Building an Outcomes Assessment Infrastructure to Assess Anxiety Treatment

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).

Inclusion Criteria:

- All youth who are eligible to participate in the McLean Anxiety Mastery Program will
be invited to participate in the research study.

- Eligibility criteria for the McLean Anxiety Mastery Program include:

- children and adolescents who are between the ages of 9 and 18 and

- who present with at least one of the following disorders:

- Separation Anxiety Disorder,

- Social Anxiety Disorder,

- Panic Disorder,

- Agoraphobia,

- Specific Phobia(s), and

- OCD.

- Interested and eligible patients and their caregivers will be asked to come to
the program and will be presented with assent and consent forms that describe the
research.

Exclusion Criteria:

- Patients ineligible for the treatment program, and therefore the study, include those
who have engaged in substance abuse during the six weeks prior to the first evaluation
(i.e., waitlist or admission) the phone screening,

- those who report that they are unwilling to refrain from self-injurious behaviors
during the waitlist and treatment periods,

- those who are actively psychotic,

- those who exhibit severe behavioral disinhibition or aggression, and

- those who express an intent and/or plan to commit suicide or homicide at the time of
their first evaluation the initial phone screening.

- Patients must be fluent in English to participate in the program because all
off-grounds exposure groups will be conducted in English (whenever possible, however,
translation services will be provided for patients whose parents are not fluent in
English).