Tetris to Reduce Intrusive Memories in Parents After PICU

Study Overview
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Brief Summary
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The purpose of this study is to examine the acceptability and feasibility of a brief behavioural intervention involving Tetris gameplay to prevent intrusive traumatic memories in parents after paediatric intensive care. The present acceptability and feasibility study seeks to answer the following questions: (1) Is this intervention acceptable to parents whose children have been admitted to PICU, (2) how practical is it to deliver the intervention in this setting, (3) willingness of hospital staff to be involved in the recruitment of participants, (4) after having taken part in the intervention themselves would parents have been willing to consent to their child taking part in the intervention, and (5) discover any challenges or barriers in carrying out this study. Furthermore, this study aims to estimate recruitment, withdrawal and dropout rate, in order to act as a preliminary test of the effect of the intervention and inform sample size estimation. The findings from this study will inform the design of a randomised control trial.

Official Title
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A Brief Intervention Involving Tetris Gameplay to Prevent Intrusive Traumatic Memories in Parents After Paediatric Intensive Care: A Feasibility Study.

Conditions
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Post-traumatic Stress Disorders

Intervention / Treatment
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* Other: Behavioral: Simple cognitive task


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Parent of a child in PICU, therefore exposed to an event meeting DSM-5 criterion for a traumatic event (APA, 2013). The parent's child must be near the point of discharge from PICU (site 1 and 2), as identified by a clinician, or on a paediatric hospital ward within 24 hours after discharge from PICU (site 2 only). Sufficient ability to read and understand English to provide consent, follow game instructions and complete measures. Have sufficient physical mobility to play TETRIS using a computer (e.g. a handheld Nintendo DS). Willing and able to complete measures and be contacted one-week and month post-intervention to complete follow-up measures. Exclusion Criteria: Parents will be excluded from the study if their child is due to be discharged to palliative care and/or if nursing/medical staff within the PICU feel it would be inappropriate to contact them/have them participate in this study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Simple cognitive task<br>A memory reactivation cue followed by playing the computer game Tetris | Other: Behavioral: Simple cognitive task<br>* A memory reactivation cue followed by playing the computer game Tetris<br>|
| No Intervention: Usual care<br>Usual care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of flashbacks recorded by participants in a Flashback Record | The primary outcome will be the number of times a participant experiences intrusive traumatic memories related to PICU and/or the events leading to their child's admission to PICU. This will be measured using a daily pen-and-paper diary in which participants will record the occurrence of intrusive memories in everyday life for one week, starting on the day after the participant completes baseline assessment (Day 1) and completed for seven days | Flashback Record will be returned to a researcher at one week follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of Event Scale-Revised (IES-R) | This is a self-report measure of common distressing reactions to trauma; it is comprised of three subscales, namely, intrusions, avoidance, and hyperarousal. | One week and one month follow-up | 
| Pediatric Emotional Distress Scale | This is a 21-item parent-report measure that assess common behaviours in young children, between 2-10 years of age, after a traumatic event. | One week and one month follow-up | 
| Children's Revised Impact of Events Scale-13 Parent Version. | This is a parent-report measure - Cries-13-PV. | One week and one month follow-up | 
| Hospital Anxiety and Depression Scale | This is a self-report questionnaire which measures anxiety and depression symptoms | One week and one month follow-up |