Being Brave + Parent Education for Childhood Anxiety Disorder

Overseen By Alayna D'Amico, BA

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Autism, Severe disruptive behavior, 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: 12

Duration: 12 weeks

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. ^{1 2 3 4 5}

Why 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. ^{1 2 3 6 7}

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

Children who are very fearful or shy, or have high levels of anxiety as reported by their parent on a questionnaire, may not be eligible to participate.

The parents are able to speak, understand, and read English

The child must have a working knowledge of English.

Exclusion Criteria

Your child has autism spectrum disorder (ASD) or significant developmental delays.

The child’s difficult behavior is so severe that it prevents them from fully participating in the study sessions.

My child has a condition that makes CBT for anxiety not suitable.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive up to 12 sessions of Parent-Child CBT using an adaptation of the Being Brave protocol

12 weeks

12 sessions (remote)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

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?

Group I: Active Treatment Experimental Treatment 1 Intervention

Up to 12 sessions of Parent-Child CBT using an adaptation of the Being Brave protocol

Group II: Parent Education Active Control 1 Intervention

Parents receive educational materials about how to help young children overcome shyness and anxiety

Group III: Monitoring Active Control 1 Intervention

Being Brave is already approved in United States for the following indications:

Approved in United States as Being Brave for:

• Generalized Anxiety Disorder
• Social Phobia
• Separation Anxiety Disorder

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Citations

1. 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

2. 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.

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

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 ...

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

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" ...

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.

6. 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.

7. acamh.org acamh.org/research-digest/brave-online-strong-reduction-in-anxiety-for-young-people/

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.