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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a single-session intervention (SSI Module) to assist children with anxiety while they await regular treatment. The goal is to determine if a one-time, focused session can reduce anxiety symptoms and enhance parental support. Researchers will compare children who receive the SSI Module to those on the waitlist to assess the intervention's impact. Families with children aged 7-17 experiencing frequent anxiety symptoms might find this trial suitable. This approach aims to make anxiety treatment more accessible and efficient. As an unphased trial, it offers families the chance to contribute to innovative research that could enhance the accessibility and effectiveness of anxiety treatment.

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 prior data suggests that this intervention is safe for children with anxiety?

Research has shown that Single-Session Interventions (SSIs) are generally safe and carry few risks. Designed to be affordable and easy to use, SSIs aim to benefit many people. Studies have found that these sessions can reduce anxiety symptoms without causing major side effects. Participants might feel some discomfort when discussing their feelings, a common experience in many types of therapy. There is also a small risk of privacy issues, as participants might be identified as having anxiety. Overall, SSIs for child anxiety have demonstrated safety with minimal risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Single-Session Intervention (SSI) for child anxiety because it offers a fast, efficient approach compared to traditional treatments like cognitive-behavioral therapy (CBT), which usually require multiple sessions over several weeks. The SSI module is designed to be completed in just one session, making it more accessible and less time-consuming for children and their families. This streamlined intervention could potentially provide quick relief from anxiety symptoms, making it a promising alternative for those seeking immediate support.

What evidence suggests that the SSI Module is effective for child anxiety?

Research shows that single-session interventions (SSIs) can help reduce anxiety in children. In this trial, participants in the "Single Session Intervention Receivers" arm will receive the SSI module, which previous studies have found promising. Specifically, one study found that when anxious parents participated in a group-based SSI, their children's anxiety symptoms decreased. Another study tested online SSIs and observed improvements in anxiety and depression over three months. These results suggest that SSIs could effectively and affordably manage anxiety in young people, especially when traditional treatments are delayed. Overall, SSIs could provide an accessible option for families waiting for more extensive therapy. ^{2 3 4 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7065925/

Future Directions in Single-Session Youth Mental Health ... One trial tested whether a group-based, single session intervention for anxious parents reduced anxiety symptoms in offspring (Cartwright-Hatton et al., 2018).

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8881339/

A Randomized Trial of Online Single Session Interventions ... We tested each SSI's effects on post-intervention (hopelessness, agency) and 3-month outcomes (depression, hopelessness, agency, generalized anxiety, COVID- ...

3. nature.com nature.com/articles/s41562-021-01235-0

A randomized trial of online single-session interventions for ... We tested each SSI's effects on post-intervention outcomes (hopelessness and agency) and three-month outcomes (depression, hopelessness, agency, ...

4. withpower.com withpower.com/trial/single-session-intervention-for-child-anxiety-812bf

Single-Session Intervention for Child Anxiety (aSSI Trial) What data supports the effectiveness of the Single-Session Intervention treatment for child anxiety? Single-session interventions (SSIs) have shown promise in ...

5. frontiersin.org frontiersin.org/journals/health-services/articles/10.3389/frhs.2022.997406/full

Harnessing the Single-Session Intervention approach to ... We propose the Single-Session Intervention approach as an unexplored path to developing low-cost and scalable implementation strategies.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10012621/

Harnessing the Single-Session Intervention approach to ... We propose the Single-Session Intervention approach as an unexplored path to developing low-cost and scalable implementation strategies.

7. ctv.veeva.com ctv.veeva.com/study/a-single-session-intervention-for-families-on-waitlists-for-child-anxiety-treatment

A Single-Session Intervention for Families on Waitlists for ... Investigators will pilot the single session intervention (SSI) with N = 5 families and use cognitive response interviewing to obtain data from parents and ...