Single-Session Intervention for Child Anxiety
(aSSI Trial)
Recruiting in Palo Alto (17 mi)
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: Florida International University
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?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.
Do I have to stop my current medications for this trial?
The trial protocol does not specify whether you need to stop taking your current medications. It seems focused on a single-session intervention for anxiety, so it's likely you can continue your medications, but please confirm with the trial organizers.
What data supports the idea that Single-Session Intervention for Child Anxiety is an effective treatment?
The available research shows that Single-Session Interventions (SSIs) are promising for treating youth anxiety. They have been found to be more beneficial for anxiety than for depression or other combined issues. However, the effects tend to decrease over time, especially after three months. Compared to other treatments, SSIs are more accessible and cost-effective, making them a good option for those who might not otherwise receive help. While the research highlights their potential, it also suggests that their long-term effectiveness needs further exploration.
12345What safety data exists for Single-Session Intervention for child anxiety?
The available research on Single-Session Interventions (SSIs) for child anxiety suggests they are promising for improving accessibility and scalability of psychological services. While specific safety data is not detailed, SSIs have demonstrated clinical utility and low cost, indicating a favorable safety profile. The One-Session Treatment for specific phobias, a related approach, is well-established and evidence-based, supporting its efficacy and safety. However, more research is needed to explore the preventive potential and safety of SSIs in children not yet experiencing symptoms.
12345Is the Single-Session Intervention (SSI Module) a promising treatment for child anxiety?
Yes, the Single-Session Intervention (SSI Module) is a promising treatment for child anxiety because it is accessible, scalable, and can be effective in a short amount of time. It helps make psychological services more available to children who might not otherwise get help.
13567Eligibility Criteria
This trial is for families with children aged 7-17 who are on waitlists for anxiety treatment and show significant anxiety symptoms, as reported by parents or the children themselves using a specific questionnaire (SCARED-C/P).Inclusion Criteria
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)
I am between 7 and 17 years old.
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.
Participant Groups
The study tests a single session intervention (SSI) module designed to educate about anxiety and teach self-regulation and cognitive restructuring techniques. It includes parental guidance on supporting their anxious child. Families will be randomly assigned to either receive this SSI or remain on the waitlist.
2Treatment groups
Active Control
Group I: Single Session Intervention ReceiversActive Control1 Intervention
Participants complete pre then receive the SSI module. Then they complete post and follow-up questionnaires.
Group II: Waitlist ControlActive Control1 Intervention
Participants complete pre, post, and follow-up questionnaires. They have the option to view the SSI module after completing follow-up questionnaires.
SSI Module is already approved in United States for the following indications:
🇺🇸 Approved in United States as Single-Session Intervention for:
- Youth anxiety disorders
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Florida International UniversityCoral Gables, FL
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Who Is Running the Clinical Trial?
Florida International UniversityLead Sponsor
References
A single-session growth mindset intervention for adolescent anxiety and depression: 9-month outcomes of a randomized trial. [2019]Single-session interventions (SSIs) show promise in the prevention and treatment of youth psychopathology, carrying potential to improve the scalability and accessibility of youth psychological services. However, existing SSIs have conferred greater benefits for youths with anxiety, compared to depression or comorbid problems, and their effects have generally waned over time - particularly for follow-ups exceeding 3 months.
Online Support and Intervention (OSI) for child anxiety: a case series within routine clinical practice. [2022]Online treatments for child anxiety offer a potentially cost-effective and non-stigmatizing means to widen access to evidence-based treatments and meet the increasing demand on services; however, uptake in routine clinical practice remains a challenge. This study conducted an initial evaluation of the clinical effectiveness, feasibility and acceptability of OSI (Online Support and Intervention for child anxiety) within clinical practice. OSI is a co-designed online therapist-supported, parent-led CBT treatment for pre-adolescent children with anxiety problems.
One-Session Treatment of Specific Phobias in Children: Recent Developments and a Systematic Review. [2020]One-Session Treatment is a well-established evidence-based treatment for specific phobias in youths that incorporates reinforcement, cognitive challenges, participant modeling, psychoeducation, and skills training into a single, massed session of graduated exposure. This review begins by briefly examining the phenomenology, etiology, epidemiology, and assessment of specific phobias and then pivots to a description of One-Session Treatment. We examine the use of One-Session Treatment with children and adolescents, briefly discussing its components and application, and subsequently review almost two decades of research supporting its efficacy. Finally, we propose future directions for research and practice.
Specific phobias in youth: a randomized controlled trial comparing one-session treatment to a parent-augmented one-session treatment. [2018]Examine the efficacy of a parent-augmented One-Session Treatment (A-OST) in treating specific phobias (SP) in youth by comparing this novel treatment to child-focused OST, a well-established treatment.
Empowering Anxious Parents to Manage Child Avoidance Behaviors: Randomized Control Trial of a Single-Session Intervention for Parental Accommodation. [2021]A majority of youth who need anxiety treatment never access support. This disparity reflects a need for more accessible, scalable interventions-particularly those that may prevent anxiety in high-risk children, mitigating future need for higher-intensity care. Self-guided single-session interventions (SSIs) may offer a promising path toward this goal, given their demonstrated clinical utility, potential for disseminability, and low cost. However, existing self-guided SSIs have been designed for completion by adolescents already experiencing symptoms, and their potential for preventing anxiety in children-for instance, by mitigating known anxiety risk factors-remains unexplored.
Examination of Web-Based Single-Session Growth Mindset Interventions for Reducing Adolescent Anxiety: Study Protocol of a 3-Arm Cluster Randomized Controlled Trial. [2023]Anxiety disorders are the most common mental disorders worldwide. In Hong Kong, 7% of adolescents are diagnosed with anxiety disorders, and 1 in every 4 secondary school students reports clinical-level anxiety symptoms. However, 65% of them do not access services. Long waitlists in public services, the high cost of private services, or the fear of being stigmatized can hinder service access. The high prevalence of anxiety and low intervention uptake indicate a pressing need to develop timely, scalable, and potent interventions suitable for adolescents. Single-session interventions (SSIs) have the potential to be scalable interventions for diagnosable or subclinical psychopathology in adolescents. Providing precise and context-adapted intervention is the key to achieving intervention efficacy.
Online intervention to reduce pediatric anxiety: An evidence-based review. [2020]Online intervention for school-age youth suffering from symptoms of generalized anxiety disorder.