Condition category
Mental and Behavioural Disorders
Date applied
25/01/2008
Date assigned
11/04/2008
Last edited
04/04/2013
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Eddie Chaplin

ORCID ID

Contact details

66 Snowsfields
Munro-Guys
London
SE1 3SS
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

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

Study hypothesis

Please note that as of 24/09/2008 this record has been updated. All updates can be found under the relevant section under the above update date.

Added as of 24/09/2008:
The primary hypothesis is that by providing a self-management assessment and intervention framework (SAINT), there will be an improvement in the individualsÂ’ general outcomes related to mental health as described in the Health of the Nation Outcome Scales for people with Learning Disabilities (HoNOS-LD) and depressive symptoms as listed in the Glasgow Depression Scale for people with Learning Difficulties (GDS-LD).

Initial 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).

Ethics approval

Added as of 24/09/2008:
Ethics approval received from the Bexley and Greenwich Research Ethics Committee on the 29th August 2008 (ref: 08/H0809/43)

Study design

Randomised controlled trial (RCT)

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

This study looks at self assessment and management of the individuals mental health particularly depression

Intervention

Added as of 24/09/2008:
The project is in three parts:

1. Delphi consultation:
The Delphi technique is used for developing consensus in areas where there is limited evidence. The consultation aims to inform the self-questionnaire within the SAINT of predictors of increased risk to others and deteriorating mental health. Subsequent interventions to promote mental well-being will also be provided. The consultation consists of three stages for questioning and feedback:
Stage 1: initial ideas in establishing risk predictors and interventions that will form the SAINT
Stage 2: review and feedback of stage 1
Stage 3: finalising the risk predictors and interventions that will form the SAINT

2. Iterative research and pilot study:
The aim of this iterative process is to establish the predictive validity of the risk indicators chosen from the Delphi consultation best thought to reflect risk and general outcomes. This will be assessed by conducting a pilot study of between 15 - 20 service users who will have the function of pre-testing and trying out the instrument. This will provide information on the utility, reliability and validity of the self-help pack in clinical use. In doing this, the following areas will be assessed:
2.1. Development and testing of accuracy of the self-help pack
2.2. Assess the feasibility of the study
2.3. Assess whether the research protocol is realistic
2.4. Assess likely success of proposed recruitment techniques
2.5. Identify logistical problems
2.6. Estimate variability in outcomes
2.7. Collect primary data
2.8. Assess proposed data collection and analysis techniques

3. Randomised controlled trial:
The RCT will see participants being randomly allocated into two groups:
Experimental group: those receiving the SAINT
Control group: those receiving treatment as usual as defined by the host clinical area

These arrangements will not exclude either group from any ongoing treatments or assessments that form part of the host clinical areas regimen. The SAINT 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 proposed treatment period will last for six months. Data will be recorded at intervals over a six month period and outcomes will be measured by the HoNOS-LD and GDS-LD prior to the introduction of the SAINT and finally after six months.

Initial 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.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Added as of 24/09/2008:
1. Increase in general mental health outcomes as defined within the HoNOS-LD, which has been specifically validated for use in intellectual disabilities populations and 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.
2. Depressive symptoms as listed in the GDS-LD. This is a 20-item scale used to measure depressive symptoms in intellectual disability populations.

Initial primary outcome measures:
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 measures

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

Overall trial start date

01/06/2008

Overall trial end date

01/06/2010

Reason abandoned

Eligibility

Participant 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 International Classification of Diseases version 10 (ICD-10) section F30 - F39
4. Able to provide written consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

88

Participant 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

Recruitment start date

01/06/2008

Recruitment end date

01/06/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

66 Snowsfields
London
SE1 3SS
United Kingdom

Sponsor information

Organisation

Estia Centre (UK)

Sponsor details

c/o Prof. N Bouras
Munro-Guys
66 Snowsfields
London
SE1 3SS
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.iop.kcl.ac.uk/

Funders

Funder type

Hospital/treatment centre

Funder name

Estia Centre (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes