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Trial registered on ANZCTR


Registration number
ACTRN12619000335190
Ethics application status
Approved
Date submitted
21/02/2019
Date registered
5/03/2019
Date last updated
23/04/2019
Date data sharing statement initially provided
5/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
mi.spot (supportive, preventative, online and targeted): a moderated online intervention for young adults who have a parent with a mental illness and/or substance use concern: A study protocol for a randomised controlled trial
Scientific title
mi.spot (supportive, preventative, online and targeted): a moderated online intervention targeting mental health and well-being for emerging adults who have a parent with a mental illness and/or substance use concern: A study protocol for a randomised controlled trial
Secondary ID [1] 297465 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Family related mental illness 311656 0
Depression 311657 0
Schizophrenia 311658 0
Anxiety 311659 0
Condition category
Condition code
Mental Health 310278 310278 0 0
Schizophrenia
Mental Health 310279 310279 0 0
Depression
Mental Health 310280 310280 0 0
Anxiety
Mental Health 310451 310451 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Mi.spot is a moderated online intervention for groups of up to 20 emerging adults (18-25 year olds) whose parent has a mental illness/substance use concern. The six week intervention is hosted on a standalone website and access to the intervention is password protected. It is based on cognitive behavioural principles, and is strength based and trauma informed. The features of the intervention are:
• a forum for youth to interact with peers - participants have the opportunity to chat to each other on group threads which are moderated by a facilitator on the mi.spot website .
• six, one hour facilitated sessions about (i) emotional regulation (ii) psycho-education, (iii) managing relationships, (iv), emotion and problem focused coping, (v) caring for others and (vi) resilience with accompanying video, audio, print resources. These will be delivered at designated times during the week and are initiated, managed and moderated by the facilitators through online conversations. Sessions are built around evidence-based literature, and all source materials are referenced in the mispot manual.
• opportunities for one-to-one counselling chats with a professional – these can be initiated by either the participant or by one of the facilitators if they believe the participant requires additional support. Number and duration will be determined by participants and facilitators in collaboration.
• private, online diary (mi.thoughts.spot) to encourage participants to apply a cognitive behavioural approach with the support of a facilitator (provided asynchronously)
All features of the website are optional (i.e. there is no mandated requirement for frequency of use) and participants may choose to “lurk” rather than actively contribute.
The intervention will be delivered from the Krongold Clinic, a university based, teaching and research clinic in Australia. Masters level psychology students will deliver the intervention, under the supervision of the intervention developers. Conduct of the trial will be led by a local principal investigator, supported by a research team, all of whom will received training in the requirements of the study protocol. Intervention facilitators are trained in the intervention by completing 2 days of face to face training using simulated online scenarios. Training is undertaken approximately 2 weeks prior to the intervention commencing and is facilitated by two experienced practitioners.
Intervention code [1] 313721 0
Behaviour
Comparator / control treatment
Participants in the control group will be given information about other local and national services (e.g. Lifeline and Beyond Blue) where they can access including online and face to face services. They will be offered the intervention after the intervention group complete the post intervention questionnaires (approximately 12 weeks after randomisation). They will complete measures at the same time as the pre, post and 6 week followup time frames of the intervention group.
Control group
Active

Outcomes
Primary outcome [1] 319175 0
Wellbeing levels will be measured using the 14 item short version of the Mental Health Continuum (MHC-SF), measuring three aspects of wellbeing; emotional, social, and psychological
Timepoint [1] 319175 0
Completed at baseline (1-2 weeks prior to the intervention) and post intervention (approximately 6 weeks post baseline – after the facilitated component of the intervention ends) and follow up 6 weeks after post intervention. Primary timepoint is 6 weeks after baseline, post intervention.
Primary outcome [2] 319176 0
Levels of depression, anxiety and stress will be measured using the short form of the DASS-21 scale
Timepoint [2] 319176 0
Completed at baseline (1-2 weeks prior to the intervention) and post intervention (approximately 6 weeks post baseline – after the facilitated component of the intervention ends) and follow up 6 weeks after post intervention. Primary timepoint is 6 weeks after baseline, post intervention.
Secondary outcome [1] 367181 0
Levels of coping will be measured using an abbreviated version of the COPE Inventory
Timepoint [1] 367181 0
Completed at baseline (1-2 weeks prior to the intervention) and post intervention (approximately 6 weeks post baseline – after the facilitated component of the intervention ends) and follow up 6 weeks after post intervention.
Secondary outcome [2] 367182 0
Levels of help seeking will be measured using the General Help Seeking Questionnaire
Timepoint [2] 367182 0
Completed at baseline (1-2 weeks prior to the intervention) and post intervention (approximately 6 weeks post baseline – after the facilitated component of the intervention ends) and follow up 6 weeks after post intervention.
Secondary outcome [3] 367183 0
Levels of social connectedness will be measured using the revised Social Connectedness Scale
Timepoint [3] 367183 0
Completed at baseline (1-2 weeks prior to the intervention) and post intervention (approximately 6 weeks post baseline – after the facilitated component of the intervention ends) and follow up 6 weeks after post intervention.
Secondary outcome [4] 367189 0
Levels of self-efficacy will be measured using the The 10 item General Self-Efficacy Scale
Timepoint [4] 367189 0
Completed at baseline (1-2 weeks prior to the intervention) and post intervention (approximately 6 weeks post baseline – after the facilitated component of the intervention ends) and follow up 6 weeks after post intervention.
Secondary outcome [5] 367190 0
Levels of psychoeducation will be measured using the Mental Health Literacy Scale
Timepoint [5] 367190 0
Completed at baseline (1-2 weeks prior to the intervention) and post intervention (approximately 6 weeks post baseline – after the facilitated component of the intervention ends) and follow up 6 weeks after post intervention.
Secondary outcome [6] 367191 0
Specifically designed for this study was an "attribution of responsibility measure" to measure how responsible participants felt for their parents’ issues.
Timepoint [6] 367191 0
Completed at baseline (1-2 weeks prior to the intervention) and post intervention (approximately 6 weeks post baseline – after the facilitated component of the intervention ends) and follow up 6 weeks after post intervention.

Eligibility
Key inclusion criteria
18-25 years of age inclusive
Volunteers responding to social media, referral or word of mouth.
Not currently in distress or crisis, as ascertained by telephone interview.
Has a parent with a mental illness or substance use concern (they do not have to be currently living with them) - based on self report
Capable of giving informed consent as identified by phone interview
Minimum age
18 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Non-English speaking
Non-Australian resident
Currently in distress or experiencing a crisis
No access to the internet, computer, tablet or mobile telephone

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation will occur via a random number generator which is computerised, and participants will be allocated according to the timing (i.e., order) of them signing up for the study. The researchers will be blind to the allocation of participants to the intervention and control conditions as informed consent and collection of the baseline data will occur via clinicians and online website. The random number allocation procedure will occur prior to the commencement of the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation sequence will be developed by computer generation of random number sequences via SPSS by the project manager prior to commencing the project, and maintained by the admin officer.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Participant numbers were initially determined by a power calculation indicating a minimum n=44 participants with Crit F=3.10 (using GPOWER 3.1, assuming 2 groups and 3 repetitions, a small effect size, an alpha of 5% and power of 95%) to be required. However based on previous dropout rates it was considered that over the time frame of data collection (including the longer frame of the wait list controls) that there may be a dropout rate from 30-40%. As a consequence we increased the recruitment numbers to n=70.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
29/04/2019
Actual
Date of last participant enrolment
Anticipated
29/07/2019
Actual
Date of last data collection
Anticipated
28/10/2019
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 302035 0
University
Name [1] 302035 0
Monash University
Country [1] 302035 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Wellington Road
Clayton,
Victoria 3000
Country
Australia
Secondary sponsor category [1] 301844 0
None
Name [1] 301844 0
Address [1] 301844 0
Country [1] 301844 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302718 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 302718 0
Ethics committee country [1] 302718 0
Australia
Date submitted for ethics approval [1] 302718 0
12/02/2019
Approval date [1] 302718 0
17/04/2019
Ethics approval number [1] 302718 0
18660

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

Contacts
Principal investigator
Name 91146 0
Prof Andrea Reupert
Address 91146 0
Monash University
19 Ancora Imparo Way
Monash University VIC 3800

(Note, Monash University is the suburb for postcode 3800)
Country 91146 0
Australia
Phone 91146 0
+61 03 9902 4587
Fax 91146 0
Email 91146 0
Andrea.reupert@monash.edu
Contact person for public queries
Name 91147 0
Andrea Reupert
Address 91147 0
Monash University
19 Ancora Imparo Way
Monash University VIC 3800

(Note: Monash University is the suburb for the postcode 3800)
Country 91147 0
Australia
Phone 91147 0
+61 03 9902 4587
Fax 91147 0
Email 91147 0
Andrea.reupert@monash.edu
Contact person for scientific queries
Name 91148 0
Andrea Reupert
Address 91148 0
Monash University
19 Ancora Imparo Way
Monash University VIC 3800

(Note: Monash University is the suburb for postcode 3800)
Country 91148 0
Australia
Phone 91148 0
+61 03 9902 4587
Fax 91148 0
Email 91148 0
Andrea.reupert@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Undecided at this stage


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
1501Study protocol    A web-based intervention for young adults whose pa... [More Details]



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseAn online intervention for 18-25-year-old youth whose parents have a mental illness and/or substance use disorder: A pilot randomized controlled trial.2022https://dx.doi.org/10.1111/eip.13274
N.B. These documents automatically identified may not have been verified by the study sponsor.