Anxiety - Parent Version (FASA-P). The FASA-P is a measure of parental accommodation. Total scores on the FASA-C range from 0 to 36, with higher scores representing more parental accommodation.	4 weeks after first session
Secondary	Family Accommodation Scale Anxiety - Child Version at Follow Up	Youth-report measure of the frequency with which parents participate in their child's anxiety-related behaviors (e.g., assisting avoidance, providing reassurance) and modification of family routines because of child anxiety over the past 3 weeks. The name of the measure is the Family Accommodation Scale Anxiety - Child Version (FASA-C). The FASA-C is a measure of parental accommodation. Total scores on the FASA-C range from 0 to 36, with higher scores representing more parental accommodation.	4 weeks after first session
Secondary	Client Satisfaction Questionnaire - Parent Report at Posttreatment	Parent report measure of consumer satisfaction with services received (e.g., "How would you rate the quality of the services you received?" and "If a friend were in need of similar help, would you recommend our program to him or her?"). The name of the measure is Client Satisfaction Questionnaire (CSQ-8). Total scores on the CSQ-8 range from 8 to 32, with higher scores representing more satisfaction with services received.	1 week after first session
Secondary	Client Satisfaction Questionnaire - Youth Report at Posttreatment	Youth-report measure of consumer satisfaction with services received (e.g., "How would you rate the quality of the services you received?" and "If a friend were in need of similar help, would you recommend our program to him or her?"). The name of the measure is Client Satisfaction Questionnaire (CSQ-8). Total scores on the CSQ-8 range from 8 to 32, with higher scores representing more satisfaction with services received.	1 week after first session
Secondary	Program Feedback Scale - Parent Report	Parent-report measure of perceived acceptability of a single session intervention (e.g. "I enjoyed the program"). The name of the measure is the Program Feedback Scale (PFS). Total scores on the PFS range from 0 to 35, with higher scores representing more acceptability.	1 week after first session
Secondary	Program Feedback Scale - Youth Report	Youth-report measure of perceived acceptability of a single session intervention (e.g. "I enjoyed the program"). The name of the measure is the Program Feedback Scale (PFS). Total scores on the PFS range from 0 to 35, with higher scores representing more acceptability.	1 week after first session