Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000790943
Ethics application status
Approved
Date submitted
17/06/2020
Date registered
6/08/2020
Date last updated
20/02/2023
Date data sharing statement initially provided
6/08/2020
Date results information initially provided
20/02/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
The School-led Preventure study: preventing adolescent mental illness & substance use through personality-targeted intervention delivered by school staff.
Scientific title
The School-led Preventure study: A cluster-randomised controlled trial to prevent adolescent alcohol misuse and mental ill-health through a personality-targeted intervention delivered by school staff.
Secondary ID [1] 301536 0
None
Universal Trial Number (UTN)
U1111-1253-6990
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alcohol and other substance use 317896 0
Depression 317897 0
Anxiety 318153 0
Condition category
Condition code
Mental Health 315934 315934 0 0
Addiction
Mental Health 316172 316172 0 0
Depression
Mental Health 316173 316173 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Preventure (Conrod, 2016) is a school-based intervention designed to prevent drug and alcohol misuse. Participating secondary schools will be randomly allocated to one of two groups. One group will serve as the control group and receive their usual Year 8 health education and the other group will receive the Preventure intervention.

Students will complete the Substance Use Risk Profile Scale (Woicik et al., 2009), a screening questionnaire previously validated in adolescents and showing good reliability and internal consistency, in Europe (Castellanos-Ryan et al., 2013), North America (Krank et al., 2011) and Australia (Newton et al., 2016). In schools allocated to the Preventure intervention, students scoring one or more standard deviations above the mean on one of four personality profiles (hopelessness, anxiety sensitivity, impulsivity and sensation seeking) as identified by the SURPS will be invited to participate in two 90-minute group workshops held at school.

These workshops incorporate components of cognitive-behavioural therapy and motivational interviewing to promote coping skills in adolescents. The focus is on motivating teenagers to understand how their personality style leads to certain emotional and behavioural reactions. Four different workshops are run, each focused on developing specialised coping skills relevant to following personality styles:

• Sensation seeking
• Impulsivity
• Anxiety sensitivity
• Negative thinking.

Student workbooks are provided to each participating student as part of the intervention. These workbooks were created by the Preventure developers and are only available to be used as part of the program. They are specific to each of the above personality types and contain exercises the group work through together during session time, which encourage students to recognise emotions and behaviours and better align these with their long-term goals. The workbooks also contain personal exercises students can complete during the session or at home, according to the facilitator and co-facilitator’s decision.

The sessions incorporate real life example scenarios and include: i) psycho-education about the specific personality style and accompanying maladaptive coping behaviours (e.g., avoidance, aggression, alcohol use); ii) development of a personalised model of the physical, cognitive and behavioural components of standard responses; and iii) motivational enhancement, goal-setting and use of cognitive-behavioural strategies to adapt problematic reactions and behaviours.

School staff delivering the intervention will receive 3 days of training by the lead CI, an approved Preventure trainer. The training will cover basic counselling skills, an understanding of the aims of the intervention, and how to implement the intervention with students. School staff will be supervised by the CI in facilitating the intervention with a separate group of students not included in the trial (in another grade), to ensure high-fidelity in delivery of the intervention. School staff will be guided through a facilitation manual during training, which they will keep and use in their implementation of the intervention. School staff will be required to complete session notes after each intervention session, to document their implementation fidelity and record any concerns.

References:
Conrod, P. J. (2016). Personality-Targeted Interventions for Substance Use and Misuse. Current addiction reports, 3(4), 426-436.

Woicik PB, Conrod P, Stewart SH, Pihl RO. (2009). The substance use risk profile scale: A scale measuring traits linked to reinforcement-specific substance use profiles. Addictive Behaviours. 32:1042-55.

Castellanos-Ryan N, O'Leary-Barrett M, Sully L, Conrod P. Sensitivity and specificity of a brief personality screening instrument in predicting future substance use, emotional, and behavioral problems: 18-month predictive validity of the substance use risk profile scale. Alcoholism, clinical and experimental research. 2013 Jan;37 Suppl 1:E281-90. PubMed PMID: 22974180. Epub 2012/09/15. eng.

Krank M, Stewart SH, O'Connor R, Woicik PB, Wall A-M, Conrod PJ. Structural, concurrent, and predictive validity of the substance use risk profile scale in early adolescence. Addictive Behaviors. 2011 2011/01/01/;36(1):37-46.

Newton NC, Barrett EL, Castellanos-Ryan N, Kelly E, Champion KE, Stapinski L, et al. (2016). The validity of the Substance Use Risk Profile Scale (SURPS) among Australian adolescents. Addictive Behaviors. 2016 2016/02/01/;53:23-30.
Intervention code [1] 317837 0
Prevention
Intervention code [2] 317838 0
Lifestyle
Intervention code [3] 317839 0
Behaviour
Comparator / control treatment
Control schools will implement health education as usual in 2020. All control schools will implement curriculum-based health education during the trial (but will vary in the method of delivery), and this group will serve as an ‘active control’. Control schools will be offered complimentary use of the intervention at the end of the study in 2022.
Control group
Active

Outcomes
Primary outcome [1] 324139 0
Alcohol use. The following measures were adapted from the School Health and Alcohol Harm Reduction Project ‘Patterns of Alcohol’ index (McBride et al., 2004): intention to try alcohol, any use of alcohol ever (at least a standard drink), the frequency and quantity of alcohol consumption in standard drinks in the past six months, and frequency of binge drinking (five or more standard drinks on one occasion) in the past six months. Alcohol-related harms will be measured with an abridged form of the Rutgers Alcohol Problem Index (RAPI) (White and Labouvie, 1989).

References:
McBride N, Farringdon F, Midford R, et al. Harm Minimization in School Drug Education: Final Results of the School Health and Alcohol Harm Reduction Project (Shahrp). Addiction. 2004 Mar;99(3):278-91. PubMed PMID: 14982537. doi: 10.1111/j.1360-0443.2003.00620.x. Epub 2004/02/26. eng.
White HR, Labouvie EW. Towards the Assessment of Adolescent Problem Drinking. Journal of studies on alcohol. 1989 Jan;50(1):30-7. PubMed PMID: 2927120. doi: 10.15288/jsa.1989.50.30. Epub 1989/01/01. eng.
Timepoint [1] 324139 0
Baseline and 6-months post-baseline (primary endpoint: 6-months post-baseline).
Primary outcome [2] 324140 0
Internalising problems were measured using the ‘Patient Health Questionnaire, modified for adolescents (PHQ-A) (Johnson et al., 2002), and the ‘Generalised Anxiety Disorder 7-item scale’ (GAD-7).

References: Johnson JG, Harris ES, Spitzer RL, et al. The Patient Health Questionnaire for Adolescents: Validation of an Instrument for the Assessment of Mental Disorders among Adolescent Primary Care Patients. Journal of Adolescent Health. 2002 Mar;30(3):196-204. PubMed PMID: 2002-02042-008. doi: http://dx.doi.org/10.1016/S1054-139X%2801%2900333-0. English. Spitzer RL, Kroenke K, Williams JB, et al. A Brief Measure for Assessing Generalized Anxiety Disorder: The Gad-7. Archives of internal medicine. 2006 May 22;166(10):1092-7. PubMed PMID: 16717171. doi: 10.1001/archinte.166.10.1092. Epub 2006/05/24. eng.
Timepoint [2] 324140 0
Baseline and 6-months post-baseline (primary endpoint: 6-months post-baseline).
Primary outcome [3] 324366 0
Externalising problems will be measured using the conduct problems and hyperactivity subscales of the Strengths and Difficulties Questionnaire (SDQ) (Goodman, 1997).

Reference:
Goodman R, Meltzer H, Bailey V. The Strengths and Difficulties Questionnaire: A Pilot Study on the Validity of the Self-Report Version. European child & adolescent psychiatry. 1998 Sep;7(3):125-30. PubMed PMID: 9826298
Timepoint [3] 324366 0
Baseline and 6-months post-baseline (primary endpoint: 6-months post-baseline).
Secondary outcome [1] 383848 0
Use of tobacco, e-cigarettes and cannabis. Assessed with a study-specific questionnaire asking the past 6-month frequency of each substance.
Timepoint [1] 383848 0
Baseline and 6-months post-baseline.
Secondary outcome [2] 383850 0
Bullying. Adapted from the Olweus Bully/Victim Questionnaire (Olweus, 1996). Reference: Olweus D. The Revised Olweus Bully/Victim Questionnaire. Bergen, Norway: University of Bergen, Research Center for Health Promotion; 1996.
Timepoint [2] 383850 0
Baseline and 6-months post-baseline.
Secondary outcome [3] 383851 0
Managing Emotions. The Difficulties in Emotion Regulation Scale (Kaufman et al., 2016). Reference: Kaufman EA, Xia M, Fosco G, et al. The Difficulties in Emotion Regulation Scale Short Form (Ders-Sf): Validation and Replication in Adolescent and Adult Samples. Journal of Psychopathology and Behavioral Assessment. 2016 2016/09/01;38(3):443-55. doi: 10.1007/s10862-015-9529-3.
Timepoint [3] 383851 0
Baseline and 6-months post-baseline.
Secondary outcome [4] 383852 0
Anxiety symptoms: Social anxiety and panic attacks. Measured by four items adapted from the Social Phobia Inventory (SPIN) and three items adapted from the Panic Attack Questionnaire.

References:
1. Connor, K., Davidson, J., Churchill, L., Sherwood, A., Weisler, R., & Foa, E. (2000). Psychometric properties of the Social Phobia Inventory (SPIN): New self-rating scale. British Journal of Psychiatry, 176(4), 379-386. doi:10.1192/bjp.176.4.379
2. Norton, G. R., Harrison, B., Hauch, J., & Rhodes, L. (2012). The Panic Attack Questionnaire. Measurement Instrument Database for the Social Science. Retrieved from www.midss.ie
Timepoint [4] 383852 0
Baseline and 6-months post-baseline.
Secondary outcome [5] 383853 0
School engagement. The Hemingway Measure of Adolescent Connectedness (Karcher & Lee, 2002). Reference: Karcher MJ, Lee Y. Connectedness among Taiwanese Middle School Students: A Validation Study of the Hemingway Measure of Adolescent Connectedness. Asia Pacific Education Review. 2002 2002/07/01;3(1):92. doi: 10.1007/BF03024924.
Timepoint [5] 383853 0
Baseline and 6-months post-baseline.
Secondary outcome [6] 383854 0
Quality of Life. Satisfaction with Life Scale – Child version (Gadermann, Schonert-Reichl, & Zumbo, 2010). Reference: Gadermann AM, Schonert-Reichl KA, Zumbo BD. Investigating Validity Evidence of the Satisfaction with Life Scale Adapted for Children. Social Indicators Research. 2010;96(2):229-47.
Timepoint [6] 383854 0
Baseline and 6-months post-baseline.
Secondary outcome [7] 383855 0
Self-compassion. Self-compassion scale: Short-form (Raes, Pommier, Neff, & Van Gucht, 2011). Reference: Raes F, Pommier E, Neff KD, et al. Construction and Factorial Validation of a Short Form of the Self-Compassion Scale. Clinical psychology & psychotherapy. 2011 May-Jun;18(3):250-5. PubMed PMID: 21584907. doi: 10.1002/cpp.702. Epub 2011/05/18. eng.
Timepoint [7] 383855 0
Baseline and 6-months post-baseline.

Eligibility
Key inclusion criteria
Participants must be fluent in English and meet one of the following criteria:
i) Year 8 student at the time of randomisation, or
ii) Staff member at a participating school.

Trial sites (schools) must:
i) Be a secondary or combined primary and secondary school in NSW, and
ii) Have school principal permission to participate in the trial
iii) Have at least 60 students enrolled in Year 8 at

Active consent must be received from participating school staff, parents and students.
Minimum age
11 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None.

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)
Allocation will be concealed. Schools will be randomly allocated to groups by an external researcher.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
An external researcher will perform blocked randomisation of schools to Preventure and control, stratified by school gender mix [co-educational, predominately male (>60%), or predominately female (>60%)], using the Blockrand package in R (Snow 2020). Allocation concealment is ensured as the external researcher does not release the randomisation until the school has been irreversibly allocated to a condition. Schools will not be masked to their allocation and will be informed whether they are in the intervention or control group. As is the case for school-based interventions of this kind, schools' allocation will not be masked to students, teachers, and researchers. Students will be blinded to the hypotheses of the study.

Reference:
Snow G. (2020). Blockrand’ randomization for block random clinical trials. 1.5 ed. p. CRAN.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Sample size calculations:
This trial is powered to detect differences between groups in the overall sample, as well as among the students scoring above average on the SURPS personality scorer (selected students). A total of 280 selected students from 10 schools are required (i.e. 28 selected students per school and 5 schools per intervention group) to achieve 80% power to detect a standardized between-group mean difference of 0.3 (p =.05) in outcomes. A between-group effect size of 0.3 is in line with effect sizes observed in previous Preventure trials (Newton et al., 2016). To account for dropouts, we aim to recruit 12 schools at baseline (6 per group) with 75 students per school, 40% of whom are expected to be selected based on previous research (Conrod, Castellanos, & Mackie, 2008), giving a total of 900 students to test the effect of the intervention.

Statistical Analysis:
Intention-to-treat analyses will be carried out for all primary and secondary outcomes. Baseline equivalence and attrition between groups will be examined using single-level analyses; one-way analyses of variance (normally distributed data), chi-squared analyses (binominal data), and Mann-Whitney U-tests (non-normally distributed data). To examine intervention by time interaction effects, mixed effects regression will be used due to the multi-level nature of the data (students nested within schools). Hypothesised intervention effects on alcohol use, anxiety and depression symptoms will be examined using mixed effects linear regression analysis (continuous data) and mixed effects logistic regression analysis (categorical data). Missing data will be handled by full information maximum likelihood, in accordance with the intention-to-treat principle, which includes all randomised participants.

References:
Newton NC, Conrod PJ, Slade T, et al. The Long-Term Effectiveness of a Selective, Personality-Targeted Prevention Program in Reducing Alcohol Use and Related Harms: A Cluster Randomized Controlled Trial. Journal of Child Psychology and Psychiatry. 2016;57(9):1056-65. doi: http://dx.doi.org/10.1111/jcpp.12558.
Conrod PJ, Castellanos-Ryan, N, and Mackie C. Personality-Targeted Interventions Delay the Growth of Adolescent Drinking and Binge Drinking. 2008 (1469-7610 (Electronic)). eng.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
12/10/2020
Actual
22/12/2020
Date of last participant enrolment
Anticipated
1/04/2022
Actual
1/07/2022
Date of last data collection
Anticipated
15/07/2022
Actual
5/12/2022
Sample size
Target
900
Accrual to date
Final
570
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 30573 0
2000 - Sydney
Recruitment postcode(s) [2] 30574 0
2300 - Newcastle
Recruitment postcode(s) [3] 30575 0
2500 - Wollongong

Funding & Sponsors
Funding source category [1] 305974 0
Charities/Societies/Foundations
Name [1] 305974 0
Australian Rotary Health
Country [1] 305974 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
The University of Sydney
Camperdown NSW 2006
Country
Australia
Secondary sponsor category [1] 306435 0
None
Name [1] 306435 0
Address [1] 306435 0
Country [1] 306435 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306214 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 306214 0
Research Integrity & Ethics Administration
Research Portfolio
Level 3, F23 Administration Building
The University of Sydney
NSW 2006 Australia
Ethics committee country [1] 306214 0
Australia
Date submitted for ethics approval [1] 306214 0
13/09/2019
Approval date [1] 306214 0
27/02/2020
Ethics approval number [1] 306214 0
2019/792

Summary
Brief summary
Anxiety, depression and alcohol use disorders are common, co-occurring and cause significant harm to individuals and society. It is critical to intervene early to prevent chronic and debilitating trajectories. Existing prevention programs among adolescents are limited in effectiveness and implementation. This project aims to examine the effectiveness of a personality-targeted program, Preventure, in preventing escalation of anxiety, depression and alcohol use in young Australians. It will be the first in Australia to test Preventure when delivered by school staff (rather than psychologists), enabling broader reach and reducing cost, thereby ensuring a model with the potential to be delivered to high schools nationally. The Preventure intervention consists of 2 x 90-minute group sessions that incorporate components of cognitive-behavioural therapy and motivational interviewing to promote coping skills in adolescents. A cluster randomised controlled trial (RCT) will be conducted with 6 high-schools allocated to receive the Preventure intervention, and 6 high-schools allocated to a control condition who will receive their usual Health and Physical Education curriculum (total n=900 students). Students will be followed-up for 6-months, with surveys at baseline, and 6-months.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 103122 0
Dr Erin Kelly
Address 103122 0
Level 6, Jane Foss Russell building (G02) University of Sydney NSW 2006
Country 103122 0
Australia
Phone 103122 0
+61 286279048
Fax 103122 0
Email 103122 0
[email protected]
Contact person for public queries
Name 103123 0
Dr Erin Kelly
Address 103123 0
Level 6, Jane Foss Russell building (G02) University of Sydney NSW 2006
Country 103123 0
Australia
Phone 103123 0
+61 286279048
Fax 103123 0
Email 103123 0
[email protected]
Contact person for scientific queries
Name 103124 0
Dr Erin Kelly
Address 103124 0
Level 6, Jane Foss Russell building (G02) University of Sydney NSW 2006
Country 103124 0
Australia
Phone 103124 0
+61 286279048
Fax 103124 0
Email 103124 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
All data will be de-identified and aggregated at the school level. IPD will not be available.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
15411Study protocolKelly, E., GrummiL, L., Birrell, L., Stapinski, L., BarreL, E., Boyle, J., Teesson, M., Newton, N. (2021). The School-led Preventure study: Protocol of a cluster-randomised controlled trial of effectiveness to prevent adolescent alcohol misuse, internalising problems, and externalising problems through a personality-targeted intervention delivered by school staff. Preventive Medicine Reports, 21, 101286https://doi.org/10.1016/j.pmedr.2020.101286 



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe school-led Preventure study: Protocol of a cluster-randomised controlled trial of effectiveness to prevent adolescent alcohol misuse, internalising problems, and externalising problems through a personality-targeted intervention delivered by school staff.2021https://dx.doi.org/10.1016/j.pmedr.2020.101286
N.B. These documents automatically identified may not have been verified by the study sponsor.