跳至主要内容
临床试验/NCT02480907
NCT02480907已完成不适用

Supporting Carers of Children and Adolescents With Eating Disorders in Austria (SUCCEAT) - A Randomized Controlled Trial to Compare Workshop, Internet-based and Conventional Parental Support Groups

Medical University of Vienna2 个研究点 分布在 1 个国家目标入组 144 人开始时间: 2014年9月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
144
试验地点
2
主要终点
Psychological morbidity and distress in caregivers are measured with the "Gerneral Health Questionnaire - 12"

研究概览

简要总结

The purpose of the "Supporting Carers of Children and Adolescents with Eating Disorders in Austria" (SUCCEAT) - study is to compare Workshop, Internet-based and Conventional Parental Support Groups for carers of chilren and adolescents between 10 and 18 years in a randomized controlled trial for the first time in Austria.

详细描述

According to NICE guidelines, eating disordered patients should be managed on an outpatient basis. This challenge seems to put a heavy burden on most caregivers. Schmidt and Treasure (2006) argued that obsessive compulsive personality traits, emotional avoidance, pro-anorectic beliefs and responses of close others like dysfunctional communication styles impair the outcome. The construct of expressed emotions reflects on the amount of criticism, hostility and emotional over-involvement expressed by relatives of psychiatric patients towards them. A special program for parents is developed to equip caregivers with knowledge and skills to change maintaining factors and therefore improve the patient's outcome. Furthermore coping strategies are provided to help carers to reduce their burden. We start a randomized controlled trial comparing two interventions with a conventional group. We compare Workshops (Intervention Group 1), Internet-based (Intervention Group 2) and Conventional (Control Group) Carers´ Support Groups. Before starting the intervention (T0, baseline), at the end of the intervention (T1) and 1 year after the intervention (T2, follow up) assessments will be conducted via questionnaires and interviews. Parents of 48 children and adolescents within the age group of 10-17 years suffering from anorexia or bulimia nervosa will be involved in each group, resulting in an overall sample size of 144. The investigators aim is to equip parents with knowledge and skills in order to support their children's recovery, prevent relapse and improve their own wellbeing. The long term goal is to provide low-threshold, cost-effective, time-efficient and superregional support for parents in the future.

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
10 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • children and adolescents aged 10-18, who suffer from anorexia or bulimia nervosa and their primary caregivers

排除标准

  • no written informed consent possible due to intelligence or no willingness by parents to include minor

研究组 & 干预措施

Workshop Group

Active Comparator

Parents of ~ 40 children and adolescents within the age group of 10-18 years suffering from anorexia or bulimia nervosa will be involved in the workshop support group for parents for a period of three months, including a written manual, a DVD (Digital Video Disc) with additional information and weekly workshops. Over the course of three months, parents will participate at the 8 workshop sessions and get the manual to read and the DVDs to use at home to illustrate workshop contents with examples and video clips.

干预措施: Workshop Group (Behavioral)

Internet-based support group

Active Comparator

Parents of ~ 40 children and adolescents within the age group of 10-18 years suffering from anorexia or bulimia nervosa will be involved in the Internet-based support group for parents, including material from the manual and the DVD and additional information available online within a structured program. Over the course of three months, parents will get access to the 8 support sessions online with the instruction to work out the program at home. Additionally email support is offered after completing each session.

干预措施: Internet-based support group (Behavioral)

Control group - TAU

No Intervention

Parents of ~ 40 children and adolescents within the age group of 10-18 years suffering from anorexia or bulimia nervosa will get treatment as usual and take part in conventional parental intervention groups.

结局指标

主要结局

Psychological morbidity and distress in caregivers are measured with the "Gerneral Health Questionnaire - 12"

时间窗: 15 months

Questionnaire

次要结局

  • Behavioral and social problems in caregivers will be measured with the "Caregiver Skills Scale" (measures caregiver skills that may be helpful in supporting people with anorexia nervosa)(15 months)
  • Emotional problems in caregivers will be measured with the "State- Trait Anxiety Inventory"(15 months)
  • Emotional Problems will be measured with the "The Family-Questionnaire" (measures the emotional climate within the Family)(15 months)
  • Behavioural and emotional problems in patients are measured via the "Youth self Report"(15 months)
  • Emotional Problems in patients are measured via the german questionnaire "Fragebogen zur gesundheitsbezogenen Lebensqualität bei Kinder und Jugendlichen" (measures life-Quality; only available in german).(15 months)
  • Behavioral and social problems in caregivers will be measured with the "Eating Disorder Symptom Impact Scale" (measures which impact the eating disorder symptoms of the patient have upon the well-being of the caregiver)(15 months)
  • Emotional problems in caregivers will be measured with the "Beck Depression Inventory" (measures the severity of Depression)(15 months)
  • Emotional problems in caregivers will be measured with the "Symptom Checklist-90-Revised" (measures psychological problems and symptoms of psychopathology)(15 months)
  • Needs of carers will be measured with the "Carers' Needs Assessment Measure" (measures the needs of carers of patients with an eating disorder)(15 months)
  • Caregiving appraisal will be measured with the "Experience of Caregiving Inventory" (measures general aspects of care giving experiences)(15 months)
  • Behavioral and social problems in caregivers will be measured with the german Version of the "University of Rhode Island Change Assessment Scale " (= Fragebogen zur Erfassung der Veränderungsbereitschaft) (measures stages of Change)(15 months)
  • Emotional Problems in patients are measured via the "Family Emotional Involvement and Criticism Scale" (measures expressed emotions)(15 months)
  • The presence of the eating disorder in the patients will be measured via the "Eating Disorder Examination" (measures the range and severity of the eating disorder components)(15 months)
  • The presence of the eating disorder in the patients will be measured via the "Anorexia Nervosa/Bulimia Nervosa Stages of Change Questionnaire" (measures the motivation to change in the patients with an eating disorder)(15 months)
  • Feasibility and Acceptability of the workshops and online modules (Treatment Satisfaction Questionnaire, developed by our research group)(15 months)

研究者

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

Dr. Andreas Karwautz

Univ. Prof. Dr.

Medical University of Vienna

研究点 (2)

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