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Behavioral Intervention
Being Brave + Parent Education for Childhood Anxiety Disorder
N/A
Recruiting
Led By Dina Hirshfeld-Becker, PhD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 1-year follow up
Awards & highlights
Summary
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.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this intervention involves behavioral therapy and education without medication, typical medical side effects are not expected. However, discussing sensitive topics may cause temporary distress or emotional discomfort.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 1-year follow up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 1-year follow up
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Response Rate (proportion of participants rated as 1 or 2 on Clinical Global Impression of Anxiety-Improvement Measure (CGI-I)
Secondary study objectives
Mean Change in Anxiety Score on the Preschool Anxiety Scale (PAS) (for those enrolled as 3-year-olds)
Mean Change in Fear/Shyness Scores on the Early Childhood Behavior Questionnaire (ECBQ) (for those enrolled as 2-year-olds)
Mean Change in number of anxiety disorders
+3 moreTrial Design
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
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Cognitive Behavioral Therapy (CBT) is a widely used treatment for Childhood Anxiety Disorder that works by helping children identify and challenge dysfunctional thoughts, behaviors, and emotions. The therapy involves teaching coping skills, problem-solving techniques, and relaxation strategies to manage anxiety.
Parent-Child CBT, specifically, includes parents in the therapeutic process to reinforce these skills at home and improve the child's support system. This approach is crucial for young patients as it not only addresses the immediate symptoms of anxiety but also equips them with long-term strategies to handle stress and anxiety, thereby reducing the likelihood of future anxiety disorders.
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
2,999 Previous Clinical Trials
13,231,410 Total Patients Enrolled
Dina Hirshfeld-Becker, PhDPrincipal InvestigatorMassachusetts General Hospital
1 Previous Clinical Trials
65 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- Your child has autism spectrum disorder (ASD) or significant developmental delays.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 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.
Research Study Groups:
This trial has the following groups:- Group 1: Active Treatment
- Group 2: Parent Education
- Group 3: Monitoring
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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