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| Name | Class |
|---|---|
| Guy's and St Thomas' NHS Foundation Trust | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Simple cognitive task | Experimental | A memory reactivation cue followed by playing the computer game "Tetris" |
|
| Usual care | No Intervention | Usual care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral: Simple cognitive task | Other | A memory reactivation cue followed by playing the computer game "Tetris" |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | One week and one month follow-up |
| Pediatric Emotional Distress Scale |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Between one week and one month follow-up. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Trudie Chalder | King's College London | Principal Investigator |
| David McCormack | Queen's University, Belfast | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Belfast Hospital for Sick Children | Belfast | BT12 6BA | United Kingdom | |||
| King's College London |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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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. |
| One week and one month follow-up |
| Children's Revised Impact of Events Scale-13 Parent Version. | This is a parent-report measure - Cries-13-PV. | One week and one month follow-up |
| Hospital Anxiety and Depression Scale | This is a self-report questionnaire which measures anxiety and depression symptoms | One week and one month follow-up |
| London |
| SE5 8AZ |
| United Kingdom |