ANZCTR - Registration

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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]

Nil

Universal Trial Number (UTN)

Trial acronym

MTL

Linked study record

Health condition

Health condition(s) or problem(s) studied:

help seeking for depression

help seeking for alcohol misuse

Condition category

Condition code

Mental Health

Depression

Mental Health

Addiction

Public Health

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]

Behaviour

Intervention code [2]

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]

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]

12 months post intervention

Secondary outcome [1]

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]

immediately after, 6 and 12 months following the intervention

Secondary outcome [2]

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]

immediately after, 6 and 12 months following the intervention

Secondary outcome [3]

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]

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]

Government body

Name [1]

NHMRC

Address [1]

National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Not yet submitted

Ethics committee name [1]

Monash University HREC

Ethics committee address [1]

National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

30/01/2013

Approval date [1]

Ethics approval number [1]

2013000141

Summary

Brief summary

Adolescence is a high-risk time for the development of mental health and substance use problems. Evidence shows that young people who experience these issues typically turn to their peers for support rather than seeking professional help. While there are numerous programs that endeavour to improve student knowledge about mental health and substance use, there are few programs that  provide students with the practical skills required to encourage their friends to seek help. MAKINGtheLINK is a school based education program that equips young people with correct information and the opportunity to practice assisting a friend at risk.

 The program teaches students practical skills regarding:
signs of problematic substance use and emotional issues,
what to say to a friend that you are concerned about to encourage them to seek help,
the types of helpers that exists and how to access them.

By comparing the knowledge and behaviours of Victorian year 9 students who receive the program with those that do not receive the program, we will be able to measure whether there are improved rates of help seeking and confidence to assist a friend to seek help amongst the group that receive the program.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Dan Lubman

Address

Turning Point Alcohol and Drug Centre,
54 Gertrude St
Fitzroy VIC 3065

Country

Australia

Phone

+613 8413 8400

Fax

dan.lubman@monash.edu

Contact person for public queries

Name

Fiona Blee

Address

Turning Point Alcohol and Drug Centre,
54 Gertrude St
Fitzroy VIC 3065

Country

Australia

Phone

+613 8413 8464

Fax

fiona.blee@easternhealth.org.au

Contact person for scientific queries

Name

Dan Lubman

Address

Turning Point Alcohol and Drug Centre,
54 Gertrude St
Fitzroy VIC 3065

Country

Australia

Phone

+613 8413 8400

Fax

dan.lubman@monash.edu

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

Source	Title	Year of Publication	DOI
Embase	Outcomes of reducing stigma towards alcohol misuse during adolescence: Results of a randomized controlled trial of the MAKINGtheLINK intervention.	2020	https://dx.doi.org/10.1186/s13034-020-00317-7
Embase	Twelve-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.	2020	https://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.

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Documents added manually

Documents added automatically