ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12619000350123

Ethics application status

Approved

Date submitted

26/02/2019

Date registered

6/03/2019

Date last updated

1/11/2022

Date data sharing statement initially provided

6/03/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

Peer Tree: a digital intervention targeting loneliness in young people

Scientific title

A randomised control trial of the Peer Tree digital intervention targeting loneliness in young people

Secondary ID [1]

Nil Known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Loneliness

Condition category

Condition code

Mental Health

Other mental health disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Participants will be assessed to determine their eligibility in the study, part of this assessment period is to confirm that participants do not meet criteria for a mental health diagnosis (e.g., mood disorder, anxiety disorder). All participants enrolled in the trial will undergo three assessment sessions: baseline (before Peer Tree), post-intervention (immediately after the 6 week intervention), and three months post-intervention. After the baseline assessment, participants will be randomised to one of the following two arms: Peer Tree Smartphone Application or Treatment as Usual.

Peer Tree Smartphone Application
Participants will use the Peer Tree smartphone application individually for approximately 5-10 minutes per day for 6 consecutive weeks. They will have the flexibility to use the app wherever and whenever they would like with researchers being able to measure meta-data for adherence to using the smartphone application. The intervention involves short video clips in the form of animations, shared experience videos, actor videos, and expert videos displaying information about different social and emotional processing and positive psychology principles. The content of the videos include a range of different themes from identifying strengths to expressing gratitude to finding wider meaning.

Participants rate their mood daily and are presented with one video per day. They answer questions about the videos to earn in-app rewards (e.g., tokens/badges to interact with the app). Challenges are provided throughout the intervention to assist participants in exercising the skills they have learnt and to maximise access building relationships, these are not compulsory but are encouraged. Participants will also be able to access an online, moderated forum where they can discuss the different topics and challenges within the app. These will be moderated by clinicians, researchers, and peer moderators to ensure the safety of the app users.

Intervention code [1]

Treatment: Other

Comparator / control treatment

Treatment as usual (TAU):
Participants in this group will complete their study as per their norm. This will act as the control condition for the intervention. Treatment as usual here refers to the participants' completing their studies as if they were not enrolled in the research project. Once the three month post-intervention assessment is held, participants will have access to the content in the form of the previous version of the app, +Connect. +Connect does not include the interactive components and previous research has shown the app to be safe for consumers to use (manuscript under review).

Control group

Active

Outcomes

Primary outcome [1]

mean UCLA Loneliness Scale (UCLA-LS)

Timepoint [1]

Baseline, End of Treatment, and three-month post intervention

Secondary outcome [1]

mean Social Interaction Anxiety Index (SIAS)

Timepoint [1]

Baseline, End of Treatment, Three-months post-intervention

Secondary outcome [2]

mean Centre for Epidemiology Studies - Depression Scale (CESD)

Timepoint [2]

Baseline, End of Treatment, Three-months post-intervention

Secondary outcome [3]

mean Positive and Negative Affect Scale (PANAS)

Timepoint [3]

Baseline, End of Treatment, Three-months post-intervention

Secondary outcome [4]

Scales of Psychological Wellbeing (SPWB)

Timepoint [4]

Baseline, End of Treatment, Three-Months Post-Intervention

Secondary outcome [5]

Assessment of Quality of Life (AQoL 4-D)

Timepoint [5]

Baseline, End of Treatment, Three-Months Post-intervention

Secondary outcome [6]

adherence assessed by PeerTree meta-data

Timepoint [6]

Baseline, End of Treatment, Three-Months Post-Intervention

Secondary outcome [7]

mean PeerTree App Acceptability Ratings derived from purpose built questionnaire

Timepoint [7]

End of Treatment

Secondary outcome [8]

mean Peer Tree app Feasibility ratings derived from purpose built questionnaire

Timepoint [8]

End of Treatment

Secondary outcome [9]

mean Peer Tree app Usability ratings derived from purpose built questionnaire

Timepoint [9]

End of Treatment

Eligibility

Key inclusion criteria

1) No diagnosis of a psychiatric or mental health condition
2) Aged between 18-25
3) Owns a smartphone device (iPhone or Android device)
4) Enrolled at Swinburne University of Technology
5) At risk of dropping out of university

Minimum age

18 Years

Maximum age

25 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

1) Diagnosed with a psychiatric illness or mental health condition
2) Mild, Moderate, or High risk to self, others, objects/property
3) under the age of 18
4) Current substance dependence or abuse

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)

Allocation is not concealed

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Computerised Sequence Allocation to Random Groups

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

All data processing and analysis will occur either in the statistical package for the social sciences (SPSS), Mplus, or R data analysis software. Data manipulation will only occur if the data violates the statistical assumptions of the tests that we would be conducting. In this instance, the data will be transformed into a format that does not jeopardise the interpretability of the scores.

We envisage that any combination of the following will be used to assess the outcomes of the study: Mixed Model ANOVAs, Standard and Hierarchical Regression, Mediation and multiple mediation, latent trajectory modelling, t-tests and comparisons, and finally correlations.

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

1/04/2019

Actual

24/02/2020

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment postcode(s) [1]

3122 - Hawthorn

Funding & Sponsors

Funding source category [1]

University

Name [1]

Swinburne University of Technology

Address [1]

Swinburne University of Technology,
PO Box 218,
Hawthorn VIC, 3122

Country [1]

Australia

Primary sponsor type

University

Name

Swinburne University of Technology

Address

Swinburne University of Technology,
P O Box 218,
HAWTHORN VIC 3122

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Swinburne University of Technology Human Research Ethics Committee

Ethics committee address [1]

Swinburne University of Technology, 
PO BOX 218, 
Hawthorn, 3122

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

01/03/2019

Approval date [1]

01/02/2019

Ethics approval number [1]

R/2019/074

Summary

Brief summary

The aim of the research project is to deliver and test an innovative digital smartphone intervention, Peer Tree, which is designed to reduce loneliness in young people and will be applied to students marked as at risk of dropping out. The intervention is administered daily for 6 weeks. 

Young people aged 18-25 years will be recruited. In accordance with a randomised control trial study design, after participants complete the baseline assessment, they will be randomised to either the treatment as usual or intervention group. Those in the waitlist group will complete treatment as usual but will be provided with the same content once they have completed the research project. This will be provided in the form of +Connect, the predecessor of Peer Tree that doesn’t not contain the forums.

Our research is expected to contribute to the development of personalised, modular mental health interventions that are cost-effective and efficient. There are currently no personalised, modular interventions available to address loneliness in tertiary education students.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Michelle lim

Address

Swinburne University of Technology,
John Street, Hawthorn, VIC, 3122, Australia

Country

Australia

Phone

+61 3 9214 5109

Fax

mlim@swin.edu.au

Contact person for public queries

Name

Michelle Lim

Address

Swinburne University of Technology,
John Street, Hawthorn, VIC, 3122, Australia

Country

Australia

Phone

+61 3 9214 4868

Fax

mlim@swin.edu.au

Contact person for scientific queries

Name

Michelle lim

Address

Swinburne University of Technology,
John Street, Hawthorn, VIC, 3122, Australia

Country

Australia

Phone

+61 3 9214 5109

Fax

mlim@swin.edu.au

Data sharing statement

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

No/undecided IPD sharing reason/comment

Our ethics board do not allow for individual participant data to be provided. Only data presented at the group level can be made readily available.

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

Source	Title	Year of Publication	DOI
Embase	A pilot randomised controlled trial of the Peer Tree digital intervention targeting loneliness in young people: a study protocol.	2023	https://dx.doi.org/10.1186/s13063-022-07029-7

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

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Documents added manually

Documents added automatically