Remote Delivery of a Visuospatial Intervention to Reduce Traumatic Intrusive Memories After Paediatric Intensive Care

NCT ID: NCT05500105

Last Updated: 2023-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-15
• Study Completion Date: 2023-06-09

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.

Conditions

Intrusion Symptom

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Simple cognitive task intervention

Session 1: A memory cue followed by playing the computer game "Tetris" (e.g. on own smartphone) with mental rotation instructions.

Options to engage in self-administered/guided booster sessions per intrusive memory.

Group Type: EXPERIMENTAL

Simple cognitive task intervention

Intervention Type: OTHER

Session 1: A memory cue followed by playing the computer game "Tetris" (e.g. on own smartphone) with mental rotation instructions.

Options to engage in self-administered/guided booster sessions per intrusive memory.

Interventions

Simple cognitive task intervention

Session 1: A memory cue followed by playing the computer game "Tetris" (e.g. on own smartphone) with mental rotation instructions.

Options to engage in self-administered/guided booster sessions per intrusive memory.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Queen's University, Belfast

OTHER

Sponsor Role: lead

Responsible Party

David McCormack

Clinical Director, Doctorate in Clinical Psychology Programme

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David McCormack, Dr

Role: PRINCIPAL_INVESTIGATOR

The Queen's University of Belfast

Lalitha Iyadurai, Dr

Role: PRINCIPAL_INVESTIGATOR

University of Oxford

Emily Holmes, Professor

Role: PRINCIPAL_INVESTIGATOR

Uppsala University / Karolinska Institutet

Locations

Queen's University Belfast

Belfast, , United Kingdom

Countries

United Kingdom

Other Identifiers

EPS 22_57

Identifier Type: -

Identifier Source: org_study_id