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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
Study Summary
This trial is testing whether a parent-child CBT protocol can help reduce anxiety disorders in young children, with follow-up one year later. The study is being conducted remotely due to the COVID-19 pandemic.
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.Check my eligibility
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.See study design
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Response Rate (proportion of participants rated as 1 or 2 on Clinical Global Impression of Anxiety-Improvement Measure (CGI-I)
Secondary outcome measures
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
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
2,933 Previous Clinical Trials
13,198,391 Total Patients Enrolled
Dina Hirshfeld-Becker, PhDPrincipal InvestigatorMassachusetts General Hospital
1 Previous Clinical Trials
65 Total Patients Enrolled
Media Library
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To whom is eligibility for this trial extended?
"To meet the criteria for admission to this trial, patients should express fear and be in between 21 months to 47 months of age. In total, 90 participants will be accepted."
Answered by AI
Does this clinical trial allow individuals who are under 45 years of age to participate?
"This trial has a set age range, wherein participants must be older than 21 months and younger than 47 months of age."
Answered by AI
What is the population size of this clinical trial?
"Affirmative. As per information hosted on clinicaltrials.gov, this medical experiment was initially published in September 2019 and is actively recruiting participants as of August 2022. 90 patients are expected to be enrolled from 1 site."
Answered by AI
Are there any current enrollment opportunities for this study?
"Affirmative. Clinicaltrials.gov displays evidence that this medical trial, initially posted on September 27 2019, is currently accepting applicants. 90 participants are being sought from one clinic location."
Answered by AI
Who else is applying?
What state do they live in?
Nebraska
Texas
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
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