Being Brave for Anxiety

(BRAVE Trial)

Overseen By Susan C Faja, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Boston Children's Hospital

Must not be taking: Anti-convulsants

Disqualifiers: Seizures, Premature birth, Genetic disorders, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 16 weeks

25 Participants Needed

Trial Summary

What is the purpose of this trial?

A within-subjects design will be used for this preliminary investigation of four biomarkers across two contexts of use: prediction of treatment response (i.e., stratification) and quantification of response (i.e., change).

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on regular psychoactive medication that alters EEG/RSA/EDR signals, you may not be eligible to participate.

What data supports the idea that Being Brave for Anxiety is an effective treatment?

The available research does not provide specific data on the effectiveness of Being Brave for Anxiety. Instead, it discusses other cognitive behavioral therapy (CBT) programs like COPE and Journey of the Brave, which have shown effectiveness in managing anxiety in children. These programs are based on similar principles as Being Brave, suggesting that CBT-based treatments can be effective for childhood anxiety. However, without direct data on Being Brave, we cannot conclusively say how effective it is compared to these other treatments. ^{1 2 3 4 5}

What safety data exists for the Being Brave treatment for anxiety?

The provided research does not contain specific safety data for the Being Brave treatment for anxiety. It discusses general issues related to adverse event monitoring in clinical trials, particularly in behavioral health, but does not mention the Being Brave program or its safety data. ^{6 7 8 9 10}

Is the treatment 'Being Brave for Anxiety' a promising treatment?

Yes, 'Being Brave for Anxiety', which is based on cognitive behavioural therapy (CBT), is a promising treatment. It has been shown to be effective in preventing anxiety in children and teenagers in Japan, and it can be delivered by classroom teachers, making it accessible and practical. ^{2 3 4 11 12}

Eligibility Criteria

This trial is for children aged 3 to nearly 7 years with autism spectrum disorder and anxiety, who can speak in short phrases or sentences and have an IQ over 80. They need a parent who speaks English fluently to participate in interviews and support the 'Being Brave' training.

Inclusion Criteria

A diagnosis of autism spectrum disorder using DSM-5 diagnostic criteria

Use of fluent 2-3 word phrases or fluent speech (i.e., Module 2 or 3 for ADOS-2)

Cognitive ability (either verbal or non-verbal IQ) > 80 using the DAS-2

Exclusion Criteria

Presence of a primary presenting problem for which the intervention would be inappropriate (e.g., obsessive-compulsive disorder, severe mood disorder, suicidality)

I experience seizures.

I have significant physical abnormalities.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Baseline biomarker scores are collected to predict response to the CBT program

1 week

1 visit (in-person)

Treatment

Participants undergo the Being Brave cognitive behavioral therapy program

16 weeks

Weekly sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

Treatment Details

Interventions

• Being Brave

Trial Overview 'Being Brave' is being tested as a treatment for anxiety in kids with autism. The study looks at how well it works by checking changes in four biomarkers before and after treatment to see if they can predict or measure improvement.

Participant Groups

Group I: Intervention Group Experimental Treatment 1 Intervention

Being Brave

Who Is Running the Clinical Trial?

Boston Children's Hospital

Lead Sponsor

Trials

801

Recruited

5,584,000+

Findings from Research

The COPE intervention, a seven-session cognitive behavioral skills-building program, significantly reduced anxiety symptoms in children, with an average decrease of 13.88 points in anxiety scores.

Children also showed increased knowledge of coping skills and improved functioning at school and home, indicating that COPE is a feasible and effective treatment option for anxious children delivered by pediatric nurse practitioners in primary care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pediatric Nurse Practitioner Management of Child Anxiety in a Rural Primary Care Clinic With the Evidence-Based COPE Program. Kozlowski, JL., Lusk, P., Melnyk, BM.[2018]

The 'Journey of the Brave' program, based on cognitive behavioral therapy (CBT), significantly reduced anxiety scores in Japanese children aged 10-12, with improvements observed immediately after the intervention and maintained at a 3-month follow-up.

In a study involving 41 children in the intervention group and 31 in the control group, the program demonstrated a mean anxiety score reduction of -5.321 at post-test and -7.104 at follow-up, indicating its effectiveness in preventing anxiety disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a cognitive behavioural therapy-based anxiety prevention programme at an elementary school in Japan: a quasi-experimental study. Urao, Y., Yoshida, M., Koshiba, T., et al.[2022]

The 'Journey of the Brave' cognitive behavioural therapy program was delivered to 149 junior high school students, but it did not result in a significant reduction in anxiety scores compared to a control group of 89 students.

While the program showed partial feasibility for implementation in a junior high school setting, further studies with larger sample sizes and better-controlled conditions are needed to assess its true efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot and feasibility study of a cognitive behavioural therapy-based anxiety prevention programme for junior high school students in Japan: a quasi-experimental study. Ohira, I., Urao, Y., Sato, Y., et al.[2022]

The study involved 124 children aged 7-14 with primary anxiety disorders, comparing the efficacy of the parent-based treatment SPACE to traditional cognitive-behavioral therapy (CBT).

SPACE was found to be noninferior to CBT in reducing anxiety symptoms and was particularly effective in decreasing family accommodation, making it a viable alternative treatment for childhood anxiety disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parent-Based Treatment as Efficacious as Cognitive-Behavioral Therapy for Childhood Anxiety: A Randomized Noninferiority Study of Supportive Parenting for Anxious Childhood Emotions. Lebowitz, ER., Marin, C., Martino, A., et al.[2021]

In a study involving 209 children aged 6-13 with anxiety disorders, adding a brief parental anxiety management (BPAM) program to family cognitive behavioral therapy (CBT) did not significantly improve treatment outcomes compared to CBT alone.

Children with nonanxious parents were more likely to be free of anxiety disorders after treatment, highlighting that parental anxiety negatively impacts treatment effectiveness, but the BPAM program did not effectively reduce parental anxiety or enhance child outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of brief parental anxiety management on child anxiety treatment outcomes: a controlled trial. Hudson, JL., Newall, C., Rapee, RM., et al.[2021]

Adverse events occurred in 1% of pediatric hospitalizations, with 0.6% being preventable, indicating that a significant number of children experience harm due to medical management rather than their underlying conditions.

The most common types of preventable adverse events were birth-related (32.2%) and diagnostic-related (30.4%), highlighting the need for targeted research and interventions in these areas to improve patient safety in pediatric care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events and preventable adverse events in children. Woods, D., Thomas, E., Holl, J., et al.[2007]

A significant 79% of pediatricians reported experiencing adverse events, with 'missing a diagnosis' being the most emotionally impactful and 'aggressive behavior' the most common, leading to higher rates of mental health issues compared to the general population.

Only 26.3% of pediatricians had access to a peer support protocol for emotional support after adverse events, highlighting the need for structured support systems and education on coping strategies to improve their mental well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Occupational well-being in pediatricians-a survey about work-related posttraumatic stress, depression, and anxiety. van Steijn, ME., Scheepstra, KWF., Yasar, G., et al.[2020]

Establishing a positive culture of error reporting in healthcare is essential for improving safety and managing adverse events.

The introduction of a 'responsibility charter' can effectively motivate and empower caregivers to analyze their errors, leading to a more professional approach to error management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The charter of responsibility for reporting errors]. Louis-Burlat, I.[2016]

In a study involving 488 participants aged 7 to 17, no significant differences in adverse events (AEs) were found between sertraline (an SSRI) and placebo, indicating that sertraline is generally safe for treating anxiety disorders in children and adolescents.

However, children (aged 12 and under) reported higher rates of psychiatric AEs across all treatment conditions, suggesting that closer monitoring for these side effects is necessary in younger patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Child/Adolescent anxiety multimodal study: evaluating safety. Rynn, MA., Walkup, JT., Compton, SN., et al.[2022]

Current clinical trials for behavioral health interventions often do not monitor adverse events as thoroughly as those for medications and medical devices, focusing mainly on serious incidents like suicide attempts and hospitalizations.

There is a need for expanded monitoring of adverse events in psychotherapy trials to better inform patients about potential risks, including temporary increases in anxiety, which are often overlooked but can impact treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The need for expanded monitoring of adverse events in behavioral health clinical trials. Peterson, AL., Roache, JD., Raj, J., et al.[2012]

A large-scale controlled trial involving 2,745 children demonstrated that the 'Journey of the Brave' cognitive behavioural therapy (CBT)-based program significantly reduced anxiety symptoms in the intervention group compared to the control group.

The intervention group showed a mean reduction in anxiety scores of -4.91, while the control group had a reduction of -2.53, indicating that the program was effective in lowering anxiety levels among children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Classroom-based cognitive behavioural therapy: a large-scale non-randomised controlled trial of the 'Journey of the Brave'. Urao, Y., Ohira, I., Koshiba, T., et al.[2021]

Cognitive Behavioral Therapy (CBT) is the only psychological intervention with strong evidence for treating anxiety in children, yet access remains limited, highlighting the need for innovative delivery methods.

Parent-led CBT has shown consistent effectiveness in recent randomized controlled trials and could be a practical solution, but there are still concerns and challenges that need to be addressed to improve its implementation and accessibility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parent-led cognitive behaviour therapy for child anxiety problems: overcoming challenges to increase access to effective treatment. Creswell, C., Chessell, C., Halliday, G.[2022]

References

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

Pediatric Nurse Practitioner Management of Child Anxiety in a Rural Primary Care Clinic With the Evidence-Based COPE Program. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Effectiveness of a cognitive behavioural therapy-based anxiety prevention programme at an elementary school in Japan: a quasi-experimental study. [2022]

3. England pubmed.ncbi.nlm.nih.gov

A pilot and feasibility study of a cognitive behavioural therapy-based anxiety prevention programme for junior high school students in Japan: a quasi-experimental study. [2022]

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

Parent-Based Treatment as Efficacious as Cognitive-Behavioral Therapy for Childhood Anxiety: A Randomized Noninferiority Study of Supportive Parenting for Anxious Childhood Emotions. [2021]

5. England pubmed.ncbi.nlm.nih.gov

The impact of brief parental anxiety management on child anxiety treatment outcomes: a controlled trial. [2021]

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

Adverse events and preventable adverse events in children. [2007]

7. Germany pubmed.ncbi.nlm.nih.gov

Occupational well-being in pediatricians-a survey about work-related posttraumatic stress, depression, and anxiety. [2020]

8. France pubmed.ncbi.nlm.nih.gov

[The charter of responsibility for reporting errors]. [2016]

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

Child/Adolescent anxiety multimodal study: evaluating safety. [2022]

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

The need for expanded monitoring of adverse events in behavioral health clinical trials. [2012]

11. England pubmed.ncbi.nlm.nih.gov

Classroom-based cognitive behavioural therapy: a large-scale non-randomised controlled trial of the 'Journey of the Brave'. [2021]

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

Parent-led cognitive behaviour therapy for child anxiety problems: overcoming challenges to increase access to effective treatment. [2022]