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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02480907
Other study ID # FA765A0304
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2014
Est. completion date March 5, 2019

Study information

Verified date March 2019
Source Medical University of Vienna
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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) CarersĀ“ 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.


Recruitment information / eligibility

Status Completed
Enrollment 144
Est. completion date March 5, 2019
Est. primary completion date March 5, 2019
Accepts healthy volunteers No
Gender All
Age group 10 Years to 18 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Workshop Group
Workshop support group
Internet-based support group
Internet based support group with E-mail coaching

Locations

Country Name City State
Austria Medical University of Vienna, Dep. of Child and Adolescent Psychiatry Vienna

Sponsors (2)

Lead Sponsor Collaborator
Medical University of Vienna Pharmig - Gesundheitsziele aus dem Rahmen-Pharmavertrag

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary Psychological morbidity and distress in caregivers are measured with the "Gerneral Health Questionnaire - 12" Questionnaire 15 months
Secondary Emotional problems in caregivers will be measured with the "Beck Depression Inventory" (measures the severity of Depression) Questionnaire 15 months
Secondary Emotional problems in caregivers will be measured with the "State- Trait Anxiety Inventory" Questionnaire 15 months
Secondary Emotional Problems will be measured with the "The Family-Questionnaire" (measures the emotional climate within the Family) Questionnaire 15 months
Secondary Emotional problems in caregivers will be measured with the "Symptom Checklist-90-Revised" (measures psychological problems and symptoms of psychopathology) Questionnaire 15 months
Secondary 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 15 months
Secondary 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 15 months
Secondary 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 15 months
Secondary Needs of carers will be measured with the "Carers' Needs Assessment Measure" (measures the needs of carers of patients with an eating disorder) Questionnaire 15 months
Secondary Caregiving appraisal will be measured with the "Experience of Caregiving Inventory" (measures general aspects of care giving experiences) Questionnaire 15 months
Secondary Behavioural and emotional problems in patients are measured via the "Youth self Report" Questionnaire 15 months
Secondary Emotional Problems in patients are measured via the "Family Emotional Involvement and Criticism Scale" (measures expressed emotions) Questionnaire 15 months
Secondary 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 15 months
Secondary 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 15 months
Secondary 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 15 months
Secondary Feasibility and Acceptability of the workshops and online modules (Treatment Satisfaction Questionnaire, developed by our research group) Questionnaire 15 months
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