Clinical trial NCT03390868: Effects of a Web-based Training Programme Focusing on Challenging Behaviour
Official title: Effects of a Web-based Training Programme for Professional Carers Working With People With Learning Disabilities Who Exhibit Challenging Behaviour
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Challenging Behaviour
Keywords: Interaction
challenging behaviour
training
Lead sponsor: Umeå University
Sponsor class: OTHER
Collaborators: name: University West, Sweden
First posted: 2018-01-04
Enrollment: 212
Sex: ALL
Minimum age (years): 18
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Intervention arm: web-based training for staff working with people with intellectuall disabilities and challenging behaviour Other: control arm
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: A literature review shows that the interaction between adult persons with intellectual disabilities and professional carers is a complex combination of verbal and non-verbal expressions. Attempts to communicate often lead to misunderstandings from both parties, as well as challenging behaviors such as aggression and violence. The literature shows that challenging behavior often leads to physical constraints. Literature studies also emphasize the importance of education, knowledge and support for staff. Therefore, we want to investigate whether it is possible to reduce challenging behavior through education on causes of challenging behavior and successful interaction for carers in special housing.

Aim: To study the effects of a web-based training program to increase staff's ability to better communicate and interact with persons with intellectual disabilities and challenging behaviors.

Method: The study has a cross-sectional design.

Intervention: The intervention was inspired by an evidence-based conceptual model for staff training in challenging behaviour. The intervention consists of a web-based training program, available for all carers working in special accommodations for people with intellectual disabilities.

The web-based training program focuses on strengthening the carers' communication skills. Video lectures on the definitions, characteristics and causes of challenging behaviour will be given. Video lectures will also be given on the importance of the carers' views on their values, emotions, abilities and attitude towards people with intellectual disabilities, and on the impact that workplace culture and environmental factors have on the quality of interactions. The web-based training program also includes written cases that gives the participants an opportunity to reflect upon approaches supporting a successful interaction. It also covers factors to consider when mental illness and challenging behaviour occur. The web-based training program includes the opportunity to follow the carers' activity regarding time and frequency of studying. The time to complete the web-based training program is estimated at approximately ten hours.

Context: The study will be conducted in twenty special community-based accommodations, group-homes, in Sweden that each houses 4-8 residents. The residents has their own private rooms, but shares a communal space with a living room and a kitchen with a dining table. The staff in the group-homes is working independently with the manager located at distance.

Participants:The carers 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.

Procedure: Prior to handing out the questionnaires, staff will receive information regarding the study and that participation is voluntary. The questionnaires will be distributed in hand and returned in pre-paid envelopes. Two reminders will be sent out to the participants. The project is approved by The Regional Ethical Review Board in Gothenburg, approval number; 355-17. 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. A project group is established with representatives from the Social Services authorities and the researchers. The implementation of the intervention will be discussed in the project group every second month throughout the study period.

Instruments: This study is planned into three phases. Baseline measures using the Checklist of Challenging Behaviour (CCB). This instrument is translated from English to Swedish and re-translated by experts in the field. It describes 32 observed behaviours relating to CB, for example, verbal, and physical aggression. Scores for items on the instrument range from 1 (the behaviour has not occurred) to 5 (the behaviour occurs daily or more often). The CCB has an acceptable level of content validity and reliability. In the second phase, the intervention will be implemented. The third phase will take place after the intervention with a follow-up period directly after the intervention and after approximately three months in order to analyse effects of the intervention.

At baseline and at follow-up, the instruments will be handed out to the carers to answer. The Job Demand-Control and Social Support (JDC-S) instrument. The JDC-S is a commonly used for investigating psychosocial working environments. This instrument has three major dimensions. First, it measures job demands, which includes psychological stressors such as time pressure, and item scores range from 1 to 4, with higher values indicating higher demands. Second, it measures job control on a scale of 1 to 4, with higher values indicating more perceived control over the job situation. Third, it measures social support, again on a scale of 1 to 4, with higher values indicating higher perceived support from co-workers and managers. In the JDC-S, high demands and low control indicate a high job strain. According to Cronbach's alpha a level of 0.73 for the dimension job demands, 0.52 for job control, and 0.81 for social support was reported.

The Controllability Beliefs Scale (CBS) is a 15-item instrument measuring the attribution of control in situations with CB. This instrument was used to measure carers' values and approaches to people with LD. Items were scored on a 5-point scale with anchored ratings from strongly agree (1) to strongly disagree (5). A two-factor structure, suggesting positive and negative attributions of control, and good internal reliability (Cronbach's alpha for total score = 0.89, 0.92 for the negative subscale and 0.73 for the positive subscale).

The Ways of Coping Questionnaire (WOCQ) measured the use of coping strategies employed by the carers. The instrument was used in this study to measure the intervention's effects in reducing feelings such as shame and guilt in the carers and in strengthening professional care. In this 40-item version of the WOCQ, translated into Swedish, participants were asked to reflect upon how they would manage specific challenging situations. The items were divided into emotion-focused coping skills and problem-focused coping skills. Each subscale was answered on a 4-point Likert scale ranging from (0) does not apply to (3) used a great deal. The instrument was used and tested in a Swedish context with a Cronbach's alpha ranging from 0.63 to 0.89 and has shown acceptable values (\> 0.7) on all subscales except for the subscales confrontational coping (0.59) and self-controlling (0.47).

Statistical analysis: Data processing and statistical calculations will be performed in the Statistical Package for Social Sciences (SPSS 23) statistics. 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.

Eligibility criteria: Inclusion Criteria:

* staff working at special accommodation for people with intellectual disabilities.
* Language: swedish

Exclusion Criteria:

* staff working short-term temporary agencies at the accommodation for people with intellectual disabilities.

Primary outcomes:
measure: Changes in communication- and interactivity skills and ability to handle challenging behaviour after web-based training program
timeFrame: Before intervention, at intervention completion an average of 12 weeks, and for a 3 month follow up after completed intervention.
Secondary outcomes:
measure: Ways of Coping Questionnaire
timeFrame: Before intervention, at intervention completion an average of 12 weeks, and for a 3 month follow up after completed intervention.
measure: The Job Demand-Control and Social Support
timeFrame: Before intervention, at intervention completion an average of 12 weeks, and for a 3 month follow up after completed intervention.
measure: The Controllability Belief Scale
timeFrame: Before intervention, at intervention completion an average of 12 weeks, and for a 3 month follow up after completed intervention.
Other outcomes:
Locations:
city: Trollhattan
country: Sweden
facility: University West
Study officials:
affiliation: Umea University
name: Helena Antonsson, Phd
role: PRINCIPAL_INVESTIGATOR
affiliation: University West
name: Catrin Alverbratt, Phd
role: PRINCIPAL_INVESTIGATOR
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