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| Name | Class |
|---|---|
| Imperial College London | OTHER |
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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.
STUDY OBJECTIVES AND PURPOSE
Aims
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
Delivery of the Psycho-educational Tool and Assessment of Parental/Guardian Stress on PICU Discharge
[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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Active Comparator | age-specific information, complemented by a follow-up targeted telephone call |
|
| Treatment as usual | No Intervention | usual information given at PICU discharge |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Age-specific information booklet and targeted telephone call | Other | age-specific information, complemented by a follow-up targeted telephone call to reduce psychological sequelae in the child and their parents after PICU discharge. |
| Measure | Description | Time Frame |
|---|---|---|
| post-traumatic stress symptoms in the parents/guardians | measured using the Impact of Events Scale, a self-report questionnaire | 6 months post PICU discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Parent/guardian general emotional state | Hospital Anxiety and Depression Questionnaire | 6 months post PICU discharge |
| Child post-traumatic stress and other emotional and behavioural problems | Questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
• Children where treatment withdrawal is being considered
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Becky Ward, BSc | Contact | 0207 594 9459 | becky.ward@imperial.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Simon Nadel, MBBS | Imperial College Healthcare NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imperial College Healthcare NHS Trust | Recruiting | London | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41015488 | Derived | 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. |
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Will share will other researchers within Imperial
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Oct 10, 2024 | |
| Reset | Nov 21, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 10, 2024 | Nov 21, 2024 |
| 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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Two-arm, parallel-group, single centre, randomised controlled trial
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| 6 months post PICU discharge |