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

Primary Purpose

Mental Health

Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Workshop Group
Internet-based support group
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mental Health focused on measuring eating disorders, caregivers, parents, skills training, workshops, support, internet, online, family

Eligibility Criteria

10 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

Workshop Group

Internet-based support group

Control group - TAU

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Emotional problems in caregivers will be measured with the "Beck Depression Inventory" (measures the severity of Depression)
Questionnaire
Emotional problems in caregivers will be measured with the "State- Trait Anxiety Inventory"
Questionnaire
Emotional Problems will be measured with the "The Family-Questionnaire" (measures the emotional climate within the Family)
Questionnaire
Emotional problems in caregivers will be measured with the "Symptom Checklist-90-Revised" (measures psychological problems and symptoms of psychopathology)
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)
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)
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)
Questionnaire
Needs of carers will be measured with the "Carers' Needs Assessment Measure" (measures the needs of carers of patients with an eating disorder)
Questionnaire
Caregiving appraisal will be measured with the "Experience of Caregiving Inventory" (measures general aspects of care giving experiences)
Questionnaire
Behavioural and emotional problems in patients are measured via the "Youth self Report"
Questionnaire
Emotional Problems in patients are measured via the "Family Emotional Involvement and Criticism Scale" (measures expressed emotions)
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).
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)
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)
Questionnaire
Feasibility and Acceptability of the workshops and online modules (Treatment Satisfaction Questionnaire, developed by our research group)
Questionnaire

Full Information

First Posted
April 7, 2015
Last Updated
March 5, 2019
Sponsor
Medical University of Vienna
Collaborators
Pharmig - Gesundheitsziele aus dem Rahmen-Pharmavertrag
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1. Study Identification

Unique Protocol Identification Number
NCT02480907
Brief Title
Supporting Carers of Children and Adolescents With Eating Disorders in Austria (SUCCEAT)
Acronym
SUCCEAT
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
September 2014 (Actual)
Primary Completion Date
March 5, 2019 (Actual)
Study Completion Date
March 5, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna
Collaborators
Pharmig - Gesundheitsziele aus dem Rahmen-Pharmavertrag

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Health
Keywords
eating disorders, caregivers, parents, skills training, workshops, support, internet, online, family

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
144 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Workshop Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Internet-based support group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control group - TAU
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Workshop Group
Intervention Description
Workshop support group
Intervention Type
Behavioral
Intervention Name(s)
Internet-based support group
Intervention Description
Internet based support group with E-mail coaching
Primary Outcome Measure Information:
Title
Psychological morbidity and distress in caregivers are measured with the "Gerneral Health Questionnaire - 12"
Description
Questionnaire
Time Frame
15 months
Secondary Outcome Measure Information:
Title
Emotional problems in caregivers will be measured with the "Beck Depression Inventory" (measures the severity of Depression)
Description
Questionnaire
Time Frame
15 months
Title
Emotional problems in caregivers will be measured with the "State- Trait Anxiety Inventory"
Description
Questionnaire
Time Frame
15 months
Title
Emotional Problems will be measured with the "The Family-Questionnaire" (measures the emotional climate within the Family)
Description
Questionnaire
Time Frame
15 months
Title
Emotional problems in caregivers will be measured with the "Symptom Checklist-90-Revised" (measures psychological problems and symptoms of psychopathology)
Description
Questionnaire
Time Frame
15 months
Title
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)
Description
Questionnaire
Time Frame
15 months
Title
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)
Description
Questionnaire
Time Frame
15 months
Title
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)
Description
Questionnaire
Time Frame
15 months
Title
Needs of carers will be measured with the "Carers' Needs Assessment Measure" (measures the needs of carers of patients with an eating disorder)
Description
Questionnaire
Time Frame
15 months
Title
Caregiving appraisal will be measured with the "Experience of Caregiving Inventory" (measures general aspects of care giving experiences)
Description
Questionnaire
Time Frame
15 months
Title
Behavioural and emotional problems in patients are measured via the "Youth self Report"
Description
Questionnaire
Time Frame
15 months
Title
Emotional Problems in patients are measured via the "Family Emotional Involvement and Criticism Scale" (measures expressed emotions)
Description
Questionnaire
Time Frame
15 months
Title
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).
Description
Questionnaire
Time Frame
15 months
Title
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)
Description
Interview
Time Frame
15 months
Title
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)
Description
Questionnaire
Time Frame
15 months
Title
Feasibility and Acceptability of the workshops and online modules (Treatment Satisfaction Questionnaire, developed by our research group)
Description
Questionnaire
Time Frame
15 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Karwautz, MD, Prof
Organizational Affiliation
Medical University Vienna
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Gudrun Wagner, Mag, Dr
Organizational Affiliation
Medical University Vienna
Official's Role
Study Director
Facility Information:
Facility Name
Medical University of Vienna, Dep. of Child and Adolescent Psychiatry
City
Vienna
ZIP/Postal Code
1090
Country
Austria

12. IPD Sharing Statement

Citations:
PubMed Identifier
29732651
Citation
Franta C, Philipp J, Waldherr K, Truttmann S, Merl E, Schofbeck G, Koubek D, Laczkovics C, Imgart H, Zanko A, Zeiler M, Treasure J, Karwautz A, Wagner G. Supporting Carers of Children and Adolescents with Eating Disorders in Austria (SUCCEAT): Study protocol for a randomised controlled trial. Eur Eat Disord Rev. 2018 Sep;26(5):447-461. doi: 10.1002/erv.2600. Epub 2018 May 6.
Results Reference
derived
Links:
URL
http://www.ess-stoerung.eu
Description
related Information

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

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