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Personalised treatment packages for adults with a learning disability

Personalised treatment packages for adults with learning disabilities who display aggression in community settings: A cluster randomised controlled trial (PETAL therapy)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN71781827
Enrollment
410
Registered
2022-11-16
Start date
2024-01-26
Completion date
Unknown
Last updated
2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intellectual disability Mental and Behavioural Disorders

Interventions

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 us

Sponsors

North London NHS Foundation Trust
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 120 Years

Inclusion criteria

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.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Aggressive challenging behaviour measured using the Aberrant Behaviour Checklist irritability scale (ABC-I) at baseline, and 4 and 9 months follow up

Secondary

MeasureTime frame
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

Countries

England, Northern Ireland, Scotland, United Kingdom, Wales

Contacts

Public ContactRebecca Griffiths
rebecca.griffiths@ucl.ac.uk+44 (0)20 7679 9319

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jul 23, 2026