Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000413426
Ethics application status
Approved
Date submitted
12/04/2025
Date registered
6/05/2025
Date last updated
6/05/2025
Date data sharing statement initially provided
6/05/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Pitjantjatjara ASSIST: A project aimed at assessing the validity, reliability and cultural appropriateness of the digital, translated and culturally-adapted Alcohol, Smoking and Substance Involvement Screening Test (ASSIST), for use in Aboriginal and Torres Strait Islander populations.
Scientific title
The Pitjantjatjara ASSIST: An order-randomised study assessing the validity, reliability and cultural appropriateness of the digital, translated and culturally-adapted Alcohol, Smoking and Substance Involvement Screening Test (ASSIST), for use in Aboriginal and Torres Strait Islander populations.
Secondary ID [1] 314199 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
alcohol use disorder 337075 0
hazardous alcohol use 337076 0
harmful use of alcohol 337077 0
alcohol dependence 337078 0
tobacco use disorder 337079 0
hazardous nicotine use 337080 0
harmful use of nicotine 337081 0
nicotine dependence 337082 0
cannabis use disorder 337083 0
hazardous cannabis use 337084 0
harmful use of cannabis 337085 0
cannabis dependence 337086 0
methamphetamine use disorder 337087 0
hazardous stimulants use 337088 0
harmful use of stimulants 337089 0
stimulants dependence 337090 0
inhalants use disorder 337091 0
hazardous inhalants use 337092 0
harmful use of inhalants 337093 0
inhalants dependence 337094 0
Condition category
Condition code
Mental Health 333510 333510 0 0
Addiction
Public Health 333511 333511 0 0
Epidemiology
Public Health 333512 333512 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participant Involvement and Procedure:
Participants will complete the Pitjantjatjara ASSIST app, a culturally-adapted and translated 8-item questionnaire that assesses risk of harm from substance use disorders [1,2]. The app focuses on five substances of concern in Pitjantjatjara communities (alcohol, tobacco, cannabis, methamphetamine, and inhalants). Participants step through the instrument sequentially for each substance, with the ability to modify responses throughout the assessment until the final question is completed. After completion, participants receive personalized feedback on substance-specific risk levels and general health advice about reducing or stopping use. Following the receipt of feedback, participants are then asked to answer three user experience questions using a 5-point Likert Scale with emoji faces to evaluate cultural acceptability.

Time Requirement:
Based on internal pilot testing, the app takes approximately 10 minutes to complete, not including the variable time participants spend reviewing their feedback, which is not time-limited.

Administration:
The app is self-administered on an iPad tablet. Before beginning, participants receive a guided visual and tactile demonstration from a research team member (either a health worker or interpreter). Research team members remain nearby to address any questions or technical issues, but participants complete the assessment independently.

Frequency:
Participants will complete the app twice during the study period: once on the initial day (either before or after the diagnostic interview, depending on randomization) and again during a follow-up session 6-14 days later.

Fidelity and Adherence Monitoring:
The app's digital format ensures standardisation of the assessment process. All participants receive the same questions in the same sequence, with built-in controls that prevent modification of responses after completion.
Randomisation and follow-up
Participants will first be randomised to complete either the Pitjantjatjara ASSIST app or the diagnostic interview first. Those assigned to the app-first condition will complete the app as outlined, then be provided a 30-minute break before completing the diagnostic interview. Those assigned to the interview-first condition will complete the diagnostic interview first, then be given a 30-minute break before completing the app.

Both groups of participants will then be followed up 7-14 days later to complete the Pitjantjatjara ASSIST app a second time.

References:
1. World Health Organization Working Group. The Alcohol, Smoking and Substance Involvement Screening Test (ASSIST): development, reliability and feasibility. Addiction. 2002 Sep;97(9):1183-94.
2. Stevens MW, Barry D, Bertossa S, Thompson M, Ali R. First-Stage Development of the Pitjantjatjara Translation of the World Health Organization’s Alcohol, Smoking and Substance Involvement Screening Test (ASSIST). Journal of the Australian Indigenous HealthInfoNet. 2022;3(4):2.
Intervention code [1] 330802 0
Early detection / Screening
Intervention code [2] 330803 0
Diagnosis / Prognosis
Intervention code [3] 330865 0
Lifestyle
Comparator / control treatment
Procedure:
Participants will complete a diagnostic interview based on the modified DIS-SAM that identifies clinical symptoms for both ICD-11 and DSM-5 substance use disorders. The interview follows a semi-structured "yarning"-style discussion framework and covers substance use over both 3-month and 12-month intervals. Each participant will complete this interview once, on the same day they complete the Pitjantjatjara ASSIST app, with the order determined by their randomization group (app-first or interview-first).

Time Requirement:
The interview is designed to be completed within 30 minutes or less.

Administration:
The interview will be conducted by a gender-matched health professional who understands Pitjantjatjara culture and context but may not be Aboriginal or fluent in the language. An Aboriginal person of the same gender as the participant will always be present during the interview to aid with interpretation and cultural context. This dual-professional approach is designed to help mitigate potential impacts of cultural differences on assessment quality.

Frequency:
Participants will complete the diagnostic interview only once during the study period. In contrast, they will complete the Pitjantjatjara ASSIST app twice: once on the initial day (either before or after the interview, depending on randomisation) and again during a follow-up session 7-14 days later.

Fidelity and Adherence Monitoring:
The interview is standardised through implementation in REDCap, ensuring that all participants receive the same questions in the same order, depending on their level of substance involvement. This standardisation, combined with the dual-professional approach (Aboriginal and non-Indigenous healthcare workers), helps maintain consistency across all interviews while allowing for culturally appropriate "yarning"-style discussions. The structured digital format in REDCap also facilitates consistent documentation and data collection across all participants.

Randomisation and follow-up:
As above, participants assigned to receive the interview first will complete the diagnostic interview with the health professional and translator, then be given a 30-minute break before completing the Pitjantjatjara ASSIST app.
Control group
Active

Outcomes
Primary outcome [1] 341084 0
Discriminant validity.
Timepoint [1] 341084 0
Only responses obtained on the first day of assessment (both ASSIST and interview) will be used to determine this outcome.
Primary outcome [2] 341085 0
Concurrent validity. Concurrent validity captures the extent to which a test aligns with the current gold-standard.
Timepoint [2] 341085 0
Only responses obtained on the first day of assessment (both ASSIST and interview) will be used to determine this outcome.
Primary outcome [3] 341087 0
Reliability (test-retest)
Timepoint [3] 341087 0
baseline and 7-14 day follow-up
Secondary outcome [1] 446175 0
Internal consistency reliability
Timepoint [1] 446175 0
Only responses obtained on the first day of assessment (ASSIST only) will be used to determine this outcome.
Secondary outcome [2] 446636 0
Diagnostic accuracy - Sensitivity
Timepoint [2] 446636 0
Only responses obtained on the first day of assessment (both ASSIST and interview) will be used to determine this outcome.
Secondary outcome [3] 446637 0
Diagnostic accuracy - Specificity
Timepoint [3] 446637 0
Only responses obtained on the first day of assessment (both ASSIST and interview) will be used to determine this outcome.
Secondary outcome [4] 446638 0
Diagnostic accuracy - positive predictive value (PPV)
Timepoint [4] 446638 0
Only responses obtained on the first day of assessment (both ASSIST and interview) will be used to determine this outcome.
Secondary outcome [5] 446639 0
Diagnostic accuracy - negative predictive value (NPV)
Timepoint [5] 446639 0
Only responses obtained on the first day of assessment (both ASSIST and interview) will be used to determine this outcome.
Secondary outcome [6] 446640 0
Positive likelihood ratio (LR+)
Timepoint [6] 446640 0
Only responses obtained on the first day of assessment (both ASSIST and interview) will be used to determine this outcome.
Secondary outcome [7] 446641 0
Negative likelihood ratio (LR-)
Timepoint [7] 446641 0
Only responses obtained on the first day of assessment (both ASSIST and interview) will be used to determine this outcome.
Secondary outcome [8] 446642 0
Clinical utility index (positive)
Timepoint [8] 446642 0
Only responses obtained on the first day of assessment (both ASSIST and interview) will be used to determine this outcome.
Secondary outcome [9] 446643 0
Clinical utility index (negative)
Timepoint [9] 446643 0
Only responses obtained on the first day of assessment (both ASSIST and interview) will be used to determine this outcome.
Secondary outcome [10] 446644 0
Cultural acceptability
Timepoint [10] 446644 0
baseline and 7-14 day follow up

Eligibility
Key inclusion criteria
Must self-identify as Pitjantjatjara- or English-speaking Anangu (meaning ‘people’ in Pitjantjatjara-Yankunytjatjara, the Traditional Owners of the APY-lands across South Australia, Northern Territory, and Western Australia)

Since participants are also required to conduct a diagnostic interview (which will be conducted in English with the aid of a translator), fluency in either (spoken or written) English or Pitjantjatjara is required.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants who appear intoxicated at the time of the interview will not be eligible to participate in the study, but will still be able to try out app should they choose

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants are first approached by the research assistant to gauge interest/suitability for participation. Those interested to participate are then randomised into either condition first, ahead of providing informed consent. Information about the study is provided to the participants through the iPad at the beginning of both the app (as part of the app's onboarding process) or the interview (as part of the interview orientation).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A link to our randomisation sequence generator (located on a centralised website:https://assistportal.com.au/randomiser/) has been embedded within each iPad. The researcher initiates the randomisation sequence on the iPad, and depending on the allocated group, obtains informed consent via the app or at the beginning of the interview.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Statistical approach:
The primary outcomes from this study include the app’s reliability, validity, diagnostic accuracy. Reliability will be assessed according to internal consistency and test-retest, using McDonald’s omega, and Cohen’s chance-corrected kappa. Validity will be assessed according to both concurrent and discriminative validity against a gold-standard clinical interview. Concurrent validity will be assessed using linear regression, while discriminant validity will be assessed using one-way ANOVA. A small subset of participants will also receive an independent evaluation from a Specialist Addiction Medicine Registrar, which will form the basis of an additional check for concurrent validity, which will be assessed using logistic regression. Diagnostic accuracy of the instrument will be assessed based on a range of indices and receiver operating characteristics (ROC) curve analysis.

SAMPLE SIZE CALCULATIONS
Since the app focuses on these five substances only, and uses existing ASSIST cut-off scores to determine three corresponding levels of risk for each (i.e., low, moderate or high), there are a total of 15 (5x3) possible substance/risk combinations. We will aim to recruit a minimum of 40 individuals to satisfy each of those outcomes (e.g., 40 participants each for low, moderate and high-risk, for each of the substances This could require up to 600 participants, though the total will likely be lower since many use multiple substances.
For the validity assessments, a series of power calculations were conducted to determine the minimum sample size needed to detect a large between-groups effect, with type-I, and type-II error rates of 5% (corresponding to a=.05), and 10% (corresponding to an a priori power of 90%) respectively. Where possible, we will also aim to recruit a 1:1 ratio of participants for each group (i.e., positive/negative cases), and so a 1:1 ratio of participants was used here. Using these parameters as default, we conducted the following power calculations in G-power [1].
For each regression model assessing concurrent validity, it was determined that a minimum of 111 participants are needed for each model (corresponding to line-of-best-fit slope of .3). For each logistic regression model assessing concurrent validity with the independent assessment, a total sample size of 62 using each substance was determined. The additional parameters used in this analysis included a probability of reaching diagnosis in the diagnosis present group of .70 (corresponding to a sensitivity of 70% and an Odds Ratio of 2.33 [.70/.30]), versus a chance probability (i.e., 50%) in the diagnosis absent group. These parameters yielded a total sample size of 62 individuals (approximately 31 in each group diagnosis present/absent assuming 1:1 sampling). For each ANOVA model assessing discriminant validity, a minimum of 96 participants using each substance are required to power the analysis (corresponding to a Cohen’s f>.40 [2). Furthermore, given there are three planned comparisons for each ANOVA model assessing discriminant validity, a Bonferroni correction was applied to the type-I error rate (i.e., .05/3). Thus the new corrected type-I error rate was reduced to .017. Therefore, the minimum number of participants to detect a large effect (Hedges’ g>.80 [3]) was 38 participants for each group. This corresponds to thirty-eight low risk, thirty-eight moderate risk, and thirty-eight high-risk individuals for each substance (which equals approximately 114 participants for each given substance). Therefore, the total sample size required for each group is 38 individuals.
For the reliability assessment, we also calculated the minimum sample size required to detect an omega coefficient of >.70, setting the type-I error rate to .05, with a minimum power of .90, with the number of scale items equal to 4 (tobacco) or 5 (all other substances). This method has been suggested previously [4,5] and has been used widely in health and medical research settings [6]. The result was a minimum sample size of 38 for a 5-item scale, and 40 for the 4-item scale. We elected to use 40 as the minimum sample size required for consistency.

REFERENCES
1. Faul, F., Erdfelder, E., Lang, A.-G., & Buchner, A. (2007). G*Power 3: A flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behavior Research Methods, 39, 175-191
2. Cohen, J. (2013). Statistical power analysis for the behavioral sciences. Routledge.
3. Hedges LV. Distribution theory for Glass's estimator of effect size and related estimators. journal of Educational Statistics. 1981 Jun;6(2):107-28. Journal of Educational Statistics, 6, 107–128.
4. Bonett, D. G. (2002). Sample size requirements for testing and estimating coefficient alpha. Journal of educational and behavioral statistics, 27(4), 335-340.
5. Streiner, D. L. (2003). Starting at the beginning: an introduction to coefficient alpha and internal consistency. Journal of personality assessment, 80(1), 99-103. https://doi.org/10.21315/mjms2018.25.6.9
6. Bujang, M. A., Omar, E. D., & Baharum, N. A. (2018). A Review on Sample Size Determination for Cronbach's Alpha Test: A Simple Guide for Researchers. The Malaysian journal of medical sciences: MJMS, 25(6), 85–99.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
17/12/2024
Date of last participant enrolment
Anticipated
17/12/2025
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
600
Accrual to date
30
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 318714 0
Government body
Name [1] 318714 0
Department of Health and Aged Care, Australian Government
Country [1] 318714 0
Australia
Primary sponsor type
University
Name
The University of Adelaide
Address
Country
Australia
Secondary sponsor category [1] 321144 0
None
Name [1] 321144 0
Address [1] 321144 0
Country [1] 321144 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317319 0
Aboriginal Health Research Ethics Committee
Ethics committee address [1] 317319 0
Ethics committee country [1] 317319 0
Australia
Date submitted for ethics approval [1] 317319 0
11/10/2023
Approval date [1] 317319 0
20/09/2024
Ethics approval number [1] 317319 0
04-23-1090
Ethics committee name [2] 317323 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [2] 317323 0
Ethics committee country [2] 317323 0
Australia
Date submitted for ethics approval [2] 317323 0
01/03/2024
Approval date [2] 317323 0
21/05/2024
Ethics approval number [2] 317323 0
2024/HRE00063
Ethics committee name [3] 317324 0
University of Adelaide Human Research Ethics Committee
Ethics committee address [3] 317324 0
Ethics committee country [3] 317324 0
Australia
Date submitted for ethics approval [3] 317324 0
21/05/2024
Approval date [3] 317324 0
02/10/2024
Ethics approval number [3] 317324 0
39232

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

Contacts
Principal investigator
Name 140686 0
A/Prof Robert Ali, AO
Address 140686 0
Level 3, Helen Mayo South Building, 1 Frome Road, The University of Adelaide, Adelaide, South Australia, 5005
Country 140686 0
Australia
Phone 140686 0
+61 401124516
Fax 140686 0
Email 140686 0
[email protected]
Contact person for public queries
Name 140687 0
Robert Ali, AO
Address 140687 0
Level 3, Helen Mayo South Building, 1 Frome Road, The University of Adelaide, Adelaide, South Australia, 5005
Country 140687 0
Australia
Phone 140687 0
+61 401124516
Fax 140687 0
Email 140687 0
[email protected]
Contact person for scientific queries
Name 140688 0
Robert Ali, AO
Address 140688 0
Level 3, Helen Mayo South Building, 1 Frome Road, The University of Adelaide, Adelaide, South Australia, 5005
Country 140688 0
Australia
Phone 140688 0
+61 401124516
Fax 140688 0
Email 140688 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Anyone
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
• Requires approval by an ethics committee
• Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
• De-identified individual participant data:
• Published results
• Primary outcome(s)
What types of analyses could be done with individual participant data?
• Systematic reviews and meta-analyses
• Studies exploring new research questions
• Health economic analyses
• Studies testing whether findings can be repeated or confirmed
When can requests for individual participant data be made (start and end dates)?
From:
At the end of the study
To:
No end date
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: contact should be made to the Chief Investigator, [email protected]

Are there extra considerations when requesting access to individual participant data?
No


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.