ISRCTN ISRCTN53763600
DOI https://doi.org/10.1186/ISRCTN53763600
Secondary identifying numbers 2.0
Submission date
20/10/2015
Registration date
08/12/2015
Last edited
04/01/2023
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
Research findings suggest that around one in six people with a learning disability (LD) are thought to have “challenging behaviours” (CB). CB may include aggression towards others, destruction of property and even self-harm. These behaviours are rated, based on how much they affect the sufferer (i.e. injury or exclusion from a community) and those around them (i.e. physical harm and stress). Some studies have shown that the way that support staff and carers in residential homes behave towards people with LD could actually trigger CB and even make it worse, through negative attitudes, prejudice, and lack of understanding and empathy. “Who’s Challenging Who?” (WCW) is a training programme which has been developed to help staff become more empathetic to those with learning disabilities so that they can better deal with challenging behaviours. The aim of this study is to see how effective the WCW programme is at improving staff attitudes and empathy towards residents with LD who show CB.

Who can participate?
Staff of community-based residential homes that cater to people with learning disabilities.

What does the study involve?
The residential homes are randomly allocated to one of two groups. For those in the first group, the social care staff of the residential home receives the WCW training. This training involves a half-day session given jointly by a trainer with a learning disability and a trainer without a learning disability. At the end of the training session, attendees develop an action plan with the trainers about improvements they can make when they return to work. Those in the second group (control group) are put on a waiting list for the length study period. After the study period, the residential homes in the second group are offered the WCW training, although no additional data is collected. Participants in both groups complete a number of questionnaires to test their empathy and confidence dealing with challenging behaviours at the start of the study, after 6 weeks and after 20 weeks.

What are the possible benefits and risks of participating?
Participants may benefit as they may be able to better empathise with those with learning disabilities as a result of this training. There are no risks of taking part in this study.

Where is the study run from?
118 residential services for people with learning disabilities in the UK

When is the study starting and how long is it expected to run for?
July 2015 to November 2017

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Prof. Richard Hastings
R.Hastings@warwick.ac.uk

Contact information

Prof Richard Hastings
Scientific

Centre for Educational Development, Appraisal, and Research (CEDAR)
Coventry
CV4 7AL
United Kingdom

Phone +44 (0)24 7652 2912
Email R.Hastings@warwick.ac.uk

Study information

Study designMulti-centre cluster randomised controlled trial
Primary study designInterventional
Secondary study designCluster randomised trial
Study setting(s)Other
Study typeOther
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleWho’s Challenging Who: a cluster randomised controlled trial to test the effectiveness of a staff training intervention to improve support staff attitudes and empathy towards adults with learning disability and challenging behaviours
Study objectivesThe Who's Challenging Who training programme will increase staff attitudes (empathy) towards residents with challenging behaviour.
Ethics approval(s)Social Care Regional Ethics Committee, 12/05/2015, ref: 15/IEC08/0030.
Health condition(s) or problem(s) studiedPeople with a learning disability (LD) and challenging behaviours (CB)
InterventionThe study will be a cluster randomised controlled trial. Residential group homes will be randomised to either:

Group 1: Homes immediately receive the "Who’s Challenging Who" (WCW) training
Group 2: Homes have delayed access to WCW training (i.e. as a waiting list control group)

In both arms of the trial, staff will continue to receive training as usual (on LD social care and specifically on CB if provided) following their organisations’ ongoing staff development policies. Outcome measures will be collected prior to randomisation (at baseline), at 6 weeks post-randomisation (following WCW training), and then again at 20 weeks post-randomisation. Following the 20 week follow-up data collection, staff in the residential homes from the waiting list control arm of the study will be offered the WCW training.

WCW was developed jointly with people with LD and CB and the training course is fully manualised. Trainers with LD and CB are trained to deliver WCW using a process that is also manualised (Co-Trainer Training). WCW training covers the following topics (from the perspective of people with LD and CB):

1. Communication and how staff listening can prevent escalation of CB
2. How the living environment contributes to frustration and CB
3. The experience of being physically restrained
4. What it is like to be on medication “for” CB
5. Experiences of feeling excluded because of CB
6. Unhelpful attitudes and behaviour of care staff, and a discussion of positive qualities that contribute to good support/care
Intervention typeBehavioural
Primary outcome measureStaff empathy for people with challenging behaviour is measured using the "Staff Empathy towards those whose Behaviour Challenges" questionnaire at baseline, 6 and 20 weeks post randomisation
Secondary outcome measures1. Staff confidence in dealing with challenging behaviours is measured using Challenging Behaviour Self-Efficacy Scale at baseline, 6 and 20 weeks post randomisation
2. Staff attitudes towards people with challenging behaviours is measured using Similarity and Empowerment attitude scales from the Community Living Attitude Scales at baseline, 6 and 20 weeks post randomisation
3. Staff work-related burnout is measured using Maslach Burnout Inventory – Human Services version at baseline and 20 weeks post randomisation
4. Staff work related positive experiences is measured using Short version of the Staff Positive Perceptions Questionnaire at baseline, 6 and 20 weeks post randomisation
5. Recorded incidents of challenging behaviour and use of restrictive practices in each residential home is measured by A count of the total number of incidents of challenging behaviour noted in the records of a residential home at baseline and 20 weeks post randomisation
Overall study start date01/07/2015
Completion date29/06/2017

Eligibility

Participant type(s)Carer
Age groupAdult
SexBoth
Target number of participants236 social care staff participants from 118 residential homes (clusters)
Key inclusion criteriaInclusion criteria for residential homes:
1. Provides services via English publically funded contracts (Local Authorities, CCGs)
2. Provides support to between one and 10 people with LD
3. The home staff provide at least some support 24 hours for the people with LD
4. The residential home is in a community setting
5. Provides care for at least one person with LD who engages in aggressive challenging behaviour
6. The residential home manager (or equivalent lead staff member) and one other support staff member can be released attend a WCW training session together

Inclusion criteria for the staff:
1. One staff member will be the group home manager or other lead staff member (as defined by the service provider organisation)
2. The second staff member will be a direct support worker whose role is no more than 50% in administrative/staff management tasks
3. Both staff work the equivalent of .70 FTE or more
Key exclusion criteriaCurrent exclusion criteria as of 27/09/2017:
Exclusion criteria for the residential homes:
1. “Inpatient” hospital facility (typically NHS or independent providers)
2. The manager does not receive approval from the service provider organisation for the residential home to be a part of the study

Exclusion criteria for staff:
1. Staff do not provide their consent to take part in the research
2. English reading skills that prevent completion of the questionnaire measures

Previous exclusion criteria:
Exclusion criteria for the residential homes:
1. “Inpatient” hospital facility (typically NHS or independent providers)
2. The manager does not receive approval from the service provider organisation for the residential home to be a part of the study
3. Home is more than 150 miles round trip by car from the University of Warwick

Exclusion criteria for staff:
1. Staff do not provide their consent to take part in the research
2. English reading skills that prevent completion of the questionnaire measures
Date of first enrolment01/11/2015
Date of final enrolment31/08/2016

Locations

Countries of recruitment

  • England
  • United Kingdom
  • Wales

Study participating centres

Centre for Educational Development, Appraisal, and Research (CEDAR)
University of Warwick
Coventry
CV4 7AL
United Kingdom
Centre for Trials Research, Cardiff Unviersity
7th Floor Neuadd Meirionnydd
Heath Park
Cardiff
CF14 4YS
United Kingdom

Sponsor information

University of Warwick
University/education

-
Coventry
CV4 7AL
England
United Kingdom

Website http://www2.warwick.ac.uk/
ROR logo "ROR" https://ror.org/01a77tt86

Funders

Funder type

Government

National Institute for Health Research
Government organisation / National government
Alternative name(s)
National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Location
United Kingdom

Results and Publications

Intention to publish date31/12/2017
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
Publication and dissemination planAll publications and presentations relating to the study will be authorised by the Research Management Group. The study report will be used for publication and presentation at scientific meetings. Investigators have the right to publish orally or in writing results of the study, subject to contract conditions with the NIHR School for Social Care Research. Published results will not contain any personal data that could allow identification of individual participants. Summaries of results will be sent to participants and participating services, after the findings have been accepted through the peer review process.
IPD sharing planThe data sharing plans for the current study are unknown and will be made available at a later date.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/09/2018 Yes No
Protocol article 05/10/2017 04/01/2023 Yes No
HRA research summary 28/06/2023 No No

Editorial Notes

04/01/2023: Publication reference added.
13/03/2020: Internal review.
26/07/2018: Publication reference added.
27/09/2017: The overall trial end date was changed from 01/11/2017 to 29/06/2017.