The purpose of this study is to test how the delivery of Cognitive Behavioral Therapy (CBT) for pediatric anxiety and OCD via different methods might increase its availability and effectiveness. CBT involves teaching the patient skills to enable them to gradually come into contact with feared situations. This process of gradually approaching feared situations is called exposure. Although CBT with exposure has the best evidence for treating anxiety disorders, not all children have equal access or respond the same way to CBT. As part of this study, patients will receive weekly CBT treatment sessions involving a combination of weekly visits with an exposure coach and one visit a month with a licensed provider (e.g., psychologist, social worker). This treatment will be delivered using one of three methods: 1) in-person (face-to-face sessions, occurring in the office and the home/community), or 2) telehealth (entirely remote sessions via web-based video conference), or 3) flexible (individualized mix of in-person and/or telehealth sessions). Eligible participants will be randomly assigned to one of these three methods. Results of this study will help determine which treatment method works best for whom.
Treatment as described above will occur as part of care at partnering community care sites in Rhode Island. Providers from the following partnering community care sites will make up patient treatment teams: Blackstone Valley Community Health Care, Family Services of Rhode Island, Gateway Healthcare, Newport Mental Health, and Thrive Behavioral Health.
The research study is being conducted by the Pediatric Anxiety Research Center at Brown University Health. The research team will conduct the study assessments that patients will be asked to participate in as study participants. Patients will be asked to complete assessments prior to starting treatment, at two time points during treatment, at the end of treatment, and at two timepoints 3 and 6 months following the end of treatment. Participants will be compensated for their time completing research assessments.
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
Other primary or co-primary psychiatric disorder which requires initiation of other active current treatment
Acute suicidality
Concurrent psychotherapy
Chronic medical illness that would preclude their active participation in treatment
Parallel
Team-delivered, exposure-based CBT
BehavioralPatient sees licensed provider 1x/month and non-licensed provider 3x/month for exposure-based cognitive behavioral therapy
Children's Yale-Brown Obsessive-Compulsive Scale Second Edition: (CY-BOCS II)
The CY-BOCS II is a measure of obsessive-compulsive symptoms and their severity. The Obsession Rating Scale assesses five domains of obsessional severity, each scored from 0 (no impairment) to 5 (extreme impairment). The Compulsion Rating Scale assesses five domains of compulsion severity using the same 0-5 scale. The total OCD severity score ranges from 0 to 50, with higher scores indicating greater symptom severity.
Client Satisfaction Questionnaire-Revised (CSQ-8-R)
The CSQ-8-R 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.
Exposure Guide
The Exposure Guide is an empirically-supported exposure therapy fidelity/quality tool completed by study therapists. It measures exposure quality, including: therapist use of specific strategies that predict clinical improvement, exposure completion, exposure difficulty, therapeutic learning, barriers to completion, and engagement.
Pediatric Anxiety Rating Scale (PARS)
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.
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.
Demographics
We will assess participant demographics, including age, gender, sex assigned at birth, sexual orientation, race, and ethnicity. We will also assess perceived financial and food insecurity.
Diagnostic Interview for Anxiety, Mood, and Obsessive-compulsive and related Neuropsychiatric Disorders (DIAMOND-Kid)
DIAMOND-Kid is a brief, semi-structured diagnostic interview for DSM-5 psychiatric disorders in children and youth.
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.
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Bradley Hospital
Lead sponsor
Patient-Centered Outcomes Research Institute
Collaborator
