User participation in clinical assessment and intervention

• Register: ISRCTN
• Last refreshed on: 13 January 2015
• Main ID: ISRCTN90833792
• Date of registration: 11/04/2008
• Prospective Registration: Yes
• Primary sponsor: Estia Centre (UK)
• 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
• Date of first enrolment: 01/06/2008
• Target sample size: 88
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN90833792
• Study type: Interventional
• Study design: Randomised controlled trial (RCT) (Treatment)

Countries of recruitment

United Kingdom

Contacts

• Name: Eddie Chaplin

Key inclusion & exclusion criteria

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
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

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

This study looks at self assessment and management of the individuals mental health particularly depression
Mental and Behavioural Disorders
Depression

Intervention(s)

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. T

Primary Outcome(s)

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(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

Secondary ID(s)

N/A

Source(s) of Monetary Support

Estia Centre (UK)