Last updated on March 2018

Building an Outcomes Assessment Infrastructure to Assess Anxiety Treatment

Brief description of study

The collection of patient self-report and diagnostic data will allow us to examine the efficacy of the treatment delivered in the McLean Anxiety Mastery Program. Using data gathered through routine clinical care, the investigators seek to explore whether patients in treatment show improvements from admission to discharge, compared to patients on the waitlist, and whether these gains are maintained three months post-discharge. The following are included as examples of some of the study's hypotheses.

Detailed Study Description

The study population will involve all assenting/consenting patients, both male and female, admitted to the McLean Anxiety Mastery Program at McLean Hospital. This program provides intensive group-based treatment for anxious youth (aged 9-18). Patients in the McLean Anxiety Mastery Program participate in a minimum of four weeks of treatment and attend the program for four days per week. Three days per week, patients attend group-based treatment for two-and-a-half hours per day. The fourth day of each week consists of a one-hour group-based treatment, a one-hour family meeting, and a one-hour exposure session that includes children and their caregivers. One day per week, parents also attend a one-hour parent guidance group as part of the overall treatment package. Patients also have psychopharmacology consultations with the program psychiatrist on a case-by-case basis. On their first birthday that falls after the date of discharge, patients are sent a birthday card that includes a greeting and reminders about coping skills that they learned in the program.

The investigators expect to recruit at least 45 assenting/consenting patients in the first year of the study. The plan is to treat six-to-eight patients during each one-month module and to have a waitlist, if interest in the program exceeds the program's capacity. If a waitlist exists, patients, who are on this waitlist, will be evaluated as the study's control group once they are four weeks away from their target admission date.

Before the patient's first assessment through the program, an Independent Assessor will inform the patient and caregivers about the opportunity to participate in a voluntary research study at the McLean Anxiety Mastery Program. Assent/consent will be requested to utilize these data for research purposes. The patient and caregivers will be told that all of the information gathered from the semi-structured clinical interviews and self- and caregiver-report measures are part of routine clinical practice, and permission is being sought to use this de-identified data for research purposes. The patient and caregivers will be reminded that their decision to or not to participate in the research study will not affect the treatment they receive.

The assessments are conducted at the following time points: 1) Four weeks pre-admission (if there is a treatment waitlist), 2) upon admission, 3) weekly while the patients are participating in treatment, 4) upon discharge, and 5) at a three-month follow-up visit. If the program is not at capacity and therefore does not have a waitlist, patients will not be asked to postpone treatment for the sake of the waitlist control assessment and, instead, will be admitted directly into the program. Patients only will be included on the waitlist, if they are approximately four weeks from program admission. If the patient is fewer than four weeks from admission, the patient's first assessment will be upon admission.

Families, who have assented/consented to participate in the research study, begin the assessment either while on the waitlist or upon admission to the program. The assessment process at each time point involves the same semi-structured interviews: the Anxiety Disorders Interview Schedule (ADIS), the Yale Global Tic Severity Scale (YGTSS) and the Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS). The same questionnaire battery also is administered on the same day as the semi-structured interviews at each of these time points. The semi-structured interviews takes approximately two-to-four hours to complete, and the remainder of the battery, the self- and parent-report measures, takes approximately 15 minutes.

Trained Independent Assessors conduct the interviews, and the self-report questionnaires are administered through REDCap Survey, a secure, HIPAA-compliant program for building and managing online surveys. The self-report measures are completed at secure computer terminals on-site at the program. If families are unable to travel to the program to complete surveys while on the waitlist or at follow-up, the Independent Assessors will use REDCap Survey to send two survey links (i.e., a parent survey and a child survey) to the caregiver and child. If a patient or family member does not complete the online survey within 48 hours, an Independent Assessor will contact them with a reminder one time via phone or e-mail. The survey does not include questions assessing risk (e.g., for suicidal ideation, self-harm, substance use).

Clinical Study Identifier: NCT02305537

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McLean Hospital

Cambridge, MA United States
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Recruitment Status: Open

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