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Tetris to Reduce Intrusive Memories in Parents After PICU

Primary Purpose

Post-traumatic Stress Disorders

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Behavioral: Simple cognitive task
Sponsored by
King's College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Post-traumatic Stress Disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Royal Belfast Hospital for Sick Children
  • King's College London

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Simple cognitive task

Usual care

Arm Description

A memory reactivation cue followed by playing the computer game "Tetris"

Usual care

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
Children's Revised Impact of Events Scale-13 Parent Version.
This is a parent-report measure - Cries-13-PV.
Hospital Anxiety and Depression Scale
This is a self-report questionnaire which measures anxiety and depression symptoms

Full Information

First Posted
December 3, 2019
Last Updated
May 26, 2020
Sponsor
King's College London
Collaborators
Guy's and St Thomas' NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT04186962
Brief Title
Tetris to Reduce Intrusive Memories in Parents After PICU
Official Title
A Brief Intervention Involving Tetris Gameplay to Prevent Intrusive Traumatic Memories in Parents After Paediatric Intensive Care: A Feasibility Study.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
December 3, 2019 (Actual)
Primary Completion Date
March 19, 2020 (Actual)
Study Completion Date
April 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
King's College London
Collaborators
Guy's and St Thomas' NHS Foundation Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-traumatic Stress Disorders

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Simple cognitive task
Arm Type
Experimental
Arm Description
A memory reactivation cue followed by playing the computer game "Tetris"
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Usual care
Intervention Type
Other
Intervention Name(s)
Behavioral: Simple cognitive task
Intervention Description
A memory reactivation cue followed by playing the computer game "Tetris"
Primary Outcome Measure Information:
Title
Number of flashbacks recorded by participants in a Flashback Record
Description
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
Time Frame
Flashback Record will be returned to a researcher at one week follow-up
Secondary Outcome Measure Information:
Title
Impact of Event Scale-Revised (IES-R)
Description
This is a self-report measure of common distressing reactions to trauma; it is comprised of three subscales, namely, intrusions, avoidance, and hyperarousal.
Time Frame
One week and one month follow-up
Title
Pediatric Emotional Distress Scale
Description
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.
Time Frame
One week and one month follow-up
Title
Children's Revised Impact of Events Scale-13 Parent Version.
Description
This is a parent-report measure - Cries-13-PV.
Time Frame
One week and one month follow-up
Title
Hospital Anxiety and Depression Scale
Description
This is a self-report questionnaire which measures anxiety and depression symptoms
Time Frame
One week and one month follow-up
Other Pre-specified Outcome Measures:
Title
Semi-structured interviews will be conducted with participants who took part in the intervention.
Description
The interview is to gain an understanding of participants views regarding being involved in the study and taking part in the intervention.
Time Frame
Between one week and one month follow-up.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Trudie Chalder
Organizational Affiliation
King's College London
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David McCormack
Organizational Affiliation
Queen's University, Belfast
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Belfast Hospital for Sick Children
City
Belfast
ZIP/Postal Code
BT12 6BA
Country
United Kingdom
Facility Name
King's College London
City
London
ZIP/Postal Code
SE5 8AZ
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

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Tetris to Reduce Intrusive Memories in Parents After PICU

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