Psycho-educational Tool to Prevent Psychological Sequelae Following Paediatric Intensive Care Unit Admission — 4PICU  

PTSD Clinical Trial

Official title: A Prospective Randomised Controlled Study of a Directed Psycho-educational Tool to Prevent Psychological Sequelae Following Paediatric Intensive Care Admission.

Status Recruiting

Clinical 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.

• 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• PTSD

• NCT number: NCT04635449
• Study type: Interventional
• Source: Imperial College Healthcare NHS Trust
• Contact: Becky Ward, BSc
• Phone: 0207 594 9459
• Email: becky.ward@imperial.ac.uk
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: July 1, 2021
• Completion date: June 2023