Clinical trial NCT04186962: Tetris to Reduce Intrusive Memories in Parents After PICU
Official title: A Brief Intervention Involving Tetris Gameplay to Prevent Intrusive Traumatic Memories in Parents After Paediatric Intensive Care: A Feasibility Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-traumatic Stress Disorders
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: Guy's and St Thomas' NHS Foundation Trust
First posted: 2019-12-05
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of flashbacks recorded by participants in a Flashback Record
timeFrame: Flashback Record will be returned to a researcher at one week follow-up
Secondary outcomes:
measure: Impact of Event Scale-Revised (IES-R)
timeFrame: One week and one month follow-up
measure: Pediatric Emotional Distress Scale
timeFrame: One week and one month follow-up
measure: Children's Revised Impact of Events Scale-13 Parent Version.
timeFrame: One week and one month follow-up
measure: Hospital Anxiety and Depression Scale
timeFrame: One week and one month follow-up
Other outcomes:
measure: Semi-structured interviews will be conducted with participants who took part in the intervention.
timeFrame: Between one week and one month follow-up.
Locations:
city: Belfast
country: United Kingdom
facility: Royal Belfast Hospital for Sick Children
city: London
country: United Kingdom
facility: King's College London
Study officials:
affiliation: King's College London
name: Trudie Chalder
role: PRINCIPAL_INVESTIGATOR
affiliation: Queen's University, Belfast
name: David McCormack
role: PRINCIPAL_INVESTIGATOR
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