Tetris to Reduce Intrusive Memories in Parents After PICU

NCT ID: NCT04186962

Last Updated: 2020-05-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-03

Study Completion Date

2020-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Post-traumatic Stress Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Simple cognitive task

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

Group Type EXPERIMENTAL

Behavioral: Simple cognitive task

Intervention Type OTHER

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

Usual care

Usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Behavioral: Simple cognitive task

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Guy's and St Thomas' NHS Foundation Trust

OTHER

Sponsor Role collaborator

King's College London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Trudie Chalder

Role: PRINCIPAL_INVESTIGATOR

King's College London

David McCormack

Role: PRINCIPAL_INVESTIGATOR

Queen's University, Belfast

Locations

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Royal Belfast Hospital for Sick Children

Belfast, , United Kingdom

Site Status

King's College London

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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262690

Identifier Type: -

Identifier Source: org_study_id

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