Building an Outcomes Assessment Infrastructure to Assess Anxiety Treatment

  • STATUS
    Recruiting
  • End date
    Oct 20, 2070
  • participants needed
    45
  • sponsor
    Mclean Hospital
Updated on 20 September 2021
anxiety
behavior therapy
agoraphobia
panic disorder
social phobia
specific phobia
anxiety treatment
anxiety disorder
separation anxiety
phobia

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).

Details
Condition Agoraphobia, Obsessive-Compulsive Disorder, Claustrophobia, Separation anxiety disorder of childhood, Panic Disorder, ANXIETY NEUROSIS, Agoraphobia (Fear of Crowds), Social Anxiety Disorder (SAD), Anxiety Disorders (Pediatric), Panic Disorders (Pediatric), Generalized Anxiety Disorder (GAD), Specific Phobia, Generalized Anxiety Disorder (GAD - Pediatric), Anxiety Disorders, Panic Disorders, Social Phobia, Phobia, Social, obsessive compulsive disorder, separation anxiety
Treatment McLean Anxiety Mastery Program
Clinical Study IdentifierNCT02305537
SponsorMclean Hospital
Last Modified on20 September 2021

Eligibility

Yes No Not Sure

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-0703> 2021_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 conducted in English (whenever possible, however, translation services will be provided for patients whose parents are not fluent in English)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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