Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001283864
Ethics application status
Approved
Date submitted
11/08/2021
Date registered
23/09/2021
Date last updated
7/04/2022
Date data sharing statement initially provided
23/09/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Self-management and recovery training (SMARTStart) to help young people make healthy choices: Pilot trial of feasibility and acceptability
Scientific title
Self-management and recovery training (SMARTStart) to help young people make healthy choices: Pilot trial of feasibility and acceptability
Secondary ID [1] 304814 0
None
Universal Trial Number (UTN)
Trial acronym
SMARTStart
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Addictive Behaviours 322879 0
Condition category
Condition code
Mental Health 320468 320468 0 0
Addiction
Public Health 321055 321055 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We aim to run a maximum of three weekly groups that run for up to 2 hours per session. In practice (i.e., out of the research setting), these groups are likely to continue running throughout the year, however for research purposes we will be assessing change over 8 weeks. Group size is likely to vary based on interest, physical capacity of program site, and participant commitments. It will be a minimum of 2 participants and capped at 20 participants. If more than 10 participants, additional peer workers and/or psychologists will be present to help manage group dynamics. Groups may be run online using videoconferencing or face to face. We have chosen to provide the upper limits of groups (i.e., 3), session running time (i.e., 2 hours), and number of participants (i.e., 20) to account for the unpredictability of interest in the study and pandemic lockdown restrictions. Participants from both eligible pathways (from headspace or other pathways) will be grouped together. No distinction will be made based on the pathway. Group participants may be grouped by age range if sufficient number of participants in these age ranges are recruited (e.g. 12-17 years olds in one group and 18-25 years old in another group).
The program will be based on SMART Recovery principles, a mutual aid group originally designed to help people with addictive behaviours, such as drug or alcohol use, or gambling. SMART Recovery is facilitated by a trained professional using Cognitive Behavioural Therapy and Motivational Interviewing techniques with a mutual aid approach where group members share experiences and ideas to support other group members. SMART Recovery is a well-established, evidence-based organisation that runs over 200 groups nationwide. The primary modifications that have been made are to establish the program as a space where young people help other young people; design the program as a social space, not a program targeting addictive behaviours or wellbeing; account for the importance of identity development and social connection in adolescent and young adult years; modify language and resources to be youth-targeted and youth-friendly; and to allow social, emotional, personal, and environmental stressors to be raised as important contributors to the health choices young people make. Examples of topics that might be raised during the weekly sessions would be related to drugs and alcohol, mental health, physical health, social relationships, managing school or work stress, and quality of life.
The study setting would be headspace Newcastle (and affiliated sites) and online using Zoom videoconference software. Due to pandemic lockdown restrictions, we are unable to identify the final setting in which we will run the groups. It is anticipated that we will deliver at least 1 face-to-face group and one videoconference group. Headspace Newcastle will have settings available on-site for small groups and has developed relationships with other sites (e.g., Newcastle Library) that may be required for larger groups. Online groups will be made available to account for possible difficulties accessing a group in Newcastle or pandemic lockdown restrictions.
The program will be delivered by one of three research psychologists (all with at least 18 months experience as a psychologist) and one of two peer workers (both with more than 5 years experience with mental health problems and the mental health service). All research psychologists and peer workers will have completed SMART training.
Attendance will be taken at each session as a measure of retention and completion of the intervention. No further fidelity assessments will be completed due to this being outside the scope of this study.
Intervention code [1] 321189 0
Treatment: Other
Intervention code [2] 321190 0
Lifestyle
Intervention code [3] 321191 0
Behaviour
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 328301 0
Feasibility, by recruitment rate of participants who are screened as eligible. Researchers involved in recruitment will maintain an enrolment log (e.g., N people contacted, N people reached, N people invited, N people eligible, N people consenting, N people completing baseline, N people in group 1-8, N people completing post-intervention survey), which will be used to assess recruitment and retention
Timepoint [1] 328301 0
End of recruitment period (anticipated 5 October 2021)
Primary outcome [2] 328302 0
Feasibility, by retention to the study (i.e. group attendance) derived from project records.
Timepoint [2] 328302 0
Post-intervention (8 weeks after intervention commencement)
Primary outcome [3] 328303 0
Acceptability of delivering SMARTStart groups for young people using the Client Satisfaction Questionnaire-8)

Timepoint [3] 328303 0
Post-intervention (8 weeks after intervention commencement)
Secondary outcome [1] 398481 0
Lifetime and recent substance use assessed by 8-item Alcohol, Smoking and Substance Involvement Screening Test Version 3.0 (ASSIST).
Timepoint [1] 398481 0
Baseline and Post-intervention (8 weeks after intervention commencement)
Secondary outcome [2] 398482 0
Psychological distress assessed by Kessler 10 (K10) measures psychological distress in the past month on a 5-point scale from ‘all of the time’ to ‘none of the time’.
Timepoint [2] 398482 0
Baseline and Post-intervention (8 weeks after intervention commencement)
Secondary outcome [3] 398483 0
Life satisfaction overall and across a number of life domains, composite of health and life achievements assessed by Personal Wellbeing Index: PWI. (Composite outcome)
Timepoint [3] 398483 0
Baseline and Post-intervention (8 weeks after intervention commencement)
Secondary outcome [4] 399340 0
Group Cohesion: The Group Climate Questionnaire Engagement scale is a 5-item scale that is commonly used to assess group cohesion in mental health settings.
Timepoint [4] 399340 0
Post-intervention (8 weeks after intervention commencement)
Secondary outcome [5] 399341 0
Social exchange: Social Exchange in Self-Help Support Groups Scale is a 29-item scale that assesses how people in self-help groups provide and receive social information.
Timepoint [5] 399341 0
Post-intervention (8 weeks after intervention commencement)
Secondary outcome [6] 399342 0
Qualitative feedback obtained in study-specific questionnaire via free-text options in online survey: Open-ended questions will ask participants “What did you get most out of participating in SMARTStart?” and “What would you change about SMARTStart to improve the program?”, and “Any other feedback?”
Timepoint [6] 399342 0
Post-intervention (8 weeks after intervention commencement)
Secondary outcome [7] 400569 0
Acceptability, as measured by study-specific questionnaire (e.g., How satisfied were you with the social aspects of the group?)
Timepoint [7] 400569 0
Post-intervention (8 weeks after intervention commencement)

Eligibility
Key inclusion criteria
Two separate inclusion criteria will be used that are based on differing recruitment pathways; one for those recruited via headspace Newcastle and one for those recruited through all other pathways.

Headspace
The inclusion criteria are:
• Aged 12 to 25 years at the time of the program
• Be engaged with a headspace Newcastle clinician
• Access to a private device with videoconferencing software (if participating via videoconference)

Other pathways
The inclusion criteria are:
• Aged 18 to 25 years at the time of the program
• Living in New South Wales
• Access to a private device with videoconferencing software (if participating via videoconference)
Minimum age
12 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Disclosure of active suicidal intent, which may include disclosure of daily suicidal ideation, intent to suicide, plan to suicide
• Inability to provide informed consent due to language or cognitive reasons.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
The primary objective of this project is to determine the feasibility and acceptability of the proposed intervention. Formal power calculations are not typically undertaken in feasibility trials. Based on the recruitment recommendations for feasibility studies we intend to recruit 20 participants to account for dropout.

We will also explore descriptive data (means, frequencies, standard deviations, percentages) for our primary outcomes. We will compare our findings to other data in the literature (not statistically).
We will compare secondary outcome data using repeated measure ANCOVA, controlling for relevant baseline demographics (e.g., age, gender, education) and the number of sessions attended.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
27/09/2021
Actual
Date of last participant enrolment
Anticipated
11/10/2021
Actual
Date of last data collection
Anticipated
5/01/2022
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 309184 0
Charities/Societies/Foundations
Name [1] 309184 0
Hunter Medical Research Institute Newcastle Permanent Charitable Foundation Grant
Country [1] 309184 0
Australia
Primary sponsor type
University
Name
The University of Newcastle
Address
University Drive
Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 310144 0
None
Name [1] 310144 0
Address [1] 310144 0
Country [1] 310144 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309042 0
The University of Newcastle Human Research Ethics Committee (HREC)
Ethics committee address [1] 309042 0
Ethics committee country [1] 309042 0
Australia
Date submitted for ethics approval [1] 309042 0
16/07/2021
Approval date [1] 309042 0
28/09/2021
Ethics approval number [1] 309042 0
H-2021-0248

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

Contacts
Principal investigator
Name 112758 0
Dr Kristen McCarter
Address 112758 0
The University of Newcastle
PO Box 833
Newcastle, NSW
2300
Country 112758 0
Australia
Phone 112758 0
+61405697756
Fax 112758 0
Email 112758 0
[email protected]
Contact person for public queries
Name 112759 0
Kristen McCarter
Address 112759 0
The University of Newcastle
PO Box 833
Newcastle, NSW
2300
Country 112759 0
Australia
Phone 112759 0
+61405697756
Fax 112759 0
Email 112759 0
[email protected]
Contact person for scientific queries
Name 112760 0
Kristen McCarter
Address 112760 0
The University of Newcastle
PO Box 833
Newcastle, NSW
2300
Country 112760 0
Australia
Phone 112760 0
+61405697756
Fax 112760 0
Email 112760 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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
12822Study protocol  [email protected]
12823Informed consent form  [email protected]
12824Ethical approval  [email protected]



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.