CompletedNot Applicable

Building an Outcomes Assessment Infrastructure to Assess Anxiety Treatment

United States559 participantsStarted 2014-10

Plain-language 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.

Who can participate

Age range

6 Years – 19 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 6 and 19 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 should complete and submit an application (https://www.mcleanhospital.org/sites/default/files/2021-07/MAMP-Application-07032021\_0.pdf) to begin the phone screen process. 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 experiencing active symptoms of psychosis, * 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 co…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Score in Spence Children's Anxiety Scale (SCAS; Spence 1997).

Timeframe: Change between 0 weeks of treatment and after weeks of treatment, change between 4 weeks of treatment and 16 weeks after treatment

Trial details

NCT IDNCT02305537

SponsorMclean Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-11

View on ClinicalTrials.gov More Social Anxiety Disorder trials