PTSDPhase 2/34PICUNCT04635449
Psycho-educational Tool to Prevent Psychological Sequelae Following Paediatric Intensive Care Unit Admission
A Phase 2/3 study testing Age-specific information booklet and targeted telephone call in people with PTSD, run by Imperial College Healthcare NHS Trust at 1 site in United Kingdom.
Trial summary
To systematically evaluate an innovative directed psycho-educational intervention consisting of written specific, age-appropriate information, complemented by a follow-up targeted telephone call in order to reduce psychological sequelae in the child and their parents/guardians after PICU discharge. Read more about this study
- Who is it for?
- Ages 0 to 16 years
- Conditions the study is for
- PTSD
- What is being tested?
- Age-specific information booklet and targeted telephone call
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 288 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jul 2021to Jun 2023
- Phase
- Phase 2/3
- 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 0 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All children and young people age 0-16 years
- > 36 weeks corrected gestational age
- Admitted to PICU >24 hours Parent(s)/guardian aged >18 years
Who cannot join
- • Children where treatment withdrawal is being considered
- Life expectancy <6 months
- Previous admission to Paediatric, or Neonatal Intensive Care for > 24 hours, in the last 12months preceding the current PICU admission
- Parent(s)/ guardian to have insufficient English to complete questionnaires
- Overseas address
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Imperial College Healthcare NHS Trust
London
Simon Nadel
About this study
Official title: A Prospective Randomised Controlled Study of a Directed Psycho-educational Tool to Prevent Psychological Sequelae Following Paediatric Intensive Care Admission.
- To systematically evaluate an innovative directed psycho-educational intervention consisting of written specific, age-appropriate information, complemented by a follow-up targeted telephone call in order to reduce psychological sequelae in the child and their parents/guardians after PICU discharge.
- To confirm the effects of the psycho-educational tool on parent and child emotional adjustment 6 months after PICU discharge; and to explore whether these outcomes are associated with the child's age; with receipt of the targeted telephone call; and/or with parental levels of stress during the child's admission.
- To obtain detailed feedback from parents/guardians and children about the different aspects of the psycho-educational intervention (the written information and the targeted telephone call) and the utility of these two psycho-educational interventions.
The study team will perform a randomised controlled trial of the intervention vs treatment as usual in children 0-16 years, stratified according to age (< 4 years and > 4 years).
It is estimated that 288 children will be required to show a difference in outcome which is PTSD in parents and children.
Read the detailed description
STUDY OBJECTIVES AND PURPOSE
Aims
- To systematically evaluate an innovative directed psycho-educational intervention consisting of written specific, age-appropriate information, complemented by a follow-up targeted telephone call in order to reduce psychological sequelae in the child and their parents/guardians after PICU discharge.
- To confirm the effects of the psycho-educational tool on parent and child emotional adjustment 6 months after PICU discharge; and to explore whether these outcomes are associated with the child's age; with receipt of the targeted telephone call; and/or with parental levels of stress during the child's admission.
- To obtain detailed feedback from parents/guardians and children about the different aspects of the psycho-educational intervention (the written information and the targeted telephone call) and the utility of these two psycho-educational interventions.
Primary Objective To determine if the psycho-educational intervention is superior to treatment as usual in reducing parental post-traumatic stress and other psychological symptoms measured at 6 months after PICU discharge.
Secondary Objectives
- To determine if the intervention is superior to treatment as usual in reducing child post-traumatic stress and other psychological symptoms measured at 6 months post PICU discharge.
- To determine whether the degree of parental stress during their child's PICU admission is particularly associated with the extent of psychological sequelae and whether the psycho-educational intervention is as less or more effective in the highly stressed families.
- To determine if adding this relatively simple, innovative and pragmatic intervention to treatment as usual will provide a cost-effective use of NHS resources
- To evaluate in detail child and parental acceptance of the intervention.
Delivery of the Psycho-educational Tool and Assessment of Parental/Guardian Stress on PICU Discharge
- Eligible families will include children 0-16 years admitted to PICU for > 24 hours, surviving to be discharged.
- Parents who are deemed to lack adequate English Language to understand the written psycho-educational tool, telephone call and questionnaires will be excluded.
[Our aim in future, if the intervention is shown to be successful, is to translate the intervention tools into the most frequently encountered foreign languages.]
After obtaining informed consent prior to the child's discharge from PICU, a parental PICU stress screening questionnaire (18), will be given to all parents/guardians prior to discharge by the researcher or appropriately trained bedside PICU nurse.
- Parents/guardians of all eligible children will be randomized using random allocation to receive either active intervention or treatment as usual (TAU).
- Those randomised to the intervention group will be given the age-appropriate written psycho-educational tool prior to PICU discharge, by the researcher. The researcher will also explain the mechanism of the targeted telephone call to be delivered 4-6 weeks after PICU discharge.
- Telephone Call:
- All parents/guardians randomised to the intervention group will be offered the directed targeted telephone call from the researcher at 4-6 weeks post hospital discharge.
- The researcher will use a protocolised, scripted interview questionnaire to discuss the contents of the tool and any psychological problems arising post PICU discharge, as well as provide information to families of ways of managing these, including, when appropriate referral to GP and local mental health services.
- The study team will record the key outcomes of the call to include:
Uptake rates and outcome; the number of families with impairing symptoms; and rates of referral to GPs and/or local mental health services.
- Conditions
- PTSD
- Being tested
- Age-specific information booklet and targeted telephone call
- 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.
Age-specific information booklet and targeted telephone callOther
age-specific information, complemented by a follow-up targeted telephone call to reduce psychological sequelae in the child and their parents after PICU discharge.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | age-specific information, complemented by a follow-up targeted telephone call Receives: Other: Age-specific information booklet and targeted telephone call |
| Treatment as usual | No intervention | usual information given at PICU discharge |
What is being measured
The primary outcome is the main question the study is designed to answer.
post-traumatic stress symptoms in the parents/guardians
measured using the Impact of Events Scale, a self-report questionnaire
Measured: 6 months post PICU discharge
Secondary outcomes (2)
Parent/guardian general emotional state
Hospital Anxiety and Depression Questionnaire
Measured: 6 months post PICU discharge
Child post-traumatic stress and other emotional and behavioural problems
Questionnaire
Measured: 6 months post PICU discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2020
- Study start1 Jul 2021
- Primary completionJun 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm, parallel-group, single centre, randomised controlled trial
- Masking
- None (open label)
- Enrolment
- 288 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College Healthcare NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Imperial College London
- Responsible party
- Sponsor
- Investigators
- Simon Nadel, MBBS, Principal investigator, Imperial College Healthcare NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04635449
- Sponsor's protocol ID
- 20SM6281
- Acronym
- 4PICU
- Status last verified
- Mar 2022
- First submitted
- 13 Nov 2020
- Last updated
- 24 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Will share will other researchers within Imperial
Publications
Bridges K, Vickers B, Mitting RB, Cooper M, Garralda E, Nadel S. Directed psychoeducational tool to prevent psychological sequelae following paediatric intensive care admission: a prospective randomised controlled study (the 4PICU study). Arch Dis Child. 2026 Jan 19;111(2):133-140. doi: 10.1136/archdischild-2025-328691.
PubMed 41015488
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomised Controlled Study of a Directed Psycho-educational Tool to Prevent Psychological Sequelae Following Paediatric Intensive Care Admission.
- ClinicalTrials.gov ID
- NCT04635449
- Acronym / sponsor ID
- 4PICU / 20SM6281
- Conditions
- PTSD
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 288 participants (estimated)
- Lead sponsor
- Imperial College Healthcare NHS TrustUniversity, hospital or other
- Collaborators
- Imperial College London
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 19 Nov 2020 (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 systematically evaluate an innovative directed psycho-educational intervention consisting of written specific, age-appropriate information, complemented by a follow-up targeted telephone call in order to reduce psychological sequelae in the child and their parents/guardians after PICU discharge.
- To confirm the effects of the psycho-educational tool on parent and child emotional adjustment 6 months after PICU discharge; and to explore whether these outcomes are associated with the child's age; with receipt of the targeted telephone call; and/or with parental levels of stress during the child's admission.
- To obtain detailed feedback from parents/guardians and children about the different aspects of the psycho-educational intervention (the written information and the targeted telephone call) and the utility of these two psycho-educational interventions.
The study team will perform a randomised controlled trial of the intervention vs treatment as usual in children 0-16 years, stratified according to age (< 4 years and > 4 years).
It is estimated that 288 children will be required to show a difference in outcome which is PTSD in parents and children.
Detailed description
STUDY OBJECTIVES AND PURPOSE
Aims
- To systematically evaluate an innovative directed psycho-educational intervention consisting of written specific, age-appropriate information, complemented by a follow-up targeted telephone call in order to reduce psychological sequelae in the child and their parents/guardians after PICU discharge.
- To confirm the effects of the psycho-educational tool on parent and child emotional adjustment 6 months after PICU discharge; and to explore whether these outcomes are associated with the child's age; with receipt of the targeted telephone call; and/or with parental levels of stress during the child's admission.
- To obtain detailed feedback from parents/guardians and children about the different aspects of the psycho-educational intervention (the written information and the targeted telephone call) and the utility of these two psycho-educational interventions.
Primary Objective To determine if the psycho-educational intervention is superior to treatment as usual in reducing parental post-traumatic stress and other psychological symptoms measured at 6 months after PICU discharge.
Secondary Objectives
- To determine if the intervention is superior to treatment as usual in reducing child post-traumatic stress and other psychological symptoms measured at 6 months post PICU discharge.
- To determine whether the degree of parental stress during their child's PICU admission is particularly associated with the extent of psychological sequelae and whether the psycho-educational intervention is as less or more effective in the highly stressed families.
- To determine if adding this relatively simple, innovative and pragmatic intervention to treatment as usual will provide a cost-effective use of NHS resources
- To evaluate in detail child and parental acceptance of the intervention.
Delivery of the Psycho-educational Tool and Assessment of Parental/Guardian Stress on PICU Discharge
- Eligible families will include children 0-16 years admitted to PICU for > 24 hours, surviving to be discharged.
- Parents who are deemed to lack adequate English Language to understand the written psycho-educational tool, telephone call and questionnaires will be excluded.
[Our aim in future, if the intervention is shown to be successful, is to translate the intervention tools into the most frequently encountered foreign languages.]
After obtaining informed consent prior to the child's discharge from PICU, a parental PICU stress screening questionnaire (18), will be given to all parents/guardians prior to discharge by the researcher or appropriately trained bedside PICU nurse.
- Parents/guardians of all eligible children will be randomized using random allocation to receive either active intervention or treatment as usual (TAU).
- Those randomised to the intervention group will be given the age-appropriate written psycho-educational tool prior to PICU discharge, by the researcher. The researcher will also explain the mechanism of the targeted telephone call to be delivered 4-6 weeks after PICU discharge.
- Telephone Call:
- All parents/guardians randomised to the intervention group will be offered the directed targeted telephone call from the researcher at 4-6 weeks post hospital discharge.
- The researcher will use a protocolised, scripted interview questionnaire to discuss the contents of the tool and any psychological problems arising post PICU discharge, as well as provide information to families of ways of managing these, including, when appropriate referral to GP and local mental health services.
- The study team will record the key outcomes of the call to include:
Uptake rates and outcome; the number of families with impairing symptoms; and rates of referral to GPs and/or local mental health services.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two-arm, parallel-group, single centre, randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Other: Age-specific information booklet and targeted telephone callage-specific information, complemented by a follow-up targeted telephone call |
| Treatment as usual | No intervention | –usual information given at PICU discharge |
Who may qualify
- Ages
- 0 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- All children and young people age 0-16 years
- > 36 weeks corrected gestational age
- Admitted to PICU >24 hours Parent(s)/guardian aged >18 years
Key exclusion criteria (5 listed)
- • Children where treatment withdrawal is being considered
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 |
|---|---|---|
| Age-specific information booklet and targeted telephone callage-specific information, complemented by a follow-up targeted telephone call to reduce psychological sequelae in the child and their parents after PICU discharge. | Other | Intervention |
Primary outcome
post-traumatic stress symptoms in the parents/guardians
Time frame: 6 months post PICU discharge
measured using the Impact of Events Scale, a self-report questionnaire
2 secondary outcomes
Parent/guardian general emotional state
Time frame: 6 months post PICU discharge
Child post-traumatic stress and other emotional and behavioural problems
Time frame: 6 months post PICU discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2022.
- Derived from this study: PubMed 41015488Bridges K, Vickers B, Mitting RB, Cooper M, Garralda E, Nadel S. Directed psychoeducational tool to prevent psychological sequelae following paediatric intensive care admission: a prospective randomised controlled study (the 4PICU study). Arch Dis Child. 2026 Jan 19;111(2):133-140. doi: 10.1136/archdischild-2025-328691.
- Individual participant dataSharing planned: Undecided. Will share will other researchers within Imperial
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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.
Simon Nadel, MBBS principal investigator
Imperial College Healthcare NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Age-specific information booklet and targeted telephone call in people with PTSD, run by Imperial College Healthcare NHS Trust 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 5 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: status not confirmed, as of the sponsor's last update on 24 Mar 2022. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Becky Ward, BSc (0207 594 9459, becky.ward@imperial.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
post-traumatic stress symptoms in the parents/guardians (time frame: 6 months post PICU discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04635449, which also lists 1 linked publication.
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 24 Mar 2022.