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Completed

NCT Number: NCT04186962

Tetris to Reduce Intrusive Memories in Parents After PICU

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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Key information

Conditions

Post-Traumatic Stress Disorders Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal Belfast Hospital for Sick Children, Belfast, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Behavioral: Simple cognitive task

Other

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

Primary outcomes

  1. Number of flashbacks recorded by participants in a Flashback Record

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

    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 outcomes

  1. Impact of Event Scale-Revised (IES-R)

    Time frame: One week and one month follow-up

    This is a self-report measure of common distressing reactions to trauma; it is comprised of three subscales, namely, intrusions, avoidance, and hyperarousal.

  2. Pediatric Emotional Distress Scale

    Time frame: One week and one month follow-up

    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.

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

    Time frame: One week and one month follow-up

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

  4. Hospital Anxiety and Depression Scale

    Time frame: One week and one month follow-up

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

Other outcomes

  1. Semi-structured interviews will be conducted with participants who took part in the intervention.

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

    The interview is to gain an understanding of participants views regarding being involved in the study and taking part in the intervention.

Sponsors and collaborators

Lead sponsor

King's College London

Other

Collaborators

  • Guy's and St Thomas' NHS Foundation Trust

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Dec 5, 2019
Registry last updated
May 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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