An interventional study of McLean Anxiety Mastery Program in Social Anxiety Disorder, Specific Phobia and Separation Anxiety Disorder, sponsored by Mclean Hospital. Completed at 1 site in United States. Open to participants aged 6 Years to 19 Years. Per ClinicalTrials.gov, last updated 2025-10-20.
Sponsored by Mclean Hospital · Not applicable, Interventional, and Treatment
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.
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).
367 studies on the registry are indexed under Phobia, Social; 58 are open to participants now.
This study's enrollment of 559 is above the median of 76 across 338 interventional studies indexed under Phobia, Social.
Browse Phobia, Social studies →Mclean Hospital is the lead sponsor of 185 studies on the registry; 32 are open to participants now.
Of its 15 completed or terminated interventional studies of FDA-regulated products, 12 (80%) have results posted.
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Eligibility criteria for the McLean Anxiety Mastery Program include:
who present with at least one of the following disorders:
Exclusion Criteria:
Participants in the McLean Anxiety Mastery Program
Behavioral: McLean Anxiety Mastery Program
Participants on the waitlist for the McLean Anxiety Mastery Program
Cognitive-Behavioral Therapy with Exposure and Response Prevention
Change in Score in Spence Children's Anxiety Scale (SCAS; Spence 1997).
The SCAS is a 44-item self-report inventory that measures anxiety severity.
Time frame: Change between 0 weeks of treatment and after weeks of treatment, change between 4 weeks of treatment and 16 weeks after treatment
Change in Score in Center for Epidemiolgic Studies Depression Scale (CES-D; Radloff 1977).
The CES-D is a 20-item self-report inventory that measures depression severity.
Time frame: Change between 0 weeks of treatment and after weeks of treatment, change between 4 weeks of treatment and 16 weeks after treatment
Change in Score in Spence Children's Anxiety Scale (SCAS - Parent Report; Spence 2000).
The SCAS -Parent Report is a 39-item parent report inventory that measures the child's anxiety severity.
Time frame: Change between 0 weeks of treatment and after weeks of treatment, change between 4 weeks of treatment and 16 weeks after treatment
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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