Adjunctive Dietary Intervention study for Challenging Behaviour in people with an Intellectual Disability: a randomised double blind placebo controlled multicentre clinical trial

Completed

• Conditions: Challenging behaviour in an intellectualy disabled population; Mental and Behavioural Disorders; Mental retardation

• Registration Number: ISRCTN56149264
• Lead Sponsor: St George's, University of London (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-10-07
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. People aged between 18 and 70
2. People with a learning disability able to show consent or assent to inclusion
3. Challenging behaviour with a frequency averaging at least once a month in the three months prior to admission to the study
4. Existing medication usage will be allowed during the trial. There is no need to stop or change medication that the client is already taking.
5. The person must be living in a setting where there is help to fill in diaries and someone from whom objective reports are available. This will include family, residential homes or inpatient centres

Exclusion Criteria

1. Explicit refusal to participate
2. Living independently
3. Acute Mental Illness (chronic stable mental illness is allowed)
4. Full autism diagnosis (this does not include single autistic features without the full diagnosis)
5. Vegetarian
6. Allergy to vitamins or fish oils

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction in frequency and intensity of challenging behaviours

Secondary Outcome Measures

Name	Time	Method
Improvements to quality of life and social functioning