NCT04635449

Brief 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.
  • 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
288

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 13, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 19, 2020

Completed
7 months until next milestone

Study Start

First participant enrolled

July 1, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

March 24, 2022

Status Verified

March 1, 2022

Enrollment Period

1.9 years

First QC Date

November 13, 2020

Last Update Submit

March 9, 2022

Conditions

PTSD

Outcome Measures

Primary Outcomes (1)

  • post-traumatic stress symptoms in the parents/guardians

    measured using the Impact of Events Scale, a self-report questionnaire

    6 months post PICU discharge

Secondary Outcomes (2)

  • Parent/guardian general emotional state

    6 months post PICU discharge

  • Child post-traumatic stress and other emotional and behavioural problems

    6 months post PICU discharge

Study Arms (2)

Intervention

ACTIVE COMPARATOR

age-specific information, complemented by a follow-up targeted telephone call

Other: Age-specific information booklet and targeted telephone call

Treatment as usual

NO INTERVENTION

usual information given at PICU discharge

Interventions

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.

Intervention

Eligibility Criteria

Age0 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Imperial College Healthcare NHS Trust

London, United Kingdom

RECRUITING

Related Publications (1)

  • 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.

    PMID: 41015488DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Simon Nadel, MBBS

    Imperial College Healthcare NHS Trust

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Becky Ward, BSc

CONTACT

0207 594 9459becky.ward@imperial.ac.uk

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Two-arm, parallel-group, single centre, randomised controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2020

First Posted

November 19, 2020

Study Start

July 1, 2021

Primary Completion

June 1, 2023

Study Completion

June 1, 2023

Last Updated

March 24, 2022

Record last verified: 2022-03

Locations

GB(1)