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

March 5, 2019 updated by: Dr. Andreas Karwautz, Medical University of Vienna

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

144

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Medical University of Vienna, Dep. of Child and Adolescent Psychiatry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Psychological morbidity and distress in caregivers are measured with the "Gerneral Health Questionnaire - 12"
Time Frame: 15 months
Questionnaire
15 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Emotional problems in caregivers will be measured with the "Beck Depression Inventory" (measures the severity of Depression)
Time Frame: 15 months
Questionnaire
15 months
Emotional problems in caregivers will be measured with the "State- Trait Anxiety Inventory"
Time Frame: 15 months
Questionnaire
15 months
Emotional Problems will be measured with the "The Family-Questionnaire" (measures the emotional climate within the Family)
Time Frame: 15 months
Questionnaire
15 months
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
15 months
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
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)
Time Frame: 15 months
Questionnaire
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)
Time Frame: 15 months
Questionnaire
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)
Time Frame: 15 months
Questionnaire
15 months
Caregiving appraisal will be measured with the "Experience of Caregiving Inventory" (measures general aspects of care giving experiences)
Time Frame: 15 months
Questionnaire
15 months
Behavioural and emotional problems in patients are measured via the "Youth self Report"
Time Frame: 15 months
Questionnaire
15 months
Emotional Problems in patients are measured via the "Family Emotional Involvement and Criticism Scale" (measures expressed emotions)
Time Frame: 15 months
Questionnaire
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).
Time Frame: 15 months
Questionnaire
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)
Time Frame: 15 months
Interview
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)
Time Frame: 15 months
Questionnaire
15 months
Feasibility and Acceptability of the workshops and online modules (Treatment Satisfaction Questionnaire, developed by our research group)
Time Frame: 15 months
Questionnaire
15 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2014

Primary Completion (Actual)

March 5, 2019

Study Completion (Actual)

March 5, 2019

Study Registration Dates

First Submitted

April 7, 2015

First Submitted That Met QC Criteria

June 22, 2015

First Posted (Estimate)

June 25, 2015

Study Record Updates

Last Update Posted (Actual)

March 7, 2019

Last Update Submitted That Met QC Criteria

March 5, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FA765A0304

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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