跳至主要内容
临床试验/NCT02305537
NCT02305537已完成不适用

Building an Outcomes Assessment Infrastructure to Assess Youth in the McLean Anxiety Mastery Program at McLean Hospital

Mclean Hospital2 个研究点 分布在 1 个国家目标入组 559 人开始时间: 2014年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
559
试验地点
2
主要终点
Change in Score in Spence Children's Anxiety Scale (SCAS; Spence 1997).

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
6 Years 至 19 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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
  • 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.

排除标准

  • 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).

结局指标

主要结局

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

时间窗: 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.

次要结局

  • Change in Score in Center for Epidemiolgic Studies Depression Scale (CES-D; Radloff 1977).(Change between 0 weeks of treatment and after weeks of treatment, change between 4 weeks of treatment and 16 weeks after treatment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sperling, Jacqueline,Ph.D.

Associate Program Director of the McLean Anxiety Mastery Program

Mclean Hospital

研究点 (2)

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