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临床试验/NCT03610373
NCT03610373已完成不适用

Personalizing Treatment Through Shared Decision Making for Youth Psychotherapy

Boston University Charles River Campus2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2016年10月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
45
试验地点
2
主要终点
Anxiety Disorders Interview Schedule for DSM-IV - Child/Parent

研究概览

简要总结

Youth depression and anxiety represent a serious public health concern, with affected youth often experiencing social, familial, and academic impairment. Research evidence supports a growing array of effective treatments for youth depression and anxiety, yet as the collection of evidence-based treatments expands, so do the challenges of utilizing the evidence: clinicians must be able to (1) access, integrate, and apply the available evidence, and (2) engage in a collaborative process with each family to develop a plan that is responsive to each family's unique characteristics, preferences, and goals. Engaging caregivers and youths as active collaborators in the treatment planning process is a patient-centered approach with the potential to improve the process and outcome of youth mental health care by facilitating the personalization of established evidence-based treatment approaches. Such collaboration, frequently referred to as shared decision-making (SDM), is a hallmark of evidence-based practice and a key feature of federal guidelines for health care delivery. However, despite growing rhetorical support for SDM, empirical support is lacking, particularly in the area of youth mental health treatment. The absence of such research is unfortunate, given the potential for SDM to facilitate the dissemination and implementation of evidence-based treatments, and to personalize the use of established treatments to increase acceptability, retention, satisfaction, and overall effectiveness.

The present project tests the feasibility and acceptability of SDM through a pilot randomized controlled trial of 40 youths (ages 7-15) meeting diagnostic criteria for an anxiety or depressive disorder. The trial will compare an evidence-based treatment that is planned collaboratively with youths and caregivers using the SDM protocol, to an evidence-based treatment that is planned by the clinician and supervisor using pretreatment assessment data. Eligible youths will received up to 26 treatment sessions at no cost and complete assessments prior to the start of treatment, at the end of treatment, and six months following the end of treatment.

研究设计

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

盲法说明

The outcomes assessors do not have access to data regarding which arm each participant is in.

入排标准

年龄范围
7 Years 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • a current DSM-5 principal diagnosis of a Major Depressive Disorder, Dysthymic Disorder, Generalized Anxiety Disorder, Separation Anxiety Disorder, Social Phobia, or Specific Phobia
  • if receiving psychiatric medication, dose will be stable for at least 3 months at enrollment with ability to maintain medication
  • youth and caregiver speak fluent English

排除标准

  • active suicidality
  • history of severe physical or mental impairments (e.g., mental retardation, autism spectrum disorders) in youth or caregiver
  • participation in additional psychosocial treatment

结局指标

主要结局

Anxiety Disorders Interview Schedule for DSM-IV - Child/Parent

时间窗: Through completion of treatment, anticipated to be an average of 5 months

The Anxiety Disorders Interview Schedule for DSM-IV - Child/Parent is an extensively tested semi-structured interview assessing the major anxiety, mood, and externalizing disorders.

次要结局

  • Satisfaction with Decision Scale(At the start of treatment, anticipated to be an average of 3 weeks after the initial assessment)

研究者

发起方
Boston University Charles River Campus
申办方类型
Other
责任方
Principal Investigator
主要研究者

David A. Langer

Research Associate Professor

Boston University Charles River Campus

研究点 (2)

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