Cognitive Behavioral Therapy for Pediatric Anxiety
(IMPACT-RI Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine how Cognitive Behavioral Therapy (CBT) can become more accessible and effective for children with anxiety or OCD (Obsessive-Compulsive Disorder). Children will participate in weekly CBT sessions with an exposure coach and receive a monthly visit from a licensed provider, using one of three methods: in-person, telehealth, or a flexible mix of both. The goal is to identify which method works best for different children. Children aged 5 to 18 who have struggled with anxiety or OCD for at least three months and require outpatient care may be suitable candidates for this trial. As an unphased trial, this study offers a unique opportunity for children to access potentially more effective therapy methods tailored to their needs.
Do I need to stop my current medications to join the trial?
The trial requires that any psychotropic medication (medications affecting the mind, emotions, and behavior) you are taking must be stable, meaning there should be no recent changes in dosage or type. If your medication is not stable, you may not be eligible to participate.
What prior data suggests that these methods of delivering CBT are safe for children with anxiety?
Research has shown that Cognitive Behavioral Therapy (CBT) is a safe treatment for children with anxiety and obsessive-compulsive disorder (OCD). Studies have found that both in-person and online therapy sessions are well-received by young patients. For instance, one study found that team-based online CBT was effective and did not cause any major side effects. Another study showed that in-office CBT for children's anxiety was also safe, with no significant negative events reported.
Research suggests that a flexible approach combining in-person and online sessions is equally safe. This method has been successfully used with young people, offering options that suit their needs without causing harm.
CBT helps children learn coping skills and involves facing their fears in a controlled way. Although this might sound intense, it is done gradually and with support, making it a safe choice for children dealing with anxiety.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it explores flexible delivery options for Cognitive Behavioral Therapy (CBT) in treating pediatric anxiety, which is traditionally managed with in-person sessions or medication. This trial is testing how allowing families to choose between in-person and telehealth sessions on a case-by-case basis might offer more personalized and accessible care. By examining these different delivery methods, the trial aims to find out how flexibility could improve engagement and outcomes for children with anxiety. This approach could make therapy more adaptable to the needs of families, potentially increasing its effectiveness and accessibility.
What evidence suggests that this trial's treatments could be effective for pediatric anxiety?
Research has shown that exposure-based Cognitive Behavioral Therapy (CBT) effectively treats anxiety and obsessive-compulsive disorder (OCD) in children. One study found that this therapy improved symptoms by 47.1%, aiding children in better managing their anxiety. In this trial, participants will receive team-delivered, exposure-based CBT through different treatment arms. One arm allows families to choose between in-person and telehealth sessions on a session-by-session basis. Another arm provides sessions exclusively in-person, while a third arm delivers sessions solely via telehealth. Strong evidence supports CBT's benefits in reducing anxiety in young people, with a key part of its success being its ability to help children gradually face their fears.45678
Are You a Good Fit for This Trial?
This trial is for children aged 5-18 with a primary or co-primary diagnosis of anxiety or OCD, who have had symptoms for at least 3 months and need outpatient care. They must have a stable parent or guardian to participate in treatment.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive weekly CBT treatment sessions involving a combination of weekly visits with an exposure coach and one visit a month with a licensed provider. Treatment is delivered using in-person, telehealth, or flexible methods.
Follow-up
Participants are monitored for safety and effectiveness after treatment, with assessments at 3 and 6 months following the end of treatment.
What Are the Treatments Tested in This Trial?
Interventions
- Team-delivered, exposure-based CBT
Trial Overview
The study tests Cognitive Behavioral Therapy (CBT) delivery methods for pediatric anxiety and OCD: in-person, telehealth, and flexible (a mix). It involves weekly sessions with an exposure coach and monthly visits with a licensed provider.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Families will only attend sessions via a secure remote video platform.
Families will only attend sessions in-person. Sessions may occur at the family's home, in the community, or in the provider's office.
Families and providers will collaboratively choose treatment delivery modality (in-person versus telehealth) on a session-by-session basis.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Bradley Hospital
Lead Sponsor
Patient-Centered Outcomes Research Institute
Collaborator
Citations
Practice-based research examining effectiveness of ...
We examined the naturalistic effectiveness of exposure-based cognitive behavioral therapy (Ex-CBT) for pediatric anxiety and obsessive- ...
Exposure-Focused Cognitive-Behavioral Therapy for Youth ...
Results. EF-CBT was associated with 3.53 higher odds of treatment response based on Clinical Global Impressions–Improvement scale (EF-CBT 47.1% ...
3.
clinicaltrials.gov
clinicaltrials.gov/study/NCT06934525?term=Mental+Disability&aggFilters=status%3ArecImplementing Team-Based Treatment for Pediatric Anxiety ...
The purpose of this study is to test how the delivery of Cognitive Behavioral Therapy (CBT) for pediatric anxiety and OCD via different methods might ...
Technology‐delivered cognitive‐behavioral therapy for ...
Conclusions. tCBT has a moderate effect on remission for pediatric ADs and clinician-rated functioning, a small effect on caregiver-reported ...
Comparing Three Modalities For Delivering Exposure ...
Exposure-based CBT is an evidence-based treatment for anxiety disorders. In this study it is delivered weekly using a team-based model including ...
Using Team-Based Behavioral Therapy by Telehealth to Treat ...
A growing body of research indicates that telehealth-delivered cognitive behavior therapy (CBT) is effective for youth with anxiety and obsessive-compulsive ...
A Team-Based Partner-Driven Model for Delivering ...
This study aims to compare team-based community delivered cognitive behavioral treatment (CBT) and office-based CBT for pediatric anxiety and obsessive ...
Open Trial of a Telehealth Adaptation of Team-Based Delivery ...
This brief report presents the results of an open trial of a telehealth adaptation of a novel team- based approach to cognitive behavioral ...
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