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

November 12, 2025 updated by: Florida International University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
59

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Jeremy Pettit, Ph.D.
  • Phone Number: 305-348-1671
  • Email: jpettit@fiu.edu

Study Contact Backup

Study Locations

  • United States
    • Florida
      • Coral Gables, Florida, United States, 33156
        • Florida International University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Waitlist Control
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
Participants complete pre then receive the SSI module. Then they complete post and follow-up questionnaires.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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 weeks after first session
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.
4 weeks after first session
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.
1 week after first session
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.
1 week after first session

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
1 week after first session
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.
1 week after first session
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.
4 weeks after first session
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.
4 weeks after first session
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.
1 week after first session
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.
1 week after first session
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.
4 weeks after first session
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.
4 weeks after first session
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.
1 week after first session
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.
1 week after first session
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.
1 week after first session
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.
1 week after first session
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.
first session at baseline
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.
first session at baseline
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.
first session at baseline
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.
first session at baseline
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.
first session at baseline
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.
first session at baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Florida International University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 10, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 9, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 24, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 3, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 24, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 12, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB-23-0040

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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