Feasibility of Conducting a Randomized Controlled Trial Comparing Standard FBT and Guided Self-Help FBT for Adolescent Anorexia Nervosa
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Treatment Retention Rate
研究概览
简要总结
This study examines a parent only Guided Self-Help for Family Based Treatment (GSH-FBT) for adolescents between the ages of 12 and 18 diagnosed with Anorexia Nervosa. Preliminary data collected in a previous study suggest that a Guided Parental Self-Help Version of FBT (GSH-FBT) has similar outcomes as therapist provided FBT.
详细描述
In this study, families will be randomized to either receive 12 weekly online sessions of Guided Self-Help for Family Based Treatment (GSH-FBT), or 15 sessions of online, professionally delivered, standard FBT over the course of 6 months. Potential subjects will be recruited from Stanford University, McMaster University, other local medical programs and clinics, and online advertisement to the population at large. If participants are deemed eligible, participants will be invited for a baseline interview during which the investigators will conduct interviews and collect questionnaire measures. Participants will complete a follow-up interview at the end of treatment and 3-month after 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
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- 否
入选标准
- •Participants are 12-18 years of age
- •Participants live with a family (some families may contain only one parent)
- •Family members fluently speak and read English and have access to a computer with internet
- •Participants meet DSM-5 criteria for AN (both subtypes)
- •IBW between 75% and 88%
- •Participants are medically stable for outpatient treatment according to the recommended thresholds of the American Academy of Pediatrics and the Society of Adolescent Medicine
- •Participants are not engaged in another individual or family based psychotherapy trial during the duration of treatment sessions in the study.
- •Medications for comorbid psychiatric disorders are OK; randomization will balance groups through tracking.
排除标准
- •Associated physical illness that necessitates hospitalization
- •Psychotic illness in any form, mental retardation, autism, or any other mental illness that would interfere with the use of psychotherapy.
- •Current dependence on drugs or alcohol
- •Physical conditions (e.g. diabetes mellitus, pregnancy) known to influence eating or weight
- •Previous (5 or more sessions of) or current FBT-AN
- •Participants and family members do not have an adequate understanding of spoken English and are not able to speak and read English in order to participate in family therapy and the assessments.
- •Current weight is less than 75% or above 88% of expected weight given age and height.
研究组 & 干预措施
FBT
Family Based Treatment (FBT) includes up to 15 session (50-60 minutes) with a trained therapist.
干预措施: Family Based Treatment (Behavioral)
FBT-GSH
Family Based Treatment Guided Self-Help (FBT-GSH) includes an online website with educational videos, readings, discussion groups, and journals. Parents assigned to this arm will have up to 12 coaching sessions (20-30 minutes) with a trained therapist.
干预措施: Guided Self-Help for Family Based Treatment (Behavioral)
结局指标
主要结局
Treatment Retention Rate
时间窗: Up to 6 months
The count of participants who did not stop treatment before finishing their randomized treatment course (FBT-V or GSH-FBT).
Number of Treatment Sessions Attended
时间窗: Through end of treatment (up to approximately 6 months)
The number of sessions completed by the the participant with the client in treatment is the actual, not planned, number of sessions actually conducted.
Recruitment Rate
时间窗: Assessed through the end of recruitment (about one year)
Number of participants enrolled in the study per month.
Treatment Acceptability Ratings
时间窗: Session 1 (approximately 5 minutes to complete questionnaire)
To assess treatment acceptability, the study used the Therapist Suitability and Patient Expectancy measure (TSPE). The TSPE was administered to parents after session 1. The scale is measured from 0-10 (with 0 as the lowest rating and 10 as the highest rating). The average score was calculated if more than one parent responded. A higher score on the TSPE indicates a better outcome.
Serious Adverse Events
时间窗: Baseline through end of treatment period (up to 6 months)
Number of events in which a participant required hospitalization
Study Retention Rate
时间窗: Up to 9 months
The number of participants who provided information for the end of treatment assessment and 3-month follow up assessment.
Treatment Acceptability Ratings
时间窗: Session 1 and Session 8 (approximately 5 minutes to complete questionnaire)
To assess treatment acceptability, the study used the Cooperation and Helpfulness sub-scales of the Helping Alliance Questionnaire (HAQ). The HAQ was administered to parents after session 1 and 8. The subscales, Helpfulness and Cooperation, are scored on a Likert scale from "Strongly feels it's true" (+3) to "Strongly feel it's not true" (-3). The sub-scales' total scores ranges are 15- to 15 for Helpfulness and -18 to 18 for Cooperation. A higher score indicates a better outcome. The average score was calculated if more than one parent responded.
次要结局
未报告次要终点
研究者
James Dale Lock
Professor of Child Psychiatry and Pediatrics in the Department of Psychiatry and Behavioral Sciences and Director of the Eating Disorder Program for Children and Adolescents
Stanford University