Tetris to Reduce Intrusive Memories in Parents After PICU

NCT04186962 | Completed

• 1 other identifier: 262690
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 2

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.

Conditions

Post-traumatic Stress Disorders

Outcome Measures

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

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

Secondary Outcomes (4)

• Impact of Event Scale-Revised (IES-R)

  One week and one month follow-up

• Pediatric Emotional Distress Scale

  One week and one month follow-up

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

  One week and one month follow-up

• Hospital Anxiety and Depression Scale

  One week and one month follow-up

Other Outcomes (1)

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

  Between one week and one month follow-up.

Study Arms (2)

Simple cognitive task

EXPERIMENTAL

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

Other: Behavioral: Simple cognitive task

Usual care

NO INTERVENTION

Usual care

Interventions

Behavioral: Simple cognitive task OTHER

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

Simple cognitive task

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• King's College London: lead
• Guy's and St Thomas' NHS Foundation Trust: collaborator

Study Sites (2)

Royal Belfast Hospital for Sick Children

Belfast, BT12 6BA, United Kingdom

Location

King's College London

London, SE5 8AZ, United Kingdom

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Trudie Chalder

  King's College London

  PRINCIPAL INVESTIGATOR

• David McCormack

  Queen's University, Belfast

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2019
• First Posted: December 5, 2019
• Study Start: December 3, 2019
• Primary Completion: March 19, 2020
• Study Completion: April 30, 2020
• Last Updated: May 27, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)