Challenging BehaviourNCT03390868
Effects of a Web-based Training Programme Focusing on Challenging Behaviour
A study testing Web-based training for staff in people with Challenging Behaviour, run by Umeå University at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 67 years
- Conditions the study is for
- Challenging Behaviour
- What is being tested?
- Web-based training for staff
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 1 siteSweden
- Study dates
- 10 Jan 2018to 15 Nov 2018
- 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 18 to 67 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- staff working at special accommodation for people with intellectual disabilities.
- Language: swedish
Who cannot join
- staff working short-term temporary agencies at the accommodation for people with intellectual disabilities.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a Web-based Training Programme for Professional Carers Working With People With Learning Disabilities Who Exhibit Challenging Behaviour
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.
Read more
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.
Read the 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.
- Conditions
- Challenging Behaviour
- Being tested
- Web-based training for staff
- Keywords
- Interaction, challenging behaviour, training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-based training for staffBehavioural
This web-based training program is focusing on strengthening the carers' communication skills. Video lectures on the definitions, characteristics and causes of challenging behavior 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 program also includes written cases that gives the participants opportunities to reflect upon approaches supporting a successful interaction. It also covers factors to consider when mental illness and challenging behavior occur. The time to complete the web-based training program is estimated at approximately ten hours.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | Phase 1, participants in the intervention group will take part in an web-based training for staff working with people with intellectual disabilities and challenging behaviour aiming to in a more effective way communicate to prevent challenging behaviour. The participants (staff) will by their own, go through the web-based training program during working hours. Measurement are conducted before intervention, at intervention completion an average of 12 weeks, and for a 3 month follow up after completed intervention Receives: Behavioral: Web-based training for staff |
| control arm | Other | Control arm: participants in the control-group will maintain regular care and have the opportunity to receive the web-based training for staff working with people with intellectual disabilities and challenging behaviour in phase 2. Receives: Behavioral: Web-based training for staff |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in communication- and interactivity skills and ability to handle challenging behaviour after web-based training program
Changes in communication- and interactivity skills and ability to handle challenging behaviour after web-based training program with The checklist of Challenging Behaviour
Measured: Before intervention, at intervention completion an average of 12 weeks, and for a 3 month follow up after completed intervention.
Secondary outcomes (3)
Ways of Coping Questionnaire
Change in coping strategies and practical problem solving with Ways of Coping Questionnaire (WOCQ). Measuring 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 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.
Measured: Before intervention, at intervention completion an average of 12 weeks, and for a 3 month follow up after completed intervention.
The Job Demand-Control and Social Support
The Job Demand-Control and Social Support (JDC-S). The 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.
Measured: Before intervention, at intervention completion an average of 12 weeks, and for a 3 month follow up after completed intervention.
The Controllability Belief Scale
Changes in values and approaches to reduce challenging behavior with The Controllability Belief Scale. 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).
Measured: Before intervention, at intervention completion an average of 12 weeks, and for a 3 month follow up after completed intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2018
- Study start10 Jan 2018
- Primary completion15 Oct 2018
- Study completion15 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Challenging BehaviourStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Intervention arm: web-based training for staff working with people with intellectuall disabilities and challenging behaviour Other: control arm
- Masking
- None (open label)
- Enrolment
- 212 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Collaborators
- University West, Sweden
- Responsible party
- Principal investigator, Helena Antonsson, Umeå University
- Investigators
- Helena Antonsson, Phd, Principal investigator, Umea UniversityCatrin Alverbratt, Phd, Principal investigator, University West
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03390868
- Sponsor's protocol ID
- Challenging behaviour
- Status last verified
- Nov 2019
- First submitted
- 29 Dec 2017
- Last updated
- 2 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Antonsson H, Graneheim UH, Isaksson U, Astrom S, Lundstrom MO. Evaluation of a Web-Based Training Program for Professional Carers Working With People With Learning Disabilities and Challenging Behavior: A Pilot Study with SSED-Design. Issues Ment Health Nurs. 2016 Oct;37(10):734-743. doi: 10.1080/01612840.2016.1189636. Epub 2016 Jun 28.
PubMed 27351080Farrell GA, Shafiei T, Salmon P. Facing up to 'challenging behaviour': a model for training in staff-client interaction. J Adv Nurs. 2010 Jul;66(7):1644-55. doi: 10.1111/j.1365-2648.2010.05340.x. Epub 2010 May 21.
PubMed 20497267Farrell GA, Salmon P. Challenging behaviour: an action plan for education and training. Contemp Nurse. 2009 Dec-2010 Jan;34(1):110-8. doi: 10.5172/conu.2009.34.1.110.
PubMed 20230177Jenkins R, Rose J, Jones T. The Checklist of Challenging Behaviour and its relationship with the Psychopathology Inventory for Mentally Retarded Adults. J Intellect Disabil Res. 1998 Aug;42 ( Pt 4):273-8. doi: 10.1046/j.1365-2788.1998.00131.x.
PubMed 9786441Joyce T, Ditchfield H, Harris P. Challenging behaviour in community services. J Intellect Disabil Res. 2001 Apr;45(Pt 2):130-8. doi: 10.1046/j.1365-2788.2001.00331.x.
PubMed 11298252Sanne B, Mykletun A, Dahl AA, Moen BE, Tell GS. Testing the Job Demand-Control-Support model with anxiety and depression as outcomes: the Hordaland Health Study. Occup Med (Lond). 2005 Sep;55(6):463-73. doi: 10.1093/occmed/kqi071. Epub 2005 Apr 21.
PubMed 15845554Pellfolk TJ, Gustafson Y, Bucht G, Karlsson S. Effects of a restraint minimization program on staff knowledge, attitudes, and practice: a cluster randomized trial. J Am Geriatr Soc. 2010 Jan;58(1):62-9. doi: 10.1111/j.1532-5415.2009.02629.x.
PubMed 20122041Dagnan D, Hull A, McDonnell A. The controllability beliefs scale used with carers of people with intellectual disabilities: psychometric properties. J Intellect Disabil Res. 2013 May;57(5):422-8. doi: 10.1111/j.1365-2788.2012.01554.x. Epub 2012 Apr 4.
PubMed 22471440Folkman S, Moskowitz JT. Coping: pitfalls and promise. Annu Rev Psychol. 2004;55:745-74. doi: 10.1146/annurev.psych.55.090902.141456.
PubMed 14744233Folkman S, Lazarus RS. The relationship between coping and emotion: implications for theory and research. Soc Sci Med. 1988;26(3):309-17. doi: 10.1016/0277-9536(88)90395-4.
PubMed 3279520Padyab, Backteman-Erlanson & Brulin. Burnout, Coping, Stress of Conscience and Psychosocial Work Environment among Patrolling Police Officers Journal of Police and Criminal Psychology December 2016, Volume 31, Issue 4, pp 229-237|
Dagnan, D., Grant, F., & McDonnell, A. (2004). Understanding challenging behaviour in older people; the development of the Controllability Beliefs Scale. Behavioural and Cognitive Psychotherapy, 32, 501-506.
Gore, N., & Umizawa, H. (2011). Challenging behavior training for teaching staff and family carers of children with intellectual disabilities: A preliminary evaluation. Journal of Policy and Practice in Intellectual Disabilities, 8, 266-275.
Harris, P., Humphreys, J., & Thomson, G. (1994). A checklist of challenging behaviour: The development of a survey instrument. Mental Handicap Research, 7, 118-133
Karasek, R., & Theorell, T. (1992). Healthy work: Stress, productivity and the reconstruction of working life. New York, NY: Basic Books.
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Web-based Training Programme for Professional Carers Working With People With Learning Disabilities Who Exhibit Challenging Behaviour
- ClinicalTrials.gov ID
- NCT03390868
- Acronym / sponsor ID
- Challenging behaviour
- Conditions
- Challenging Behaviour
- Keywords
- Interaction, challenging behaviour, training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 212 participants (actual)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Collaborators
- University West, Sweden
- Study start
- 10 Jan 2018 (actual)
- Primary completion
- 15 Oct 2018 (actual)
- Study completion
- 15 Nov 2018 (actual)
- First posted
- 4 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Intervention arm: web-based training for staff working with people with intellectuall disabilities and challenging behaviour Other: control arm
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Behavioral: Web-based training for staffPhase 1, participants in the intervention group will take part in an web-based training for staff working with people with intellectual disabilities and challenging behaviour aiming to in a more effective way communicate to prevent challenging behaviour. The participants (staff) will by their own, go through the web-based training program during working hours. Measurement are conducted before intervention, at intervention completion an average of 12 weeks, and for a 3 month follow up after completed intervention |
| control arm | Other | Behavioral: Web-based training for staffControl arm: participants in the control-group will maintain regular care and have the opportunity to receive the web-based training for staff working with people with intellectual disabilities and challenging behaviour in phase 2. |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- staff working at special accommodation for people with intellectual disabilities.
- Language: swedish
Key exclusion criteria (1 listed)
- staff working short-term temporary agencies at the accommodation for people with intellectual disabilities.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Web-based training for staffThis web-based training program is focusing on strengthening the carers' communication skills. Video lectures on the definitions, characteristics and causes of challenging behavior 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 program also includes written cases that gives the participants opportunities to reflect upon approaches supporting a successful interaction. It also covers factors to consider when mental illness and challenging behavior occur. The time to complete the web-based training program is estimated at approximately ten hours. | Behavioural | Intervention arm, control arm |
Primary outcome
Changes in communication- and interactivity skills and ability to handle challenging behaviour after web-based training program
Time frame: Before intervention, at intervention completion an average of 12 weeks, and for a 3 month follow up after completed intervention.
Changes in communication- and interactivity skills and ability to handle challenging behaviour after web-based training program with The checklist of Challenging Behaviour
3 secondary outcomes
Ways of Coping Questionnaire
Time frame: Before intervention, at intervention completion an average of 12 weeks, and for a 3 month follow up after completed intervention.
The Job Demand-Control and Social Support
Time frame: Before intervention, at intervention completion an average of 12 weeks, and for a 3 month follow up after completed intervention.
The Controllability Belief Scale
Time frame: Before intervention, at intervention completion an average of 12 weeks, and for a 3 month follow up after completed intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2019.
- Background: PubMed 27351080Antonsson H, Graneheim UH, Isaksson U, Astrom S, Lundstrom MO. Evaluation of a Web-Based Training Program for Professional Carers Working With People With Learning Disabilities and Challenging Behavior: A Pilot Study with SSED-Design. Issues Ment Health Nurs. 2016 Oct;37(10):734-743. doi: 10.1080/01612840.2016.1189636. Epub 2016 Jun 28.
- Background: PubMed 20497267Farrell GA, Shafiei T, Salmon P. Facing up to 'challenging behaviour': a model for training in staff-client interaction. J Adv Nurs. 2010 Jul;66(7):1644-55. doi: 10.1111/j.1365-2648.2010.05340.x. Epub 2010 May 21.
- Background: PubMed 20230177Farrell GA, Salmon P. Challenging behaviour: an action plan for education and training. Contemp Nurse. 2009 Dec-2010 Jan;34(1):110-8. doi: 10.5172/conu.2009.34.1.110.
- Background: PubMed 9786441Jenkins R, Rose J, Jones T. The Checklist of Challenging Behaviour and its relationship with the Psychopathology Inventory for Mentally Retarded Adults. J Intellect Disabil Res. 1998 Aug;42 ( Pt 4):273-8. doi: 10.1046/j.1365-2788.1998.00131.x.
- Background: PubMed 11298252Joyce T, Ditchfield H, Harris P. Challenging behaviour in community services. J Intellect Disabil Res. 2001 Apr;45(Pt 2):130-8. doi: 10.1046/j.1365-2788.2001.00331.x.
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- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helena Antonsson, Phd principal investigator
Umea University
Catrin Alverbratt, Phd principal investigator
University West
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Web-based training for staff in people with Challenging Behaviour, run by Umeå University at 1 site in Sweden.
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 2 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 2 Dec 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 Sweden. 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?
Changes in communication- and interactivity skills and ability to handle challenging behaviour after web-based training program (time frame: Before intervention, at intervention completion an average of 12 weeks, and for a 3 month follow up after completed intervention.). 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 NCT03390868, which also lists 17 linked publications.
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 2 Dec 2019.