What side effects are associated with this type of intervention?

Cognitive Behavioral Therapy (CBT) is a common treatment for childhood anxiety disorders and is generally well-tolerated with minimal side effects. It focuses on modifying dysfunctional emotions, behaviors, and thoughts through structured sessions. Pharmacotherapy, often used in conjunction with CBT, typically involves Selective Serotonin Reuptake Inhibitors (SSRIs) like fluoxetine or sertraline. Common side effects of SSRIs include gastrointestinal issues, sleep disturbances, and increased anxiety or agitation initially. Both treatments aim to reduce anxiety symptoms effectively, with CBT being preferred due to its lower risk profile.

What prior FDA approvals exist?

The FDA has approved several selective serotonin reuptake inhibitors (SSRIs) for the treatment of childhood anxiety disorders, including fluoxetine, sertraline, and fluvoxamine. These medications are often used in conjunction with Cognitive Behavioral Therapy (CBT), which focuses on modifying dysfunctional emotions, behaviors, and thoughts. CBT is considered a first-line treatment for childhood anxiety disorders, and SSRIs are typically used when CBT alone is insufficient or not accessible. The combination of pharmacotherapy and CBT has been shown to be effective in managing symptoms of anxiety in children.

What other types of research exist?

Promising novel alternatives to Parent-Child Cognitive Behavioral Therapy for childhood anxiety disorders include: 1) Online Cognitive Behavioral Therapy (CBT), which has shown efficacy in reducing anxiety symptoms through remote sessions, making it accessible and convenient. 2) Integrative Medicine approaches that combine conventional and complementary therapies, such as mindfulness and relaxation techniques, which have supportive evidence for reducing anxiety. 3) Pharmacotherapy options like selective serotonin reuptake inhibitors (SSRIs) for severe cases, which can be combined with psychotherapy for enhanced outcomes. 4) Hypnotherapy, particularly gut-directed hypnotherapy, which has shown promise in managing anxiety-related symptoms in children.

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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

No Placebo-Only Group

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 1-year follow up for reporting.

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 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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

Do I qualify?Apply below to find out

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.