Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
 
ClinicalTrials.gov Identifier: NCT03528109
Recruitment Status : Recruiting
First Posted : May 17, 2018
Last Update Posted : September 25, 2019
Sponsor:
Collaborators:
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 Anxiety OCD Phobia Agoraphobia Generalized Anxiety Generalized Anxiety Disorder Selective Mutism Separation Anxiety Social Anxiety Social Anxiety Disorder Panic Disorder 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.

Layout table for study information
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: In-treatment and follow-up (6-12 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: In-treatment and follow-up (6-12 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: In-treatment and follow-up (6-12 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. Clinical Global Impression Scales [ Time Frame: In-treatment and follow-up (6-12 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.

  3. Child Sheehan Disability Scale [ Time Frame: In-treatment and follow-up (6-12 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.

  4. Homework Compliance Form [ Time Frame: Up to 6 months ]
    The measure tracks both the quality and quantity of homework completed between treatment sessions. This form has been used previously by our research group in large-scale treatment trials, and has been helpful in determining barriers to homework completion.

  5. Exposure Guide [ Time Frame: Up to 6 months ]
    The Exposure Guide is a exposure therapy fidelity/quality tool completed by study therapists. This tool collects information regarding the use of specific therapeutic tools during exposures.

  6. Therapeutic Alliance Scales for Caregivers and Parents (TASCP) [ Time Frame: Up to 6 months ]
    The TASCP is a 12-item measure of therapeutic alliance between a caregiver and his/her child's therapist. This measure assesses the bond and collaboration between caregiver and therapist. Each item is rated using a scale from 0: "not true" to 4: "very much true."

  7. Therapeutic Alliance Scales for Children-Revised (TASC-r) [ Time Frame: Up to 6 months ]
    75 The TASC-r is a 12-item measure of therapeutic alliance between a child and his/her therapist. This measure assesses the degree of affective bond between child and therapist, as well as amount of therapeutic task collaboration. Each item is rated using a scale from 0: "not true" to 4: "very much true."

  8. Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) [ Time Frame: In-treatment and follow-up (6-12 months) ]
    The PQ-LES-Q is a 13-item measure of child functioning in life that uses a 5-point ratings scale, with higher scores indicating better quality of life. This measure has both parent and child versions, assessing the same items from both child and parent perspectives. The measure assesses quality of the child's life in a variety of domains.

  9. Top Problems Assessment (TPA) [ Time Frame: In-treatment and follow-up (6-12 months) ]
    The TPA is designed to independently solicit from youth and parent the top 3 problems they feel are most important to address in treatment. This is an idiographic measure of impairment that is driven by the individual needs and desires of the consumer. Respondents rate how much each problem bothers them from 0 ("not at all") to 10 (very, very much).

  10. Caregiver Strain Questionnaire (CSQ) [ Time Frame: In-treatment and follow-up (6-12 months) ]
    The CSQ assesses parent perceptions of the extent to which caring for a child with emotional problems affects several domains, including family life and relationships, demands on time, financial strain, disruption of social life, worry, guilt, and fatigue. This is a 21-item self-report measure that calls for parents to rate the extent of strain for each item using a 0 ("not at all") to 4 ("very much") scale.

  11. Barriers to Treatment Questionnaire - Parent Version (BTQ-P) [ Time Frame: In-treatment and follow-up (6-12 months) ]
    The BTQ-P is a 28-item measure adapted from the BTQ to assess parent perceptions of barriers to accessing treatment for their child's anxiety. The measure is completed at the outset of treatment and assesses such domains as logistic and financial barriers, stigma, and aspects of treatment. Items are rated on a 0 ("not at all true") to 2 ("mostly true") scale.

  12. Pediatric Accommodation Scale-Parent Report (PAS-PR) [ Time Frame: In-treatment and follow-up (6-12 months) ]
    The PAS-PR is a 5-item questionnaire assessing the frequency and interference associated with accommodating the child's anxiety. Each item is followed by a series of common examples to illustrate the principle of accommodation for parents. Responses for frequency include 0 (never), 1 (rarely), 2 (occasionally), 3 (often), and 4 (always). Response options for interference due to accommodation include 0 (none), 1 (mild), 2 (moderate), 3 (severe), and 4 (extreme).

  13. Randomization Debrief [ Time Frame: Administered at baseline ]
    We will record reactions from caregivers and child to treatment assignment using this clinician-rated measure. It includes capturing both verbatim responses from caregivers and child, as well as asking for interviewer impressions reactions from caregivers and child to treatment group assignment following randomization. The clinician also records the likelihood that the family will remain in the study and adhere to study protocols.

  14. Treatment Expectancy [ Time Frame: Administered at baseline ]
    This measure is a 3-item self-report questionnaire that captures parental beliefs about the efficacy about each treatment condition (office-based or home/community-based) using a scale from 1:"I expect my child will be very much improved," to 7: "I expect my child will be very much worse." The parent is also asked to select which treatment option would be best for their family. There is also a patient version of this measure used to capture patient beliefs about the efficacy about each treatment condition (office-based or home/community-based) using the same scale. The patient is asked to select which treatment option they believe would be best for them and their family. The patient version of this measure will be completed by youth 12+.

  15. The Social Responsiveness Scale, Second Edition (SRS-2) [ Time Frame: Administered at baseline and at discharge (up to 6-months) ]
    The SRS-2 is a 65-item self-report measure administered to caregivers or teachers to assess their perception of the presence of a child's social impairment. This measure is used to evaluate children aged 4-18 years old. Items are rated on a scale from 1 ("not true") to 4 ("almost always true").

  16. Affective Reactivity Index - Parent Version (ARI-P) [ Time Frame: In-treatment and follow-up (6-12 months) ]
    The ARI-P is a 7-item parent report questionnaire assessing child's irritability. The items are each given a rating of: "not true," "somewhat true" or "certainly true".

  17. Affective Reactivity Index - Self Report (ARI-S) [ Time Frame: In-treatment and follow-up (6-12 months) ]
    The ARI-S is a 7-item self-report report questionnaire assessing irritability. The items are each given a rating of: "not true," "somewhat true" or "certainly true".

  18. Distress Intolerance Index [ Time Frame: In-treatment and follow-up (6-12 months) ]
    The Distress Intolerance Index is a 10-item self-report report questionnaire assessing the inability to tolerate negative somatic and emotional states. Items are rated on a 5-point scale from "very little" (0) to "very much".

  19. Parent Accommodation Scale (PAS) [ Time Frame: In-treatment and follow-up (6-12 months) ]
    The PAS is a 12-item questionnaire assessing the frequency of and beliefs about parental accommodation. The frequency of parental accommodation is measured on a scale from "Never/Almost Never" (0), to "Always/Almost Always" (3). The beliefs about parental accommodation are measured on a scale from "Strongly Disagree" (0), to "Strongly Agree" (3).

  20. Feedback Forms - Caregiver and Child Versions [ Time Frame: Administered only at discharge, up to 6-months into study ]
    The feedback form is a 3-item self-report questionnaire that asks caregivers or child which treatment group their family was in and for open-ended feedback about their experience in the study (i.e. what did they really like, what would they change, general suggestions/ comments). All responses on this survey are received anonymously. Caregivers and children complete separate feedback forms. Children 8+ will complete the child version of this measure.

  21. End of Treatment Form [ Time Frame: Administered only at discharge, up to 6-months into study ]
    This form captures whether the patient ended treatment before or at 6 months, as well as the reasons for discontinuation (e.g., scheduling, transportation, financial, treatment fit, symptoms) that apply. This form also gathers information about whether referrals were provided to the family upon study discharge.

  22. Sharing Study Findings [ Time Frame: Administered only at discharge, up to 6-months into study ]
    This 7-item measure asks for participants' caregivers to discuss to whom they would like the findings of the study to be disseminated (i.e., local policy makers, educators, etc.). Additionally, it asks for information on how they would like findings to be shared (i.e., via social media, presentations, etc.) as well as caregivers to share highlights of their experience in the study.

  23. Treatment Attendance [ Time Frame: Up to 6 months ]
    We will record the rate of session reschedules, cancellations and no-shows, along with the overall number of sessions attended. We will also document the reason why a scheduled appointment does not occur using the Treatment Cancellation Form.

  24. Reasons for Treatment Discontinuation form [ Time Frame: Administered only at discharge, up to 6-months into study ]
    This is a case record form that documents any change in patient status (e.g., drop-out and premature termination) and the reasons for such changes.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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 ClinicalTrials.gov identifier (NCT number): NCT03528109


Contacts
Layout table for location contacts
Contact: Jennifer Freeman, PhD 4014321057 jfreeman@lifespan.org
Contact: Elena Schiavone, BA 401-432-1635 eschiavone@lifespan.org

Locations
Layout table for location information
United States, Rhode Island
Bradley Hospital Recruiting
Riverside, Rhode Island, United States, 02915
Contact: Jennifer Freeman, PhD    401-432-1057    jfreeman@lifespan.org   
Contact: Elena Schiavone, BA    401-432-1635    eschiavone@lifespan.org   
Sponsors and Collaborators
Bradley Hospital
Brown University
Patient-Centered Outcomes Research Institute
Investigators
Layout table for investigator information
Principal Investigator: Jennifer Freeman, PhD Warren Alpert Medical School of Brown University

Layout table for additonal information
Responsible Party: Bradley Hospital
ClinicalTrials.gov Identifier: NCT03528109     History of Changes
Other Study ID Numbers: IHS-2017C1-6400
First Posted: May 17, 2018    Key Record Dates
Last Update Posted: September 25, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Mutism
Disease
Anxiety Disorders
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Panic Disorder
Phobia, Social
Agoraphobia
Anxiety, Separation
Pathologic Processes
Mental Disorders
Personality Disorders
Phobic Disorders
Neurodevelopmental Disorders
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms