ClinicalTrials.gg
CompletedNCT02305537Updated Oct 20, 2025

Building an Outcomes Assessment Infrastructure to Assess Anxiety Treatment

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

Phase
Not applicable
Study type
Interventional
Enrollment
559
Allocation
Non-randomized
Ages
6 Years to 19 Years
Sex
All
01

Study 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.

Read the detailed 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).

02

Conditions studied

  • Social Anxiety Disorder
  • Specific Phobia
  • Separation Anxiety Disorder
  • Panic Disorder
  • Agoraphobia
  • Obsessive-Compulsive Disorder
03

In context

Phobia, Social

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 →

Lead sponsor

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.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 19 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 conducted in English (whenever possible, however, translation services will be provided for patients whose parents are not fluent in English).
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
559 participants (actual)

Study arms

  • Experimental
    Treatment (Cognitive-Behavioral Therapy)

    Participants in the McLean Anxiety Mastery Program

    Behavioral: McLean Anxiety Mastery Program

  • No intervention
    Waitlist

    Participants on the waitlist for the McLean Anxiety Mastery Program

Interventions

  • BehavioralMcLean Anxiety Mastery Program

    Cognitive-Behavioral Therapy with Exposure and Response Prevention

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Other outcomes

  1. 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

07

Study locations

1 site
  • McLean Hospital
    Cambridge, Massachusetts 02138, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 20, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02305537
Lead sponsor
Mclean Hospital
Responsible party
Sperling, Jacqueline,Ph.D. (Associate Program Director of the McLean Anxiety Mastery Program, Mclean Hospital) — Principal investigator
First posted
Dec 2, 2014
Start date
Oct 2014
Primary completion
Nov 2024
Completion
Nov 2024
Last update
Oct 20, 2025

Study contacts

Jacqueline Sperling, Ph.D.
principal investigator · Mclean Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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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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