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Trial registered on ANZCTR


Registration number
ACTRN12613000080729
Ethics application status
Approved
Date submitted
11/08/2012
Date registered
22/01/2013
Date last updated
4/02/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Cost-utility evaluation of ASSIST (Alcohol, Smoking and Substance Involvement Screening Test) linked Brief Intervention for substance abuse.
Scientific title
The Cost-utility evaluation of ASSIST(Alcohol, Smoking and Substance Involvement Screening Test) linked Brief Intervention for Reduction of Substance Abuse in Primary Health Care Setting.
Secondary ID [1] 280782 0
Nil
Universal Trial Number (UTN)
U 1111-1132-3633
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Substance abuse. 286842 0
Condition category
Condition code
Mental Health 287156 287156 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
After administer the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) and provide the
Brief Intervention (BI)composed of 9 steps :1. Feedback
2. Advice 3. Responsibility 4. Concern about ASSIST score
5. Good things about substance use. 6. Less good things about substance use. 7. Summarise 8. Concern about less good things
9. Take home information & booklet
provide BI each participant about 10-15 minutes
Intervention code [1] 285211 0
Other interventions
Comparator / control treatment
Standard treatment is the simple advice after administer ASSIST and will be offered the brief intervention (if necessary) after 6 months.
Control group
Active

Outcomes
Primary outcome [1] 287463 0
The specific substance score are assessed by tool, ASSIST questionnaire.
Timepoint [1] 287463 0
Baseline, at 3 months and 6 months after intervention commecement
Primary outcome [2] 287731 0
Baseline, at 3 months and 6 months after intervention commecement
Timepoint [2] 287731 0
Baseline, at 3 months and 6 months after intervention commecement
Secondary outcome [1] 298208 0
The cost-utility of ASSIST-linked BI is assessed by Schedule for the Evaluation of Individual Quality of Life (SEIQoL)
Timepoint [1] 298208 0
Baseline, at 3 months and 6 months after intervention commecement

Eligibility
Key inclusion criteria
1.Scores in the moderate risk range between 4 and 26 for other substance and between 11 and 26 for alcohol of the ASSIST for specific substances
2. Ages 16 to 65 years
3. Be able to communicate in Jawee or Thai
4. Be willing to participate in a 6-month follow-up where they return to the clinic for interview
5. Be physically well enough to participate in a 30-minute interview and intervention session
6. Has fixed address and be able to provide contact details of their home
Minimum age
16 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- ASSIST score in the high risk category
(27 or higher for any of the substances
- has severe cognitive impairment or intectual disability
-has tendency to violent or aggressive behaviour
-is intoxicated or going through withdrawal from alcohol or other drugs

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomization will be done prior to the commence of the study. The method of allocation concealment used sealed envelopes. 1. sealed opaque envelopes 2. The randomized code will be kept in a sealed envelope and numbered for individual patient. 3. The researcher assistant was at central administration site Allocating the treatment 1. The participant who is in a moderate risk level of the ASSIST (score 4-26 for other substance and score 11-26 for alcohol ), will be checked for his/her inclusion/exclusion criteria by a research assistance. The eligible participant will be recruited into the study. 2. The research assistant will administer the ASI, TLFB, SOCRETES, Life Event Record Form and SEIQol. This process will be carried out in a private room in the study hospital. 3. Upon the completion of the above CRFs, the research assistant opens the randomization code envelope. The subject who is randomized into the BI group will be sent to the research nurse who will provide the BI. The subject who is assigned to the control group will be given a standard intervention by the research nurse. 4. After completion of the BI or standard intervention, the appointment will be set for the subject to come back to the clinic at 3-month and at completion of the 6-month follow-up period.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization will be done prior to the commence of the study, using randomization permutation block.

The randomised code will be kept in a sealed envelope and numbered for individual patient.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/05/2011
Actual
15/10/2011
Date of last participant enrolment
Anticipated
15/12/2012
Actual
31/12/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
250
Accrual to date
Final
Recruitment outside Australia
Country [1] 4393 0
Thailand
State/province [1] 4393 0
Songkhla Province
Country [2] 4394 0
Thailand
State/province [2] 4394 0
Pattani Province

Funding & Sponsors
Funding source category [1] 285794 0
Government body
Name [1] 285794 0
Integrated Management for Alcohol Intervention Program(I-MAP)
Country [1] 285794 0
Thailand
Primary sponsor type
Government body
Name
Integrated Management for Alcohol Intervention Program(I-MAP)
Address
Suanprong Hospital
131, Chunglow Road, Meung Districk, Chaing mai Province
50100
Country
Thailand
Secondary sponsor category [1] 285384 0
None
Name [1] 285384 0
Address [1] 285384 0
Country [1] 285384 0
Other collaborator category [1] 276910 0
Hospital
Name [1] 276910 0
Prince of Songkla Hoapital
Address [1] 276910 0
Hat yai, Songkhla Province,90110
Country [1] 276910 0
Thailand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287586 0
Faculty of Medicine, Prince Songkla University,
Ethics committee address [1] 287586 0
Ethics committee country [1] 287586 0
Thailand
Date submitted for ethics approval [1] 287586 0
Approval date [1] 287586 0
15/10/2010
Ethics approval number [1] 287586 0
53-330-18-5-2

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34396 0
Mrs patimoh nima
Address 34396 0
Faculty of Medicine, Prince of Songkla University
Hatyai, SongKhla province. Thailand.
90110
Country 34396 0
Thailand
Phone 34396 0
+66 86-9559522
Fax 34396 0
Email 34396 0
[email protected]
Contact person for public queries
Name 17643 0
Patimoh Nima
Address 17643 0
Faculty of Medicine, Prince of Songkla University
Hatyai, SongKhla province. Thailand.
90110
Country 17643 0
Thailand
Phone 17643 0
+66 86-9559522
Fax 17643 0
Email 17643 0
[email protected]
Contact person for scientific queries
Name 8571 0
Patimoh Nima
Address 8571 0
Faculty of Medicine, Prince of Songkla University
Hatyai, SongKhla province. Thailand.
90110
Country 8571 0
Thailand
Phone 8571 0
+66 86-9559522
Fax 8571 0
Email 8571 0
[email protected]

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.