Aggression in patients with learning disabilities in secure care Mental and Behavioural Disorders Developmental disorder of scholastic skills, unspecified
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult between the age of 18 to 60 years 2. An inpatient in a NHS secure hospital, with an IQ of between 55 and 79 (within a range including moderate, mild, and borderline intellectual functioning) 3. Able to give informed consent 4. Having a clinical profile, as assessed by the local clinical team, as requiring psychotherapy
Exclusion criteria
Exclusion criteria: 1. Unable to give informed consent 2. Having no clinical indicators for the psychotherapeutic treatment in their clinical profile 3. Had a planned discharge from hospital within 12 months of the start of the study 4. Were undergoing medication dose titration for the treatment of acute psychotic symptoms
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility assessed by: 1. Recruitment and consent, such as patients’ willingness to be randomised and clinicians willingness to recruit their patients into the study; assessed by the recruitment target being met for the number of consented participants at enrolment (n=20) 2. Identifying issues related to seeking informed consent and risks of coercion, including potential for patients to participate in the study believing it will positively or negatively influence their inpatient treatment or detention under the mental health act; assessed during enrolment from the number of patients agreeing and/or declining to participate and the responses collected from patients declining to participate after receiving study participant information. 3. Procedures and materials, including suitability of study information, suitability of outcome measures, appraising burden of outcome measures and validated tools and suitability of outcome data collection procedures for maintaining data integrity from multiple study sites; assessed by local research assistants reporting feedback from patients at each data collection point (baseline, post- (18 weeks), follow-up (30 weeks)) on the burden of outcome questionnaires. The level of completion of questionnaires (instrument and item response rates) will be monitored and recorded within routine data integrity checks. 4. Describing routine care/treatment as usual, identifying characteristics of treatment as usual across multiple sites, levels of high and medium/low security, and individualised patient care pathways; assessed via an inventory of participant care plans found within medical records conducted by research assistants for all enrolled participants across multiple-sites at baseline. 5. Attrition and acceptability, including rates of attendance for treatment, reasons for non-attendance and/or drop-out, and lack of retention for data collection at the follo | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Aggression measured using the Modified Overt Aggression Scale (MOAS) – observational, collected by research assistant weekly for 30 weeks 2. Psychiatric/mental health symptoms measured using the Brief Symptom Inventory (BSI), administered by a research assistant at baseline/pre-, post- (18 weeks), and follow-up (week 30) 3. Anger measured using the Novaco Anger Scale (NAS) administered by a research assistant at baseline/pre-, post- (18 weeks), and follow-up (week 30) 4. Anxiety measured using the Glasgow Anxiety Scale for people with intellectual disability (GAS-ID) administered by a research assistant at baseline/pre-, post- (18 weeks), and follow-up (week 30) 5. Quality of life - capability measured using the ICEpop CAPability Quality of Life measure for Adults (ICECAP-A V2) administered by a research assistant at baseline/pre-, post- (18 weeks), and follow-up (week 30) 6. Therapeutic alliance measured using the Working Alliance Inventory (WAI-Therapist) completed by study therapists at the first therapy session and at 3-week intervals following the start of treatment for 18 weeks | — |
Countries
England, United Kingdom