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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.
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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.
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Secondary ID [1]
280782
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Nil
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Universal Trial Number (UTN)
U 1111-1132-3633
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Substance abuse.
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Condition category
Condition code
Mental Health
287156
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0
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Addiction
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Other interventions
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Comparator / control treatment
Standard treatment is the simple advice after administer ASSIST and will be offered the brief intervention (if necessary) after 6 months.
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Control group
Active
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Outcomes
Primary outcome [1]
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The specific substance score are assessed by tool, ASSIST questionnaire.
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Assessment method [1]
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Timepoint [1]
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Baseline, at 3 months and 6 months after intervention commecement
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Primary outcome [2]
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Baseline, at 3 months and 6 months after intervention commecement
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Assessment method [2]
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Timepoint [2]
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Baseline, at 3 months and 6 months after intervention commecement
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Secondary outcome [1]
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The cost-utility of ASSIST-linked BI is assessed by Schedule for the Evaluation of Individual Quality of Life (SEIQoL)
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Assessment method [1]
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Timepoint [1]
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Baseline, at 3 months and 6 months after intervention commecement
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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
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Minimum age
16
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Educational / counselling / training
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Allocation to intervention
Randomised controlled trial
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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.
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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.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Date of first participant enrolment
Anticipated
1/05/2011
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Actual
15/10/2011
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Date of last participant enrolment
Anticipated
15/12/2012
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Actual
31/12/2012
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
250
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
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Thailand
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State/province [1]
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Songkhla Province
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Country [2]
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Thailand
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State/province [2]
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Pattani Province
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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Integrated Management for Alcohol Intervention Program(I-MAP)
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Address [1]
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Suanprong Hospital
131, Chunglow Road, Meung District, Chiang mai Province'
50100
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Country [1]
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Thailand
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Primary sponsor type
Government body
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Name
Integrated Management for Alcohol Intervention Program(I-MAP)
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Address
Suanprong Hospital
131, Chunglow Road, Meung Districk, Chaing mai Province
50100
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Country
Thailand
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
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Other collaborator category [1]
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Hospital
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Name [1]
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Prince of Songkla Hoapital
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Address [1]
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Hat yai, Songkhla Province,90110
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Country [1]
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Thailand
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Faculty of Medicine, Prince Songkla University,
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Ethics committee address [1]
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Faculty of Medicine,
Prince Songkla University,
Songkhla,Thailand 90110
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Ethics committee country [1]
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Thailand
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Date submitted for ethics approval [1]
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Approval date [1]
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15/10/2010
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Ethics approval number [1]
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53-330-18-5-2
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Summary
Brief summary
Alcohol and drug use leads to the highest Disability Adjusted Life Years (DALY) loss from several diseases and conditions, e.g. traffic accidents, cancers, liver cirrhosis, homicide and suicide. The WHO Alcohol, Smoking, Substance Involvement Screening Test (ASSIST) and its linked Brief intervention (BI) can help prevent this loss by detecting the harmful substance use and providing intervention at an early stage before it has caused serious diseases or other problems.
Objectives of this study aimed to evaluate the effectiveness and costs of the ASSIST-linked BI and standard intervention and also evaluate the cost-utility of ASSIST-linked BI for reduction of substance use in primary health care (PHC) settings.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Mrs patimoh nima
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Address
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Faculty of Medicine, Prince of Songkla University
Hatyai, SongKhla province. Thailand.
90110
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Country
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Thailand
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Phone
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+66 86-9559522
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Mrs Patimoh Nima
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Address
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Faculty of Medicine, Prince of Songkla University
Hatyai, SongKhla province. Thailand.
90110
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Country
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Thailand
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Phone
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+66 86-9559522
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Mrs Patimoh Nima
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Address
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Faculty of Medicine, Prince of Songkla University
Hatyai, SongKhla province. Thailand.
90110
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Country
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Thailand
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Phone
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+66 86-9559522
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Fax
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Email
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[email protected]
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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.
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