Clinical trial NCT02480907: Supporting Carers of Children and Adolescents With Eating Disorders in Austria (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
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health
Keywords: eating disorders
caregivers
parents
skills training
workshops
support
internet
online
family
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
Collaborators: name: Pharmig - Gesundheitsziele aus dem Rahmen-Pharmavertrag
First posted: 2015-06-25
Enrollment: 144
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Psychological morbidity and distress in caregivers are measured with the "Gerneral Health Questionnaire - 12"
timeFrame: 15 months
Secondary outcomes:
measure: Emotional problems in caregivers will be measured with the "Beck Depression Inventory" (measures the severity of Depression)
timeFrame: 15 months
measure: Emotional problems in caregivers will be measured with the "State- Trait Anxiety Inventory"
timeFrame: 15 months
measure: Emotional Problems will be measured with the "The Family-Questionnaire" (measures the emotional climate within the Family)
timeFrame: 15 months
measure: Emotional problems in caregivers will be measured with the "Symptom Checklist-90-Revised" (measures psychological problems and symptoms of psychopathology)
timeFrame: 15 months
measure: 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)
timeFrame: 15 months
measure: 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)
timeFrame: 15 months
measure: 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)
timeFrame: 15 months
measure: Needs of carers will be measured with the "Carers' Needs Assessment Measure" (measures the needs of carers of patients with an eating disorder)
timeFrame: 15 months
measure: Caregiving appraisal will be measured with the "Experience of Caregiving Inventory" (measures general aspects of care giving experiences)
timeFrame: 15 months
measure: Behavioural and emotional problems in patients are measured via the "Youth self Report"
timeFrame: 15 months
measure: Emotional Problems in patients are measured via the "Family Emotional Involvement and Criticism Scale" (measures expressed emotions)
timeFrame: 15 months
measure: 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).
timeFrame: 15 months
measure: 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)
timeFrame: 15 months
measure: 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)
timeFrame: 15 months
measure: Feasibility and Acceptability of the workshops and online modules (Treatment Satisfaction Questionnaire, developed by our research group)
timeFrame: 15 months
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna, Dep. of Child and Adolescent Psychiatry
Study officials:
affiliation: Medical University Vienna
name: Andreas Karwautz, MD, Prof
role: STUDY_DIRECTOR
affiliation: Medical University Vienna
name: Gudrun Wagner, Mag, Dr
role: STUDY_DIRECTOR
References:
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.