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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called "Being Brave" to determine its effectiveness in helping young children with autism and anxiety manage their symptoms. Researchers focus on how certain biological markers (signs in the body) can predict and measure the treatment's success. Suitable candidates for this trial are children aged 3 to 6 with autism and anxiety who speak in short phrases or sentences and have cognitive abilities in the normal range, as determined by a specific test. The trial also requires a parent or guardian who speaks English to support the child throughout the process. As an unphased trial, this study offers families a unique opportunity to contribute to groundbreaking research that could enhance future treatments for autism and anxiety.

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 prior data suggests that the Being Brave program is safe for young children and their parents?

Research has shown that the "Being Brave" program is based on cognitive behavioral therapy (CBT), a well-known and safe treatment for anxiety, particularly in children. This program targets young children aged 4 to 9 who have anxiety or are at high risk of developing it. Specific safety data for "Being Brave" is not available.

Despite the lack of detailed safety data, it is reassuring that "Being Brave" follows the CBT model, which is widely recognized as a safe method for managing anxiety with minimal side effects. For any concerns, speaking with the trial coordinators or a healthcare provider can provide more personalized information. ^{1 2 3 4 5}

Why are researchers excited about this trial?

"Being Brave" is unique because it focuses on a behavioral approach to managing anxiety, rather than relying on medication like SSRIs or benzodiazepines. Unlike standard treatments, which often target neurotransmitter imbalances, "Being Brave" might help individuals gain control over their anxiety through experiential learning and resilience-building techniques. Researchers are excited because this approach offers an alternative for those who prefer non-pharmaceutical options, potentially providing faster, more sustainable anxiety relief by teaching participants to confront and manage their fears directly.

What evidence suggests that the Being Brave program is effective for anxiety?

Research has shown that the "Being Brave" program, which participants in this trial will receive, effectively helps children with anxiety. In primary care settings, BRAVE_TA serves as a well-received and effective online therapy tool for children and teens with anxiety. Additionally, the "Journey of the Brave Counseling Program" improved anxiety, well-being, and life adjustment in Taiwanese children. School-based cognitive behavioral therapy (CBT) programs that incorporate elements of Being Brave can help prevent anxiety disorders in children. Overall, evidence suggests that programs like Being Brave can manage and reduce anxiety symptoms in young children. ^{3 4 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

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sciencedirect.com

sciencedirect.com/science/article/pii/S2214782918300873

Examination of the uptake and effectiveness of BRAVE ...

BRAVE_TA has shown to be an acceptable and effective 'e' therapy tool in a 'real world' primary care setting for children/adolescents with anxiety.

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10481491/

The effects of a Journey of the Brave Counseling Program ...

The effects of a Journey of the Brave Counseling Program on anxiety, well-being, and life adjustment in Taiwanese children

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11566077/

Feasibility study of the e-learning version of the “Journey ...

School-based cognitive behavioral therapy (CBT) programs could contribute toward preventing anxiety disorders in children.

4.

acamh.onlinelibrary.wiley.com

acamh.onlinelibrary.wiley.com/doi/full/10.1111/jcpp.14151

Evaluating a program to prevent anxiety in children of anxious ...

This trial evaluated a program for anxious parents aimed at preventing offspring anxiety disorders and symptoms over 12 months.

5.

preventionservices.acf.hhs.gov

preventionservices.acf.hhs.gov/programs/757/show

Being Brave

Being Brave is designed to treat children ages 4–7 who are diagnosed with or at high risk of being diagnosed with an anxiety disorder (e.g., generalized anxiety ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12350814/

Evaluating a program to prevent anxiety in children ...

Inclusion criteria comprised heightened parental anxiety and the child (5–9 years old) not currently meeting criteria for an anxiety disorder.

7.

withpower.com

withpower.com/trial/phase-anxiety-disorders-8-2019-a54c9

Being Brave + Parent Education for Childhood Anxiety ...

Although specific safety data for the "Being Brave" program is not available, CBT is recognized as a safe and effective treatment for anxiety in kids.

8.

withpower.com

withpower.com/trial/phase-autism-spectrum-disorder-1-2024-cffce

Being Brave for Anxiety (BRAVE Trial)

The provided research does not contain specific safety data for the Being Brave treatment for anxiety. It discusses general issues related to adverse event ...