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CompletedNCT04186962Updated May 27, 2020

Tetris to Reduce Intrusive Memories in Parents After PICU

An interventional study of Behavioral: Simple cognitive task in Post-traumatic Stress Disorders, sponsored by King's College London. Completed at 2 sites in United Kingdom. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-05-27.

Sponsored by King's College London · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
19
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

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Conditions studied

  • Post-traumatic Stress Disorders
03

In context

Stress Disorders, Traumatic

1,147 studies on the registry are indexed under Stress Disorders, Traumatic; 108 are open to participants now.

This study's enrollment of 19 is below the median of 60 across 908 interventional studies indexed under Stress Disorders, Traumatic.

Browse Stress Disorders, Traumatic studies →

Lead sponsor

King's College London is the lead sponsor of 506 studies on the registry; 125 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
19 participants (actual)

Study arms

  • Experimental
    Simple cognitive task

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

    Other: Behavioral: Simple cognitive task

  • No intervention
    Usual care

    Usual care

Interventions

  • OtherBehavioral: Simple cognitive task

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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Flashback Record will be returned to a researcher at one week follow-up

Secondary outcomes

  1. 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.

    Time frame: One week and one month follow-up

  2. 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.

    Time frame: One week and one month follow-up

  3. Children's Revised Impact of Events Scale-13 Parent Version.

    This is a parent-report measure - Cries-13-PV.

    Time frame: One week and one month follow-up

  4. Hospital Anxiety and Depression Scale

    This is a self-report questionnaire which measures anxiety and depression symptoms

    Time frame: One week and one month follow-up

Other outcomes

  1. 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.

    Time frame: Between one week and one month follow-up.

07

Study locations

2 sites
  • Royal Belfast Hospital for Sick Children
    Belfast, BT12 6BA, United Kingdom
  • King's College London
    London, SE5 8AZ, United Kingdom
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 27, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04186962
Lead sponsor
King's College London
Collaborators
Guy's and St Thomas' NHS Foundation Trust
Responsible party
Sponsor
First posted
Dec 5, 2019
Start date
Dec 3, 2019
Primary completion
Mar 19, 2020
Completion
Apr 30, 2020
Last update
May 27, 2020

Study contacts

Trudie Chalder
principal investigator · King's College London
David McCormack
principal investigator · Queen's University, Belfast

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.

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