Psychological treatment for men with intellectual and/or developmental disabilities and harmful sexual behaviour
| ISRCTN | ISRCTN21187053 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN21187053 |
| IRAS number | 291027 |
| Secondary identifying numbers | IRAS 291027 |
- Submission date
- 11/05/2021
- Registration date
- 21/05/2021
- Last edited
- 20/11/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
There is considerable public concern about men who commit sexual offences. Such men are typically offered group cognitive behaviour therapy (CBT), both in prison and in the community. This form of therapy for sex offenders has been repeatedly evaluated and most trials have found it to be effective in reducing reoffending. However, men who show harmful sexual behaviours (HSB) and have intellectual and or developmental
disabilities (IDD) have often been excluded from this form of treatment so that in the past they have rarely been offered CBT.
This proposed research project aims to evaluate the effectiveness of the SOTSEC-ID CBT group for men with IDD and harmful sexual behaviour, using the gold standard method for evaluating the effectiveness of treatments, i.e. a randomised controlled trial.
Who can participate?
Men with intellectual and/or developmental disabilities and harmful sexual behaviour
What does the study involve?
The plan is for groups of men with IDD who show harmful sexual behaviours to be assessed for sexual knowledge, victim empathy, cognitive distortions, and harmful sexual behaviours, and then the groups will be allocated randomly to be treated with SOTSEC-ID group CBT (with risk management) or TAU (treatment as usual). The men will be re-assessed at the end of six months and followed up at 1 year (all groups) and 2 years(intervention groups only).
What are the possible benefits and risks of participating?
Possible benefits include improvements (reductions) in harmful sexual behaviours, and cognitive distortions, and improvements in sexual knowledge and empathy. Risks include that this is lengthy treatment and intensive which may not suit everyone.
Where is the study run from?
University of Kent (UK)
When is the study starting and how long is it expected to run for?
From October 2021 to September 2025
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
Prof Glynis Murphy, g.h.murphy@kent.ac.uk
Contact information
Scientific
Tizard Centre
University of Kent
Canterbury
CT2 7NS
United Kingdom
 ORCID ID |
0000-0001-7817-5861 |
|---|---|
| Phone | +44 (0)1227 823960 |
| g.h.murphy@kent.ac.uk |
Study information
| Study design | Multi-centre single-blinded cluster randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | Community |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | RCT of group CBT for men with intellectual and/or developmental disabilities and harmful sexual behaviour (HaSB-IDD) |
| Study acronym | HaSB-IDD |
| Study hypothesis | 1. To determine whether the SOTSEC-ID group CBT program, combined with risk management: 1.1. Reduces cognitive distortions in men with intellectual and/or developmental disabilities and harmful sexual behaviour 1.2. Prevents or reduces their further harmful sexual behavior 1.3. Improves their sexual knowledge, empathy, locus of control, and self-esteem, in comparison to men in the control group receiving Treatment As Usual (TAU) 2. To examine the costs and cost-effectiveness of this treatment 3. To examine therapist, carer and service user views of treatment (through smaller qualitative studies) |
| Ethics approval(s) | Approved 05/01/2022, Nottingham 2 Research Ethics Committee (Equinox House, City Link, Nottingham, NG2 4LA; +44 (0)207 104 8169; nottingham2.rec@hra.nhs.uk), ref: 21/EM/0270 |
| Condition | Harmful sexual behaviour in men with intellectual and/or developmental disabilities |
| Intervention | This is a cluster randomized trial of a form of group cognitive behavioural treatment know as SOTSEC-ID (see https://www.kent.ac.uk/tizard/sotsec). After assessing site eligibility, sites will be randomised to Arm A or Arm B. Arm A consists of 6 months of CBT treatment (using SOTSEC-ID), plus risk management. Arm B is treatment as usual (mainly risk management). Therapists cannot be blind to treatment. Research workers collecting assessment and outcome data will be blind to treatment. |
| Intervention type | Behavioural |
| Primary outcome measure | Cognitive distortions measured using the Questionnaire on Attitudes Consistent with Sexual Offending (QACSO) score at baseline, 6, 12, and 24 months |
| Secondary outcome measures | 1. Harmful sexual behaviour measured using all reports from case files, carers, police, etc at baseline, 6, 12, and 24 months 2. Sexual knowledge measured using the General Sexual Knowledge Questionnaire at baseline, 6, 12, and 24 months 3. Victim empathy measured using the Victim Empathy Scale (VES-A), adapted from Beckett and Fisher’s Victim Empathy Scale at baseline, 6, 12, and 24 months 4. Locus of control measured using the Nowicki-Strickland Locus of Control Scale at baseline, 6, 12, and 24 months 5. Self-esteem measured using the Rosenberg self esteem scale at baseline, 6, 12, and 24 months 6. Service use measured using the Client Services Receipt Inventory at baseline, 6, 12, and 24 months 7. Quality of life measured using the EuroQol 5-dimension 5-level (EQ-5D-5L) questionnaire at baseline, 6, 12, and 24 months |
| Overall study start date | 01/10/2021 |
| Overall study end date | 30/09/2025 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target number of participants | 240 (30 clusters with 8 men each) |
| Participant inclusion criteria | 1. Borderline or mild intellectual disability (ie an IQ below 79) and deficits in adaptive behaviours 2. Documented history of one or more incidents of harmful sexual behavior (HSB) 3. Relatively good verbal comprehension (to be judged by clinicians) 4. Capacity to make a decision as to whether they wish to take part in trial 5. Autism, additional mental health needs (as long as this would not prevent participation in the CBT group as judged by clinicians), and criminal convictions for HSB will not be reasons for exclusion |
| Participant exclusion criteria | 1. Insufficient or receptive language to take part in group CBT 2. Mental health difficulties that would prevent him from taking part in group CBT (as judged by clinicians) 3. Resident in prison or in high secure services, or on probation 4. Does not have the capacity to make a decision as to whether to take part in the trial |
| Recruitment start date | 01/04/2022 |
| Recruitment end date | 01/04/2024 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Bow Arrow Lane
Dartford
DA2 6PB
United Kingdom
Hopewood Park Hospital
Ryhope
Sunderland
SR2 0NB
United Kingdom
Pinewood Place
Dartford
DA2 7WG
United Kingdom
Delta Point
Greets Green Road
West Bromwich
West Bromwich
B70 9PL
United Kingdom
Second Floor
Newland House
Campbell Square
Northampton
NN1 3EB
United Kingdom
Wells Road Centre
Mapperley
Nottingham
NG3 3AA
United Kingdom
Sponsor information
University/education
Canterbury
Canterbury
CT2 7NS
England
United Kingdom
| Phone | +44 (0)1227 764000 |
|---|---|
| researchculture@kent.ac.uk | |
| Website | www.kent.ac.uk |
"ROR" |
https://ror.org/00xkeyj56 |
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 | 01/04/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The study protocol will be published in a peer-review publication. The Statical Analysis Plan will be approved by the Trial Management Group and available from the Chief Investigator post analysis. The results of the study will be disseminated via: 1. An overall project report to the HTA 2. Six open-access publications: one on the protocol; two quantitative reports of the results; two qualitative reports; one health economics paper 3. Two papers in professional journals (e.g. the Tizard Learning Disability Review) 4. A website dedicated to the project 5. Annual ‘progress reports’ to the Seattle Club Conference on Research in Intellectual and Developmental Disabilities, which is the major UK research meeting in this area 6. End of project presentations to the International Association for the Scientific Study of Intellectual Disability (IASSID), National Organisation for the Treatment of Abusers (NOTA), BPS forensic conference and the British Association for Behavioural and Cognitive Psychotherapy (BABCP) 7. Dissemination to public bodies and charities e.g. Mencap, BILD, and CBF |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Prof Murphy, Chief Investigator (g.h.murphy@kent.ac.uk) and Prof Lee Shepstone Lead Statistician (l.shepstone@uea.ac.uk). All data will be potentially available, all of it will be already anonymised. These will not be available until October 2027. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
20/11/2023: The sponsor contact email has been changed.
28/04/2022: The following changes have been made:
1. The recruitment end date has been changed from 01/04/2022 to 01/05/2022.
2. The ethics approval has been added.
3. The trial website has been added.
11/05/2021: Trial’s existence confirmed by the National Institute for Health Research (NIHR).
