Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001136998p
Ethics application status
Submitted, not yet approved
Date submitted
3/09/2020
Date registered
30/10/2020
Date last updated
30/10/2020
Date data sharing statement initially provided
30/10/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot trial investigating the effect of self-compassion training on mental health in adolescents with Type 1 diabetes
Scientific title
Making Friends with Yourself: A pilot randomized controlled trial investigating the effect of videoconference self-compassion training on mental health and wellbeing in adolescents with Type 1 diabetes
Secondary ID [1] 302231 0
None
Universal Trial Number (UTN)
U1111-1257-8900
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 Diabetes 318931 0
Anxiety 319297 0
Depression 319298 0
Condition category
Condition code
Metabolic and Endocrine 316906 316906 0 0
Diabetes
Mental Health 316907 316907 0 0
Anxiety
Mental Health 317265 317265 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Making Friends with Yourself is an 8-week manualised group program developed by Karen Bluth and Lorraine Hobbes (https://centerformsc.org/msc-teens-adults/). Please note, the manual is only available to trained facilitators and is not available publicly.

In this study, the program will be delivered by two clinical psychologists who are trained to facilitate the program. The program will be delivered as a group intervention via Zoom (up to 16 participants per group, including 2 facilitators), and participants will access it from home or another location of their choosing. It involves one session (1.5 hours duration) per week for 8 weeks. Participants are not required to complete any at-home activities.

The program involves psychoeducation on each of the following topics: self-compassion, self-criticism, mindfulness, stress, wellbeing, and values. Participants engage in structured group discussion, self-reflection exercises, and art activities. They also practice meditation exercises. A session attendance checklist will be used to monitor adherence to the intervention.
Intervention code [1] 318520 0
Prevention
Intervention code [2] 318760 0
Behaviour
Comparator / control treatment
The comparator is a wait list control group. Participants will access treatment as usual. They will receive the Making Friends with Yourself program at the end of the follow-up period (12 weeks post-enrolment).
Control group
Active

Outcomes
Primary outcome [1] 325009 0
Self-compassion (assessed using The Self-Compassion Scale for Youth)
Timepoint [1] 325009 0
Baseline (before commencement of intervention), Post-test (8 weeks after baseline) and follow-up (12 weeks after baseline)
Primary outcome [2] 325010 0
Anxiety (assessed using the Generalized Anxiety Disorders 7-item scale)
Timepoint [2] 325010 0
Baseline (before commencement of intervention), Post-test (8 weeks after baseline) and follow-up (12 weeks after baseline)
Primary outcome [3] 325011 0
Depression (assessed using the 9-item Patient Health Questionnaire)
Timepoint [3] 325011 0
Baseline (before commencement of intervention), Post-test (8 weeks after baseline) and follow-up (12 weeks after baseline)
Secondary outcome [1] 386539 0
Diabetes management (assessed using the parent-report Diabetes Management Questionnaire)
Timepoint [1] 386539 0
Baseline (before commencement of intervention), Post-test (8 weeks after baseline) and follow-up (12 weeks after baseline)
Secondary outcome [2] 386540 0
Metabolic control, assessed as proportion of time spent in target glucose range (70-180mg/dL), will be assessed by accessing continuous glucose monitor data,
Timepoint [2] 386540 0
Baseline (before commencement of intervention, follow-up (12 weeks after baseline)
Secondary outcome [3] 387506 0
Health-related Quality of Life (assessed using the Assessment of Quality of Life - 6 Dimension)
Timepoint [3] 387506 0
Baseline (before commencement of intervention), Post-test (8 weeks after baseline) and follow-up (12 weeks after baseline)
Secondary outcome [4] 387507 0
Feasibility will be measured by examining proportion of participants consenting, commencing, and completing all sessions. For the intervention to be considered feasible, we have set a threshold of greater than or equal to 50% of contacted participants consenting to to enrolment; greater than or equal to 70% of consented participants commencing the experimental condition and greater than equal to 50% of consented participants completing all intervention sessions in the experimental arm.
Timepoint [4] 387507 0
Baseline (prior to the intervention) and post-test (8 weeks after baseline)
Secondary outcome [5] 387508 0
Acceptability, which will be measured by coding qualitative data collected via interviews with participants
Timepoint [5] 387508 0
Between post-test (8 weeks post baseline) and follow up (12 weeks post baseline)

Eligibility
Key inclusion criteria
(1) Aged 14-17 years of age
(2) Diagnosed with Type 1 Diabetes
(3) Using Continuous Glucose Monitoring (CGM)
(4) Able to speak and understand English
(5) Able to access Zoom
Minimum age
14 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Elevated self-harm or suicide risk (score of 4 or more on the Columbia Suicide Severity Rating Scale (C-SSRS) )

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Concealed allocation using an automated randomisation process (via Qualtrics)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
While the purpose of the study is not hypothesis testing, we will calculate differences between the experimental group and the control condition for the primary and secondary outcomes.

Baseline characteristics of participants will be reported to describe the sample. Descriptive statistics will be used to summarize quantitative data collected for each of the feasibility domains.

Feasibility metrics will address the A process for Decision-making after Pilot and feasibility Trials (ADePT) framework.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/11/2020
Actual
Date of last participant enrolment
Anticipated
30/07/2021
Actual
Date of last data collection
Anticipated
30/11/2021
Actual
Sample size
Target
28
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 306652 0
Other Collaborative groups
Name [1] 306652 0
Children's Diabetes Centre
Country [1] 306652 0
Australia
Primary sponsor type
University
Name
Telethon Kids Institute
Address
15 Hospital Avenue, Nedlands, WA 6009
Country
Australia
Secondary sponsor category [1] 307203 0
None
Name [1] 307203 0
N/A
Address [1] 307203 0
N/A
Country [1] 307203 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 306834 0
University of Western Australia Human Research Ethics Committee
Ethics committee address [1] 306834 0
35 Stirling Hwy, Crawley WA 6009
Ethics committee country [1] 306834 0
Australia
Date submitted for ethics approval [1] 306834 0
16/07/2020
Approval date [1] 306834 0
Ethics approval number [1] 306834 0

Summary
Brief summary
The aim of this project is to pilot a randomized controlled trial of an 8-week group self-compassion training program (Making Friends with Yourself; MFY) delivered via videoconference, for young people (14-17 years) with Type 1 diabetes. We will assess whether the program is acceptable and determine whether it is feasible to do a larger study of the program. We will do this by asking participants what they think about the program and also looking at how long it takes us to recruit participants, how many people complete the intervention, and how many of the participants are satisfied with the program. We will also collect data on self-compassion, mental health, diabetes management, quality of life, and metabolic control. This data will be collected before the program commences, after the program is complete, and again at 4 weeks after program completion. This data will help us to design future studies to test the whether the program is effective for improving mental and physical health outcomes in young people with Type 1 diabetes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 105174 0
Dr Amy Finlay-Jones
Address 105174 0
Telethon Kids Institute, 15 Hospital Avenue, Nedlands, WA 6009
Country 105174 0
Australia
Phone 105174 0
+61863191808
Fax 105174 0
Email 105174 0
[email protected]
Contact person for public queries
Name 105175 0
Ms Tammy Gibbs
Address 105175 0
Telethon Kids Institute, 15 Hospital Avenue, Nedlands, WA 6009
Country 105175 0
Australia
Phone 105175 0
+61863191645
Fax 105175 0
Email 105175 0
[email protected]
Contact person for scientific queries
Name 105176 0
Dr Amy Finlay-Jones
Address 105176 0
Telethon Kids Institute, 15 Hospital Avenue, Nedlands, WA 6009
Country 105176 0
Australia
Phone 105176 0
+61863191808
Fax 105176 0
Email 105176 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
Small group of participants with sensitive health data


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
9044Statistical analysis plan  [email protected]
9045Study protocol  [email protected]
9046Informed consent form  [email protected]
9047Ethical approval  [email protected]



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
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