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临床试验/NCT03855553
NCT03855553Unknown1 期

Disseminating Eating Disorders Education and Treatment Across Multiple Levels of Care: Improving Access in the Rhode Island Medicaid Population

The Miriam Hospital2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年1月1日最近更新:
适应症

试验速览

阶段
1 期
入组人数
20
试验地点
2
主要终点
BMI percentile

研究概览

简要总结

The goals of this project are to 1) develop training opportunities for master's-level and pre-doctoral psychology students in evidence-based assessment and treatment of adolescent EDs; 2) to provide the healthcare workforce, including licensed health professionals such as primary care physicians and behavioral health interventionists, with knowledge and competence to recognize early symptoms of and intervention strategies for EDs; and 3) to test the efficacy of delivering two evidence-based treatments for adolescent eating disorders, Family Based Treatment (FBT) and Enhanced Cognitive Behavioral Therapy (CBT-E), in the home-based setting.

详细描述

The complete project will incorporate three phases. Phase I is designed to gather information from existing licensed health professionals in the community who serve Medicaid populations on their knowledge needs and priorities related to screening and intervening with patients with eating disorders. Phase I will comprise eating disorder psycho-education, implementation of workshops, and supervision among primary care professionals and mental health workers. Responses will inform the content of in-services and program development (e.g., monthly consultation services, ongoing multi-family support groups) provided in Phase II.

During Phase II, families containing a child with a restrictive-type eating disorder will be recruited to receive treatment from the clinicians assessed and trained during Phase I. Families will be assigned to receive either Family Based Treatment (FBT) or Enhanced Cognitive Behavioral Therapy (CBT-E) to treat their adolescent's eating disorder. Treatment will occur over 10-16 weeks, depending on the family's needs and availability. Families will be assessed at pre-treatment, post-treatment, and 1-year follow-up.

Phase III will consist of follow-up with the families and clinicians, and further development of training/education approaches for the Rhode Island healthcare workforce.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
12 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

BMI percentile

时间窗: 1 year follow up

Eating disorder symptomology, as assessed by the ED-15.

时间窗: post treatment (week 17)

Patient will complete the Eating Disorder 15 (ED-15) to assess the frequency and severity of specific eating disorder behaviors and cognitions. Average scores from the 15-item measure range from 1 - 5, with higher scores indicating higher eating disorder symptomology.

Eating disorder symptomology, as assessed by ED-15.

时间窗: 1 year follow-up

Patient will complete the Eating Disorder 15 (ED-15) to assess the frequency and severity of specific eating disorder behaviors and cognitions. Average scores from the 15-item measure range from 1 - 5, with higher scores indicating higher eating disorder symptomology.

Perceived efficacy of treatment, as assessed by the CSQ

时间窗: 1 year follow-up

The Client Satisfaction Questionnaire (CSQ) is an 8-item measure that assesses how successful the patient perceived treatment to be. Average scores range from 1 - 4, with higher scores indicating higher satisfaction and perceived efficacy.

Perceived efficacy of treatment, as assessed by the TSPE.

时间窗: 1 year follow-up

One item from the Treatment Suitability and Patient Expectancy (TSPE) survey will assess how successful the patient perceived treatment to be. This item ranges from 0 - 10, with higher scores indicating higher perceived efficacy.

Perceived feasibility of treatment, as assessed by the TSPE.

时间窗: post treatment (week 17)

One item from the Treatment Suitability and Patient Expectancy (TSPE) survey will assess how feasible the patient perceived treatment to be. This item ranges from 0 - 10, with higher scores indicating higher feasibility.

Perceived feasibility of treatment, as assessed by the CSQ.

时间窗: post treatment (week 17)

Two items from the 8-item Client Satisfaction Questionnaire (CSQ) will assess how suitable/feasible treatment was based on the patient's needs, family dynamics, schedule constraints, etc. Average scores range from 1 - 4, with higher scores indicating higher feasibility.

Eating disorder symptomology, as assessed by the EDE-Q.

时间窗: post treatment (week 17)

Patient will complete the Eating Disorder Examination Questionnaire (EDE-Q) to assess the frequency and severity of specific eating disorder behaviors and cognitions. Averages of the 28-item measure range from 0 to 6, with higher score indicating higher eating disorder symptomology.

Perceived efficacy of treatment, as assessed by the TSPE

时间窗: post treatment (week 17)

One item from the Treatment Suitability and Patient Expectancy (TSPE) survey will assess how successful the patient perceived treatment to be. This item ranges from 0 - 10, with higher scores indicating higher perceived efficacy.

Eating disorder symptomology, as assessed by EDE-Q

时间窗: 1 year follow-up

Patient will complete the Eating Disorder Examination Questionnaire (EDE-Q) to assess the frequency and severity of specific eating disorder behaviors and cognitions. Average scores of the 28-item measure range from 0 to 6, with higher score indicating higher eating disorder symptomology.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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