AzTrials
AzTrials

Mental HealthSUCCEATNCT02480907

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

A study testing Workshop Group and Internet-based support group in people with Mental Health, run by Medical University of Vienna at 1 site in Austria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 10 to 18 years
Conditions the study is for
Mental Health
What is being tested?
Workshop Group and Internet-based support group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
144 participants
Where
1 siteAustria
Study dates
Sep 2014to 5 Mar 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • children and adolescents aged 10-18, who suffer from anorexia or bulimia nervosa and their primary caregivers

Who cannot join

  • no written informed consent possible due to intelligence or no willingness by parents to include minor

Trial locations and contacts

1 site in 1 country.

Austria1 site

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

    Vienna, 1090

Other trials in Austria

About this study

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

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.

Read the 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.

Conditions
Mental Health
Being tested
Workshop Group, Internet-based support group
Keywords
eating disorders, caregivers, parents, skills training, workshops, support, internet, online, family
Medical subject headings
Psychological Well-Being, Feeding and Eating Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Workshop GroupBehavioural

    Workshop support group

  • Internet-based support groupBehavioural

    Internet based support group with E-mail coaching

Study groups in NCT02480907
Study groupRoleWhat they receive
Workshop GroupActive comparatorParents 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.
Receives: Behavioral: Workshop Group
Internet-based support groupActive comparatorParents 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.
Receives: Behavioral: Internet-based support group
Control group - TAUNo interventionParents 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 being measured

The primary outcome is the main question the study is designed to answer.

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

    Questionnaire

    Measured: 15 months

Secondary outcomes (15)

  1. Emotional problems in caregivers will be measured with the "Beck Depression Inventory" (measures the severity of Depression)

    Questionnaire

    Measured: 15 months

  2. Emotional problems in caregivers will be measured with the "State- Trait Anxiety Inventory"

    Questionnaire

    Measured: 15 months

  3. Emotional Problems will be measured with the "The Family-Questionnaire" (measures the emotional climate within the Family)

    Questionnaire

    Measured: 15 months

  4. Emotional problems in caregivers will be measured with the "Symptom Checklist-90-Revised" (measures psychological problems and symptoms of psychopathology)

    Questionnaire

    Measured: 15 months

  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)

    Questionnaire

    Measured: 15 months

  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)

    Questionnaire

    Measured: 15 months

  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)

    Questionnaire

    Measured: 15 months

  8. Needs of carers will be measured with the "Carers' Needs Assessment Measure" (measures the needs of carers of patients with an eating disorder)

    Questionnaire

    Measured: 15 months

  9. Caregiving appraisal will be measured with the "Experience of Caregiving Inventory" (measures general aspects of care giving experiences)

    Questionnaire

    Measured: 15 months

  10. Behavioural and emotional problems in patients are measured via the "Youth self Report"

    Questionnaire

    Measured: 15 months

  11. Emotional Problems in patients are measured via the "Family Emotional Involvement and Criticism Scale" (measures expressed emotions)

    Questionnaire

    Measured: 15 months

  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).

    Questionnaire

    Measured: 15 months

  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)

    Interview

    Measured: 15 months

  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)

    Questionnaire

    Measured: 15 months

  15. Feasibility and Acceptability of the workshops and online modules (Treatment Satisfaction Questionnaire, developed by our research group)

    Questionnaire

    Measured: 15 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jun 2015 (estimated)
  2. Study startSep 2014
  3. Primary completion5 Mar 2019
  4. Study completion5 Mar 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
144 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02480907
Sponsor's protocol ID
FA765A0304
Acronym
SUCCEAT
Status last verified
Mar 2019
First submitted
7 Apr 2015
Last updated
7 Mar 2019
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 29732651

Questions about this trial

What is this clinical trial studying?

A study testing Workshop Group and Internet-based support group in people with Mental Health, run by Medical University of Vienna at 1 site in Austria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Psychological morbidity and distress in caregivers are measured with the "Gerneral Health Questionnaire - 12" (time frame: 15 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02480907, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2019.

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