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Completed

NCT Number: NCT05841680

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

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.

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Key information

Conditions

Anxiety Disorders Mental Disorders

Age range

7 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Florida International University

Coral Gables, Florida, 33156, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SSI Module

Behavioral

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.

Primary outcomes

  1. Screen for Child Anxiety Related Emotional Disorders - Parent Version at Posttreatment

    Time frame: 1 week after first session

    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.

  2. Screen for Child Anxiety Related Emotional Disorders - Child Version at Posttreatment

    Time frame: 1 week after first session

    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.

  3. Screen for Child Anxiety Related Emotional Disorders - Parent Version at Follow up

    Time frame: 4 weeks after first session

    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. Screen for Child Anxiety Related Emotional Disorders - Child Version at Follow-Up

    Time frame: 4 weeks after first session

    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.

Secondary outcomes

  1. Screen for Child Anxiety Related Emotional Disorders - Child Version at Pre

    Time frame: first session at baseline

    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.

  2. Screen for Child Anxiety Related Emotional Disorders - Parent Version at Pre

    Time frame: first session at baseline

    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.

  3. Child Anxiety Impact Scale - Parent Version at Pre

    Time frame: first session at baseline

    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.

  4. Child Anxiety Impact Scale - Child Version at Pre

    Time frame: first session at baseline

    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.

  5. Child Anxiety Impact Scale - Parent Version at Posttreatment

    Time frame: 1 week after first session

    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.

  6. Child Anxiety Impact Scale - Child Version at Posttreatment

    Time frame: 1 week after first session

    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.

  7. Child Anxiety Impact Scale - Parent Version at Follow Up

    Time frame: 4 weeks after first session

    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.

  8. Child Anxiety Impact Scale - Child Version at Follow Up

    Time frame: 4 weeks after first session

    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.

  9. Family Accommodation Scale Anxiety - Parent Version at Pre

    Time frame: first session at baseline

    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.

  10. Family Accommodation Scale Anxiety - Child Version at Pre

    Time frame: first session at baseline

    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.

  11. Family Accommodation Scale Anxiety - Parent Version at Posttreatment

    Time frame: 1 week after first session

    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.

  12. Family Accommodation Scale Anxiety - Child Version at Posttreatment

    Time frame: 1 week after first session

    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.

  13. Family Accommodation Scale Anxiety - Parent Version at Follow Up

    Time frame: 4 weeks after first session

    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.

  14. Family Accommodation Scale Anxiety - Child Version at Follow Up

    Time frame: 4 weeks after first session

    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.

  15. Client Satisfaction Questionnaire - Parent Report at Posttreatment

    Time frame: 1 week after first session

    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.

  16. Client Satisfaction Questionnaire - Youth Report at Posttreatment

    Time frame: 1 week after first session

    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.

  17. Program Feedback Scale - Parent Report

    Time frame: 1 week after first session

    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.

  18. Program Feedback Scale - Youth Report

    Time frame: 1 week after first session

    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.

Sponsors and collaborators

Lead sponsor

Florida International University

Other

Registry information

Official study title

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

Acronym: aSSI

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 3, 2023
Registry last updated
Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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