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临床试验/NCT05500105
NCT05500105已完成不适用

Remote Delivery of a Visuospatial Intervention, Involving Tetris Computer Game Play, to Reduce Intrusive Memories in Parents After Paediatric Intensive Care Intensive Care: a Feasibility Study

Queen's University, Belfast2 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2022年9月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
17
试验地点
2
主要终点
Number of intrusive memories of traumatic event(s) - change in number of intrusive memories is being assessed.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Parent of a child who was discharged from PICU or NICU at least one month prior to study recruitment.
  • Parent who is currently experiencing persistent intrusive memories (at least a minimum of three intrusive memories in the past week).
  • Parent who has access to, and sufficient ability to use an electronic device (smartphone/tablet and/or computer/laptop) for remote delivery.
  • Adult aged 18 or older
  • Live in the UK or Ireland

排除标准

  • Parent of a child who was discharged from PICU or NICU less than one month prior to study recruitment.
  • Parent who experienced less than three intrusive memories in the past week
  • Parent who does not have access to, and ability to, use an electronic device e.g., computer or smartphone.
  • Younger than 18 years old
  • Does not live in the UK or Ireland

结局指标

主要结局

Number of intrusive memories of traumatic event(s) - change in number of intrusive memories is being assessed.

时间窗: At baseline for 7 days, After session 1 for 7 days, and 7 days prior to follow-up at one month post intervention.

Number of intrusive memories of traumatic event(s) recorded by participants in a brief diary daily for 7 days.

次要结局

  • Intrusive memory ratings(1 week follow-up and 1 month follow-up)
  • Work and Social Adjustment Scale (WSAS; Mundt et al., 2002)(Baseline, 1 week follow-up and 1 month follow-up)
  • Patient Health Questionnaire-9 item (PHQ-9; Kroenke et al., 2001)(Baseline, 1 week follow-up, and 1 month follow-up)
  • Generalised Anxiety Disorder-7 item questionnaire (GAD-7; Spitzer et al., 2006)(Baseline, 1 week follow-up, and 1 month follow-up)
  • Impact of Events Scale-Revised (IES-R; Weiss and Marmar, 1997)(Baseline, 1 week follow-up, and 1 month follow-up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

David McCormack

Clinical Director, Doctorate in Clinical Psychology Programme

Queen's University, Belfast

研究点 (2)

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