A Single-Session Intervention for Families on Waitlists for Child Anxiety
Phase: NA
Conditions: Anxiety Disorders
Sponsor: Florida International University

OFFICIAL TITLE OF STUDY: A Single-Session Intervention for Families on Waitlists for Child Anxiety 
Treatment 
 
NCT NUMBER: NCT05841680 
 
DATE: 10-15-2025 
 
 

PROTOCOL 
Youth with Anxiety Disorders on Waitlists for Treatment: A Critical Need 
Anxiety disorders are among the most prevalent and impairing disorders in children and adolescents (“youth”) 
(CDC, 2022). It is well documented that the mental health system is under-resourced and unable to meet the treatment 
needs of youth, including youth with anxiety disorders, creating a bottleneck problem for service providers (Kazdin, 
2019). This bottleneck results in lengthy wait lists for services, spanning months and even years in some instances (Blech 
et al., 2017; Stallard et al., 2007; Steinert et al., 2017). These lengthy wait times prolong the distress and impairment 
experienced by youth with anxiety disorders and their families.  
These data highlight the critical need to move beyond traditional services delivery approaches for youth with 
anxiety disorders. In making this move, there is urgency to develop and evaluate least restrictive interventions that are 
both accessible to families and do not place further burden on the already under-resourced mental health system. As a step 
towards addressing this need, we propose to develop and evaluate a least restrictive intervention for families on waitlists 
for treatment of youth anxiety.  
Single-Session Interventions Delivered Remotely: A Promising Solution 
Digital and telehealth methods offer promising approaches for developing least restrictive interventions because 
they reduce burden and increase accessibility (Comer & Myers, 2016). We build on our prior work and leverage both of 
these methods, digital and telehealth, in developing a remotely-delivered single session intervention (SSI) for families on 
waitlists for anxiety services. SSIs condense and deliver evidence-based interventions within a single session; their brevity 
opens new avenues to increase access to and efficiency of care, and decrease length and cost of care (Schleider & Weisz, 
2017; Schleider, 2020). Emerging evidence supports the promise of SSIs as stand-alone treatments and adjunctive 
treatments (Hoyt et al., 2018), including for anxiety disorders in youth (Schleider & Weisz, 2017). Further, data support 
the acceptability of SSIs to clients on waitlists for psychological services (Schleider et al., 2020b). However, we are not 
aware of any SSIs that have been developed and evaluated for youth on waitlists for anxiety treatment.   
Our own data also support the promise of digital and telehealth methods and SSIs as least restrictive approaches 
to treating youth anxiety. This includes randomized controlled trial data supporting the efficacy of digitally-delivered 
attention training (e.g., Pettit et al., 2020, 2022) and promising pilot data supporting the feasibility and acceptability of a 
telehealth-delivered single session psychoeducation intervention for youth who experienced a return of anxiety following 
positive response to cognitive-behavioral treatment (Cabrera et al., 2022). In this proposal, we build on these supportive 
data and extend our efforts to a novel impacted population, families on waitlists for treatment of youth anxiety.  
Anxiety Management Support While Families Wait: A Novel SSI 
Our primary goal in developing a SSI for families on waitlists for treatment of youth anxiety is to provide short-
term reductions in anxiety symptom severity and impairment while families wait for more intensive treatment. A 
secondary goal is to explore whether a SSI could reduce families’ need for more intensive treatment, meaning that 
families no longer feel the need to pursue more intensive treatment following completion of the SSI. We ground our 
proposed SSI in cognitive behavioral principles because cognitive behavioral treatments (CBTs) are the leading evidence-
based approach for anxiety disorders in youth (Higa-McMillan et al., 2016).   
Because it is not feasible to include all components of CBTs for youth anxiety in a SSI, we prioritize evidence-
based components that are able to be understood and implemented by families following only a single session. This 
includes 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. Given 
parents’ important roles in facilitating implementation and practice of material presented in CBT approaches for youth 
anxiety (Silverman & Kurtines, 1996), we also will involve parents in the SSI and present strategies on how parents can 
support their children in managing anxious feelings and thoughts. In designing the module, we will leverage best practices 
for remotely delivered SSIs, including the use of engaging visual content with corresponding audio and interactive 
vignettes as well as comprehension checks (Schleider et al., 2020a). Details on the SSI components are provided in 
Methods.  
Specific Aims 
We will pursue the following aims in N = 60 families on waitlists for outpatient psychosocial treatment for youth 
anxiety. 

Aim 1 Pilot Phase: Develop and pilot a SSI tailored for families on waitlists for outpatient psychosocial 
treatment for youth anxiety disorders. We will pilot the SSI with N = 5 families and use cognitive response interviewing 
to obtain data from parents and children, ensuring the content is understandable and accessible. We will refine the SSI 
based on these data. 
Following the Pilot Phase, we 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. We 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. We 
hypothesize that anxiety symptom severity and impairment will be significantly lower among youth who receive the 
refined SSI relative to youth on waitlist control.  
Approach 
We will first pilot the SSI with five families and use cognitive response interviewing to obtain data from youth 
and parents, ensuring that the content is understandable and accessible. The SSI will be refined based on these data. Will 
then will evaluate the refined SSI in a sample of 60 youth participants and their parents. Participants recruited for this 
study will be youth 7-17 years old on waitlists at outpatient clinics to receive psychosocial treatment for anxiety disorders. 
Following an intake evaluation, eligible participants will be randomly assigned to one of two arms: the SSI (n=30) or the 
waitlist control (n=30).  
Inclusion Criteria. (A) Be between ages 7 and 17 years; (B) 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. (A) parent report of past diagnosis of Autism Spectrum Disorder, Intellectual Disability, 
Bipolar Disorder, Tourette’s Disorder, Psychotic Disorders, or Substance Use Disorders; (B) show high likelihood of 
hurting themselves or others; (C) not having access/connectivity needed for telehealth video conferencing to complete the 
module.  
Procedures  
Pilot Phase. Because our module integrates existing strategies and content found in evidence-based CBTs (see 
SSI Module below), our pilot phase prioritizes user experience (youths, parents) over expert content review. We will 
identify N = 5 families on our waitlist and administer the SSI module content to each youth-parent dyad. In cognitive 
response interviews, we will use verbal probing to ask youths and parents to provide feedback on module content (e.g., 
“what strategies do you find most helpful?, “which strategies were more difficult to understand?” , “was there anything 
you disliked about the module?”), duration (e.g., “did you find the length of the module to be appropriate?”), and graphics 
(e.g., “was the module visually stimulating?”, “what would help make module more interesting to view?”). We will use 
data obtained in these interviews to further refine the SSI module, ensuring clear and simple language that is accessible 
and engaging to youths and parents. 
Test Phase. Upon contacting our outpatient clinic, parents will complete a screener to assess inclusion/exclusion 
criteria. Eligible youth and parents will then be presented with web-based assent/consent forms. Families who provide 
consent/assent will then complete the PRE evaluation consisting of demographics, SCARED-C/P and Child Anxiety 
Impact Scale – Child and Parent Versions (CAIS-C/P). Following completion of the PRE evaluation, families will be 
randomized immediately to either the SSI or waitlist control. Parents of the youth randomized to the SSI will receive a 
secure link via email containing the module and will be instructed to open it immediately.  Both parent and youth will 
participate in the interactive module simultaneously. After completing the SSI, families will be granted access to view the 
module video an unlimited number of times and access to reference guides that summarize the module content.  
Parents and youth will complete a POST evaluation one week after PRE and a Follow-Up evaluation four weeks 
after PRE. The POST and Follow-Up evaluations will consist of the same measures as the PRE evaluation, plus the 
Program Feedback Scale (PFS) and Client Satisfaction Questionnaire – 8 (CSQ-8) at POST and the Treatment Utilization 
Questionnaire at Follow-Up.  
SSI Module  
The module contains video segments presenting psychoeducation content and evidence-based practices for 
managing/reducing anxiety. Interactive exercises and comprehension questions are embedded throughout the module to 

solidify understanding of concepts and correct misunderstandings. The module includes 4 main elements based on 
evidenced-based practices for managing/reducing anxiety (Higa-McMillan et al., 2016) and practices in single session 
intervention design (Schleider et al., 2020a).   
1. Psychoeducation on the tripartite model of anxiety—how anxiety manifests itself through thoughts, feelings, and 
behaviors. 
2. Psychoeducation and practice on self-regulation strategies to manage physiological manifestations of anxiety (i.e., 
feelings). Families will be introduced to “staying in the moment” and “relaxation strategies” and will have the 
opportunity to practice implementing the chosen strategy.  
3. Explanation and practice of cognitive restructuring of anxious thoughts into neutral or realistic thoughts.  
4. Evidence-based strategies on how parents can support their children in managing their anxious feelings and 
thoughts.  
 
Measures 
Primary Outcome.  
Youth anxiety outcome measure completed by parents and youths. Screen for Child Anxiety Related Emotional 
Disorders—Child and Parent Versions (SCARED-C/P; Birmaher et al. 1997). The SCARED, child and parent versions, 
are 41-item rating scales that assess anxiety symptom severity. Items are rated on a 3-point Likert scale ranging from “Not 
true or hardly ever true” to “Very true or often true”. 
Primary Outcomes.  
Youth anxiety impact measure completed by parents and youths. Child Anxiety Impact Scale – Child and Parent 
Versions (CAIS-C/P; Langley et al., 2004). The CAIS, child and parent versions, assess the impact of anxiety symptoms 
on the psychosocial functioning of youth. Items are rated on a 4-point Likert scale from “Not at all” to “Very much.”  
Intervention Acceptability measure completed by parents. The Program Feedback Scale (PFS; Schleider et al., 
2020b). The PFS assess acceptability and user perceptions of web-based single session interventions. Seven items are 
rated on a 5-point Likert scale, ranging from “1” to “5” and participants are asked to share what the liked and what they 
would change about the intervention in an open-response format. A mean score of ≥3 indicates acceptability and positive 
program evaluation.  
Treatment Satisfaction measure completed by parents and youths.  The Client Satisfaction Questionnaire— 8-
item version (CSQ-8; Larsen et al. 1979). The CSQ-8 is a widely used measure of satisfaction with mental health services 
(Sitzia, 1999).  
Treatment Utilization measure completed by parents. Because families sometimes initiate alternative treatments 
during clinical trials, we will collect data on youths’ usage of medication and/or psychosocial treatment at any point 
during their participation (Kolko, 2000). Additionally, we will collect data on whether or not families opted to remain on 
the treatment waitlist.  
 
STATISTICAL ANALYSIS PLAN 
Data management protocols will be used to ensure data integrity. Missing values will be estimated using full 
information maximum likelihood where applicable. A Holm modified Bonferroni correction will be used to control 
experiment wise error rate.  
 
Aim 1: To examine the influence of the SSI on anxiety and anxiety impact (impairment), we will use two-way 
analyses of covariance in a structural equation modeling (SEM) framework (Rausch et al., 2003). We will use a maximum 
likelihood estimator with robust standard errors (MLR) as implemented in the MPlus 8.8 statistical software program. In 
each model, participant age, treatment condition, and the PRE-score on the outcome variable will be included as 
covariates. Robust likelihood ratio tests will be used to examine differences between PRE and POST mean scores and 
POST and FOLLOW-UP mean scores).  
Aim 2: To examine acceptability, we will examine total mean scores of parents’ responses on the PFS. A mean 
score ≥3 indicates acceptability and positive program evaluation. To examine satisfaction, we will examine youth and 
parent total mean scores on the CSQ-8. Consistent with past studies (Larsen et al., 1979; Smith et al., 2014), we will 
categorize overall satisfaction ratings as ‘‘poor’’ (score = 8–13), ‘‘fair’’ (score = 14–19), ‘‘good’’ (score = 20–25) and 
‘‘excellent’’ (score = 26–32).