Anxiety Clinical Trial
— IMPACTOfficial title:
Comparison of Patient-Centered Versus Provider-Centered Delivery of Cognitive Behavioral Treatment (CBT) for Pediatric Anxiety and Obsessive Compulsive Disorder (OCD)
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.
Status | Recruiting |
Enrollment | 379 |
Est. completion date | February 1, 2025 |
Est. primary completion date | July 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 5 Years to 18 Years |
Eligibility | 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 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 |
Country | Name | City | State |
---|---|---|---|
United States | Bradley Hospital | Riverside | Rhode Island |
Lead Sponsor | Collaborator |
---|---|
Bradley Hospital | Brown University, Patient-Centered Outcomes Research Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Children's Yale-Brown Obsessive-Compulsive Scale | 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. | In-treatment and follow-up (6-12 months) | |
Primary | Pediatric Anxiety Rating Scale | 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. | In-treatment and follow-up (6-12 months) | |
Secondary | Client Satisfaction Questionnaire-8 | 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. | In-treatment and follow-up (6-12 months) | |
Secondary | Clinical Global Impression Scales | 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. | In-treatment and follow-up (6-12 months) | |
Secondary | Child Sheehan Disability Scale | 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. | In-treatment and follow-up (6-12 months) | |
Secondary | Homework Compliance Form | 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. | Up to 6 months | |
Secondary | Exposure Guide | 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. | Up to 6 months | |
Secondary | Therapeutic Alliance Scales for Caregivers and Parents (TASCP) | 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." | Up to 6 months | |
Secondary | Therapeutic Alliance Scales for Children-Revised (TASC-r) | 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." | Up to 6 months | |
Secondary | Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) | 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. | In-treatment and follow-up (6-12 months) | |
Secondary | Top Problems Assessment (TPA) | 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). | In-treatment and follow-up (6-12 months) | |
Secondary | Caregiver Strain Questionnaire (CSQ) | 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. | In-treatment and follow-up (6-12 months) | |
Secondary | Barriers to Treatment Questionnaire - Parent Version (BTQ-P) | 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. | In-treatment and follow-up (6-12 months) | |
Secondary | Pediatric Accommodation Scale-Parent Report (PAS-PR) | 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). | In-treatment and follow-up (6-12 months) | |
Secondary | Randomization Debrief | 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. | Administered at baseline | |
Secondary | Treatment Expectancy | 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+. | Administered at baseline | |
Secondary | The Social Responsiveness Scale, Second Edition (SRS-2) | 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"). | Administered at baseline and at discharge (up to 6-months) | |
Secondary | Affective Reactivity Index - Parent Version (ARI-P) | 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". | In-treatment and follow-up (6-12 months) | |
Secondary | Affective Reactivity Index - Self Report (ARI-S) | 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". | In-treatment and follow-up (6-12 months) | |
Secondary | Distress Intolerance Index | 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". | In-treatment and follow-up (6-12 months) | |
Secondary | Parent Accommodation Scale (PAS) | 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). | In-treatment and follow-up (6-12 months) | |
Secondary | Feedback Forms - Caregiver and Child Versions | 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. | Administered only at discharge, up to 6-months into study | |
Secondary | End of Treatment Form | 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. | Administered only at discharge, up to 6-months into study | |
Secondary | Sharing Study Findings | 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. | Administered only at discharge, up to 6-months into study | |
Secondary | Treatment Attendance | 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. | Up to 6 months | |
Secondary | Reasons for Treatment Discontinuation form | 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. | Administered only at discharge, up to 6-months into study |
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