Tetris to Reduce Intrusive Memories in Parents After PICU

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

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.

Study Overview

• Status: Completed
• Conditions: Post-traumatic Stress Disorders
• Intervention / Treatment: Other: Behavioral: Simple cognitive task

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Belfast, United Kingdom, BT12 6BA
    • Royal Belfast Hospital for Sick Children
  • London, United Kingdom, SE5 8AZ
    • King's College London

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual care
Experimental: Simple cognitive task; A memory reactivation cue followed by playing the computer game "Tetris"	Other: Behavioral: Simple cognitive task; A memory reactivation cue followed by playing the computer game "Tetris"

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Semi-structured interviews will be conducted with participants who took part in the intervention.	The interview is to gain an understanding of participants views regarding being involved in the study and taking part in the intervention.	Between one week and one month follow-up.

Collaborators and Investigators

• Sponsor: King's College London
• Collaborators: Guy's and St Thomas' NHS Foundation Trust
• Investigators: Principal Investigator: David McCormack, Queen's University, Belfast

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2019
• Primary Completion (Actual): March 19, 2020
• Study Completion (Actual): April 30, 2020

Study Registration Dates

• First Submitted: December 3, 2019
• First Submitted That Met QC Criteria: December 3, 2019
• First Posted (Actual): December 5, 2019

Study Record Updates

• Last Update Posted (Actual): May 27, 2020
• Last Update Submitted That Met QC Criteria: May 26, 2020
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: 262690

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No