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

• ClinicalTrials.gov Identifier: NCT05500105
• Recruitment Status: Completed
• First Posted: August 12, 2022
• Last Update Posted: November 18, 2023
• Sponsor: Queen's University, Belfast
• Information provided by (Responsible Party): David McCormack, Queen's University, Belfast

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Intrusion Symptom	Other: Simple cognitive task intervention	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 17 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: September 15, 2022
• Actual Primary Completion Date: June 9, 2023
• Actual Study Completion Date: June 9, 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Other: 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.

Outcome Measures

Primary Outcome Measures :

1. Number of intrusive memories of traumatic event(s) - change in number of intrusive memories is being assessed. [ Time Frame: 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.

Secondary Outcome Measures :

1. Impact of Events Scale-Revised (IES-R; Weiss and Marmar, 1997) [ Time Frame: Baseline, 1 week follow-up, and 1 month follow-up ]
   Self-report measure that assesses subjective distress after a traumatic event (with reference to study event[s]) in the last week. Here we include the intrusion subscale (8 items) and the avoidance subscale (8 items). Items are rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). Subscale scores are calculated for the Intrusion or Avoidance items summed (ranging from 0 to 32 each). Higher scores indicate worse outcome.
2. Intrusive memory ratings [ Time Frame: 1 week follow-up and 1 month follow-up ]
   It is a 9-item a self-report questionnaire which assesses a number of intrusive memories characteristics. It is adapted from an ongoing trial of the intervention in the UK (GAINS study; ClinicalTrials.gov Identifier: NCT04992390)
3. Patient Health Questionnaire-9 item (PHQ-9; Kroenke et al., 2001) [ Time Frame: Baseline, 1 week follow-up, and 1 month follow-up ]
   It is a 9-item self-report measure of depressive symptoms.
4. Generalised Anxiety Disorder-7 item questionnaire (GAD-7; Spitzer et al., 2006) [ Time Frame: Baseline, 1 week follow-up, and 1 month follow-up ]
   It is a 7-item self-report measure of generalised anxiety symptoms.
5. Work and Social Adjustment Scale (WSAS; Mundt et al., 2002) [ Time Frame: Baseline, 1 week follow-up and 1 month follow-up ]
   It is is a 5-item scale measuring an individual's ability to function in five domains of everyday life; work, home management, social leisure activities, private leisure activities and close relationships.

Other Outcome Measures:

1. Self-administered use of the intervention [ Time Frame: 1 week follow-up and 1 month follow-up ]
   It is a self-report measure containing 4 items which will be used to assess adherence to self-administered 'booster' sessions of the intervention. It is adapted from ongoing trial of the intervention in Sweden (EKUT-P study; ClinicalTrials.gov Identifier: NCT04460014)
2. Interview with participants regarding participation [ Time Frame: 1 month follow-up ]
   A semi-structured interview regarding their experience of taking part in the study.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

United Kingdom

Queen's University Belfast

Belfast, United Kingdom, BT7 1PT

Sponsors and Collaborators

Queen's University, Belfast

Investigators

• Principal Investigator: David McCormack, Dr; The Queen's University of Belfast
• Principal Investigator: Lalitha Iyadurai, Dr; University of Oxford
• Principal Investigator: Emily Holmes, Professor; Uppsala University / Karolinska Institutet

More Information

• Responsible Party: David McCormack, Clinical Director, Doctorate in Clinical Psychology Programme, Queen's University, Belfast
• ClinicalTrials.gov Identifier: NCT05500105
• Other Study ID Numbers: EPS 22_57
• First Posted: August 12, 2022
• Last Update Posted: November 18, 2023
• Last Verified: November 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: All IPD that underlie results in a publication will be made available starting 6 months after publication. An anonymised database of individual participant data, along with a data dictionary, as well as the Clinical Study Report (which will include summarised anonymised participant data), will be shared on the Open Science Framework.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF)
• Time Frame: Starting 6 months after publication of a paper.
• Access Criteria: All IPD that underlie results in a publication will be made available starting 6 months after publication. An anonymised database of individual participant data, along with a data dictionary, as well as the Clinical Study Report (which will include summarised anonymised participant data), will be shared on the Open Science Framework.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No