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Supporting Carers of Children and Adolescents with Eating Disorders in Austria (SUCCEAT): Study protocol for a randomised controlled trial.

ABSTRACT: Supporting Carers of Children and Adolescents with Eating Disorders in Austria (SUCCEAT) is an intervention for carers of children and adolescents with anorexia nervosa and atypical anorexia nervosa. This paper describes the study protocol for a randomised controlled trial including the process and economic evaluation. Carers are randomly allocated to one of the 2 SUCCEAT intervention formats, either 8 weekly 2-hr workshop sessions (n = 48) or web-based modules (n = 48), and compared with a nonrandomised control group (n = 48). SUCCEAT includes the cognitive-interpersonal model, cognitive behavioural elements, and motivational interviewing. The goal is to provide support for carers to improve their own well-being and to support their children. Outcome measures include carers' distress, anxiety, depression, expressed emotions, needs, motivation to change, experiences of caregiving, and skills. Further outcome measures are the patients' eating disorder symptoms, emotional problems, behavioural problems, quality of life, motivation to change, and perceived expressed emotions. These are measured before and after the intervention, and 1-year follow-up.

SUBMITTER: Franta C

PROVIDER: S-EPMC6175075 | biostudies-literature | 2018 Sep

REPOSITORIES: biostudies-literature

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Supporting Carers of Children and Adolescents with Eating Disorders in Austria (SUCCEAT): Study protocol for a randomised controlled trial.

Franta Claudia C Philipp Julia J Waldherr Karin K Truttmann Stefanie S Merl Elisabeth E Schöfbeck Gabriele G Koubek Doris D Laczkovics Clarissa C Imgart Hartmut H Zanko Annika A Zeiler Michael M Treasure Janet J Karwautz Andreas A Wagner Gudrun G

European eating disorders review : the journal of the Eating Disorders Association 20180506 5

Supporting Carers of Children and Adolescents with Eating Disorders in Austria (SUCCEAT) is an intervention for carers of children and adolescents with anorexia nervosa and atypical anorexia nervosa. This paper describes the study protocol for a randomised controlled trial including the process and economic evaluation. Carers are randomly allocated to one of the 2 SUCCEAT intervention formats, either 8 weekly 2-hr workshop sessions (n = 48) or web-based modules (n = 48), and compared with a nonr ...[more]

PMID: 29732651

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Project description:IntroductionAdolescent eating patterns are characterised by high consumption of unhealthy foods, which has resulted in an increasing prevalence of overweight and chronic diseases. It is crucial to promote healthy eating habits, and nutritional interventions based on the transtheoretical model have been found to be especially effective. Mobile health strategies also seem promising for adolescents. This study aims to outline a smartphone intervention via WhatsApp for adolescents to promote healthy eating consumption, better nutritional knowledge, self-efficacy in the adoption of healthy practices and progress through the stages of change.Methods and analysisThere will be three distinct groups in this randomised study: a general intervention group (GG), in which the participants will receive the same healthy eating messages, based on the Brazilian food guide; a tailored intervention group (TG), in which the participants will receive healthy eating messages based on their stage of change; and a control group (CG), in which participants will receive messages on a different theme. Possession of a smartphone, use of WhatsApp and being a senior student (16-19 years) from a public school of the Federal District of Brazil will be the study's inclusion criteria. Rural schools will be excluded. The sample size estimated is 390 individuals: 38 in the GG, 314 in the TG and 38 in the CG. The intervention will last 6 weeks, with a daily message sent to the students. We will investigate nutritional knowledge, self-efficacy in the adoption of healthy eating practices, food consumption and stages of change using preintervention and postintervention questionnaires. Memorisation of the messages will be also assessed.Ethics and disseminationThe study was approved by the University of Brasília, School of Health Sciences and Research Ethics Committee. At the end of the study, the participating schools will receive a printed report with the main results of the intervention.Trial registration numberRBR-5b9jk7.

Project description:Previous research has suggested that music therapy may facilitate skills in areas typically affected by autism spectrum disorders such as social interaction and communication. However, generalisability of previous findings has been restricted, as studies were limited in either methodological accuracy or the clinical relevance of their approach. The aim of this study is to determine effects of improvisational music therapy on social communication skills of children with autism spectrum disorders. An additional aim of the study is to examine if variation in dose of treatment (i.e., number of music therapy sessions per week) affects outcome of therapy, and to determine cost-effectiveness.Children aged between 4;0 and 6;11 years who are diagnosed with autism spectrum disorder will be randomly assigned to one of three conditions. Parents of all participants will receive three sessions of parent counselling (at 0, 2, and 5 months). In addition, children randomised to the two intervention groups will be offered individual, improvisational music therapy over a period of five months, either one session (low-intensity) or three sessions (high-intensity) per week. Generalised effects of music therapy will be measured using standardised scales completed by blinded assessors (Autism Diagnostic Observation Schedule, ADOS) and parents (Social Responsiveness Scale, SRS) before and 2, 5, and 12 months after randomisation. Cost effectiveness will be calculated as man years. A group sequential design with first interim look at N = 235 will ensure both power and efficiency.Responding to the need for more rigorously designed trials examining the effectiveness of music therapy in autism spectrum disorders, this pragmatic trial sets out to generate findings that will be well generalisable to clinical practice. Addressing the issue of dose variation, this study's results will also provide information on the relevance of session frequency for therapy outcome.Current Controlled Trials ISRCTN78923965.

Project description:BackgroundFamily members of relatives with eating disorders experience high levels of distress due to the difficulties in their care giving role. However no measures have been developed to measure the specific impact that an individual with an eating disorder has on family life. The aim of this study was to develop a measure to assess the specific caregiving burden of both anorexia nervosa and bulimia nervosa. A secondary aim was to examine whether this measure was sensitive to change.MethodsA new scale, the Eating Disorders Symptom Impact Scale (EDSIS), was generated by a panel of clinicians and researchers based upon quantitative and qualitative work with carers and reviewed by a panel of "expert carers". A cross-sectional study was conducted among carers of relatives with an eating disorder to examine the properties of the new scale. In addition, participants from an ongoing pre-and-post design study completed several self-report questionnaires to assess the sensitivity of the EDSIS to change.ResultsA sample of 196 carers of relatives with an eating disorder aged 25-68 compted the scale. A 24-item EDSIS scale was derived with four factors: nutrition, guilt, dysregulated behaviour and social isolation. These explained 58.4% of the variance in carer distress. Reliability was acceptable (Cronbach's alpha ranged from 0.84 to 0.90). The convergent validity of the EDSIS subscales was moderately supported by correlations with a general caregiving measure (Experience of Caregiving Inventory (ECI), r = 0.42 to 0.60), psychological distress (General Health Questionnaire (GHQ-12), r = 0.33) and perceived functioning of the relative (Children Global Assessment Scale (CGAS), r = -30). A sample of 57 primary caregivers completed pre-post intervention assessments and the overall scale (t = 2.3, p < 0.05) and guilt subscale (t = 3.4, p < 0.01) were sensitive to change following a skills training workshop.ConclusionThe EDSIS instrument has good psychometric properties and may be of value to assess the impact of eating disorder symptoms on family members. It may be of value to highlight carers' needs and to monitor the effectiveness of family based interventions.

Project description:IntroductionReducing length of hospital stay for stroke survivors often creates a shift in the responsibility of care towards informal carers. Adjustment to the caregiving process is experienced by many carers as overwhelming, complex and demanding and can have a detrimental impact on mental and physical health and well-being. National policy guidelines recommend that carers' needs are considered and addressed; despite this, few interventions have been developed and empirically evaluated. We developed a biopsychosocial intervention in collaboration with carers of stroke survivors. Our aim is to determine whether the intervention can be delivered in a group setting and evaluated using a randomised controlled trial (RCT).Methods and analysisFeasibility RCT and nested qualitative interview study. We aim to recruit up to 40 stroke carers within 1?year of the stroke onset. Carers are randomised to usual care or usual care plus biopsychosocial intervention. Each intervention group will consist of five stroke carers. The intervention will focus on: psychoeducation, psychological adjustment to stroke, strategies for reducing unwanted negative thoughts and emotions and problem-solving strategies. The main outcome is the feasibility of conducting an RCT. Carer outcomes at 6?months include: anxiety and depression, quality of life and carer strain. Data are also collected from stroke survivors at baseline and 6?months including: level of disability, anxiety and depression, and quality of life.Ethics and disseminationFavourable ethical opinion was provided by East Midlands - Nottingham2 Research Ethics Committee (14/EMI/1264). This study will determine whether delivery of the biopsychosocial intervention is feasible and acceptable to stroke carers within a group format. It will also determine whether it is feasible to evaluate the effects of the biopsychosocial intervention in an RCT. We will disseminate our findings through peer-reviewed publications and presentations at national and international conferences.Trial registration numberISRCTN15643456; Pre-results.

Project description:Background:Parent carers of disabled children are at increased risk of mental and physical health problems. They often experience challenges to maintaining good health which have implications for their well-being and their ability to care for their children. In response to these needs, researchers and parent carers developed the Healthy Parent Carers (HPC) programme. It is a peer-led, group-based intervention that promotes behaviours associated with health and well-being. The aims of this trial are to assess the acceptability of the HPC programme and the feasibility of its delivery in the community and to assess the feasibility and acceptability of the design of the definitive trial to evaluate the programme's effectiveness and cost-effectiveness. Methods:We will establish six research sites and train facilitators to deliver the manualised intervention. Parent carers of children with special educational needs and disabilities will be individually randomised, stratified by group delivery site, to either take part in a group programme and online resources (intervention) or to receive access to the online resources only (control). Measures of mental health; well-being; health-related quality of life; health behaviours; patient activation; protective factors such as resilience, social connections, and practical support; and use of health care, social care, and wider societal resources will be collected before randomisation (baseline), immediately post-intervention, and 6 months later. Recruitment of participants, adherence to the programme, and the dose received will be assessed. Group sessions will be audio-recorded to evaluate the fidelity of delivery and participant engagement. Participants' and facilitators' feedback on the programme content and delivery, their experience, and the acceptability of the outcome measures and trial design will be collected through feedback forms, interviews, and focus groups. Discussion:This trial will assess whether the programme delivery and evaluative trial design are feasible, to inform whether to progress to a definitive randomised controlled trial to test the effectiveness and cost-effectiveness of the Healthy Parent Carers programme. Trial registration:ISRCTN, ISRCTN151144652, registered on 25 October 2018; ClinicalTrials.gov, NCT03705221, registered on 15 October 2018.

Project description:INTRODUCTION:Antipsychotic treatment in early-onset schizophrenia (EOS) lacks a rich evidence base, and efforts to rank different drugs concerning their efficacy have not proven any particular drug superior. In contrast to the literature regarding adult-onset schizophrenia (AOS), comparative effectiveness studies in children and adolescents are limited in number and size, and only a few meta-analyses based on conventional methodologies have been conducted. METHODS AND ANALYSES:We will conduct a network meta-analysis of all randomised controlled trials (RCTs) that evaluate antipsychotic therapies for EOS to determine which compounds are efficacious, and to determine the relative efficacy and safety of these treatments when compared in a network meta-analysis. Unlike a contrast-based (standard) meta-analysis approach, an arm-based network meta-analysis enables statistical inference from combining both direct and indirect comparisons within an empirical Bayes framework. We will acquire eligible studies through a systematic search of MEDLINE, the Cochrane Central Registry of Controlled Trials, Clinicaltrials.gov and Centre for Reviews and Dissemination databases. Eligible studies should randomly allocate children and adolescents presenting with schizophrenia or a related non-affective psychotic condition to an intervention group or to a control group. Two reviewers will-independently and in duplicate-screen titles and abstracts, complete full text reviews to determine eligibility, and subsequently perform data abstraction and assess risk of bias of eligible trials. We will conduct meta-analyses to establish the effect of all reported therapies on patient-relevant efficacy and safety outcomes when possible. ETHICS AND DISSEMINATION:No formal ethical procedures regarding informed consent are required as no primary data collection is undertaken. The review will help facilitate evidence-based management, identify key areas for future research, and provide a framework for conducting large systematic reviews combining direct and indirect comparisons. The study will be disseminated by peer-reviewed publication and conference presentation. TRIAL REGISTRATION NUMBER:PROSPERO CRD42013006676.

Dataset Information

Supporting Carers of Children and Adolescents with Eating Disorders in Austria (SUCCEAT): Study protocol for a randomised controlled trial.

Publications

Supporting Carers of Children and Adolescents with Eating Disorders in Austria (SUCCEAT): Study protocol for a randomised controlled trial.

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