| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN90833792 |
| Date ISRCTN assigned | 11/04/2008 |
| Local reference number(s) | N/A |
| Public title | User participation in clinical assessment and intervention |
| Scientific title | The role of a Self-Assessment and INTervention package (SAINT) in improving general mental health outcomes and reducing depressive symptoms within an intellectual disability population |
| Acronym | SAINT |
| Disease/condition/study domain | This study looks at self assessment and management of the individuals mental health particularly depression |
| Study hypothesis | The primary hypothesis is that by providing a self-management assessment and intervention framework (SAINT), used in partnership by staff and service users there will be an improvement in general outcomes as described in the Health of the Nation Outcome Scales for people with Learning Disabilities (HoNOS-LD) and depressive symptoms as listed in the Beck Depression Inventory (BDI). |
| Design/methodology | Randomised controlled trial (RCT) |
| Research ethics review | It is my intention to submit to ethics once I have the confirmation from Oxleas NHS Foundation Trust that they will participate. The invitation is currently being considered. The study will be submitted centrally and to Bromley Ethics Committee. Pending as of 25/01/2008. |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Aged over 18, either sex
2. Mild intellectual disabilities as defined by an intelligence quotient [IQ] of between 50 - 70 (as measured by the Wechsler Adult Intelligence Scale - Revised [WAIS-R] and/or Wechsler Adult Intelligence Scale version three [WAIS-III]; a short IQ or WAIS will be performed where there is doubt)
3. Affective disorders in the Internation Classification of Diseases version 10 (ICD-10) section F30 - F39
4. Able to provide written consent |
| Participants - exclusion criteria | 1. Service users suffering from head injury, post development
2. Service users with an IQ of under 50
3. Service users with an IQ of over 70
4. Service users who lack capacity |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Anticipated start date | 01/06/2008 |
| Anticipated end date | 01/06/2010 |
| Status of trial | Ongoing |
| Target number of participants | 88 |
| Interventions | Both the experimental and control groups will receive treatment as usual that will include physical, psychological and social approaches. In the experimental group the SAINT self-management pack will be implemented. This involves self assessment and intervention from the service user with support where necessary. Due to the differing abilities this will be achieved with direction and support from the allocated nurse where appropriate.
The pack will be constructed following a delphi consultation which is designed to obtain consensus of expert and service user opinion. |
| Primary outcome measure(s) | Increase in general mental health outcomes as defined within the HoNOS-LD, which has been specifically validated for use in intellectual disabilities populations. Roy et al (2002), reports that the HoNOS-LD is designed to monitor risk and vulnerability, and provides "a systematic summary of behaviours and functioning". It has 18 items graded for severity on a five point scale. The HoNOS-LD is specifically aimed at people with intellectual disability regardless of degree of impairment and who have co-existing mental health needs.
The BDI is a 21-item scale. The highest score on each of the questions is three, the highest possible total for the whole test is sixty-three. The lowest possible score for the whole test is zero. |
| Secondary outcome measure(s) | Accuracy of service user self perception regarding risk and mental well being and its predictive validity will be examined via the self assessment and intervention logs. This data will be supplemented with an augmented Clinical Services Receipt Inventory to examine resource issues and quality of life questionnaires to examine what role support networks and standard of living might play in self intervention and management. The 'Quality of Life Scale' is a 40-item scale conducted by interview. The items are divided into four subscales:
1. Competence/productivity
2. Self-determination/independence
3. Satisfaction
4. Social belonging/integration in the community |
| Sources of funding | Estia Centre (UK) |
| Sponsor name | Estia Centre (UK) |
| Sponsor details | c/o Prof. N Bouras
Munro-Guys
66 Snowsfields
London
United Kingdom
SE1 3SS |
| Sponsor website | http://www.slam.nhs.uk/services/servicedetail.aspx?dir=6&id=751 |
| Contact name | Mr Eddie Chaplin |
| Contact details | 66 Snowsfields
Munro-Guys
London
United Kingdom
SE1 3SS |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN90833792 |
| Date last extracted from ISRCTN register | 17/04/2008 |
