Tetris to Reduce Intrusive Memories in Parents After PICU

Post-traumatic Stress Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04186962
• Other study ID #: 262690
• Status: Completed
• Phase: N/A
• Start date: December 3, 2019
• Est. completion date: April 30, 2020

Study information

• Verified date: December 2019
• Source: King's College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: April 30, 2020
• Est. primary completion date: March 19, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Post-traumatic Stress Disorders
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Other:
• Behavioral: Simple cognitive task
A memory reactivation cue followed by playing the computer game "Tetris"

Locations

Country	Name	City	State
United Kingdom	Royal Belfast Hospital for Sick Children	Belfast
United Kingdom	King's College London	London

Sponsors (2)

Lead Sponsor	Collaborator
King's College London	Guy's and St Thomas' NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.
Primary	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	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
Secondary	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
Secondary	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
Secondary	Hospital Anxiety and Depression Scale	This is a self-report questionnaire which measures anxiety and depression symptoms	One week and one month follow-up