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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
  • Imperial College Healthcare NHS Trust

    London

    Simon Nadel

    Recruiting

Other trials in United Kingdom

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 groups in NCT04635449
Study groupRoleWhat they receive
InterventionActive comparatorage-specific information, complemented by a follow-up targeted telephone call
Receives: Other: Age-specific information booklet and targeted telephone call
Treatment as usualNo interventionusual information given at PICU discharge

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)
  1. Parent/guardian general emotional state

    Hospital Anxiety and Depression Questionnaire

    Measured: 6 months post PICU discharge

  2. 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.

  1. First posted19 Nov 2020
  2. Study start1 Jul 2021
  3. Primary completionJun 2023 (estimated)
  4. Study completionJun 2023 (estimated)

Resources

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)
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

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.

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