Clinical trial NCT05500105: Remote Delivery of a Visuospatial Intervention to Reduce Traumatic Intrusive Memories After Paediatric Intensive Care
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intrusion Symptom
Lead sponsor: Queen's University, Belfast
Sponsor class: OTHER
First posted: 2022-08-12
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Number of intrusive memories of traumatic event(s) - change in number of intrusive memories is being assessed.
timeFrame: At baseline for 7 days, After session 1 for 7 days, and 7 days prior to follow-up at one month post intervention.
Secondary outcomes:
measure: Impact of Events Scale-Revised (IES-R; Weiss and Marmar, 1997)
timeFrame: Baseline, 1 week follow-up, and 1 month follow-up
measure: Intrusive memory ratings
timeFrame: 1 week follow-up and 1 month follow-up
measure: Patient Health Questionnaire-9 item (PHQ-9; Kroenke et al., 2001)
timeFrame: Baseline, 1 week follow-up, and 1 month follow-up
measure: Generalised Anxiety Disorder-7 item questionnaire (GAD-7; Spitzer et al., 2006)
timeFrame: Baseline, 1 week follow-up, and 1 month follow-up
measure: Work and Social Adjustment Scale (WSAS; Mundt et al., 2002)
timeFrame: Baseline, 1 week follow-up and 1 month follow-up
Other outcomes:
measure: Self-administered use of the intervention
timeFrame: 1 week follow-up and 1 month follow-up
measure: Interview with participants regarding participation
timeFrame: 1 month follow-up
Locations:
city: Belfast
country: United Kingdom
facility: Queen's University Belfast
Study officials:
affiliation: The Queen's University of Belfast
name: David McCormack, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Oxford
name: Lalitha Iyadurai, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Uppsala University / Karolinska Institutet
name: Emily Holmes, Professor
role: PRINCIPAL_INVESTIGATOR
References: