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Supporting Carers of Children and Adolescents With Eating Disorders in Austria (SUCCEAT) (SUCCEAT)

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ClinicalTrials.gov Identifier: NCT02480907
Recruitment Status : Recruiting
First Posted : June 25, 2015
Last Update Posted : October 2, 2017
Sponsor:
Collaborator:
Pharmig - Gemeinsame Gesundheitsziele aus dem Rahmen-Pharmavertrag
Information provided by (Responsible Party):
Dr. Andreas Karwautz, Medical University of Vienna

April 7, 2015
June 25, 2015
October 2, 2017
September 2014
December 2017   (Final data collection date for primary outcome measure)
Psychological morbidity and distress in caregivers are measured with the "Gerneral Health Questionnaire - 12" [ Time Frame: 15 months ]
Questionnaire
Same as current
Complete list of historical versions of study NCT02480907 on ClinicalTrials.gov Archive Site
  • Emotional problems in caregivers will be measured with the "Beck Depression Inventory" (measures the severity of Depression) [ Time Frame: 15 months ]
    Questionnaire
  • Emotional problems in caregivers will be measured with the "State- Trait Anxiety Inventory" [ Time Frame: 15 months ]
    Questionnaire
  • Emotional Problems will be measured with the "The Family-Questionnaire" (measures the emotional climate within the Family) [ Time Frame: 15 months ]
    Questionnaire
  • Emotional problems in caregivers will be measured with the "Symptom Checklist-90-Revised" (measures psychological problems and symptoms of psychopathology) [ Time Frame: 15 months ]
    Questionnaire
  • 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) [ Time Frame: 15 months ]
    Questionnaire
  • 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) [ Time Frame: 15 months ]
    Questionnaire
  • 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) [ Time Frame: 15 months ]
    Questionnaire
  • Needs of carers will be measured with the "Carers' Needs Assessment Measure" (measures the needs of carers of patients with an eating disorder) [ Time Frame: 15 months ]
    Questionnaire
  • Caregiving appraisal will be measured with the "Experience of Caregiving Inventory" (measures general aspects of care giving experiences) [ Time Frame: 15 months ]
    Questionnaire
  • Behavioural and emotional problems in patients are measured via the "Youth self Report" [ Time Frame: 15 months ]
    Questionnaire
  • Emotional Problems in patients are measured via the "Family Emotional Involvement and Criticism Scale" (measures expressed emotions) [ Time Frame: 15 months ]
    Questionnaire
  • 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). [ Time Frame: 15 months ]
    Questionnaire
  • 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) [ Time Frame: 15 months ]
    Interview
  • 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) [ Time Frame: 15 months ]
    Questionnaire
  • Feasibility and Acceptability of the workshops and online modules (Treatment Satisfaction Questionnaire, developed by our research group) [ Time Frame: 15 months ]
    Questionnaire
  • Emotional problems in caregivers will be measured with the "Beck Depression Inventory", the "State Trait Anxiety Inventory", "The Family-Questionnaire" and the "Symptom Checklist-90-Revised" [ Time Frame: 15 months ]
    Questionnaire
  • Behavioral and social problems in caregivers will be measured with the "Caregiver Scale"; "Eating Disorder Symptom Eating Scale"; and "University of Rhode Island Change Assessment Scale " [ Time Frame: 15 months ]
    Questionnaire
  • Needs of carers and caregiving appraisal will be measured with the "Carers' Needs Assessment Measure" and the "Experience of Caregiving Inventory" [ Time Frame: 15 months ]
    Questionnaire
  • The presence of the eating disorder in the patients will be measured via the "Eating Disorder Examination", the "Anorexia Nervosa/Bulimia Nervosa Stages of Change Questionnaire" and the "Eating Disorder Examination" [ Time Frame: 15 months ]
    Questionnaires and Interview
  • Emotional Problems in patients are measured via the "Youth self Report", "The Family Emotional Involvement and Criticism Scale" and the "Fragebogen zur gesundheitsbezogenen Lebensqualität bei Kinder und Jugendlichen" (measures life-Quality). [ Time Frame: 15 months ]
    Questionnaire
  • Feasibility and Acceptability of the workshops and online modules (Treatment Satisfaction Questionnaire, developed by our research group) [ Time Frame: 15 months ]
    Questionnaire
Not Provided
Not Provided
 
Supporting Carers of Children and Adolescents With Eating Disorders in Austria (SUCCEAT)
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
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.
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.
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Mental Health
  • Behavioral: Workshop Group
    Workshop support group
  • Behavioral: Internet-based support group
    Internet based support group with E-mail coaching
  • Active Comparator: Workshop Group
    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.
    Intervention: Behavioral: Workshop Group
  • Active Comparator: Internet-based support group
    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.
    Intervention: Behavioral: Internet-based support group
  • No Intervention: Control group - TAU
    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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
144
Same as current
December 2018
December 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • no written informed consent possible due to intelligence or no willingness by parents to include minor
Sexes Eligible for Study: All
10 Years to 18 Years   (Child, Adult)
No
Contact: Andreas Karwautz, MD, Prof 0043 1 40400 ext 30570 andreas.karwautz@meduniwien.ac.at
Contact: Gudrun Wagner, Mag, Dr 0043 1 40400 ext 30170 gudrun.wagner@meduniwien.ac.at
Austria
 
 
NCT02480907
FA765A0304
No
Not Provided
Not Provided
Dr. Andreas Karwautz, Medical University of Vienna
Medical University of Vienna
Pharmig - Gemeinsame Gesundheitsziele aus dem Rahmen-Pharmavertrag
Study Director: Andreas Karwautz, MD, Prof Medical University Vienna
Study Director: Gudrun Wagner, Mag, Dr Medical University Vienna
Medical University of Vienna
September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP