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Psycho-educational Tool to Prevent Psychological Sequelae Following Paediatric Intensive Care Unit Admission

NCT04635449 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 288

Last updated 2022-03-24

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Age-specific information booklet and targeted telephone call

age-specific information, complemented by a follow-up targeted telephone call to reduce psychological sequelae in the child and their parents after PICU discharge.

Sponsors & Collaborators

  • Imperial College London

    collaborator OTHER

  • Imperial College Healthcare NHS Trust

    lead OTHER

Principal Investigators

  • Simon Nadel, MBBS · Imperial College Healthcare NHS Trust

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
0 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-01
Primary Completion
2023-06-30
Completion
2023-06-30

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04635449 on ClinicalTrials.gov