Post-traumatic Stress DisordersNCT04186962
Tetris to Reduce Intrusive Memories in Parents After PICU
A study testing Behavioral: Simple cognitive task in people with Post-traumatic Stress Disorders, run by King's College London at 2 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Post-traumatic Stress Disorders
- What is being tested?
- Behavioral: Simple cognitive task
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 3 Dec 2019to 30 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Royal Belfast Hospital for Sick Children
Belfast, BT12 6BA
King's College London
London, SE5 8AZ
About this study
Official title: A Brief Intervention Involving Tetris Gameplay to Prevent Intrusive Traumatic Memories in Parents After Paediatric Intensive Care: A Feasibility Study.
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
- Being tested
- Behavioral: Simple cognitive task
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral: Simple cognitive taskOther
A memory reactivation cue followed by playing the computer game "Tetris"
| Study group | Role | What they receive |
|---|---|---|
| Simple cognitive task | Experimental | A memory reactivation cue followed by playing the computer game "Tetris" Receives: Other: Behavioral: Simple cognitive task |
| Usual care | No intervention | Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Flashback Record will be returned to a researcher at one week follow-up
Secondary outcomes (4)
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.
Measured: One week and one month follow-up
Pediatric Emotional Distress Scale
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.
Measured: 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.
Measured: One week and one month follow-up
Hospital Anxiety and Depression Scale
This is a self-report questionnaire which measures anxiety and depression symptoms
Measured: One week and one month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2019
- Study start3 Dec 2019
- Primary completion19 Mar 2020
- Study completion30 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-traumatic Stress DisordersStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Trudie Chalder, Principal investigator, King's College LondonDavid McCormack, Principal investigator, Queen's University, Belfast
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04186962
- Sponsor's protocol ID
- 262690
- Status last verified
- Dec 2019
- First submitted
- 3 Dec 2019
- Last updated
- 27 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Brief Intervention Involving Tetris Gameplay to Prevent Intrusive Traumatic Memories in Parents After Paediatric Intensive Care: A Feasibility Study.
- ClinicalTrials.gov ID
- NCT04186962
- Acronym / sponsor ID
- 262690
- Conditions
- Post-traumatic Stress Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust
- Study start
- 3 Dec 2019 (actual)
- Primary completion
- 19 Mar 2020 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 5 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simple cognitive task | Experimental | Other: Behavioral: Simple cognitive taskA memory reactivation cue followed by playing the computer game "Tetris" |
| Usual care | No intervention | –Usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral: Simple cognitive taskA memory reactivation cue followed by playing the computer game "Tetris" | Other | Simple cognitive task |
Primary outcome
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
4 secondary outcomes
Impact of Event Scale-Revised (IES-R)
Time frame: One week and one month follow-up
Pediatric Emotional Distress Scale
Time frame: One week and one month follow-up
Children's Revised Impact of Events Scale-13 Parent Version.
Time frame: One week and one month follow-up
Hospital Anxiety and Depression Scale
Time frame: One week and one month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Trudie Chalder principal investigator
King's College London
David McCormack principal investigator
Queen's University, Belfast
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral: Simple cognitive task in people with Post-traumatic Stress Disorders, run by King's College London at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2020.