ANZCTR - Registration

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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]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Family related mental illness

Depression

Schizophrenia

Anxiety

Condition category

Condition code

Mental Health

Schizophrenia

Mental Health

Depression

Mental Health

Anxiety

Mental Health

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]

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]

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]

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]

Levels of depression, anxiety and stress will be measured using the short form of the DASS-21 scale

Timepoint [2]

Secondary outcome [1]

Levels of coping will be measured using an abbreviated version of the COPE Inventory

Timepoint [1]

Secondary outcome [2]

Levels of help seeking will be measured using the General Help Seeking Questionnaire

Timepoint [2]

Secondary outcome [3]

Levels of social connectedness will be measured using the revised Social Connectedness Scale

Timepoint [3]

Secondary outcome [4]

Levels of self-efficacy will be measured using the The 10 item General Self-Efficacy Scale

Timepoint [4]

Secondary outcome [5]

Levels of psychoeducation will be measured using the Mental Health Literacy Scale

Timepoint [5]

Secondary outcome [6]

Specifically designed for this study was an "attribution of responsibility measure" to measure how responsible participants felt for their parents’ issues.

Timepoint [6]

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors

Funding source category [1]

University

Name [1]

Monash University

Address [1]

Wellington Road
Clayton,
Victoria 3000

Country [1]

Australia

Primary sponsor type

University

Name

Monash University

Address

Wellington Road
Clayton,
Victoria 3000

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Monash University Human Research Ethics Committee

Ethics committee address [1]

Clayton campus
Wellington Road
Clayton
Victoria 3800

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

12/02/2019

Approval date [1]

17/04/2019

Ethics approval number [1]

18660

Summary

Brief summary

The transition to adulthood can be a vulnerable period for emerging adults who have a parent with mental illness or substance use concern. Compared to their same aged peers, this group of youth face increased risks to their own mental health and commonly do not engage with traditional face-to-face health services or have access to age-appropriate, targeted interventions. Increased engagement may result through providing an online intervention. This controlled trial examines the utility of mi.spot (mental illness: supportive, preventative, online, targeted) online intervention for emerging adults aged 18 to 25 years who have a parent with a mental illness or substance use concern. The research will investigate the impact of the mi. spot intervention on the mental health and wellbeing of an intervention group compared to a control group waiting to participate in the intervention. The two groups will be compared pre, post and 6 weeks follow-up after the intervention period.

Trial website

https://www.mispot.org.au

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Andrea Reupert

Address

Monash University
19 Ancora Imparo Way
Monash University VIC 3800

(Note, Monash University is the suburb for postcode 3800)

Country

Australia

Phone

+61 03 9902 4587

Fax

[email protected]

Contact person for public queries

Name

Prof Andrea Reupert

Address

Monash University
19 Ancora Imparo Way
Monash University VIC 3800

(Note: Monash University is the suburb for the postcode 3800)

Country

Australia

Phone

+61 03 9902 4587

Fax

[email protected]

Contact person for scientific queries

Name

Prof Andrea Reupert

Address

Monash University
19 Ancora Imparo Way
Monash University VIC 3800

(Note: Monash University is the suburb for postcode 3800)

Country

Australia

Phone

+61 03 9902 4587

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

Undecided at this stage

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
1501	Study 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

Source	Title	Year of Publication	DOI
Embase	An online intervention for 18-25-year-old youth whose parents have a mental illness and/or substance use disorder: A pilot randomized controlled trial.	2022	https://dx.doi.org/10.1111/eip.13274

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically