Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-25 @ 3:30 AM
NCT ID:
NCT05500105
Brief Summary:
This study aims to examine the feasibility and acceptability of a brief intervention, involving a imagery-competing task, remotely delivered to parents who are currently experiencing persistent intrusive traumatic memories at least one month following their child's discharge from intensive care.
Detailed Description:
This is a feasibility study of a brief intervention, involving a visuospatial intervention (i.e. an imagery-competing task), remotely delivered to parents who are currently experiencing persistent intrusive traumatic memories at least one month following their child's discharge from the paediatric intensive care unit (PICU) or neonatal intensive care (NICU).
This study seeks to examine the feasibility and acceptability of delivering this brief intervention remotely with parents currently experiencing persistent intrusive traumatic memories at least one month following their child's discharge from PICU or NICU. The study aims to estimate recruitment, retention, outcome completion and adherence rates, assess acceptability, and in addition to explore the preliminary effect of the intervention on primary and secondary outcomes. Specifically, this study seeks to answer the following questions:
1. How willing are parents, who are currently experiencing persistent intrusive traumatic memories, at least one month following their child's discharge from PICU or NICU, to take part in this brief intervention delivered remotely?
2. How willing are parents to remain in the study until completion at follow up?
3. How willing are participants to complete all outcome measures?
4. How acceptable is this intervention to parents when delivered remotely?
5. Having taken part in the study, how willing are these parents to give consent for their child to take part in this intervention?
6. Having completed the intervention, how willing are parents to be part of a randomised control group?
7. Does this intervention help reduce the number of intrusive memories participants experience, as well as symptoms of anxiety, depression and PTS from baseline to follow-up?
Please note: After approximately six months into recruitment the enrolment target of 20 participants had not been achieved, only 12 participants had consented to take part in the study by this time. After reflecting on the recruitment process it was decided to include parents whose child had either been admitted to paediatric intensive care (PICU) or neonatal intensive care (NICU). The rationale for this was that research evidence demonstrates that admission to either a NICU or a PICU is similarly stressful for parents (Seideman et al., 1997) and many commonalities exist between them, "most notably the similarity of parent and staff experiences and the coexisting medical, psychological and developmental needs of babies and children" (Atkins \& Syed-Sabir, 2022, p.9). Parents who have had a child in intensive care can experience intrusive memories whether that be paediatric or neonatal intensive care. Therefore, in light of this, it seemed worthwhile to see if explicitly seeking to recruit parents whose child had been admitted to PICU or NICU would improve participant enrolment. On 10th March 2023, after receiving approval from the research ethics committee, the study documents were amended (e.g., advert, participant information sheet etc.) to explicitly extend to parents who have had a child in intensive care to include parents whose child has been in either PICU or NICU.
Study:
NCT05500105
Study Brief:
Protocol Section:
NCT05500105