Exposure Therapy for Child Anxiety
(IMPACT Trial)
Trial Summary
Do I have to stop taking my current medications for the trial?
The trial does not specify if you must stop taking your current medications. However, if you are on psychotropic medication, it must be stable to participate.
What data supports the idea that Exposure Therapy for Child Anxiety is an effective treatment?
The available research shows that Exposure Therapy, especially when combined with parent coaching, leads to significant improvements in children with anxiety disorders. One study found that children who received parent-coached exposure therapy showed greater improvement compared to those who received traditional cognitive behavioral therapy. This improvement was maintained even after three months, suggesting that Exposure Therapy can be more effective and require fewer sessions. Additionally, another study highlighted that community therapists who used exposure-focused treatment protocols increased their use of evidence-based treatment, although the quality of exposure needs to be improved for better outcomes. Compared to psychoanalytic therapy, which showed moderate improvements, Exposure Therapy appears to offer more immediate and significant benefits for treating child anxiety.12345
What safety data exists for exposure therapy for child anxiety?
The provided research primarily focuses on prolonged exposure therapy (PE) for PTSD in adults, particularly in military personnel and female assault victims. While these studies highlight PE as an effective treatment, they also mention concerns about potential symptom worsening, which may deter clinicians from using it. However, specific safety data for exposure therapy in child anxiety is not directly addressed in these studies.678910
Is Exposure Therapy a promising treatment for child anxiety?
What is the purpose of this trial?
There is strong evidence that cognitive behavioral therapy (CBT) with exposure is the preferred treatment for youth with anxiety disorders, but outpatient services that provide this type of treatment are limited. Even for those who do have access to anxiety-specific treatment, a traditional outpatient model of treatment delivery may not be suitable. Among the numerous logistical barriers to treatment access and response is the inability to generalize treatment tools to settings outside of the office. Patient-centered (home-based or telehealth; patient-centered telehealth closed as of 5/1/21) treatment models that target symptoms in the context in which they occur could be more effective, efficient, and accessible for families. The present study aims to compare the efficacy, efficiency, and feasibility of patient centered home-based CBT and patient centered telehealth CBT with a traditional office-based model of care. The question proposed, including proposed outcomes, have been generated and developed by a group of hospital, payer, patient and family stakeholders who will also contribute to the iterative process of protocol revision. The investigators anticipate 379 anxious youth to be randomized to receive outpatient treatment using telehealth (patient-centered telehealth closed as of 5/1/21), home-based services, or treatment as usual using a traditional outpatient model. Results of this study are expected to provide evidence for the efficacy and efficiency of patient-centered treatment, as well as increase treatment access and family engagement in the treatment process.
Research Team
Jennifer Freeman, PhD
Principal Investigator
Warren Alpert Medical School of Brown University
Eligibility Criteria
This trial is for children and teens aged 5-18 with anxiety or OCD, who need outpatient care. They must have had symptoms for at least 3 months and a stable parent or guardian to participate in treatment. It's not for those with certain psychiatric disorders, unstable medication use, acute suicidality, or other concurrent psychotherapy.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive cognitive behavioral therapy (CBT) for anxiety and OCD through different delivery models: patient-centered home-based, patient-centered telehealth, and provider-centered office-based.
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Exposure Therapy
Exposure Therapy is already approved in United States for the following indications:
- Posttraumatic Stress Disorder (PTSD)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Bradley Hospital
Lead Sponsor
Patient-Centered Outcomes Research Institute
Collaborator
Brown University
Collaborator