379 Participants Needed

Exposure Therapy for Child Anxiety

(IMPACT Trial)

KS
JF
Overseen ByJennifer Freeman, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

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?

Yes, Exposure Therapy is a promising treatment for child anxiety. It is a well-established method that helps people face their fears in a safe way, which can reduce anxiety over time. This approach has been shown to be effective in treating anxiety and stress-related issues.6781011

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

JF

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

You have a responsible and stable parent or guardian who can be involved in your treatment.
I have been diagnosed with anxiety or OCD as my main health issue.
I need medical care but can go home after.
See 5 more

Exclusion Criteria

I am starting treatment for another major mental health condition.
You have symptoms of severe confusion or seeing or hearing things that aren't real.
You have a conduct disorder.
See 5 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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.

24 weeks
4 visits per month (combination of in-person and telehealth)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Treatment Details

Interventions

  • Exposure Therapy
Trial Overview The study tests how well cognitive behavioral therapy (CBT) with exposure works when done at home or via telehealth compared to the traditional office-based approach. The goal is to see which method helps youth with anxiety more effectively and makes treatment easier to access.
Participant Groups
3Treatment groups
Experimental Treatment
Active Control
Group I: patient-centered telehealth CBTExperimental Treatment1 Intervention
60 minute telehealth exposure therapy with a PhD psychologist once per month and a 90 minute telehealth CBT with a mobile exposure coach three times per month for a total of four visits per month (once per week). Patient-centered telehealth was closed when the recruitment goal was met in May 2021.
Group II: patient-centered home CBTExperimental Treatment1 Intervention
60 minute office-based exposure therapy with a PhD psychologist once per month and a 90 minute community-based CBT with a mobile exposure coach three times per month for a total of four visits per month (once per week)
Group III: Provider-centeredActive Control1 Intervention
60 minute office-based exposure therapy with a PhD psychologist four times per month (once per week)

Exposure Therapy is already approved in United States for the following indications:

🇺🇸
Approved in United States as Prolonged Exposure Therapy for:
  • Posttraumatic Stress Disorder (PTSD)

Find a Clinic Near You

Who Is Running the Clinical Trial?

Bradley Hospital

Lead Sponsor

Trials
22
Recruited
1,900+

Patient-Centered Outcomes Research Institute

Collaborator

Trials
592
Recruited
27,110,000+

Brown University

Collaborator

Trials
480
Recruited
724,000+

Findings from Research

Long-term follow-up (8 to 13 years post-treatment) of 67 participants showed that exposure-based cognitive behavioral therapy (CBT) for phobic and anxiety disorders in children and adolescents resulted in sustained remission of targeted anxiety symptoms into young adulthood.
The study found that both group and individual treatment approaches yielded similar long-term benefits, indicating that the effectiveness of exposure-based CBT extends beyond initial treatment, helping to maintain mental health during critical developmental years.
Cognitive behavioral treatment for childhood anxiety disorders: long-term effects on anxiety and secondary disorders in young adulthood.Saavedra, LM., Silverman, WK., Morgan-Lopez, AA., et al.[2021]
In a preliminary trial with 14 children aged 7 to 14, both cognitive behavioral therapy (CBT) and parent-coached exposure therapy were found to be safe and effective for treating childhood anxiety disorders, with significant improvements observed in both groups.
Parent-coached exposure therapy showed greater effectiveness than traditional CBT, with moderate to large effect sizes for most measures, and it required fewer appointments while maintaining its benefits over a three-month follow-up.
The feasibility of improving CBT for childhood anxiety disorders through a dismantling study.Whiteside, SP., Ale, CM., Young, B., et al.[2018]
A brief training using the Anxiety Coach application helped 17 community therapists become more open to and use exposure therapy techniques with 32 youth aged 8-18, indicating that technology-assisted training can enhance therapists' willingness to adopt evidence-based practices.
Despite the increased use of exposure therapy, the study found no significant improvement in patient symptoms, suggesting that simply increasing the quantity of exposure is not enough; the quality and intensity of the exposure techniques used also need to be addressed.
Using Technology to Promote Therapist Use of Exposure Therapy for Childhood Anxiety Disorders: A Randomized Pilot Study.Whiteside, SPH., Biggs, BK., Ollendick, TH., et al.[2023]

References

Cognitive behavioral treatment for childhood anxiety disorders: long-term effects on anxiety and secondary disorders in young adulthood. [2021]
The feasibility of improving CBT for childhood anxiety disorders through a dismantling study. [2018]
Using Technology to Promote Therapist Use of Exposure Therapy for Childhood Anxiety Disorders: A Randomized Pilot Study. [2023]
[Effectiveness of Psychoanalytic Psychotherapy for Children and Adolescents with Severe Anxiety Psychopathology in a Naturalistic Treatment Setting]. [2019]
The SmartCAT: an m-health platform for ecological momentary intervention in child anxiety treatment. [2022]
Primum non nocere (first do no harm): symptom worsening and improvement in female assault victims after prolonged exposure for PTSD. [2014]
The efficacy of 90-min versus 60-min sessions of prolonged exposure for PTSD: A randomized controlled trial in active-duty military personnel. [2022]
The effects of a prolonged exposure workshop with and without consultation on provider and patient outcomes: a randomized implementation trial. [2022]
Perceptions and experiences of web-prolonged exposure for posttraumatic stress disorder: A mixed-methods study. [2022]
[Prolonged Exposure Therapy for Post-traumatic Stress Disorder]. [2018]
Preliminary Implementation Outcomes of a Free Online Toolkit to Support Exposure Therapy Implementation for Youth. [2023]
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