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

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.

Study Overview

• Status: Recruiting
• Conditions: PTSD
• Intervention / Treatment: Other: Age-specific information booklet and targeted telephone call

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.

• Study Type: Interventional
• Enrollment (Anticipated): 288
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Becky Ward, BSc; Phone Number: 0207 594 9459; Email: becky.ward@imperial.ac.uk

Study Locations

• United Kingdom
  • London, United Kingdom
    • Recruiting
    • Imperial College Healthcare NHS Trust
    • Contact: Simon Nadel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• • 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intervention; age-specific information, complemented by a follow-up targeted telephone call	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.
No Intervention: Treatment as usual; usual information given at PICU discharge

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	6 months post PICU discharge

Collaborators and Investigators

• Sponsor: Imperial College Healthcare NHS Trust
• Collaborators: Imperial College London
• Investigators: Principal Investigator: Simon Nadel, MBBS, Imperial College Healthcare NHS Trust

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: November 13, 2020
• First Submitted That Met QC Criteria: November 13, 2020
• First Posted (Actual): November 19, 2020

Study Record Updates

• Last Update Posted (Actual): March 24, 2022
• Last Update Submitted That Met QC Criteria: March 9, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 20SM6281

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Will share will other researchers within Imperial

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No