Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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] 297533 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Loneliness 311744 0
Condition category
Condition code
Mental Health 310369 310369 0 0
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] 313769 0
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] 319247 0
mean UCLA Loneliness Scale (UCLA-LS)
Timepoint [1] 319247 0
Baseline, End of Treatment, and three-month post intervention
Secondary outcome [1] 367413 0
mean Social Interaction Anxiety Index (SIAS)
Timepoint [1] 367413 0
Baseline, End of Treatment, Three-months post-intervention
Secondary outcome [2] 367414 0
mean Centre for Epidemiology Studies - Depression Scale (CESD)
Timepoint [2] 367414 0
Baseline, End of Treatment, Three-months post-intervention
Secondary outcome [3] 367415 0
mean Positive and Negative Affect Scale (PANAS)
Timepoint [3] 367415 0
Baseline, End of Treatment, Three-months post-intervention
Secondary outcome [4] 367417 0
Scales of Psychological Wellbeing (SPWB)
Timepoint [4] 367417 0
Baseline, End of Treatment, Three-Months Post-Intervention
Secondary outcome [5] 367418 0
Assessment of Quality of Life (AQoL 4-D)
Timepoint [5] 367418 0
Baseline, End of Treatment, Three-Months Post-intervention
Secondary outcome [6] 367419 0
adherence assessed by PeerTree meta-data
Timepoint [6] 367419 0
Baseline, End of Treatment, Three-Months Post-Intervention
Secondary outcome [7] 367421 0
mean PeerTree App Acceptability Ratings derived from purpose built questionnaire
Timepoint [7] 367421 0
End of Treatment
Secondary outcome [8] 367422 0
mean Peer Tree app Feasibility ratings derived from purpose built questionnaire
Timepoint [8] 367422 0
End of Treatment
Secondary outcome [9] 367423 0
mean Peer Tree app Usability ratings derived from purpose built questionnaire
Timepoint [9] 367423 0
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?
No
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
42
Accrual to date
40
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 25823 0
3122 - Hawthorn

Funding & Sponsors
Funding source category [1] 302091 0
University
Name [1] 302091 0
Swinburne University of Technology
Country [1] 302091 0
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] 301912 0
None
Name [1] 301912 0
Address [1] 301912 0
Country [1] 301912 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302770 0
Swinburne University of Technology Human Research Ethics Committee
Ethics committee address [1] 302770 0
Ethics committee country [1] 302770 0
Australia
Date submitted for ethics approval [1] 302770 0
01/03/2019
Approval date [1] 302770 0
01/02/2019
Ethics approval number [1] 302770 0
R/2019/074

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

Contacts
Principal investigator
Name 91342 0
Dr Michelle lim
Address 91342 0
Swinburne University of Technology,
John Street, Hawthorn, VIC, 3122, Australia
Country 91342 0
Australia
Phone 91342 0
+61 3 9214 5109
Fax 91342 0
Email 91342 0
[email protected]
Contact person for public queries
Name 91343 0
Michelle Lim
Address 91343 0
Swinburne University of Technology,
John Street, Hawthorn, VIC, 3122, Australia
Country 91343 0
Australia
Phone 91343 0
+61 3 9214 4868
Fax 91343 0
Email 91343 0
[email protected]
Contact person for scientific queries
Name 91344 0
Michelle lim
Address 91344 0
Swinburne University of Technology,
John Street, Hawthorn, VIC, 3122, Australia
Country 91344 0
Australia
Phone 91344 0
+61 3 9214 5109
Fax 91344 0
Email 91344 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
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
SourceTitleYear of PublicationDOI
EmbaseA pilot randomised controlled trial of the Peer Tree digital intervention targeting loneliness in young people: a study protocol.2023https://dx.doi.org/10.1186/s13063-022-07029-7
N.B. These documents automatically identified may not have been verified by the study sponsor.