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Building an Outcomes Assessment Infrastructure to Assess Anxiety Treatment

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ClinicalTrials.gov Identifier: NCT02305537
Recruitment Status : Recruiting
First Posted : December 2, 2014
Last Update Posted : March 21, 2018
Sponsor:
Information provided by (Responsible Party):
Sperling, Jacqueline,Ph.D., Mclean Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Social Anxiety Disorder Specific Phobia Separation Anxiety Disorder Panic Disorder Agoraphobia Obsessive-Compulsive Disorder Behavioral: McLean Anxiety Mastery Program Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Building an Outcomes Assessment Infrastructure to Assess Youth in the McLean Anxiety Mastery Program at McLean Hospital
Study Start Date : October 2014
Estimated Primary Completion Date : October 2024
Estimated Study Completion Date : October 2030

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Treatment (Cognitive-Behavioral Therapy)
Participants in the McLean Anxiety Mastery Program
Behavioral: McLean Anxiety Mastery Program
Cognitive-Behavioral Therapy with Exposure and Response Prevention

No Intervention: Waitlist
Participants on the waitlist for the McLean Anxiety Mastery Program



Primary Outcome Measures :
  1. Change in Score in Spence Children's Anxiety Scale (SCAS; Spence 1997). [ Time Frame: Change between 0 weeks of treatment and after weeks of treatment, change between 4 weeks of treatment and 16 weeks after treatment ]
    The SCAS is a 44-item self-report inventory that measures anxiety severity.


Secondary Outcome Measures :
  1. Change in Score in Center for Epidemiolgic Studies Depression Scale (CES-D; Radloff 1977). [ Time Frame: Change between 0 weeks of treatment and after weeks of treatment, change between 4 weeks of treatment and 16 weeks after treatment ]
    The CES-D is a 20-item self-report inventory that measures depression severity.


Other Outcome Measures:
  1. Change in Score in Spence Children's Anxiety Scale (SCAS - Parent Report; Spence 2000). [ Time Frame: Change between 0 weeks of treatment and after weeks of treatment, change between 4 weeks of treatment and 16 weeks after treatment ]
    The SCAS -Parent Report is a 39-item parent report inventory that measures the child's anxiety severity.

  2. Change in Score in Screen for Child Anxiety Related Disorders-PARENT Version (SCARED; Birmaher, Brent, Chiappetta, Bridge, Monga, & Baugher 1999). [ Time Frame: Change between 0 weeks of treatment and after weeks of treatment, change between 4 weeks of treatment and 16 weeks after treatment ]
    The SCARED is a 41-item measure that assesses various forms of anxiety in youth.

  3. Change in Score in Clinical Severity Ratings of Diagnoses Determined by the Anxiety Disorders Interview Schedule Child Version: Child and Parent Interview Schedules (ADIS-C, Silverman & Albano, 1996). [ Time Frame: Change between 0 weeks of treatment and after weeks of treatment, change between 4 weeks of treatment and 16 weeks after treatment ]
    The ADIS-IV is a semi-structured diagnostic interview used to assess anxiety and other often comorbid disorders in youth. As part of this interview, "Clinical Severity Ratings" (CSRs) will be made for each disorder. CSR ratings are scored on a Likert scale, ranging from 0 ("not at all severe") to 8 ("very severe"), and score of 4 or above indicates clinical significance (i.e., meets criteria for the diagnosis).

  4. Change in Score in Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS; Scahill et al., 1997). [ Time Frame: Change between 0 weeks of treatment and after weeks of treatment, change between 4 weeks of treatment and 16 weeks after treatment ]
    The CY-BOCS is a semi-structured interview that consists of a symptom checklist measuring the presence of 54 OCD symptoms and a 10-item severity scale.

  5. Change in Score in Yale Global Tic Severity Scale (YGTSS; Leckman et al. 1989). [ Time Frame: Change between 0 weeks of treatment and after weeks of treatment, change between 4 weeks of treatment and 16 weeks after treatment ]
    The YGTSS is a 10-item semi-structured interview that measures the number, frequency, intensity, complexity, and interference of motor and phonic tics.



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Ages Eligible for Study:   9 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02305537


Locations
United States, Massachusetts
McLean Hospital Recruiting
Cambridge, Massachusetts, United States, 02138
Contact: Jacqueline Sperling, Ph.D.    617-674-5335    jsperling@mclean.harvard.edu   
Contact: Kathryn Boger, Ph.D.    617-674-5334    kboger@partners.org   
Principal Investigator: Jacqueline Sperling, Ph.D.         
Sub-Investigator: Kathryn Boger, Ph.D.         
Sponsors and Collaborators
Mclean Hospital
Investigators
Principal Investigator: Jacqueline Sperling, Ph.D. Mclean Hospital

Responsible Party: Sperling, Jacqueline,Ph.D., Associate Program Director of the McLean Anxiety Mastery Program, Mclean Hospital
ClinicalTrials.gov Identifier: NCT02305537     History of Changes
Other Study ID Numbers: 2014P000353
First Posted: December 2, 2014    Key Record Dates
Last Update Posted: March 21, 2018
Last Verified: March 2018

Additional relevant MeSH terms:
Phobia, Social
Phobic Disorders
Disease
Anxiety Disorders
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Panic Disorder
Agoraphobia
Anxiety, Separation
Pathologic Processes
Mental Disorders
Personality Disorders
Neurodevelopmental Disorders