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Trial registered on ANZCTR


Registration number
ACTRN12609000775213
Ethics application status
Approved
Date submitted
24/08/2009
Date registered
7/09/2009
Date last updated
9/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Thai Family Support (TFS): Working with families of young substance users in primary health care
Scientific title
Working with families of young substance users in primary health care: The effect of the Thai Family Support (TFS) program on quality of life, general psychological wellbeing and family relationships.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Family support 243578 0
Youth substance use 243579 0
Condition category
Condition code
Mental Health 239832 239832 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Thai Family Support is an intervention for families of young substance users. This intervention was developed based on the 5-step method and Community Reinforcement And Family Training program together with Thai culture. It comprises about 14 hours of group treatment with the families of the substance users delivered over 6 sessions over 6 weeks. The treatment is designed specifically to support family members, so the substance users themselves do not attend. Sessions cover a variety of skills and techniques to help families deal with their substance-using relatives and help them manage their psychological functions and maintain well-being.
Intervention code [1] 241141 0
Treatment: Other
Intervention code [2] 241225 0
Prevention
Comparator / control treatment
control group (delayed group condition) will receive the same intervention after finished the intervention group (immediate group condition) finished all sessions.
Control group
Active

Outcomes
Primary outcome [1] 240659 0
Quality of life as measured by the World Health Organization Quality of Life-Brief-Thai Questionnaire (WHOQOL-Bref-THAI).
Timepoint [1] 240659 0
In both groups: Baseline, 7 weeks post-randomisation and 3 months post-randomisation.
Primary outcome [2] 240660 0
General psychological wellbeing as measured by the Thai General Health Questionnaire-28 (Thai GHQ28).
Timepoint [2] 240660 0
In both groups: Baseline, 7 weeks post-randomisation and 3 months post-randomisation.
Primary outcome [3] 240661 0
Family relationship as measured with the Family Attitude Scale and Family Environment Scale.
Timepoint [3] 240661 0
In both groups: Baseline, 7 weeks post-randomisation and 3 months post-randomisation.
Secondary outcome [1] 257226 0
Nil
Timepoint [1] 257226 0
Nil

Eligibility
Key inclusion criteria
Key inclusion criteria: Participants have to be

- Aged over 18 years
- A member of the nuclear or extended family, or another person with a
close relationship with a substance user (SU) (e.g. spouse, unmarried intimate partner, parent, children, grand parent, sibling, other relatives, or boyfriend/girlfriend)
- Sufficient contact with substance users such as living with them or in contact with
them on at least 40% of days in the prior 3 months (including telephone contacts)
- Living less than 30 kilometres radius from the research site.
- His/her substance using relative does not enter alcohol or other drug treatments (except for any religion treatment)
- The person's substance using relative is a young person aged between 14 – 30 years
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Key exclusion criteria:
People will be excluded if they:
- Met criteria for an alcohol or substance use disorder as assessed according to the Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV).
- Having illicit drug use or engaged in any domestic violence
- Met criteria of DSM-IV for serious psychotic disorders that is of
sufficient severity to interfere with understanding of the program’s procedure.
- His/her substance using relative engaged in previous drug and alcohol treatment in the past 3 months
- His/her substance using relative met criteria of DSM-IV in serious psychotic disorder that is of sufficient severity to interfere with understanding of the program’s procedure

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be recruited both from the community (in response to advertising and promotion) and from three primary health care units (PCUs) in Udonthani Province, Thailand. Community members can self-refer in response to advertising, while PCU staff will refer potetial participants to the reseracher, with the participant's consent. Participants will be given information about the study and will sign a consent form before undertaking assessment. At the end of the assessment, if the participant is eligible, they will be randomly assigned to receive the Thai Family Support Program either immediately or after a delay of 6-8 weeks.
Randomisations will generated by someone not connected to the study and will be sealed in envelopes that are opened by the researcher at the end of assesesment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will occur separately for each PCU (three in total). Randomisations will be generated using a web-based program in permutations of 2 and 4. They will be sealed in envelopes, that will only be opend by the researcher at the end of assessment.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Multiple baseline.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/09/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment outside Australia
Country [1] 1956 0
Thailand
State/province [1] 1956 0
Udonthani

Funding & Sponsors
Funding source category [1] 237512 0
University
Name [1] 237512 0
Queensland University of Technology
Country [1] 237512 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology
Address
GPO Box 2434, Brisbane QLD 4000
Country
Australia
Secondary sponsor category [1] 237012 0
Individual
Name [1] 237012 0
Prof Ian Shochet
Address [1] 237012 0
Queensland University of Technology
School of Psychology and Counselling
GPO Box 2434, Brisbane QLD 4000
Country [1] 237012 0
Australia
Secondary sponsor category [2] 237013 0
Individual
Name [2] 237013 0
Adchara Khamchiangta
Address [2] 237013 0
Queensland University of Technology
Institute of Health and Biomedical Innovation
GPO Box 2434, Brisbane QLD 4000
Country [2] 237013 0
Australia
Other collaborator category [1] 822 0
Other
Name [1] 822 0
Udonthani Provincial Health Office
Address [1] 822 0
4 Athibodi Road,
Muang District,
Udonthani, Thailand, 41000
Country [1] 822 0
Thailand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243667 0
Queensland University of Technology Human Research Ethics Committee
Ethics committee address [1] 243667 0
QUT
GPO Box 2434, Brisbane, QLD, 4000
Ethics committee country [1] 243667 0
Australia
Date submitted for ethics approval [1] 243667 0
Approval date [1] 243667 0
01/09/2009
Ethics approval number [1] 243667 0
0900000705

Summary
Brief summary
The National household Survey on Substance and Alcohol Use in Thailand showed that approximately 2.5 million people had used at least one kind of substance in their lifetime. That comprised 5.42% of the total population aged between 12-65 years in 2007. It has become strongly evident that alcohol and drug use of individuals can seriously affect family members who live with them, as well as their close friends. Impacts on families who are living with a substance user fall into 5 areas: physical and psychological health of family members, poor family relationships resulting from their relative's substance use, financial impacts and employment impacts, disruption of social life, and impact on families in relation to different types of substance. Despite the deep and wide-ranging impact of substance use on other family members, families typically receive little or no support from treatment services, which instead, tend to focus attention on helping the substance user. The objectives of this program are to: a) Increase well-being of Concerned Significant Others (CSOs) and reduce mental distress b) Increase rates of Substance Users (SUs) seeking help and engaging in treatment , and c) Improve relationships between Concern Significant Others (CSOs) and Substance Users (SUs).
Trial website
Nil
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30062 0
Address 30062 0
Country 30062 0
Phone 30062 0
Fax 30062 0
Email 30062 0
Contact person for public queries
Name 13309 0
Adchara Khamchiangta
Address 13309 0
Institute of Health and Biomedical Innovation (IHBI)
60 Musk Ave
Kelvin Grove
QLD 4059
Country 13309 0
Australia
Phone 13309 0
+61 7 31386398
Fax 13309 0
+61 7 31386030
Email 13309 0
[email protected]
Contact person for scientific queries
Name 4237 0
Professor David J. Kavanagh
Address 4237 0
IHBI
60 Musk Ave
Kelvin Grove
QLD 4059
Country 4237 0
Australia
Phone 4237 0
+61 7 31386143
Fax 4237 0
+61 7 31386030
Email 4237 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
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Documents added automatically
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