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Improving Access to Child Anxiety Treatment (IMPACT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03528109
Recruitment Status : Recruiting
First Posted : May 17, 2018
Last Update Posted : May 17, 2019
Brown University
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Bradley Hospital

Brief Summary:
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) 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 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 333 anxious youth to be randomized to receive outpatient treatment using 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.

Condition or disease Intervention/treatment Phase
Obsessive-Compulsive Disorder Anxiety Disorders Pediatric Disorder Cognitive Behavior Therapy Exposure Therapy Behavioral: Exposure Therapy Not Applicable

Detailed Description:
Anxiety disorders are a significant public health problem that cause suffering for youth and their families, derail normal childhood development, and when left untreated persist into adulthood with high societal costs. Cognitive Behavioral Treatment (CBT) including exposure therapy is the treatment of choice, yet multiple barriers limit access to care. Even for families with access to care, traditional provider-centered (office based) treatment presents challenges and can limit effectiveness for many youth and families. Home- and Community-based exposure therapy is efficacious for patients who previously did not improve with provider-centered services, and input from family stakeholders suggests that treatment in these settings is an optimal match for their needs. Patient-centered models involving home visits and provider teams have consistently demonstrated increased treatment accessibility and engagement. However, there has been no comprehensive comparison of exposure delivered by patient-centered teams using home visits versus by provider-centered office visits alone for childhood anxiety. The absence of comparative effectiveness research (CER) data impedes targeted use of patient centered versus traditional outpatient treatment and would better allocate limited resources, provide the best quality care, and help patients and families make educated decisions about their treatment choices. The overall goal of this proposal is to compare two models of service delivery, patient-centered delivery (utilizing novel deployment of personnel) vs. traditional provider-centered delivery, of CBT in youth ages 5-18 receiving exposure therapy for anxiety. A total of 333 children will be treated, with 166 (or 167) children randomly assigned to each of the treatment conditions. A trained independent evaluator (IE) blind to condition will measure patient and family treatment engagement, anxiety symptoms/severity, and functional impairment at baseline, during active treatment at weeks 6, 12, 18, and 24, and 3- and 6-month follow-up after acute treatment. The primary aims are to compare the relative effectiveness of patient-centered vs. provider-centered treatment for: 1) improving family treatment engagement/satisfaction, 2) reducing anxiety symptoms, and 3) reducing associated disability (quality of life and functional impairment). Secondary outcomes are to understand moderators of treatment response including: severity of illness, caregiver burden/family accommodation, and barriers to treatment access and to explore group differences in time course of response, durability of treatment gains, provider volume/capacity and efficiency in patient centered versus provider centered treatment.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 333 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Patient-Centered Versus Provider-Centered Delivery of Cognitive Behavioral Treatment (CBT) for Pediatric Anxiety and Obsessive Compulsive Disorder (OCD)
Actual Study Start Date : July 1, 2018
Estimated Primary Completion Date : April 1, 2023
Estimated Study Completion Date : May 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: patient-centered CBT
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)
Behavioral: Exposure Therapy
A type of Cognitive Behavioral Therapy shown to be effective in the treatment of pediatric OCD and anxiety

Active Comparator: Provider-centered
60 minute office-based exposure therapy with a PhD psychologist four times per month (once per week)
Behavioral: Exposure Therapy
A type of Cognitive Behavioral Therapy shown to be effective in the treatment of pediatric OCD and anxiety

Primary Outcome Measures :
  1. Children's Yale-Brown Obsessive-Compulsive Scale [ Time Frame: 6 months ]
    The CY-BOCS is a measure of obsessive compulsive symptoms and severity. The Obsession Rating Scale measures 5 domains of obsessional severity on a scale from 0 (no impairment) to 4 (extreme impairment.) The Compulsion Rating Scale measures 5 domains of compulsion severity on a scale from 0 (no impairment) to 5 (extreme impairment.) The total range of OCD severity is reported on a scale from 0-40, with a higher score indicating greater severity.

  2. Pediatric Anxiety Rating Scale [ Time Frame: 6 months ]
    The PARS is a measure of anxiety symptoms and severity. The Anxiety Severity Items are 7 questions meant to assess the frequency of anxiety symptoms and associated impairment. Items are measured on a scale from 0 (none) to 5 (extreme).The total range of anxiety severity is reported on a scale from 0-35, with a higher score indicating greater severity.

Secondary Outcome Measures :
  1. Client Satisfaction Questionnaire-8 [ Time Frame: 6 months ]
    The CSQ-8 measures consumer satisfaction with mental health services; satisfaction is measured using 8 items on a scale from 1 (Poor) to 4 (Excellent). Total satisfaction ranges from 8-32, with a high score indicating greater satisfaction.

  2. Working Alliance Inventory - short revised [ Time Frame: 6 months ]
    The WAI is a measure of therapeutic alliance.

  3. Clinical Global Impression Scales [ Time Frame: 6 months ]
    The CGI is a clinician-rated measures of global severity and improvement. The Severity of illness scale reports the severity of current symptoms on a scale from 1 (not at all ill) to 7 (among the most extremely ill patients.) The Global Improvement Scale tracks improvement since treatment initiation on a scale from 1 (very much improved) to 7 (very much worse). The highest possible score on either scale is 7, indicating extreme severity or worse treatment outcome.

  4. Pediatric Quality of Life Inventory [ Time Frame: 6 months ]
    The PEDsQL measures overall child functioning.

  5. Child Sheehan Disability Scale [ Time Frame: 6 months ]
    The CSDS measures the extent to which anxiety symptoms interfere with functioning. The Disability Scale measures the degree to which anxiety impacts school, social, and home life on a scale from 0 (Not at all) to 10 (very, very much.) Total anxiety-related impairment ranges from 0-30, with higher scores indicating greater impairment.

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • age 5-18 inclusive
  • primary or co-primary DSM-V diagnosis of anxiety or OCD
  • symptom duration of at least 3 months
  • outpatient care needed
  • presence of a stable parent, or guardian, who can participate in treatment
  • client and guardian are English speaking

Exclusion Criteria:

  • other primary or co-primary psychiatric disorder which requires initiation of other active current treatment
  • documented mental retardation
  • thought disorder or psychotic symptoms
  • conduct disorder
  • acute suicidality
  • concurrent psychotherapy
  • chronic medical illness that would preclude their active participation in treatment
  • treatment with psychotropic medication that is not stable

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03528109

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Contact: Jennifer Freeman, PhD 4014321057
Contact: Elena Schiavone, BA 401-432-1635

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United States, Rhode Island
Bradley Hospital Recruiting
Riverside, Rhode Island, United States, 02915
Contact: Jennifer Freeman, PhD    401-432-1057   
Contact: Elena Schiavone, BA    401-432-1635   
Sponsors and Collaborators
Bradley Hospital
Brown University
Patient-Centered Outcomes Research Institute
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Principal Investigator: Jennifer Freeman, PhD Warren Alpert Medical School of Brown University

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Responsible Party: Bradley Hospital Identifier: NCT03528109     History of Changes
Other Study ID Numbers: IHS-2017C1-6400
First Posted: May 17, 2018    Key Record Dates
Last Update Posted: May 17, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anxiety Disorders
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Pathologic Processes
Mental Disorders
Personality Disorders