Single-Session Intervention for Child Anxiety

(aSSI Trial)

Overseen By Victoria M Cabrera

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Florida International University

Disqualifiers: Autism, Intellectual disability, Bipolar, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

65 Participants Needed

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.

Will I have to stop taking my current medications?

The trial information 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 unlikely that medication changes are required.

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. ^{1 2 3 4 5}

What data supports the effectiveness of the Single-Session Intervention treatment for child anxiety?

Single-session interventions (SSIs) have shown promise in treating youth anxiety, with benefits observed in reducing anxiety symptoms. Additionally, online support and intervention (OSI) for child anxiety, which is a similar approach, has been evaluated as effective and feasible in clinical practice. ^{1 2 3 4 5}

What 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. ^{1 2 3 4 5}

Is the Single-Session Intervention for Child Anxiety safe for children?

The Single-Session Intervention (SSI) for child anxiety is generally considered safe, as it is a low-intensity, evidence-based treatment that has been used successfully in various forms, such as One-Session Treatment for specific phobias in children, without significant safety concerns reported in the research. ^{1 2 3 4 5}

Is 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. ^{1 3 5 6 7}

How is the Single-Session Intervention (SSI) Module treatment for child anxiety different from other treatments?

The Single-Session Intervention (SSI) Module is unique because it is designed to be completed in just one session, making it more accessible and scalable compared to traditional multi-session therapies. It focuses on providing immediate support and can be self-guided, which helps overcome barriers like long waitlists and high costs associated with conventional treatments. ^{1 3 5 6 8}

Eligibility 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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pilot Phase

Develop and pilot a single session intervention (SSI) tailored for families on waitlists for outpatient psychosocial treatment for youth anxiety disorders. Includes psychoeducation, self-regulation strategies, and cognitive restructuring.

Not specified

Test Phase

Examine acceptability and satisfaction of the refined SSI, and demonstrate reductions in youth anxiety symptom severity.

4 weeks

1 session (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including follow-up questionnaires.

4 weeks

Follow-up questionnaires

Treatment Details

Interventions

• SSI Module

Trial Overview 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.

Participant Groups

Group I: Single Session Intervention Receivers Active Control 1 Intervention

Participants complete pre then receive the SSI module. Then they complete post and follow-up questionnaires.

Group II: Waitlist Control Active Control 1 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

Who Is Running the Clinical Trial?

Florida International University

Lead Sponsor

Trials

114

Recruited

19,400+

Findings from Research

A novel single-session intervention (SSI) teaching a growth mindset significantly improved depression and anxiety symptoms in high-risk adolescents (ages 12-15) over a 9-month follow-up, with effect sizes indicating moderate improvements in depression (d = .60) and small improvements in anxiety (d = .28).

The intervention also enhanced youths' perceived behavioral control, suggesting that teaching the belief in the malleability of personality can be an effective and scalable approach to support mental health in young people.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A single-session growth mindset intervention for adolescent anxiety and depression: 9-month outcomes of a randomized trial. Schleider, J., Weisz, J.[2019]

The Online Support and Intervention (OSI) program for child anxiety showed significant improvement in anxiety symptoms, with most children reaching below the clinical cut-off after treatment and maintaining progress at a 4-week follow-up.

Parents reported high satisfaction with OSI, and the program demonstrated excellent uptake and engagement, indicating it is a feasible and acceptable option for treating anxiety in pre-adolescent children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Online Support and Intervention (OSI) for child anxiety: a case series within routine clinical practice. Hill, C., Chessell, C., Percy, R., et al.[2022]

One-Session Treatment is an effective, evidence-based approach for treating specific phobias in youths, combining various therapeutic techniques into a single session of graduated exposure.

Research over nearly two decades supports the efficacy of One-Session Treatment, highlighting its potential as a comprehensive intervention for children and adolescents with specific phobias.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

One-Session Treatment of Specific Phobias in Children: Recent Developments and a Systematic Review. Davis, TE., Ollendick, TH., Öst, LG.[2020]

A study involving 97 youth with specific phobias found that both the parent-augmented One-Session Treatment (A-OST) and the established child-focused One-Session Treatment (OST) were similarly effective immediately after treatment and at the 1-month follow-up, with about 50% of participants showing significant improvement.

However, at the 6-month follow-up, OST showed slightly better outcomes than A-OST, indicating that adding parental involvement did not enhance the effectiveness of the treatment over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Specific phobias in youth: a randomized controlled trial comparing one-session treatment to a parent-augmented one-session treatment. Ollendick, TH., Halldorsdottir, T., Fraire, MG., et al.[2018]

Project EMPOWER, a web-based self-guided intervention for parents, significantly reduced parental accommodation of child anxiety and increased distress tolerance in parents, indicating its potential effectiveness in preventing anxiety in children.

The intervention was well-received by parents, who found it easy to use and helpful, suggesting it could be a scalable and accessible option for families at risk of anxiety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Empowering Anxious Parents to Manage Child Avoidance Behaviors: Randomized Control Trial of a Single-Session Intervention for Parental Accommodation. Sung, JY., Mumper, E., Schleider, JL.[2021]

A study involving 549 adolescents aged 12-16 will compare the effectiveness of two single-session interventions (SIGMA and SSI-GP) against an active control in reducing anxiety symptoms, with results expected by January 2024.

The research aims to establish scalable and self-accessible interventions for anxiety, addressing the high prevalence of anxiety disorders among adolescents in Hong Kong, where many do not seek help due to various barriers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Examination of Web-Based Single-Session Growth Mindset Interventions for Reducing Adolescent Anxiety: Study Protocol of a 3-Arm Cluster Randomized Controlled Trial. Zhu, S., Tse, S., Chan, KL., et al.[2023]

A review of 20 studies on online interventions for school-age youth with generalized anxiety disorder found that cognitive behavioral therapy (CBT) programs, particularly the COPE program, led to significant improvements in anxiety symptoms and overall development.

The COPE-online program is highlighted as a cost-effective intervention that can enhance early screening and timely support for children experiencing anxiety, making it a valuable tool in mental health care for youth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Online intervention to reduce pediatric anxiety: An evidence-based review. Santilhano, M.[2020]

References

1. England pubmed.ncbi.nlm.nih.gov

A single-session growth mindset intervention for adolescent anxiety and depression: 9-month outcomes of a randomized trial. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Online Support and Intervention (OSI) for child anxiety: a case series within routine clinical practice. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

One-Session Treatment of Specific Phobias in Children: Recent Developments and a Systematic Review. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Specific phobias in youth: a randomized controlled trial comparing one-session treatment to a parent-augmented one-session treatment. [2018]

5. Canada pubmed.ncbi.nlm.nih.gov

Empowering Anxious Parents to Manage Child Avoidance Behaviors: Randomized Control Trial of a Single-Session Intervention for Parental Accommodation. [2021]

6. Canada pubmed.ncbi.nlm.nih.gov

Examination of Web-Based Single-Session Growth Mindset Interventions for Reducing Adolescent Anxiety: Study Protocol of a 3-Arm Cluster Randomized Controlled Trial. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Online intervention to reduce pediatric anxiety: An evidence-based review. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

An open-label trial of escitalopram in children and adolescents with social anxiety disorder. [2022]