Personalised treatment packages for adults with a learning disability
| ISRCTN | ISRCTN71781827 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN71781827 |
| IRAS number | 316749 |
| Secondary identifying numbers | IRAS 316749, CPMS 53581 |
- Submission date
- 15/08/2022
- Registration date
- 16/11/2022
- Last edited
- 09/04/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
The PETAL programme is designed to help adults with a learning disability who display aggression and those who support them work together to better understand and meet the person’s individual needs. Although there are some issues that are commonly experienced, everyone is different, so a personalised approach is needed. 10-25% of adults with mild to severe learning disabilities display aggression. This behaviour affects their quality of life, leading to exclusion from social networks and community facilities including access to healthcare, placement breakdown, inability to stay in the family home, seclusion, overmedication etc.
A better understanding of the causes of an individual’s aggressive behaviour and coproducing a personalised treatment package could make a significant difference to their quality of life. We work with adults with a learning disability and their families and paid carers to develop the PETAL therapy to address aggression and test if it works better than the current approaches available.
Who can participate?
Adults with learning disabilities and their carers (family or paid)
What does the study involve?
The PETAL therapy has four phases which are presented below:
1. Review the evidence about which psychosocial treatments for aggression work for adults with learning disabilities and for other client groups. We reviewed the manuals and how they are delivered.
2. Talk to adults with a learning disability who have good outcomes, and those with poorer outcomes, their family or paid carers and professionals. With those who reported things went well, we asked why they thought that was so. Where it did not go so well and explored what might have been more helpful.
3. Use routinely collected NHS data to assess how adults with a learning disability who display aggression respond to treatments. This enabled us to better understand what influences patient outcomes and to inform the design of PETAL therapy.
4. Use the findings from 1, 2 and 3, and worked with adults with learning disabilities, carers and professionals, to develop a personalised treatment package called PETAL therapy. We developed a manual. We will train NHS staff in how to deliver the personalised treatment package and will test whether it is practical and acceptable, making changes if needed.
5. Find out, in a large trial, whether the personalised treatment package makes a positive difference to the health and quality of life of adults with a learning disability and how cost-effective it is.
What are the possible benefits and risks of participating?
There are a number of potential benefits to this study. At the moment, there is not a consistent approach to the management of aggression in adults with intellectual disabilities across the UK. If the PETAL therapy is effective, then it could be rolled out in all NHS services for adults with intellectual disabilities. Without evidence, we cannot convince health and social care services to change their usual practices. In addition, professionals, family, and paid carers would have gained special skills to better support adults with intellectual disabilities with aggressive challenging behaviour. There are no identified disadvantages to taking part in this research. Nonetheless, there is a time commitment to attend the PETAL therapy sessions over a period of 14 weeks. In addition, each research visit and interview might last for about 1 hour. If you find the PETAL therapy sessions, the research visits, or the interview too long, you may request a break.
Where is the study run from?
North London NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
October 2021 to September 2025
Who is funding the study?
National Institute for Health and Care Research (UK)
Who is the main contact?
Prof. Angela Hassiotis, a.hassiotis@ucl.ac.uk
Contact information
Principal Investigator
Division of Psychiatry
Maple House
149 Tottenham Court Road
London
W1T 7NF
United Kingdom
 ORCID ID |
0000-0002-9800-3909 |
|---|---|
| Phone | +44 (0)2079743788 |
| a.hassiotis@ucl.ac.uk |
Public
Trial manager
Division of Psychiatry
University College London
149 Tottenham Court Road
London
W1T 7NF
United Kingdom
| Phone | +44 (0)20 7679 9319 |
|---|---|
| rebecca.griffiths@ucl.ac.uk |
Scientific
Programme manager
Division of Psychiatry
University College London
149 Tottenham Court Road
London
W1T 7NF
United Kingdom
| ORCID ID |
0000-0002-9901-2284 |
|---|---|
| Phone | +44 (0)203 108 7815 |
| r.royston@ucl.ac.uk |
Study information
| Study design | Cluster randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | Community |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Personalised treatment packages for adults with learning disabilities who display aggression in community settings: A cluster randomised controlled trial (PETAL therapy) |
| Study acronym | PETAL therapy |
| Study hypothesis | The PETAL therapy alongside usual care significantly reduces aggressive challenging behaviour in adults with intellectual disability compared to usual care alone at 9 months post-randomisation |
| Ethics approval(s) | Approved 31/10/2022, Health and Care Research Wales (Castlebridge 4, Cardiff, CF11 9AB, Wales, UK; +44 (0)2920 230457; HCRW.approvals@wales.nhs.uk, Wales.REC7@wales.nhs.uk), ref: 22/WA/0267 |
| Condition | Intellectual disability |
| Intervention | Current interventions as of 03/01/2024: We will randomise clusters (i.e., community learning disability services) to one of the two intervention arms. Intervention arms: The PETAL therapy alongside usual care. The PETAL therapy for aggressive challenging behaviour is a manualised personalised multicomponent package. It has been developed following a realist review of the evidence, qualitative interviews with people who had received an intervention for aggressive challenging behaviour, previous work by the co-applicant group and consultation with experts and experts by experience (i.e., family carers and people with intellectual disability). The PETAL therapy includes 7 modules and 2 review sessions that need to be completed within 14 weeks. The duration of each module can last up to 2 hours. The duration may differ depending on the person and their needs (i.e., some people may only be able to manage 40-minute sessions) and some people may need several breaks during the session. Sessions will be dyadic (the person with a learning disability and a family or paid carer). Control arm: Usual care alone. That means any care that is available within services across the UK. Previous interventions: We will randomise clusters (i.e., community learning disability services) to one of the two intervention arms. Intervention arms: The PETAL therapy alongside usual care. The PETAL therapy for aggressive challenging behaviour is a manualised personalised multicomponent package. It has been developed following a realist review of the evidence, qualitative interviews with people who had received an intervention for aggressive challenging behaviour, previous work by the co-applicant group and consultation with experts and experts by experience (i.e., family carers and people with intellectual disability). The PETAL therapy includes 7 modules and 2 review sessions that need to be completed within 14 weeks. The duration of each module can last up to 2 hours. The duration may differ depending on the person and their needs (i.e., some people may only be able to manage 40-minute sessions) and some people may need several breaks during the session. Sessions will be dyadic or triadic (with or without a carer or the adult with the intellectual disability). Control arm: Usual care alone. That means any care that is available within services across the UK. |
| Intervention type | Behavioural |
| Primary outcome measure | Aggressive challenging behaviour measured using the Aberrant Behaviour Checklist irritability scale (ABC-I) at baseline, and 4 and 9 months follow up |
| Secondary outcome measures | Current secondary outcome measures as of 09/06/2023: 1. Episodes of physical aggression measured using the Behaviour Problems Inventory-short (BPI-S) at baseline, and 4 and 9 months follow up 2. Risk measured using the Threshold Assessment Grid (TAG) at baseline, and 4 and 9 months follow up 3. Family carer and paid carer confidence in managing aggression measured using the Difficult Behaviour Self-Efficacy scale at baseline, and 4 and 9 months follow up 4. Family carer wellbeing measured using the Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) at baseline, and 4 and 9 months follow up 5. Family carer Social Care Related Quality of Life measured using the Adult Social Care Outcomes Toolkit (ASCOT) at baseline, and 4 and 9 months follow up 6. Service use and medications measured using the Client Service Receipt Inventory (CSRI) at baseline, and 4 and 9 months follow up 7. Adult with intellectual disability health-related quality of life measured using the EuroQoL five Dimensions Scale (EQ-5D-3L) proxy and EuroQoL EQ-5D Learning disability (EQ-5D-LD) at baseline, and 4 and 9 months follow up Other measures 1. Demographic data collected at baseline only 2. Clinical characteristics, including general ability of the person with an intellectual disability measured using the Adaptive Behaviour Scale-Short Version (ABS-S) at baseline only 3. Mental health status measured using the Moss Psychiatric Assessment Schedules (Moss-PAS (ID); formerly known as mini PAS-ADD), at baseline only 4. Adverse Events will be collected at 4 and 9 months follow up 5. Other therapies received by participant will be collected at baseline only 6. Staffing per team will be collected at baseline only _____ Previous secondary outcome measures: 1. Episodes of physical aggression measured using the Behaviour Problems Inventory-short (BPI-S) at baseline, and 4 and 9 months follow up 2. Mental health status measured using the Moss Psychiatric Assessment Schedules (Moss-PAS (ID); formerly known as mini PAS-ADD), at baseline, and 4 and 9 months follow up 3. Risk measured using the Threshold Assessment Grid (TAG) at baseline, and 4 and 9 months follow up 4. Family carer and paid carer confidence in managing aggression measured using the Difficult Behaviour Self-Efficacy scale at baseline, and 4 and 9 months follow up 5. Family carer wellbeing measured using the Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) at baseline, and 4 and 9 months follow up 6. Family carer Social Care Related Quality of Life measured using the Adult Social Care Outcomes Toolkit (ASCOT) at baseline, and 4 and 9 months follow up 7. Paid and family carer distress measured using the Kessler Psychological Distress Scale (K6) at baseline, and 4 and 9 months follow up 8. Service use and medications measured using the Client Service Receipt Inventory (CSRI) at baseline, and 4 and 9 months follow up 9. Adult with intellectual disability health-related quality of life measured using the EuroQoL five Dimensions Scale (EQ-5D) proxy at baseline, and 4 and 9 months follow up 10. Demographic data collected at baseline only 11. Clinical characteristics, including general ability of the person with an intellectual disability measured using the Adaptive Behaviour Scale-Short Version (ABS-S) at baseline, and 4 and 9 months follow up 12. Adverse Events measured using data recorded in the study log at baseline, 4 and 9 months follow up |
| Overall study start date | 01/10/2021 |
| Overall study end date | 30/09/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 410 |
| Participant inclusion criteria | Current inclusion criteria as of 09/06/2023: 1. Aged 18 years or over 2. Living in the community (e.g., residential care home, supported living, family home) 3. Registered with and/or eligible to receive support from community learning disabilities services 4. Incidents of physical aggression to people or property for at least 3 months. It is likely that people will have several additional comorbid behaviours such as verbal aggression, mental health problems, self-injury, stereotypies etc. 5. Consent to participate provided in keeping with UK capacity legislation or assent from family/nominated consultees for those lacking capacity 6. Family carer/other member able to understand English _____ Previous inclusion criteria: 1. Aged 18 years old and over living in the community 2. Being under the care of a community intellectual disability service 3. Having a diagnosis of intellectual disability diagnosis by community intellectual disability service 4. Weekly incidents of physical aggression to people or property over 3 months 5. Consent to participate provided in keeping with UK capacity legislation or assent from their family/nominated consultees for those lacking capacity 6. Family carer able to understand English or questionnaire version available in the participant’s language. |
| Participant exclusion criteria | Current exclusion criteria as of 09/06/2023: 1. Currently being an inpatient 2. Alcohol or drug dependent 3. Current enrolment in another clinical trial _____ Previous exclusion criteria: 1. Not having an intellectual disability diagnosis 2. Alcohol or drug dependent 3. Current enrolment in another clinical trial |
| Recruitment start date | 26/01/2024 |
| Recruitment end date | 30/09/2025 |
Locations
Countries of recruitment
- England
- Northern Ireland
- Scotland
- United Kingdom
- Wales
Study participating centres
St. Pancras Hospital
4 St. Pancras Way
London
NW1 0PE
United Kingdom
Dryden Road
Exeter
EX2 5AF
United Kingdom
Bowthorpe Road
Norwich
NR2 3TU
United Kingdom
Upper Newtownards Road
Dundonald
Belfast
BT16 1RH
United Kingdom
Altnagelvin Area Hospital Site
Glenshane Road
Londonderry
BT47 6SB
United Kingdom
Craigavon Area Hospital
68 Lurgan Road, Portadown
Craigavon
BT63 5QQ
United Kingdom
180-194 High Street
Teddington
TW11 8HU
United Kingdom
Long Leys Road
Lincoln
LN1 1FS
United Kingdom
9 Alie Street
London
E1 8DE
United Kingdom
County Hall
Leicester Road
Leicester
LE3 8RA
United Kingdom
Sandford Road
Littlemore
Oxford
OX4 4XN
United Kingdom
Heights Lane
Bradford
BD9 6DP
United Kingdom
22 Hollyfield Road
Surbiton
KT5 9AL
United Kingdom
C E M E Centre
Marsh Way
Rainham
RM13 8GQ
United Kingdom
West Park Hospital
Edward Pease Way
Darlington
DL2 2TS
United Kingdom
Bracknell
RG12 1LH
United Kingdom
Martineau Lane
Norwich
NR1 2DH
United Kingdom
Beaconsfield Close
Hatfield
AL10 8YE
United Kingdom
Fulbourn Hospital
Fulbourn
Cambridge
CB21 5EF
United Kingdom
Ashton-under-lyne
OL6 7SR
United Kingdom
Holt Street
Birmingham Science Park, Aston
Birmingham
B7 4BN
United Kingdom
77 London Road
Kettering
NN15 7PW
United Kingdom
London
SE1 2TZ
United Kingdom
Sponsor information
Hospital/treatment centre
Noclor NHS Research Office
Regis Road
London
NW5 3EG
England
United Kingdom
| contact.noclor@nhs.net | |
| Website | https://www.noclor.nhs.uk/ |
Funders
Funder type
Government
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 date | 01/06/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in publicly available repository |
| Publication and dissemination plan | Planned publication in high-impact and peer-reviewed journal Additional forms of dissemination of findings and engagement with the public and professional stakeholders include the following: 1. Contribution via publications to clinical guidelines, e.g., NICE 2. Presentations at scientific and professional, conferences and meetings on a local, national, and international level including those that address service user and parent/paid carer groups 3. A leaflet summarising the main results of the study will be disseminated to participants and services (sites) that participated in the study. We will also consider making short videos about the programme to enhance accessibility and increase audience reach. Dissemination will be in easy-read and plain English language to enhance accessibility. If family members of some participants have no understanding of English, we can provide a translated study summary. 4. The project website will contain information about the programme, links to published articles and progress reports 5. Newsletters will be produced and sent to all participants and participating services every six months 6. Social media such as Twitter will be used to increase programme visibility and to communicate with the wider scientific and clinical community 7. We will utilise the contacts and network of all co-applicants in order to access policymakers and other influencers and engage a wide audience 8. We will liaise with the communications departments of participating organisations to prepare briefings of the findings for policymakers and commissioners 9. A one-day dissemination event for the main results of the programme with invitees from a variety of stakeholders (carers, adults with intellectual disabilities), NHS England, clinicians, and commissioners of services |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a publicly available repository |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
09/04/2025: The following changes were made to the trial record:
1. The sponsor details were changed from Camden and Islington NHS Foundation Trust to North London NHS Foundation Trust.
2. The recruitment start date was changed from 14/12/2023 to 26/01/2024.
3. The recruitment end date was changed from 14/04/2025 to 30/09/2025.
4. The study participating centre Camden and Islington NHS FT was removed and North London NHS Foundation Trust, Devon Partnership NHS Trust, Norfolk Community Health and Care NHS Trust, South Eastern Health and Social Care Trust, Western Health and Social Care Trust, Southern Health and Social Care Trust, Hounslow and Richmond Community Healthcare NHS Trust, Lincolnshire Partnership NHS Foundation Trust, East London NHS Foundation Trust, Leicestershire Partnership NHS Trust, Oxford Health NHS Foundation Trust, Bradford District Care Trust, Yourhealthcare Community Interest Company, North East London NHS Foundation Trust, Tees, Esk and Wear Valleys NHS Foundation Trust, Berkshire Healthcare NHS Trust Headquarters, Norfolk and Suffolk NHS Foundation Trust, Hertfordshire Partnership University NHS Foundation Trust, Cambridgeshire and Peterborough NHS Foundation Trust, Pennine Care NHS Foundation Trust, Birmingham Community Healthcare NHS Foundation Trust, Northamptonshire Healthcare NHS Foundation Trust, NHS South East London Icb - 72q were added.
5. The plain English summary was updated to reflect these changes.
09/07/2024: The participant level data sharing statement was added.
03/01/2024: The following changes were made to the study record:
1. Contact details and interventions updated.
2. The recruitment start date was changed from 01/03/2023 to 14/12/2023.
3. The recruitment end date was changed from 30/01/2024 to 14/04/2025.
09/06/2023: The following changes were made to the trial record:
1. The scientific title was changed from "Personalised treatment packages for adults with learning disabilities who display aggression in community settings: A cluster randomised controlled trial (PETAL)" to "Personalised treatment packages for adults with learning disabilities who display aggression in community settings: A cluster randomised controlled trial (PETAL therapy)".
2. The acronym was changed from PETAL to PETAL therapy.
3. The secondary outcome measures were changed.
4. The inclusion criteria were changed.
5. The exclusion criteria were changed.
6. The phrase PETAL intervention was changed to PETAL therapy throughout the record.
08/11/2022: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).
