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

Study Overview
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Brief Summary
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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.

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

Conditions
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Anxiety Disorders

Intervention / Treatment
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* Behavioral: SSI Module


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Waitlist Control<br>Participants complete pre, post, and follow-up questionnaires. They have the option to view the SSI module after completing follow-up questionnaires. | |
| Active Comparator: Single Session Intervention Receivers<br>Participants complete pre then receive the SSI module. Then they complete post and follow-up questionnaires. | Behavioral: SSI Module<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 |