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The Promoting Resilience in Stress Management Intervention for Parents (PRISM-P): A pilot randomised controlled trial in parents of children with Type 1 diabetes

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12622000096752
Enrollment
30
Registered
2022-01-24
Start date
2022-04-07
Completion date
2022-10-20
Last updated
2023-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This project aims to pilot the Promoting Resilience in Stress Management for Parents (PRISM-P) intervention in parents of young children with T1D. PRISM-P consists of four skill-based modules: stress management, goal setting, cognitive restructuring, and benefit-finding. This pilot study aims to examine the acceptability, appropriateness, feasibility, and preliminary efficacy of PRISM-P.

Interventions

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 sched

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.

Sponsors

Telethon Kids Institute
Lead SponsorOther Collaborative groups

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Exclusion criteria

None.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026