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Challenging Behaviour clinical trials

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NCT ID: NCT03390868 Completed - Clinical trials for Challenging Behaviour

Effects of a Web-based Training Programme Focusing on Challenging Behaviour

Start date: January 10, 2018
Phase: N/A
Study type: Interventional

The interaction between people with intellectual disabilities and professional carers is often influenced by communicative difficulties contributing challenging behaviours. Aim: The aim of this study is to evaluate a web-based training program aimed at improving carers' abilities to interact with people with learning disabilities who exhibit challenging behaviours and to explore carers' experiences of participating in such a program. Method: This study has a cross-sectional design. Sample: The study will be conducted in twenty special community-based accommodations, group-homes, in Sweden that each houses 4-8 residents. The staff in the group-homes is working independently with the manager located at distance.The staff (N=221) in this study works with people with intellectual disabilities who has different functional levels, from moderate to profound intellectual disabilities. They have different educational backgrounds: from basic nursing education at the college level to university degree. Intervention: The intervention consists of a web-based training program, available for all staff working in special accommodations for people with intellectual disabilities. The web-based training program focuses on strengthening the carers' communication skills. Procedure: The social Services authorities and the managers from each home agreed to the project. The carers have given their informed consent to attend the study. The participants will by their own during working hour go through the web-based program. The time to complete the web-based training program is estimated at approximately ten hours. Data-analysis: Descriptive statistics will be used for demographic data. Proportions will be compared to the chi-square test. The mean values between the groups will be compared by t-test or Mann-Whitney's U-test, as appropriate. Changes in the mean between and in the groups will be compared with paired t-test. Double-sided significance test will be used throughout. Data will be presented at a group level.

NCT ID: NCT03086876 Completed - Clinical trials for Challenging Behaviour

Evaluation of Parent Intervention for Challenging Behaviour in Children With Intellectual Disabilities (EPICC-ID)

Start date: June 1, 2017
Phase: N/A
Study type: Interventional

Children with intellectual disabilities are likely to present with challenging behaviour. Parent mediated interventions have shown utility in influencing child behaviour, although there is a paucity of UK research into challenging behaviour interventions in this population. NICE guidelines favour Stepping Stones Triple P (SSTP) as a challenging behaviour intervention and this trial aims to evaluate its clinical and cost effectiveness in preschool children with moderate to severe intellectual disabilities.The trial launched in 2017 at four sites across England, with the aim of recruiting 258 participants (aged 30-59 months). The Intervention Group receive nine weeks of SSTP parenting therapy (six group sessions and three individualised face to face or telephone sessions) in addition to Treatment as Usual (TAU) whilst the TAU group receive available services in each location. Both study groups undergo the study measurements at baseline and at four and twelve months. Outcome measures include parent reports and structured observations of behaviour. Service use and health related quality of life data is also being collected to carry out a cost effectiveness and utility evaluation. Findings from this study will inform policy regarding interventions for challenging behaviour in young children with moderate to severe intellectual disabilities.

NCT ID: NCT01680276 Active, not recruiting - Clinical trials for Challenging Behaviour

Clinical and Cost Effectiveness of Positive Behaviour Support: a Trial

PBS
Start date: November 2012
Phase: Phase 3
Study type: Interventional

Many people with intellectual disability have challenging behaviour which often has serious consequences such as the prescription of long term medication, in-patient admissions and disruption of normal daily activities. Community intellectual disability services may have difficulties in helping people with challenging behavior. Available research suggests that Positive Behavior Support (PBS), a training system that teaches staff how to manage these situations, can benefit service users who may show improvements in challenging behavior and quality of life. The investigators do not know of any study so far that has examined the clinical and cost effectiveness of PBS that is provided by staff in routine clinical practice in community intellectual disability services. If PBS proved to be better than treatment as usual, it would have important implications for the management of a very vulnerable group of service users. In this trial, health staff will receive accredited training in PBS available in a manual written by PBS experts. It will give details of how to understand challenging behavior and develop a management plan and how to implement it and monitor whether it has achieved its goals. Twenty community intellectual disability services and 260 service users with mild to severe intellectual disability and challenging behavior will be invited to take part in the study. The sample size calculations are based on our pilot study and allow for non participation of 10% and inflation due to the number of community intellectual disability teams and staff that will take part. The teams will be randomly allocated into one of two conditions. Half will be in the PBS arm (but will also have treatment as usual) and half will be in the treatment as usual only group. The investigators will carry out assessments of challenging behavior, use of services, quality of life, mental health, aggression and family and paid carer burden at six and 12 months. The investigators will monitor treatment fidelity and the investigators will talk to a sample of paid and family carers, service users, staff and managers about what they think of the treatment and how best the investigators can deliver it in routine care. The main outcome is reduction in challenging behavior at one year after the randomization. The investigators will also carry out a health economic evaluation to examine the costs and consequences of staff training in PBS.