Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000024741
Ethics application status
Approved
Date submitted
8/01/2013
Date registered
9/01/2013
Date last updated
9/01/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of social skills and relationship education on the knowledge and attitudes of people with intellectual disability.
Scientific title
Using the Assessment of sexual knowledge (ASK) to measure the effect of participating in social skills and relationship education on the knowledge and attitudes of people with intellectual disability.
Secondary ID [1] 281736 0
nil
Universal Trial Number (UTN)
U1111-1136-8165
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mild-moderate intellectual disability 288041 0
Condition category
Condition code
Mental Health 288418 288418 0 0
Learning disabilities

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group education on Socail Skills and Relationships (SS&R) in a workshop format with of 6-8 participants.
The duration is once per week and the frequency of education sessions for 8 weeks of 90 minute sessions.
Intervention code [1] 286273 0
Other interventions
Comparator / control treatment
Design compares pre- and post-intervention measures for all participants. There is no control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 288585 0
The primary outcome is to increse the participants realtionship and sexual knowledge.
The tool used to determine the primary outcome is the Assessment of Sexual Knowledge (ASK).
Timepoint [1] 288585 0
Baseline and 9 weeks later
Secondary outcome [1] 300537 0
Secondary outcome will involve comparing the baseline ASK scores with the post ASK scores to determine if the SS&R course is meeting the information needs of the clients referred to the Intellectual Disabiity Service for relationship ans sexual issues.
Timepoint [1] 300537 0
Baseline and 9 weeks later

Eligibility
Key inclusion criteria
Disability: Mild or moderate intellectual disability.
Presenting problems: Related to difficulties with relationships and/or sexual behaviour.
Minimum age
17 Years
Maximum age
26 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
People with no evidence of learning disability.
People whose communication is impaired to the point where they are unlikely to benefit from this type of intervention.
People with major sensory deficits.
People who present a high likelihood of showing aggressive behaviour in the group setting.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
there will be no randomised allocation of subjects in this trail
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Recruitment of study participants:

Participants will be recruited from those people who are referred to the IDS because of their challenging behaviours. Normal criteria for referral to the Behavioural Support Team (BST) is:
* the client must have an intellectual disability (ID),
* must be over seventeen years of age and
* have challenging behaviours that impact on themselves or others, placing them at risk.
Each referral is discussed at the weekly multidisciplinary meeting and if it is accepted the referral is then discussed at a further BST meeting where it is placed on a waiting list. One of two possibilities will then occur.
1. The referral is allocated to a clinician’s caseload and after an initial assessment the client could be re-referred to the researcher to complete the next Social Skills and Realtionship (SS&R )course.
2. The BST decided to place the client directly onto the SS&R course wait list.
An additional criterion for attendance to any SS&R course offered by the BST is that a component of the client’s challenging behaviour must be of a sexual nature. If members of the BST believe the client requires education regarding sexuality and relationships, the client will be referred to the SS&R course.

Each potential client will be invited to participate in this research. If they choose to participate they will be:
1. Asked for permission to use their data from the pre & post ASK assessments
2. They will participate in the SS&R course which will be run over 8 weeks for 90 minutes per week.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Comparison of mean ASK scores pre and post SS&R course intervention.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/12/2012
Actual
18/12/2012
Date of last participant enrolment
Anticipated
31/03/2013
Actual
7/01/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 4780 0
New Zealand
State/province [1] 4780 0
Otago

Funding & Sponsors
Funding source category [1] 286525 0
Self funded/Unfunded
Name [1] 286525 0
Country [1] 286525 0
Primary sponsor type
Hospital
Name
Southern District Health Board
Address
Intellectual Disability Service
Wakari Hospital
Southern DHB
Private Bag 1921
Dunedin 9054
New Zealand
Country
New Zealand
Secondary sponsor category [1] 285313 0
None
Name [1] 285313 0
Address [1] 285313 0
Country [1] 285313 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288598 0
Southern Health and Disability Ethics Commitee
Ethics committee address [1] 288598 0
1 the Terrace
PO Box 5013
Wellington 6011
Ethics committee country [1] 288598 0
New Zealand
Date submitted for ethics approval [1] 288598 0
12/11/2012
Approval date [1] 288598 0
07/01/2013
Ethics approval number [1] 288598 0
12/sth/45

Summary
Brief summary
The stated goal of the research project is to determine the effect of undertaking a Social Skills and Relationship (SS&R) course which will impact on the knowledge, attitudes and behaviours related to sexuality for people with an intellectual disability (ID).

A well-used and respected tool within the Behaviour Support Team (BST) is the Assessment of Sexual Knowledge (ASK). This is the main tool currently available to the researcher and her BST colleagues when assessing clients sexual knowledge. One of the components for the research project is to analyse the scores of the pre and post ASK assessments for each of the SS&R Course participants to determine if the programme has been tailored to suit the individual educational needs of the group. It is envisaged an increase in scores may occur in the clients’ scores once the programme is completed.

The ASK involves a series of pictures being shown to the client and a number of set questions, that are sequentially graded are asked by the administrator of the ASK. The client’s answers are recorded on set answer sheets by the administrator and a standardised scoring system is utilised. The ASK has high levels of test-retest reliability of 76% and can be utilised to test individuals both prior to commencing an education programme and again upon its completion.
Trial website
Trial related presentations / publications
Public notes
After meeting with the HDEC committee, they suggested inviting the then current group of clients who were attending the pilot SS&R group to participate in the study as HDEC viewed the study as an audit.
Peliminary approval for the study was granted subject to a few word changes on the participant consent form. Full approval has now been received.

Contacts
Principal investigator
Name 36862 0
Dr David Bathgate
Address 36862 0
Dr. David Bathgate
Intellectual Disability Service
Wakari Hospital
Southern DHB
Private Bag 1921, Dunedin 9054, New Zealand
Country 36862 0
New Zealand
Phone 36862 0
reception: 64 03 470 9330
Fax 36862 0
64 03 4769964
Email 36862 0
david.bathgate@southerndhb.govt.nz
Contact person for public queries
Name 36863 0
Ms Cate Shields
Address 36863 0
Intellectual Disability Service
Wakari Hospital
Southern DHB
Private Bag 1921, Dunedin 9054, New Zealand
Country 36863 0
New Zealand
Phone 36863 0
64 03 4769751
Fax 36863 0
64 03 4769964
Email 36863 0
cate.shields@southerndhb.govt.nz
Contact person for scientific queries
Name 36864 0
Dr David Bathgate
Address 36864 0
Dr. David Bathgate
Intellectual Disability Service
Wakari Hospital
Southern DHB
Private Bag 1921, Dunedin 9054, New Zealand
Country 36864 0
New Zealand
Phone 36864 0
64 03 470 9330
Fax 36864 0
64 03 4769964
Email 36864 0
david.bathgate@southerndhb.govt.nz

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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