Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT02305537 |
Other study ID # |
2014P000353 |
Secondary ID |
|
Status |
Recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
October 2014 |
Est. completion date |
October 2070 |
Study information
Verified date |
March 2023 |
Source |
Mclean Hospital |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
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.
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 6-19). 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, a clinician 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 child- 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) upon admission, 2) weekly
while the patients are participating in treatment, 3) upon discharge, and 4) at a three-month
follow-up visit.
The child- and parent--report questionnaires are administered through REDCap Survey, a
secure, HIPAA-compliant program for building and managing online surveys. The measures are
completed on families' devices at home. If a patient or family member does not complete the
online survey within 48 hours, a clinician 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).