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Trial registered on ANZCTR


Registration number
ACTRN12613000235707
Ethics application status
Not yet submitted
Date submitted
25/02/2013
Date registered
27/02/2013
Date last updated
27/02/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Improving help seeking and peer support for substance use and emotional problems: a cluster randomised controlled trial
Scientific title
Improving self reported help seeking and peer support for substance use and emotional problems among year 9 students: a cluster randomised controlled trial of the MAKINGtheLINK education program
Secondary ID [1] 281331 0
Nil
Universal Trial Number (UTN)
Trial acronym
MTL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
help seeking for depression 287549 0
help seeking for alcohol misuse 287550 0
Condition category
Condition code
Mental Health 287874 287874 0 0
Depression
Mental Health 288755 288755 0 0
Addiction
Public Health 288831 288831 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention consists of five interactive classroom activities run over 3 school periods (average period is 50 minutes), plus a booster session (to reiterate key messages and practice encouraging a friend to seek help) one month later. Program is delivered by an experienced external facilitator with assistance of the classroom teacher.

The five interactive sessions are as follows:

Activity One - Ranking for Risk - students rank problem situations of young people according to how concerned they are and who they think needs help (method: small group activity, then shared with larger group)

Activity Two - Myth or Fact? - students are presented with statements about alcohol use and mental health and must decide whether they are myth or fact (method: small group activity)

Activity Three - Under Construction - students watch an animation about the effects of risky drinking on the different areas of the adolescent brain and impact on behaviour (method: role play)

Activity Four - Helpers - students learn about the different types of helpers that they can access and decide which helper the young person in the story should seek help from (method: whole class discussion)

Activity Five - Helping Jason - students watch video clips about Jason's alcohol use and how it impacts his behaviour and relationships. Students then discuss the approach Jason's friends' take in talking to him about their concerns and assisting him to seek professional help.

Booster Session - reiterates learning's from other activities (web based sessions)
Intervention code [1] 285793 0
Behaviour
Intervention code [2] 286598 0
Prevention
Comparator / control treatment
Waitlist control (program offered to waitlist control after all data has been collected from both the IV and control group e.g. 12 months after program has been run with IV group)
Control group
Active

Outcomes
Primary outcome [1] 288096 0
Participation in the intervention will lead to increased help seeking behaviour (from formal and informal sources) for alcohol & mental health issues.

This will be assessed using a questionnaire administered to all students (both in the IV and control groups). The survey will be repeated at 4 time points: pre and post the intervention as well as 6 and 12 months after the intervention.

The questionnaire includes several questions asking for self reports of help seeking activities (e.g. have you asked for help or advice for an alcohol problem in the past 6 weeks?, have you asked for help or advice for an emotional problem problem such as feeling depressed or stressed out in the past 6 weeks?).
Timepoint [1] 288096 0
12 months post intervention
Secondary outcome [1] 299425 0
Participation in the intervention will lead to increased confidence to seek help for self.

This will be assessed using a questionnaire administered to all students (both in the IV and control groups). The survey will be repeated at 4 time points: pre and post the intervention as well as 6 and 12 months after the intervention.

The questionnaire includes a question specifically asking about confidence to seek help for self (e.g. overall, how confident are you to seek help for yourself for an alcohol problem if you need to?) as well as the General Help Seeking Questionnaire (Wilson, 2005).
Timepoint [1] 299425 0
immediately after, 6 and 12 months following the intervention
Secondary outcome [2] 301257 0
Participation in the intervention will lead to increased confidence to assist a peer to seek help.

This will be assessed using a questionnaire administered to all students (both in the IV and control groups). The survey will be repeated at 4 time points: pre and post the intervention as well as 6 and 12 months after the intervention.

The questionnaire includes a question specifically asking about confidence to seek help for a friend (e.g. how confident would you feel to help "Sarah" see a professional?) (Sarah is a pretend person that a vignette is written about in the questionnaire).
Timepoint [2] 301257 0
immediately after, 6 and 12 months following the intervention
Secondary outcome [3] 301258 0
Participation in the intervention will lead to a reduction in psychological barriers for help-seeking associated with alcohol and depression.

This will be assessed using a questionnaire administered to all students (both in the IV and control groups). The survey will be repeated at 4 time points: pre and post the intervention as well as 6 and 12 months after the intervention.

The questionnaire includes a question specifically asking about psychological barriers to help seeking (the Barriers to Adolescent Help Seeking survey (BASH-B; Kulh, J., Jarkon-Horlick, L. & Morrissey, 1997).
Timepoint [3] 301258 0
immediately after 6 and 12 months post intervention

Eligibility
Key inclusion criteria
year 9 classes from Victorian Secondary schools with at least 50 students in the year group
Minimum age
13 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- schools involvement in other health promotion classes that may confound the trial

- schools beyond a 50km radius from Melbourne CBD

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
School groups will be recruited to the study and undergo baseline testing before being allocated to either the control or intervention group. After baseline testing, each school will be allocated a number.

This list of numbers will be randomly generated in 2 columns using the website random.org. These two columns will represent the 'intervention' group (1st column) and 'control' group (2nd column).

The relevant group name (e.g. 'intervention' or 'control')will then written on a piece of cardboard with the number of the participant school on the front. These pairings will be placed in sealed envelopes and provided to another researcher who will open the envelopes and match the name of the school group, to the number and grouping.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Use of the website 'random.org'. This list of numbers will be randomly generated in 2 columns using the website random.org.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2013
Actual
Date of last participant enrolment
Anticipated
1/06/2013
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 286098 0
Government body
Name [1] 286098 0
NHMRC
Country [1] 286098 0
Australia
Primary sponsor type
Individual
Name
Prof. Dan Lubman
Address
Turning Point Alcohol & Drug Centre
52-64 Gertrude Street
Fitzroy VIC 3056
Country
Australia
Secondary sponsor category [1] 285537 0
None
Name [1] 285537 0
Address [1] 285537 0
Country [1] 285537 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 288825 0
Monash University HREC
Ethics committee address [1] 288825 0
Ethics committee country [1] 288825 0
Australia
Date submitted for ethics approval [1] 288825 0
30/01/2013
Approval date [1] 288825 0
Ethics approval number [1] 288825 0
2013000141

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

Contacts
Principal investigator
Name 34783 0
Prof Dan Lubman
Address 34783 0
Turning Point Alcohol and Drug Centre,
54 Gertrude St
Fitzroy VIC 3065
Country 34783 0
Australia
Phone 34783 0
+613 8413 8400
Fax 34783 0
Email 34783 0
[email protected]
Contact person for public queries
Name 18030 0
Fiona Blee
Address 18030 0
Turning Point Alcohol and Drug Centre,
54 Gertrude St
Fitzroy VIC 3065
Country 18030 0
Australia
Phone 18030 0
+613 8413 8464
Fax 18030 0
Email 18030 0
[email protected]
Contact person for scientific queries
Name 8958 0
Dan Lubman
Address 8958 0
Turning Point Alcohol and Drug Centre,
54 Gertrude St
Fitzroy VIC 3065
Country 8958 0
Australia
Phone 8958 0
+613 8413 8400
Fax 8958 0
Email 8958 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
SourceTitleYear of PublicationDOI
EmbaseOutcomes of reducing stigma towards alcohol misuse during adolescence: Results of a randomized controlled trial of the MAKINGtheLINK intervention.2020https://dx.doi.org/10.1186/s13034-020-00317-7
EmbaseTwelve-month outcomes of MAKINGtheLINK: A cluster randomized controlled trial of a school-based program to facilitate help-seeking for substance use and mental health problems.2020https://dx.doi.org/10.1016/j.eclinm.2019.11.018
N.B. These documents automatically identified may not have been verified by the study sponsor.