search
Back to results

Quality Assessment in Exposure Therapy

Primary Purpose

Obsessive-Compulsive Disorder in Children

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exposure Therapy
Sponsored by
Bradley Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obsessive-Compulsive Disorder in Children

Eligibility Criteria

5 Years - 25 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient at a Community Mental Health Agency that is partnering with this study
  • Primary or co-primary diagnosis of OCD, Separation Anxiety, Social Anxiety, Panic Disorder, or Specific Phobia.
  • Children < age 12 have a caretaker available to participate in treatment
  • Patient and parent/legal guardian are English speaking

Exclusion Criteria:

  • Concurrent psychotherapy for treatment of anxiety
  • Psychosis, Pervasive Developmental Disorder, or Mental Retardation

Sites / Locations

  • Emma Pendleton Bradley Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Exposure Therapy with fidelity checklist

Arm Description

Therapist and parent/child participants will complete an Exposure Guide after each session.

Outcomes

Primary Outcome Measures

Clinical Global Impression Scales
The Clinical Global Impression Scales (CGI) are brief, clinician-rated measures of global severity and improvement in treatment for children and adults.

Secondary Outcome Measures

Full Information

First Posted
June 1, 2017
Last Updated
July 7, 2022
Sponsor
Bradley Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT03182101
Brief Title
Quality Assessment in Exposure Therapy
Official Title
Quality Assessment in Exposure Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 13, 2017 (Actual)
Primary Completion Date
May 1, 2022 (Actual)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bradley Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This project will test a measure of treatment quality, Exposure Guide, for therapists using exposure therapy for youths and young adults with anxiety or OCD. We anticipate that users of this measure will be able to complete it reliably, find it acceptable, and that the measure will predict patient outcome. This project will include 40 therapists treating 300 anxious youth and young adults ages 5-25 at a large community mental health agency. Results of this study will establish the Exposure Guide as a measure of exposure quality in real world settings.
Detailed Description
Empirically supported behavioral treatments cannot be effectively disseminated without understanding key quality components. Mechanism-informed quality measures have extraordinary potential to enhance pragmatism by eliminating unnecessary elements and targeting multiple problems and populations, and to enhance predictive value by detecting mechanism engagement early in treatment. Community Mental Health Agencies (CMHAs), however, are often ill-equipped to use such measures of treatment quality due to burden and limited resources. Exposure therapy for anxiety is an ideal prototype for testing a practical, mechanism-informed quality measure in CMHAs given its potential for public health impact and clear theory of mechanism. The Exposure Guide (EG), a brief quality tool measuring therapist behaviors and mechanism, was developed based on microanalytic coded data showing a strong link between therapist behavior and patient outcome across three RCTs of exposure therapy in youth. Initial psychometrics for the EG using these RCT data are promising showing reliability, construct validity, and predictive validity, and pilot data suggests it may be acceptable and feasible in a community setting. Building upon these findings, we propose to test this novel measure of exposure quality, EG, in a community setting including its reliability and validity, its pragmatism, and which community end-users can become reliable and valid reporters. Therapists at a large local CMHA (N = 40) treating anxious youth and young adults ages 5-25 (N = 300) will participate in this study. The EG will be completed by 1) agency supervisors monthly, 2) therapists per session, 3) patient/families per session, and 4) study raters per session. Results from this study will establish an innovative model for measuring therapeutic elements that trigger mechanism of change in real-world therapy as well as inform future use of EG as a training tool to improve exposure quality in community settings.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive-Compulsive Disorder in Children

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
177 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exposure Therapy with fidelity checklist
Arm Type
Experimental
Arm Description
Therapist and parent/child participants will complete an Exposure Guide after each session.
Intervention Type
Behavioral
Intervention Name(s)
Exposure Therapy
Intervention Description
Exposure Therapy is a form of Cognitive Behavioral Therapy. There is strong evidence for exposure as a necessary and primary ingredient for treating anxiety and OCD, and exposure is the most common practice element in treatment protocols for anxiety.
Primary Outcome Measure Information:
Title
Clinical Global Impression Scales
Description
The Clinical Global Impression Scales (CGI) are brief, clinician-rated measures of global severity and improvement in treatment for children and adults.
Time Frame
Through study completion, an average of 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient at a Community Mental Health Agency that is partnering with this study Primary or co-primary diagnosis of OCD, Separation Anxiety, Social Anxiety, Panic Disorder, or Specific Phobia. Children < age 12 have a caretaker available to participate in treatment Patient and parent/legal guardian are English speaking Exclusion Criteria: Concurrent psychotherapy for treatment of anxiety Psychosis, Pervasive Developmental Disorder, or Mental Retardation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristen Benito, PhD
Organizational Affiliation
The Warren Alpert Medical School of Brown University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emma Pendleton Bradley Hospital
City
Riverside
State/Province
Rhode Island
ZIP/Postal Code
02915
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Twice yearly data sharing through NDCT
IPD Sharing Time Frame
Secondary outcome data will be uploaded biannually beginning in January of 2018. Primary outcomes will be made available within 6 months of study completion.

Learn more about this trial

Quality Assessment in Exposure Therapy

We'll reach out to this number within 24 hrs