PTSDNCT04041401
The Experiences of Children and Caregivers Given PICU Storybooks
An observational study of PTSD and Critical Illness, run by University of Surrey at 1 site in United Kingdom.
Trial summary
1. To assess the acceptability and feasibility of a study design aimed at evaluating the efficacy of a newly developed intervention for children and their caregivers following discharge from PICU 2. To assess the acceptability of the newly developed 'storybook intervention' Read more about this study
- Who is it for?
- Ages 3 years and olderHealthy volunteers can take part
- Conditions the study is for
- PTSD, Critical Illness, Depression
- What is being tested?
- PICU storybook
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Jun 2019to 28 Feb 2020
- Phase
- Observational
- 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 3 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Critically ill patients and their caregivers admitted to the PICU at St George's Hospital PICU.
Who may be able to join
- Parent-child dyads where the child has been admitted to the St Georges Hospital PICU during the recruitment phase.
- At time of discharge, the parent is at least 18 years old, and the child is between 3 and 15 years old with an assumed cognitive ability of at least 3 years.
- Child's admission was at least 24 hours in duration.
Who cannot join
- Parent-child dyads that do not meet all inclusion criteria above, or;
- The child's admission was due to a non-accidental injury or they are known to be the subject of safeguarding concerns within their family;
- Either the parent or child has a severe visual impairment, or the parent is unable to read.
- The child is 'Looked after'/in foster care.
- The child is discharged from PICU to end of life care.
- Either the parent or child is participating in other intervention research for PICU survivors, is in receipt of psychological therapy in relation to the admission, or has already received a storybook about this most recent PICU admission.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Paediatric Intensive Care Unit (PICU) 'Storybooks' Intervention for Children and Their Caregivers: a Case-series Feasibility Study
- To assess the acceptability and feasibility of a study design aimed at evaluating the efficacy of a newly developed intervention for children and their caregivers following discharge from PICU
- To assess the acceptability of the newly developed 'storybook intervention'
Read the detailed description
Admission to a Paediatric Intensive Care Unit (PICU) can be extremely stressful for patients and their caregivers. Both are at heightened risk of psychological distress, including post-traumatic stress symptoms (PTSS), which sometimes persist for months or years post-discharge. Unfortunately, few post-PICU psychological interventions have been studied. Documented challenges in PICU research (e.g. low recruitment rates) means feasibility issues require investigation before investing resources in intervention trials.
In adult intensive-care, diaries are used to help patients and families undergo key processes that underpin therapies to reduce PTSS: talking about and understanding their experiences. In the only published study exploring paediatric ICU diaries, families gave positive feedback, but their clinical effectiveness has not yet been evaluated. Further, it is hypothesised that formatting diaries as 'storybooks' is more adaptable to the developmental variation of the paediatric population.
Using a case-series design, this research aims to establish the feasibility of recruiting to a study evaluating PICU storybooks. It will explore the acceptability of research tasks to families, the utility and sensitivity of psychometric measures, plus how storybooks are used and perceived in supporting psychological recovery. It is anticipated that the findings will directly inform the planning of a larger scale evaluation study, and adaptations to the intervention. The hope is this will lead to improved support for families leaving PICU.
Pairs of caregivers and their children aged 3-15 will be recruited upon discharge from a PICU and will receive an individualised, developmentally-appropriate storybook about their PICU experiences. At discharge, and one, three and six months post-discharge, caregivers and children aged 8+ will complete questionnaires about psychological distress symptoms (depression, anxiety and PTSS) and their impact on functioning. Participants will be asked to keep a brief log of their storybook use and will be interviewed about their experience of the intervention and research procedures at three and six months post-discharge.
- Conditions
- PTSD, Critical Illness, Depression, Anxiety, Quality of Life
- Being tested
- PICU storybook
- Keywords
- paediatric intensive care unit, intervention, PTSD, storybook, Narrative, Feasibility, Case-series
- Medical subject headings
- Stress Disorders, Post-Traumatic, Critical Illness, Depression, Anxiety Disorders, Narration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PICU storybookOther
Narrative and developmentally appropriate intervention
| Study group | Role | What they receive |
|---|---|---|
| Children and their Caregivers | Children following discharge from PICU and their caregivers receiving a storybook intervention. Receives: Other: PICU storybook |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment and retention rate
Percentage of participants approached, recruited and retained.
Measured: 6 months
Questionnaire completion rate
Percentage of questionnaires administered that were completed.
Measured: 6 months
Success rate of intervention delivery within 4-6 weeks post-discharge
Proportion of storybooks given to family within 6 weeks
Measured: 6 months
Acceptability of intervention and research participation: qualitative interview
Child and parent reported qualitative interview data regarding acceptability of intervention and research design in the first three months.
Measured: 3 months
Acceptability of intervention and research participation: qualitative interview
Child and parent reported qualitative interview data regarding acceptability of intervention and research design over six months.
Measured: 6 months
Secondary outcomes (7)
Post-traumatic Adjustment Screen (parent participants)
This is a brief measure consisting of 10 items that ask parents to rate the extent to which they experienced factors relating to before, during or after their child's intensive care unit stay. Each item is rated on a 5 point scale, from 0= not at all to 4=totally. Scores are summed to provide a total (0- 40), with totals above 16 indicating risk of post-traumatic stress.
Measured: 24 hours
Work and Social Adjustment scale (parent participants; change being assessed)
This is a five-item measure assessing functional impairment in relation to work, home management, social leisure activities, private leisure activities, and family and relationships. Each item is rated on a nine-point scale ranging from 0 (no impairment) to 8 (severe impairment) and all items scores are added together to give a total score indicating mild (0-9), moderate (10-19) or severe (20-40) impairment.
Measured: 24 hours, 1 month, 3 months and 6 months
Paediatric Quality of Life (PedsQL) (child participants; change being assessed)
The PedsQL is a 23-item generic measure of health-related quality of life divided into four dimensions (Physical, Emotional, Social, School) designed for 2-18 year olds. It is available in four separate versions for ages 2-4, 5-7, 8-12 and 12-18 year olds (self-report versions available for children 8 years and above). Each item is rated on a 5-pint scale from 0=never, to 4=almost always, where 0= a score of 100, 1= score of 75, 2=score of 50, 3=score of 25 and 4= score of 0. Scores from different items can be summed to compute two Summary Scores (the Psychosocial Health Summary Score and the Physical Health Summary Score), or all can be summed to provide a total score. Higher scores indicate better health related quality of life.
Measured: 24 hours, 1 month, 3 months and 6 months
Strength and Difficulties Questionnaire (SDQ) (child participants; change being assessed)
The SDQ comprises of 25 questions on psychological attributes, divided into five 5-item symptom subscales: Conduct Problems, Peer relationships, Emotional Symptoms, Hyperactivity-Inattention, and Prosocial Behaviour. Items are rated on 3-point scale (0= not true, 1= somewhat true, 2= certainly true) and summed to provide total scores for each scale.
Measured: 24 hours, 1 month, 3 months and 6 months
The Hospital Anxiety and Depression Scale (HADS) (for parent participants; change being assessed)
This is a self-report scale containing two 7- item Likert subscales to assess the presence of symptoms of anxiety and depression. Items are rated on a scale from 0-3, with higher scores indicating greater symptom severity. Items are combined and summed to give a total score for anxiety and a total score for depression symptoms.
Measured: 24 hours, 1 month, 3 months and 6 months
The PTSD (post traumatic stress disorder) Checklist for DSM (diagnostic statistical manual) 5 (PCL5) (for parent participants; change being assessed)
This is a 20-item self-report measure in which participants rate how much they are bothered by symptoms of PTSD on a 5-point scale (0 = "Not at all" to 4 = "Extremely"). A total symptom severity score (range - 0-80) can be obtained by summing the scores for each of the 20 items, with scores of 33-80 indicating clinical levels of symptoms.
Measured: 1 month, 3 months and 6 months
The Child revised Impact of Events Scale - 8 (CRIES-8) (For child participants; change being assessed)
This is an 8-item self report measure in which participants rate how much they experience symptoms of PTSD on a 4-point scale (0= not at all, 1=rarely, 3=sometimes, 5=often). Scores are added together to give a total score (0-40), with scores over 17 suggestive of clinical levels of symptoms.
Measured: 1 month, 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2019
- Study start5 Jun 2019
- Primary completion29 Jan 2020
- Study completion28 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSDStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Surrey
- Sponsor type
- University, hospital or other
- Collaborators
- St George's University Hospitals NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Dr Ellie Atkins, Principal investigator, St George's Hospital Paediatric Psychology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04041401
- Sponsor's protocol ID
- SPON 2018 021 FHMS
- Status last verified
- Dec 2023
- First submitted
- 5 Jun 2019
- Last updated
- 19 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Paediatric Intensive Care Unit (PICU) 'Storybooks' Intervention for Children and Their Caregivers: a Case-series Feasibility Study
- ClinicalTrials.gov ID
- NCT04041401
- Acronym / sponsor ID
- SPON 2018 021 FHMS
- Conditions
- PTSD, Critical Illness, Depression, Anxiety, Quality of Life
- Keywords
- paediatric intensive care unit, intervention, PTSD, storybook, Narrative, Feasibility, Case-series
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of SurreyUniversity, hospital or other
- Collaborators
- St George's University Hospitals NHS Foundation Trust
- Study start
- 5 Jun 2019 (actual)
- Primary completion
- 29 Jan 2020 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 1 Aug 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.
- To assess the acceptability and feasibility of a study design aimed at evaluating the efficacy of a newly developed intervention for children and their caregivers following discharge from PICU
- To assess the acceptability of the newly developed 'storybook intervention'
Detailed description
Admission to a Paediatric Intensive Care Unit (PICU) can be extremely stressful for patients and their caregivers. Both are at heightened risk of psychological distress, including post-traumatic stress symptoms (PTSS), which sometimes persist for months or years post-discharge. Unfortunately, few post-PICU psychological interventions have been studied. Documented challenges in PICU research (e.g. low recruitment rates) means feasibility issues require investigation before investing resources in intervention trials.
In adult intensive-care, diaries are used to help patients and families undergo key processes that underpin therapies to reduce PTSS: talking about and understanding their experiences. In the only published study exploring paediatric ICU diaries, families gave positive feedback, but their clinical effectiveness has not yet been evaluated. Further, it is hypothesised that formatting diaries as 'storybooks' is more adaptable to the developmental variation of the paediatric population.
Using a case-series design, this research aims to establish the feasibility of recruiting to a study evaluating PICU storybooks. It will explore the acceptability of research tasks to families, the utility and sensitivity of psychometric measures, plus how storybooks are used and perceived in supporting psychological recovery. It is anticipated that the findings will directly inform the planning of a larger scale evaluation study, and adaptations to the intervention. The hope is this will lead to improved support for families leaving PICU.
Pairs of caregivers and their children aged 3-15 will be recruited upon discharge from a PICU and will receive an individualised, developmentally-appropriate storybook about their PICU experiences. At discharge, and one, three and six months post-discharge, caregivers and children aged 8+ will complete questionnaires about psychological distress symptoms (depression, anxiety and PTSS) and their impact on functioning. Participants will be asked to keep a brief log of their storybook use and will be interviewed about their experience of the intervention and research procedures at three and six months post-discharge.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children and their Caregivers | – | Other: PICU storybookChildren following discharge from PICU and their caregivers receiving a storybook intervention. |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Critically ill patients and their caregivers admitted to the PICU at St George's Hospital PICU.
Key inclusion criteria (3 listed)
- Parent-child dyads where the child has been admitted to the St Georges Hospital PICU during the recruitment phase.
- At time of discharge, the parent is at least 18 years old, and the child is between 3 and 15 years old with an assumed cognitive ability of at least 3 years.
- Child's admission was at least 24 hours in duration.
Key exclusion criteria (6 listed)
- Parent-child dyads that do not meet all inclusion criteria above, or;
- The child's admission was due to a non-accidental injury or they are known to be the subject of safeguarding concerns within their family;
- Either the parent or child has a severe visual impairment, or the parent is unable to read.
- The child is 'Looked after'/in foster care.
- The child is discharged from PICU to end of life care.
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 |
|---|---|---|
| PICU storybookNarrative and developmentally appropriate intervention | Other | Children and their Caregivers |
Primary outcome
Recruitment and retention rate
Time frame: 6 months
Percentage of participants approached, recruited and retained.
Questionnaire completion rate
Time frame: 6 months
Percentage of questionnaires administered that were completed.
Success rate of intervention delivery within 4-6 weeks post-discharge
Time frame: 6 months
Proportion of storybooks given to family within 6 weeks
Acceptability of intervention and research participation: qualitative interview
Time frame: 3 months
Child and parent reported qualitative interview data regarding acceptability of intervention and research design in the first three months.
Acceptability of intervention and research participation: qualitative interview
Time frame: 6 months
Child and parent reported qualitative interview data regarding acceptability of intervention and research design over six months.
7 secondary outcomes
Post-traumatic Adjustment Screen (parent participants)
Time frame: 24 hours
Work and Social Adjustment scale (parent participants; change being assessed)
Time frame: 24 hours, 1 month, 3 months and 6 months
Paediatric Quality of Life (PedsQL) (child participants; change being assessed)
Time frame: 24 hours, 1 month, 3 months and 6 months
Strength and Difficulties Questionnaire (SDQ) (child participants; change being assessed)
Time frame: 24 hours, 1 month, 3 months and 6 months
The Hospital Anxiety and Depression Scale (HADS) (for parent participants; change being assessed)
Time frame: 24 hours, 1 month, 3 months and 6 months
The PTSD (post traumatic stress disorder) Checklist for DSM (diagnostic statistical manual) 5 (PCL5) (for parent participants; change being assessed)
Time frame: 1 month, 3 months and 6 months
The Child revised Impact of Events Scale - 8 (CRIES-8) (For child participants; change being assessed)
Time frame: 1 month, 3 months and 6 months
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 19 Dec 2023.
- Individual participant dataSharing planned: Undecided
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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.
Dr Ellie Atkins principal investigator
St George's Hospital Paediatric Psychology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PTSD and Critical Illness, run by University of Surrey at 1 site 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 3 inclusion and 6 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 19 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Recruitment and retention rate (time frame: 6 months). The study lists 5 primary outcomes in all. 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 19 Dec 2023.