Being Brave for Anxiety
(BRAVE Trial)
Recruiting in Palo Alto (17 mi)
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Boston Children's Hospital
Must not be taking: Anti-convulsants
Disqualifiers: Seizures, Premature birth, Genetic disorders, others
No Placebo Group
Approved in 2 Jurisdictions
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.
12345What 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.
678910Is 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.
2341112Eligibility 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
+3 more
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.
+8 more
Trial 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)
Participant Groups
'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.
1Treatment groups
Experimental Treatment
Group I: Intervention GroupExperimental Treatment1 Intervention
Being Brave
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Boston Children's Hospital, Two Brookline PlaceBrookline, MA
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Who Is Running the Clinical Trial?
Boston Children's HospitalLead Sponsor
References
Pediatric Nurse Practitioner Management of Child Anxiety in a Rural Primary Care Clinic With the Evidence-Based COPE Program. [2018]Anxiety is the most common mental health disorder in children. Many communities have shortages of mental health providers, and the majority of children with anxiety are not receiving the evidence-based treatment they need. The purpose of this pilot study was to assess the feasibility and effects of a brief seven-session cognitive behavioral skills-building intervention, Creating Opportunities for Personal Empowerment (COPE), which was delivered to anxious children by a pediatric nurse practitioner in a primary care setting.
Effectiveness of a cognitive behavioural therapy-based anxiety prevention programme at an elementary school in Japan: a quasi-experimental study. [2022]The efficacy of cognitive behavioural therapy (CBT) for anxiety related problems in children is empirically supported. In addition, universal anxiety prevention programmes based on CBT have been demonstrated in recent years. The purpose of this study was to verify the effectiveness of a CBT based original programme 'Journey of the Brave,' aiming to prevent anxiety disorders and anxiety-related problems for Japanese children aged 10-12 years old.
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]There is a good deal of evidence that cognitive behavioural therapy is effective for children and adolescents with anxiety-related problems. In Japan, an anxiety prevention programme based on cognitive behavioural therapy called 'Journey of the Brave' has been developed, and it has been demonstrated to be effective for elementary school students (aged 10-11 years). The purpose of this study was to have classroom teachers deliver the programme to junior high school students (aged 12-13 years) and to test the feasibility and efficacy of the programme in this setting.
Parent-Based Treatment as Efficacious as Cognitive-Behavioral Therapy for Childhood Anxiety: A Randomized Noninferiority Study of Supportive Parenting for Anxious Childhood Emotions. [2021]Treatment for childhood anxiety disorders is insufficient in many cases. Parent involvement has been examined to augment child-based cognitive-behavioral therapy (CBT), but no studies have compared the efficacy of stand-alone parent-based treatment to CBT. Research implicates family accommodation in the maintenance and course of childhood anxiety. Supportive Parenting for Anxious Childhood Emotions (SPACE) is a parent-based treatment that reduces accommodation of childhood anxiety. This study compared SPACE to CBT in a noninferiority trial.
The impact of brief parental anxiety management on child anxiety treatment outcomes: a controlled trial. [2021]Parental anxiety is a risk to optimal treatment outcomes for childhood anxiety disorders. The current trial examined whether the addition of a brief parental anxiety management (BPAM) program to family cognitive behavioral therapy (CBT) was more efficacious than family CBT-only in treating childhood anxiety disorders. Two hundred nine children (aged 6-13 years, 104 female, 90% Caucasian) with a principal anxiety disorder were randomly allocated to family CBT with a five-session program of BPAM (n = 109) or family CBT-only (n = 100). Family CBT comprised the Cool Kids program, a structured 12-week program that included both mothers and fathers. Overall, results revealed that the addition of BPAM did not significantly improve outcomes for the child or the parent compared to the CBT-only group at posttreatment or 6-month follow-up. Overall, however, children with nonanxious parents were more likely to be diagnosis free for any anxiety disorder compared to children with anxious parents at posttreatment and 6-month follow-up. BPAM did not produce greater reductions in parental anxiety. The results support previous findings that parent anxiety confers poorer treatment outcomes for childhood anxiety disorders. Nevertheless the addition of BPAM anxiety management for parents in its current format did not lead to additional improvements when used as an adjunct to family CBT in the treatment of the child's anxiety disorder. Future benefits may come from more powerful methods of reducing parents' anxiety.
Adverse events and preventable adverse events in children. [2007]Patient safety has been recognized as an important problem in health care. However, knowledge about adverse events and preventable adverse events in children is relatively limited.
Occupational well-being in pediatricians-a survey about work-related posttraumatic stress, depression, and anxiety. [2020]The objective of this study was to study mental health, coping, and support after work-related adverse events among pediatricians. Physicians are frequently exposed to adverse events. It makes them at risk for posttraumatic stress disorder (PTSD), depression, and anxiety disorders. Besides the personal impact, physicians could pose a threat towards patients, as mental health problems are associated with medical errors. A questionnaire was sent to all members of the Pediatric Association of The Netherlands in October 2016. The questionnaire focused on adverse events, coping, and support. The Hospital Anxiety and Depression Scale and the Trauma Screening Questionnaire were included for evaluation of anxiety, depression, and posttraumatic stress. Four hundred ten questionnaires (18.9%) were eligible for analysis. Seventy-nine % (n = 325) of the respondents experienced adverse events, with "missing a diagnosis" having the most emotional impact and "aggressive behavior" as the most common adverse event. Nine (2.2%) pediatricians scored above the cut-off value on the Trauma Screening Questionnaire, indicative of PTSD. In total, 7.3% (n = 30) and 14.1% (n = 58) scored above the cut-off values in the Hospital Anxiety and Depression Scale, indicative of depression and anxiety. Only 26.3% reported to have a peer support protocol available for emotional support following adverse events.Conclusion: Pediatricians experience a considerable amount of adverse and potentially traumatizing events associated with significantly higher mental health problems compared to the general high-income population. Aggression towards pediatricians seems to be a common problem. Protocolled (peer) support should be implemented. What is known: • Physicians are frequently exposed to adverse events. It makes physicians at risk for depression, anxiety, and posttraumatic stress. • Physicians who are affected by these events pose a threat towards patients, as mental health problems are associated with medical errors. What is new: • Pediatricians experience a considerable amount of adverse and potentially traumatizing events associated with significantly higher mental health problems. • It is advised that (peer) support after adverse events is protocolled and education on coping strategies is implemented, to improve mental well-being of pediatricians.
[The charter of responsibility for reporting errors]. [2016]Developing safety in health care through the reporting of adverse events requires the establishment of a positive culture of error reporting. The implementation of a 'responsibility charter' motivates, empowers and professionalises caregivers in the analysis of their errors.
Child/Adolescent anxiety multimodal study: evaluating safety. [2022]To evaluate the frequency of adverse events (AEs) across 4 treatment conditions in the Child/Adolescent Anxiety Multimodal Study (CAMS), and to compare the frequency of AEs between children and adolescents.
The need for expanded monitoring of adverse events in behavioral health clinical trials. [2012]Monitoring for possible adverse events is ethically required by Institutional Review Boards and Good Clinical Practice guidelines for all human research involving the delivery of treatment interventions in a clinical trial. The monitoring of adverse events is a well-established and routine practice for contemporary clinical trials involving medications and medical devices. However, these same guidelines have not been fully integrated into clinical trials involving the use of behavioral health interventions and psychotherapy. Most behavioral health clinical trials limit adverse event monitoring to serious adverse events such as suicide attempts, completed suicides, and psychiatric hospitalizations. Other possible "side effects" of psychotherapy, such as temporary increases in anxiety, are often considered a normal part of therapy and are therefore not documented as possible adverse events. This manuscript reviews a variety of reasons for the limited adverse event monitoring in behavioral health clinical trials and highlights the importance of incorporating expanded adverse event monitoring into future behavioral health clinical trials. Without understanding the nature and prevalence of adverse events, patients cannot be informed adequately of the possible risks and benefits of behavioral interventions prior to engaging in treatment.
Classroom-based cognitive behavioural therapy: a large-scale non-randomised controlled trial of the 'Journey of the Brave'. [2021]In Japan, 'Journey of the Brave', a cognitive behavioural therapy (CBT)-based anxiety preventive education programme, was previously developed and its effectiveness examined in two small-scale controlled trials. These studies had some limitations, including a small number of participants and not having regular classroom teachers as programme facilitators. Therefore, we conducted a large-scale controlled trial, with teachers as programme implementers.
Parent-led cognitive behaviour therapy for child anxiety problems: overcoming challenges to increase access to effective treatment. [2022]Anxiety problems have a particularly early age of onset and are common among children. As we celebrate the anniversary of the BABCP, it is important to recognise the huge contribution that cognitive behavioural therapy (CBT) has made to the treatment of anxiety problems in children. CBT remains the only psychological intervention for child anxiety problems with a robust evidence base, but despite this, very few children with anxiety problems access CBT. Creative solutions are urgently needed to ensure that effective treatments can be delivered at scale. Here we focus on parent-led CBT as this offers a potential solution that is brief and can be delivered by clinicians without highly specialised training. Over the last decade there has been a substantial increase in randomised controlled trials evaluating this approach with consistent evidence of effectiveness. Nonetheless clinicians, and parents, often have concerns about trying the approach and can face challenges in its delivery.