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

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

90 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests if a parent-child therapy can help reduce anxiety in very young children and keep it low. The therapy involves teaching both the child and parent ways to handle anxiety through structured sessions, now conducted remotely. Parent-only psychological interventions can be effective treatments for child anxiety.

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 data supports the effectiveness of the treatment Being Brave for childhood anxiety disorder?

Research shows that cognitive behavioral therapy (CBT) is effective for treating anxiety in children. Programs like Cool Kids, which are based on CBT and involve both children and their parents, have been successful in reducing anxiety symptoms and improving daily functioning. This suggests that similar CBT-based programs, like Being Brave, could also be effective for childhood anxiety. ^{1 2 3 4 5}

Is the Being Brave program safe for children?

The available research does not provide specific safety data for the Being Brave program, but cognitive behavioral therapy (CBT), which the program is based on, is generally considered safe for children with anxiety-related problems. ^{1 6 7 8 9}

How is the Being Brave treatment different from other treatments for childhood anxiety?

The Being Brave treatment is unique because it combines cognitive behavioral therapy (CBT) techniques with parent education, focusing on both the child and their parents to address anxiety. This dual approach helps parents learn how to support their children effectively, which is not typically emphasized in standard CBT treatments for childhood anxiety. ^{1 6 8 9 10}

Research Team

Dina Hirshfeld-Becker, PhD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 Cool Kids (CK) program, a 10-session cognitive behavioral therapy (CBT) group intervention, effectively reduced anxiety symptoms in 57 Spanish children and adolescents aged 7-17 with anxiety disorders, as evidenced by global registered measures.

Participants who attended more sessions of the CK program experienced greater improvements, indicating that increased engagement in the therapy correlates with better outcomes in reducing anxiety severity and enhancing daily functioning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cool Kids: Cognitive Behavioral Therapy in a Spanish Sample of Children and Adolescents with Anxiety Disorders. Galí, D., Forcadell, E., Primé-Tous, M., et al.[2023]

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]

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]

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]

References

1. 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]

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

Cool Kids: Cognitive Behavioral Therapy in a Spanish Sample of Children and Adolescents with Anxiety Disorders. [2023]

3. 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]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Efficacy of an internet-based CBT program for children with comorbid High Functioning Autism Spectrum Disorder and anxiety: A randomised controlled trial. [2018]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Evaluating Delivery of a CBT-Based Group Intervention for Schoolchildren With Emotional Problems: Examining the Reliability and Applicability of a Video-Based Adherence and Competence Measure. [2021]

6. 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]

7. England pubmed.ncbi.nlm.nih.gov

A Measure of Safety Behaviors for Use with Young People: Subtle Avoidance Measure for Youth. [2022]

8. 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]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Development and initial evaluation of the COnfident Parent INternet Guide program for parents of 3-8 year olds. [2023]

10. 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]