Being Brave + Parent Education for Childhood Anxiety Disorder
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if Cognitive Behavioral Therapy (CBT), specifically the Being Brave program, combined with parent education, can reduce anxiety in young children. The focus is on children aged 2-3 who exhibit high levels of fear, shyness, or anxiety. Participants are divided into three groups: one receives therapy sessions, another receives educational materials, and the last group is monitored. Families with a very fearful or shy child who speaks English might find this trial suitable. As an unphased trial, it offers families the chance to contribute to understanding effective anxiety treatments for young children.
Will I have to stop taking my current medications?
The trial protocol does not specify whether participants need to stop taking their current medications.
What prior data suggests that this protocol is safe for young children with anxiety?
Research has shown that Cognitive Behavioral Therapy (CBT) is a well-known treatment that is generally safe and effective for reducing anxiety in children. Although specific safety data for the "Being Brave" program is not available, CBT is widely recognized as safe and effective for kids.
CBT helps children manage their feelings by changing negative thoughts. This approach has significantly reduced anxiety symptoms in young people. Most children who participate in CBT programs experience improvements in their anxiety levels.
Therefore, even without detailed safety data for "Being Brave," using CBT techniques in this program has a strong history of being safe and helpful for children with anxiety.12345Why are researchers excited about this trial?
Researchers are excited about the Being Brave treatment for childhood anxiety because it offers a unique approach to therapy by directly involving both the child and their parent. Unlike traditional treatments that might focus solely on the child, Being Brave uses a Parent-Child Cognitive Behavioral Therapy (CBT) model that strengthens the parent-child relationship while addressing anxiety. This method not only provides children with tools to manage their anxiety but also equips parents with the knowledge to support their children's emotional growth. Additionally, the inclusion of educational materials helps parents understand and address shyness and anxiety effectively, potentially leading to more sustainable outcomes.
What evidence suggests that this trial's treatments could be effective for childhood anxiety?
Research shows that the "Being Brave" program, which employs Cognitive Behavioral Therapy (CBT), aims to assist young children at risk of developing anxiety disorders. Participants in this trial may receive up to 12 sessions of Parent-Child CBT using an adaptation of the Being Brave protocol. Studies have found that similar CBT programs for children, such as the "Journey of the Brave," effectively reduce anxiety symptoms. The "Being Brave" program targets children aged 4 to 7 and has successfully addressed anxiety-related issues. Early results suggest the program helps children manage anxiety and adjust better in daily life. Although data for 2- and 3-year-olds is limited, the program adapts these proven CBT strategies for younger children.12367
Who Is on the Research Team?
Dina Hirshfeld-Becker, PhD
Principal Investigator
Massachusetts General Hospital
Are You a Good Fit for This Trial?
This trial is for 2 to 3-year-old children who show high levels of fear or shyness, or have anxiety. Both the child and parents must understand and speak English. It's not suitable for kids with autism, global developmental delays, severe depression, disruptive behavior that could hinder participation in therapy sessions.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive up to 12 sessions of Parent-Child CBT using an adaptation of the Being Brave protocol
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Being Brave
- Parent Education
Trial Overview
The study tests a Cognitive Behavioral Therapy (CBT) program called 'Being Brave' along with parent education to reduce childhood anxiety. Initially office-based, it now operates remotely due to COVID-19. Success will be measured by reduced anxiety at one year after treatment.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Active Control
Up to 12 sessions of Parent-Child CBT using an adaptation of the Being Brave protocol
Parents receive educational materials about how to help young children overcome shyness and anxiety
Being Brave is already approved in United States for the following indications:
- Generalized Anxiety Disorder
- Social Phobia
- Separation Anxiety Disorder
Find a Clinic Near You
Who Is Running the Clinical Trial?
Massachusetts General Hospital
Lead Sponsor
Citations
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
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.
Feasibility study of the e-learning version of the “Journey ...
We developed an e-learning version of a school-based anxiety-prevention CBT program, “Journey of the Brave,” which was effective in Japan, to make it more ...
Being Brave + Parent Education for Childhood Anxiety ...
The "Being Brave" program, which uses CBT, targets children aged 4–7 who might develop anxiety disorders. Although specific safety data for the "Being Brave" ...
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.
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.
BRAVE-ONLINE elicits a strong reduction in anxiety for ...
Most young people responded well to iCBT: most completed the program, and showed a strong and significant reduction in anxiety symptoms.
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