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Behavioral Intervention

Exposure Therapy for Child Anxiety (IMPACT Trial)

N/A
Recruiting
Led By Jennifer Freeman, PhD
Research Sponsored by Bradley Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
primary or co-primary DSM-V diagnosis of anxiety or OCD
age 5-18 inclusive
Timeline
Screening 3 weeks
Treatment Varies
Follow Up in-treatment and follow-up (6-12 months)
Awards & highlights

IMPACT Trial Summary

This trial will compare the effectiveness of three different types of treatment for anxiety disorders in children and adolescents. The three types of treatment are cognitive behavioral therapy with exposure (CBT), patient-centered telehealth CBT (PCT-CBT; patient-centered telehealth closed as of 5/1/21), and traditional outpatient CBT. The trial will involve 379 participants who will be randomly assigned to one of the three treatment groups. The primary outcome measures will be the changes in the participants' anxiety symptoms, functioning, and quality of life from baseline to follow-up.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this trial involves psychological therapy rather than medication, typical medical side effects are not expected. However, participants may experience temporary increases in anxiety during exposure therapy as they face their fears.

IMPACT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with anxiety or OCD as my main health issue.
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I am between the ages of 5 and 18.
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My symptoms have lasted for at least 3 months.
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I have been diagnosed with anxiety or OCD.
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My symptoms have lasted for at least 3 months.
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I am between the ages of 5 and 18.

IMPACT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~in-treatment and follow-up (6-12 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and in-treatment and follow-up (6-12 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Children's Yale-Brown Obsessive-Compulsive Scale
Pediatric Anxiety Rating Scale
Secondary outcome measures
Affective Reactivity Index - Parent Version (ARI-P)
Affective Reactivity Index - Self Report (ARI-S)
Barriers to Treatment Questionnaire - Parent Version (BTQ-P)
+21 more

IMPACT Trial Design

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)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Exposure Therapy
2016
N/A
~170

Find a Location

Who is running the clinical trial?

Patient-Centered Outcomes Research InstituteOTHER
551 Previous Clinical Trials
29,997,069 Total Patients Enrolled
Bradley HospitalLead Sponsor
16 Previous Clinical Trials
1,115 Total Patients Enrolled
3 Trials studying Obsessive-Compulsive Disorder
244 Patients Enrolled for Obsessive-Compulsive Disorder
Brown UniversityOTHER
456 Previous Clinical Trials
557,975 Total Patients Enrolled
8 Trials studying Obsessive-Compulsive Disorder
90 Patients Enrolled for Obsessive-Compulsive Disorder

Media Library

Exposure Therapy (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT03528109 — N/A
Obsessive-Compulsive Disorder Research Study Groups: patient-centered home CBT, Provider-centered, patient-centered telehealth CBT
Obsessive-Compulsive Disorder Clinical Trial 2023: Exposure Therapy Highlights & Side Effects. Trial Name: NCT03528109 — N/A
Exposure Therapy (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03528109 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the chief goals of this medical investigation?

"The primary purpose of this clinical trial, which is monitored over a period ranging from 6-12 months, is to assess Pediatric Anxiety Rating Scale. Secondary objectives include the Client Satisfaction Questionnaire-8 (CSQ-8), Homework Compliance Form and Exposure Guide - three measures employed by researchers to gauge consumer satisfaction with mental health services, track homework completion between therapy sessions, and measure therapeutic fidelity/quality respectively."

Answered by AI

Are there any qualifications for me to be accepted into the clinical trial?

"This scientific investigation is seeking 379 candidates aged between 5 and 18 with selective mutism. To be admitted, they must have been experiencing symptoms for at least 3 months; require outpatient care; possess a primary or secondary DSM-V diagnosis of anxiety disorder or OCD; and have an adult guardian who is willing to take part in the treatment process."

Answered by AI

How many participants are being enlisted in this clinical experiment?

"Indeed, details on clinicaltrials.gov demonstrate that this experiment is presently recruiting participants. It was first publicized online on July 1st 2018 and most recently updated on August 2nd 2022; it seeks to enroll 379 individuals from a single centre."

Answered by AI

Are those under the age of fifty-five admissible to participate in this experiment?

"This medical experiment seeks to enrol patients between the ages of 5 and 18."

Answered by AI

Is enrollment open for this research experiment?

"Based on the details found on clinicaltrials.gov, this trial is actively looking for volunteers to participate in it. Initially posted on July 1st 2018 and last modified August 2nd 2022, the medical research could benefit from more participants."

Answered by AI

Who else is applying?

What state do they live in?
Nebraska
Texas
Maryland
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
3+
Recent research and studies
clinicaltrials.govStudy
Improving Access to Child Anxiety Treatment
2018. "Improving Access to Child Anxiety Treatment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03528109.
All > Anxiety Disorder > Social Anxiety
~16 spots leftby Jul 2024
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