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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Simple cognitive task intervention | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Simple cognitive task intervention | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of intrusive memories of traumatic event(s) - change in number of intrusive memories is being assessed. | Number of intrusive memories of traumatic event(s) recorded by participants in a brief diary daily for 7 days. | At baseline for 7 days, After session 1 for 7 days, and 7 days prior to follow-up at one month post intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Impact of Events Scale-Revised (IES-R; Weiss and Marmar, 1997) | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Self-administered use of the intervention | 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) | 1 week follow-up and 1 month follow-up |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen's University Belfast | Belfast | BT7 1PT | United Kingdom |
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.
Starting 6 months after publication of a paper.
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.
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| Baseline, 1 week follow-up, and 1 month follow-up |
| Intrusive memory ratings | 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) | 1 week follow-up and 1 month follow-up |
| Patient Health Questionnaire-9 item (PHQ-9; Kroenke et al., 2001) | It is a 9-item self-report measure of depressive symptoms. | Baseline, 1 week follow-up, and 1 month follow-up |
| Generalised Anxiety Disorder-7 item questionnaire (GAD-7; Spitzer et al., 2006) | It is a 7-item self-report measure of generalised anxiety symptoms. | Baseline, 1 week follow-up, and 1 month follow-up |
| Work and Social Adjustment Scale (WSAS; Mundt et al., 2002) | 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. | Baseline, 1 week follow-up and 1 month follow-up |
| Interview with participants regarding participation | A semi-structured interview regarding their experience of taking part in the study. | 1 month follow-up |