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Trial registered on ANZCTR


Registration number
ACTRN12625000155493
Ethics application status
Approved
Date submitted
7/01/2025
Date registered
10/02/2025
Date last updated
10/02/2025
Date data sharing statement initially provided
10/02/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the impact of a community-led, trauma-informed psychosocial intervention on health outcomes of children and young people with Type 1 Diabetes: Wellbeing-T1D
Scientific title
Evaluating the impact of a community-led, trauma-informed psychosocial intervention on diabetes-related resilience and health outcomes of children and young people with Type 1 Diabetes: Wellbeing-T1D
Secondary ID [1] 313644 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psychosocial wellbeing of adolescents with Type 1 diabetes 336212 0
Condition category
Condition code
Mental Health 332744 332744 0 0
Other mental health disorders
Metabolic and Endocrine 332861 332861 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We will pilot test (including acceptability and preliminary effectiveness) an intervention co-designed with adolescents with T1D, young adults with T1D (aged 18-30 years), parents of children with T1D, and clinicians involved in the care of children and adolescents with T1D.

The co-design process took place in 2023 and comprised interviews and focus groups (semi-structured using a study-specific questionnaire, lasting 45 minutes to 60 minutes) with:
• 9 parents of children with T1D
• 9 clinicians from the Perth Children's Hospital Diabetes Clinic
• 5 adolescents (aged 13-17 years) with T1D
• 7 young people (aged 18-30 years) with T1D

Data was collected to:
1. To characterise the Medical Trauma Pathway for young people living with T1D.
2. To ascertain the determinants which allow them to become more resilient,
3. To determine the behaviours, psychological processes and constructs to determine how to best mitigate the development of post traumatic stress (i.e., develop the most appropriate interventions).

Data was analysed using reflective thematic analysis with themes identified determining the intervention sessions (outlined in more detail below).

Themes were checked with participants in a second round of focus groups with the same parents, adolescents and young people, Once themes were confirmed by these participants, the research team developed mock-ups of the intervention content. This was presented to these participants again in a 3rd round of focus groups and interviews (lasting 30 minutes) to gather feedback on content, structure and look and feel.

The research team made the changes suggested in the co-design process, and the intervention described in this trial registration has been developed according to this codesign process. The codesign process was completed in late 2024, and it anticipated that the intervention will be undertaken in the first and second quarters of 2025.

We will employ a double arm, pre-post longitudinal study design which will allow us to determine the potential effectiveness of the intervention content and delivery. There will be an intervention group (Wellbeing group) and a non-intervention group (treatment as usual; TAU). We aim to recruit 40 adolescents to take part in this study. Upon providing consent to participate in the study (T1), the young people and a caregiver/caregiver will complete baseline psychosocial measures which will measure diabetes resilience, perceived stress, optimism, and self-compassion. In addition, clinical data regarding their diagnostic experience and adverse events relating to T1D since diagnosis will be obtained through the Western Australian Children’s Diabetes Database (WACDD). Participants will be stratified by age group (13-15 years and 16-17 years), and randomly allocated to the intervention (n=20) or non-intervention group (n=20). The age groups have been stratified due to potential developmental differences between 13- and 17-year-old participants.

Once randomised, the young people in the intervention arm will then partake in semi-structured intake interviews with the intervention facilitators, using a study-specific interview schedule, to determine their main psychosocial needs. These will be conducted by a member of the research team, all of whom have backgrounds in Public Health, and/or Psychology. It is anticipated that interviews will take between 45 and 60 minutes.

Following this, young people in the intervention arm will be grouped, with each group containing between 3-5 participants. This is because the intervention will have group and individual components. The intervention will also consist of 5 modules which will be delivered in one-hour sessions over 5 weeks. The first and last sessions will be group sessions, with the middle three sessions being delivered to participants individually. The sessions will be facilitated through MS Teams and recorded. The intervention content will be housed on Genially, a cloud-based platform for building interactive learning and communication experiences.

Sessions will be run by members of the research team, all of whom have backgrounds in Public Health, and/or Psychology.

Intervention sessions comprise:

Session 1: Trauma, The Brain and T1D - groups of 3-5 participants
The first intervention session will focus on psychoeducation on the concept of how traumatic experiences (stemming from general adverse situations or can be T1D-related) can shape current stress responses. Participants will first meet other members of their group in this session, allowing for the normalisation of stressful experiences through the opportunity for sharing of lived experiences and validating others’ stories with T1D. It will teach participants different ways to de-escalate stress responses through mindfulness, controlled breathing and grounding techniques run in a group activity format, with the aim to encourage mindful emotional awareness to help reduce feelings of overwhelm and panic. The session will end on ways to embed self-care and grounding techniques throughout their week.

Session 2: Emotions, Thoughts and Behaviours (Part 1) – individual

Managing reactions (thoughts). Building from session 1, the content of session 2 will teach the young person to recognise their emotional responses to stressful situations. It will be centred around psychoeducation and is based on the key concepts of cognitive behavioural therapy. This will involve learning how to appraise emotions and physical sensations in the body, and identifying how emotions, physical sensations and thoughts go hand in hand and influence each other. We will encourage the young person to bringing awareness to different thinking patterns, and learning how to identify helpful versus unhelpful thinking patterns. Utilising the ABC framework, participants will identify a T1D-related activating event (A) that may trigger certain emotions, sensations and thoughts, and assess their beliefs (B) that come resultant of these. This will allow them to put their beliefs ‘on trial’ in activity assessing whether they are helpful or unhelpful when coping with their T1D and daily life.

Session 3: Emotions, Thoughts and Behaviours (Part 2).- individual

Managing reactions (behaviour). This session will build on the concepts learned in session 2, by completing the ‘ABC’ framework and identifying the conclusions (C) of the beliefs the adolescent experiences following their identified activating event. It will explore helpful versus unhelpful coping behaviours when faced with stressful situations. This will target withdrawal and avoidance behaviours in relation to T1D management as well as other stressors.

Session 4: Storytelling and Narrative Approach – individual

This session will require participants to tell their story and experiences of medical trauma in relation to their T1D from a strength-based approach. This will allow them to identify areas of resilience and strength throughout their journey. Following a higher rest of re-traumatisation when discussing these experiences, content within session 1 (mindfulness and grounding techniques) may be revisited. In addition, strengths-based future thinking to enhance optimism will be employed.

Session 5: Problem solving and preventing setbacks –groups of 3-5 participants

This group session will be a final discussion revisiting content of the previous sessions to consolidate the learnings and check in on participants. It will discuss worrying, how to reduce rumination and implement problem solving. Problem solving skills, such as goal setting, will be taught. This last session will involve brainstorming a safety net for support, the development of a healthy-coping protocol and a post-treatment plan.

Session attendance will be monitored using an excel spreadsheet specific to the intervention group.

The non-intervention group will receive standard care at Perth Children’s Hospital (PCH). Once the intervention group have completed all 5 sessions (T2), all participants (including both intervention and non-intervention arms) will then immediately complete the same measures again to determine any immediate impact of the intervention. Finally, 4 weeks after completing the intervention/T2 questionnaires, all participants will complete the measures once again for a final follow up (T3). At T3, the intervention arm participants will also be asked to complete a semi-structured interview to discuss the acceptability of the intervention content and design, and to have a nuanced discussion about the potential impacts of the intervention on their psychosocial outcomes. After all follow-ups have been completed, the intervention materials and the content on Genially will be disseminated to the non-intervention group. After the last follow-up with participants in the non-intervention arm, the young people will be offered a follow-up phone call with a mental health clinician (who is part of the research team) to discuss if they require assistance with mental health referral. The entire intervention will be completed online and no visits to PCH are required.

Intervention code [1] 330239 0
Prevention
Comparator / control treatment
There will be a non-intervention group who will receive treatment as usual for the Perth Children's Hospital (PCH) Diabetes Clinic. Treatment as usual comprises adolescents being referred to a PCH social worker or mental health nurse on request, either by the patient, their family or the clinical team.
Control group
Active

Outcomes
Primary outcome [1] 340269 0
Diabetes related resilience
Timepoint [1] 340269 0
T1: pre-intervention, T2: immediately post completion of the 5 week intervention. T3, 4 weeks post completion of the 5 week intervention
Primary outcome [2] 340270 0
Diabetes related resilience
Timepoint [2] 340270 0
T1: pre-intervention, T2: immediately post completion of the 5 week intervention. T3, 4 weeks post completion of the 5 week intervention
Primary outcome [3] 340271 0
Youth-reported burden and negative emotions related to living with T1D.
Timepoint [3] 340271 0
T1: pre-intervention, T2: immediately post completion of the 5 week intervention. T3, 4 weeks post completion of the 5 week intervention
Secondary outcome [1] 443553 0
How one typically acts towards themselves in difficult times.
Timepoint [1] 443553 0
T1: pre-intervention, T2: immediately post completion of the 5 week intervention. T3, 4 weeks post completion of the 5 week intervention
Secondary outcome [2] 443554 0
How one typically acts towards themselves in difficult times.
Timepoint [2] 443554 0
T1: pre-intervention, T2: immediately post completion of the 5 week intervention. T3, 4 weeks post completion of the 5 week intervention
Secondary outcome [3] 443555 0
Measure of how one rates their future and outcomes/life outlook in terms of their optimism versus pessimism.
Timepoint [3] 443555 0
T1: pre-intervention, T2: immediately post completion of the 5 week intervention. T3, 4 weeks post completion of the 5 week intervention
Secondary outcome [4] 443556 0
Acceptability of Intervention
Timepoint [4] 443556 0
T3, 4 weeks post completion of the 5 week intervention
Secondary outcome [5] 443557 0
Intervention Appropriateness
Timepoint [5] 443557 0
T3, 4 weeks post completion of the 5 week intervention

Eligibility
Key inclusion criteria
• English speaking Adolescents living with T1D aged between 13 and 17 years.
• One caregiver of the participating 13-17 year old adolescent.
• Adolescents must have received their diagnosis of T1D more than 6 months prior to enrolling in the study.
• Adolescents must have access to a laptop or tablet and be able to access the internet.
Minimum age
13 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Young people (aged 13-17 years old) and caregivers who do not consent.
• In the intake interview, adolescents who report that they have a suicide plan/intent or have been self-injuring will be excluded and referred to a psychologist on the research team.
• Where participants discuss family and domestic violence, they will be excluded from our study and instead referred to the clinical team at PCH who will facilitate a referral to the Child Protection Unit.
• Young people and/or caregivers who are not able to engage in the intervention due to pre-existing conditions or circumstances (e.g., cognitive impairment, intellectual disabilities, adverse mental health outcomes, substance use concerns).

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created in Excel
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
Quantitative data will be analysed to determine relationships between mental health measures and independent variables such as demographics and medical characteristics using basic descriptive analyses, and whether our intervention improves the mental health of adolescents who live with T1D. Longitudinal data from intervention and control groups will be subject to within and between comparisons across timepoints. Depending on the normality of data, ANOVA (parametric) or Friedman’s test (non-parametric) will be used. As this is a pilot trial, calculation of power or an effect size is not relevant. The level of significance to be used is an alpha value of 0.05. The Reliable Change Index may also be used at an individual level for participants in the intervention group, as these have been shown to be effective in detecting change in clinical populations. The results of the analysis will enable the research team to identify improvements in mental health, and determine if our intervention design is suitable for a future roll-out.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
17/02/2025
Actual
Date of last participant enrolment
Anticipated
30/04/2025
Actual
Date of last data collection
Anticipated
31/07/2025
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 27453 0
Perth Children's Hospital - Nedlands
Recruitment postcode(s) [1] 43565 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 318111 0
Charities/Societies/Foundations
Name [1] 318111 0
The Kids Research Institute, Embrace Big Ideas Grant
Country [1] 318111 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
The Kids Research Institute
Address
Country
Australia
Secondary sponsor category [1] 320486 0
Hospital
Name [1] 320486 0
Perth Children's Hospital
Address [1] 320486 0
Country [1] 320486 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316756 0
Department of Health WA Human Research Ethics Committee
Ethics committee address [1] 316756 0
Ethics committee country [1] 316756 0
Australia
Date submitted for ethics approval [1] 316756 0
28/11/2024
Approval date [1] 316756 0
15/12/2024
Ethics approval number [1] 316756 0

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

Contacts
Principal investigator
Name 138914 0
Dr Alix Woolard
Address 138914 0
The Kids Research institute Australia, Perth Children's Hospital, 15 Hospital Avenue, Nedlands, WA 6009
Country 138914 0
Australia
Phone 138914 0
+61 8 6319 1000
Fax 138914 0
Email 138914 0
alix.woolard@thekids.org.au
Contact person for public queries
Name 138915 0
Karen Lombardi
Address 138915 0
The Kids Research institute Australia, Perth Children's Hospital, 15 Hospital Avenue, Nedlands, WA 6009
Country 138915 0
Australia
Phone 138915 0
+61 8 6319 1000
Fax 138915 0
Email 138915 0
karen.lombardi@thekids.org.au
Contact person for scientific queries
Name 138916 0
Karen Lombardi
Address 138916 0
The Kids Research institute Australia, Perth Children's Hospital, 15 Hospital Avenue, Nedlands, WA 6009
Country 138916 0
Australia
Phone 138916 0
+61 8 6319 1000
Fax 138916 0
Email 138916 0
karen.lombardi@thekids.org.au

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


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
No additional documents have been identified.