Being Brave + Parent Education for Childhood Anxiety Disorder

Recruiting in Palo Alto (17 mi)

Overseen byDina Hirshfeld-Becker, PhD

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Massachusetts General Hospital

No Placebo Group

Approved in 2 Jurisdictions

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.

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.

Participant Groups

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.

3Treatment groups

Experimental Treatment

Active Control

Group I: Active TreatmentExperimental Treatment1 Intervention

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

Group II: Parent EducationActive Control1 Intervention

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

Group III: MonitoringActive Control1 Intervention

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

🇺🇸 Approved in United States as Being Brave for: