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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 - Gesundheitsziele aus dem Rahmen-Pharmavertrag
Information provided by (Responsible Party):
Dr. Andreas Karwautz, Medical University of Vienna

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Mental Health Behavioral: Workshop Group Behavioral: Internet-based support group Not Applicable

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : September 2014
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Behavioral: Workshop Group
Workshop support 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.
Behavioral: Internet-based support group
Internet based support group with E-mail coaching

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.



Primary Outcome Measures :
  1. Psychological morbidity and distress in caregivers are measured with the "Gerneral Health Questionnaire - 12" [ Time Frame: 15 months ]
    Questionnaire


Secondary Outcome Measures :
  1. Emotional problems in caregivers will be measured with the "Beck Depression Inventory" (measures the severity of Depression) [ Time Frame: 15 months ]
    Questionnaire

  2. Emotional problems in caregivers will be measured with the "State- Trait Anxiety Inventory" [ Time Frame: 15 months ]
    Questionnaire

  3. Emotional Problems will be measured with the "The Family-Questionnaire" (measures the emotional climate within the Family) [ Time Frame: 15 months ]
    Questionnaire

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. Caregiving appraisal will be measured with the "Experience of Caregiving Inventory" (measures general aspects of care giving experiences) [ Time Frame: 15 months ]
    Questionnaire

  10. Behavioural and emotional problems in patients are measured via the "Youth self Report" [ Time Frame: 15 months ]
    Questionnaire

  11. Emotional Problems in patients are measured via the "Family Emotional Involvement and Criticism Scale" (measures expressed emotions) [ Time Frame: 15 months ]
    Questionnaire

  12. 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

  13. 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

  14. 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

  15. Feasibility and Acceptability of the workshops and online modules (Treatment Satisfaction Questionnaire, developed by our research group) [ Time Frame: 15 months ]
    Questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02480907


Contacts
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

Locations
Austria
Medical University of Vienna, Dep. of Child and Adolescent Psychiatry Recruiting
Vienna, Austria, 1090
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   
Principal Investigator: Andreas Karwautz, MD, Prof         
Sub-Investigator: Gudrun Wagner, Mag, Dr         
Sponsors and Collaborators
Medical University of Vienna
Pharmig - Gesundheitsziele aus dem Rahmen-Pharmavertrag
Investigators
Study Director: Andreas Karwautz, MD, Prof Medical University Vienna
Study Director: Gudrun Wagner, Mag, Dr Medical University Vienna

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Andreas Karwautz, Univ. Prof. Dr., Medical University of Vienna
ClinicalTrials.gov Identifier: NCT02480907     History of Changes
Other Study ID Numbers: FA765A0304
First Posted: June 25, 2015    Key Record Dates
Last Update Posted: October 2, 2017
Last Verified: September 2017

Keywords provided by Dr. Andreas Karwautz, Medical University of Vienna:
eating disorders
caregivers
parents
skills training
workshops
support
internet
online
family

Additional relevant MeSH terms:
Feeding and Eating Disorders
Mental Disorders