Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000096752
Ethics application status
Approved
Date submitted
16/12/2021
Date registered
24/01/2022
Date last updated
14/03/2023
Date data sharing statement initially provided
24/01/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The Promoting Resilience in Stress Management Intervention for Parents (PRISM-P): A pilot randomised controlled trial in parents of children with Type 1 diabetes
Scientific title
The Promoting Resilience in Stress Management Intervention for Parents (PRISM-P): A pilot feasibility randomised controlled trial in parents of children with Type 1 diabetes
Secondary ID [1] 306066 0
Reference number from funding body: Y21G-BEBK
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Caregiver-related stress 324714 0
Condition category
Condition code
Mental Health 322162 322162 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Promoting Resilience in Stress Management Intervention (PRISM-P) is a manualised intervention that consists of three one-on-one sessions with a trained interventionist. Within this intervention, the following four modules will be covered: stress management, goal setting, cognitive restructuring, and benefit-finding. These modules will be covered across two sessions and there will be a third booster session. Each session will go for approximately 45 - 60 minutes and the sessions will be scheduled approximately 2 weeks apart. All sessions will be delivered over videocalling software (Zoom). The strategies taught in PRISM-P are commonly used in cognitive behavioural therapy, however, the intervention also incorporates semi-structured discussions around gratitude. Intervention adherence will be monitored through session attendance checklists. Session fidelity will also be assessed by a third party using a fidelity checklist that was developed by the creators of PRISM-P. The fidelity checklist will ensure that all interventionists are delivering the core components of each module. Participants who are allocated to the intervention group (n = 15) and complete the intervention, will be asked to take part in a post intervention interview. No more than 15 participants will be asked to take part in the post-intervention interview. This interview will be conducted over a recorded Zoom call by a member of the research team and will be thematically analysed.
Intervention code [1] 322474 0
Treatment: Other
Comparator / control treatment
The control group will receive usual care, which currently does not include psychological support for parents. Rather, the care provided focuses on improving/optimising the child's physical and psychological wellbeing. Once the control group have completed all outcome measures, they will be offered the intervention. This will ensure that all participants who enrol in the study have equal opportunity to access the intervention.
Control group
Active

Outcomes
Primary outcome [1] 329933 0
Acceptability. This will be measured quantitatively through the Acceptability of Intervention Measure. Qualitative information on this construct will also be obtained through a semi-structured post-intervention interview.
Timepoint [1] 329933 0
6 weeks post baseline assessment.
Primary outcome [2] 329934 0
Appropriateness. This will be measured quantitatively through the Intervention Appropriateness Measure. Qualitative information on this construct will also be obtained through a semi-structured post-intervention interview.
Timepoint [2] 329934 0
6 weeks post baseline assessment.
Primary outcome [3] 329935 0
Feasibility. This will be measured through enrolment and retention rates throughout the intervention period, which will be obtained through an audit of the study records.
Timepoint [3] 329935 0
6 weeks post baseline assessment (i.e., once PRISM-P has been delivered to the intervention group).
Secondary outcome [1] 404341 0
Primary outcome: Preliminary efficacy. This will be measured quantitatively through the Connor-Davidson Resilience Scale,
Timepoint [1] 404341 0
0 weeks (baseline assessment), 6 weeks post baseline assessment, and 12 weeks post baseline assessment.
Secondary outcome [2] 404342 0
Primary outcome: Preliminary efficacy. This will be measured quantitatively through the Problem Areas in Diabetes Survey – Parent Revised version,
Timepoint [2] 404342 0
0 weeks (baseline assessment), 6 weeks post baseline assessment, and 12 weeks post baseline assessment.
Secondary outcome [3] 404794 0
Primary outcome: Preliminary efficacy. This will be measured quantitatively through the Diabetes Benefit Finding Scale, Parent Version.
Timepoint [3] 404794 0
0 weeks (baseline assessment), 6 weeks post baseline assessment, and 12 weeks post baseline assessment.
Secondary outcome [4] 405175 0
Child glycaemic control. This will be measured through the HbA1c levels of the participant's child, which is collected through routine blood tests.
Timepoint [4] 405175 0
0 weeks (baseline assessment) and 12 weeks post baseline assessment.
Secondary outcome [5] 405176 0
Negative emotional symptoms. This will be measured through the Depression, Anxiety and Stress Scale (DASS-21).
Timepoint [5] 405176 0
0 weeks (baseline assessment), 6 weeks post baseline assessment, and 12 weeks post baseline assessment.

Eligibility
Key inclusion criteria
1. Participant is a primary caregiver of a child aged 11 years and under (at the time of enrolment) with Type 1 diabetes.
2. The parent and child are residents of Western Australia.
3. The child has been living with Type 1 diabetes for longer than 6 months.
4. The participant can speak and understand English.
5. The participant has access to reliable internet.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None.

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)
Central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Adaptive randomisation.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Quantitative outcomes on measures assessing acceptability, appropriateness, and feasibility will be compared to a cutoff that has been determined a priori. For measures assessing preliminary efficacy, differences in mean scores will be compared between intervention and control groups. Post-interview transcriptions will be thematically analysed through content analysis.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
4/04/2022
Actual
7/04/2022
Date of last participant enrolment
Anticipated
25/07/2022
Actual
20/10/2022
Date of last data collection
Anticipated
5/09/2022
Actual
5/12/2022
Sample size
Target
30
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 21353 0
Perth Children's Hospital - Nedlands

Funding & Sponsors
Funding source category [1] 310402 0
Charities/Societies/Foundations
Name [1] 310402 0
Diabetes Australia
Country [1] 310402 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Telethon Kids Institute
Address
Perth Children's Hospital, 15 Hospital Ave, Nedlands WA, 6009.
Country
Australia
Secondary sponsor category [1] 311558 0
None
Name [1] 311558 0
Address [1] 311558 0
Country [1] 311558 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310051 0
WA Child and Adolescent Health Service Human Research Ethics Committee.
Ethics committee address [1] 310051 0
Ethics committee country [1] 310051 0
Australia
Date submitted for ethics approval [1] 310051 0
20/08/2021
Approval date [1] 310051 0
15/09/2021
Ethics approval number [1] 310051 0
RGS0000004818

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

Contacts
Principal investigator
Name 116314 0
Dr Keely Bebbington
Address 116314 0
Perth Children's Hospital, 15 Hospital Ave, Nedlands WA 6009.
Country 116314 0
Australia
Phone 116314 0
+61 8 6319 1766
Fax 116314 0
Email 116314 0
[email protected]
Contact person for public queries
Name 116315 0
Keely Bebbington
Address 116315 0
Perth Children's Hospital, 15 Hospital Ave, Nedlands WA 6009.
Country 116315 0
Australia
Phone 116315 0
+61 8 6319 1766
Fax 116315 0
Email 116315 0
[email protected]
Contact person for scientific queries
Name 116316 0
Jesse Ingram
Address 116316 0
Perth Children's Hospital, 15 Hospital Ave, Nedlands WA 6009.
Country 116316 0
Australia
Phone 116316 0
+61 8 6319 1766
Fax 116316 0
Email 116316 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
Ethics approval for data sharing is not in place for this study.


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.