Does a Follow-up Appointment Help Parents of Children on PICU?

NCT01628263 | Completed

• 1 other identifier: CH/2011/3827
• Study Type: interventional
• Target: 127
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of our study is to determine the feasibility of carrying out a randomized controlled trial (RCT) to investigate whether screening parents of children admitted to pediatric intensive care unit (PICU) so as to target follow-up at those most at risk of developing posttraumatic stress disorder (PTSD), is effective at reducing adverse psychological sequelae.

Conditions

Post Traumatic Stress Disorder

Keywords

PICU; Follow up; PTSD

Outcome Measures

Primary Outcomes (2)

• The Impact of Event Scale-Revised (IES-R)

  Widely used self-report measure of responses to trauma

  5 months post discharge

• Hospital Anxiety & Depression Scale (HADS)

  Widely used self-report measure of anxiety and depression

  5 months post discharge

Secondary Outcomes (1)

• Feedback Questionnaire

  6 months post discharge

Study Arms (2)

Follow up Clinic

EXPERIMENTAL

Participants will receive an offer of a follow up clinic two months post discharge, staffed by the unit Clinical Psychologist, a PICU doctor and PICU nurse.

Other: Follow up Clinic for High risk participants

Control

NO INTERVENTION

Participants will not receive an offer of a follow up clinic

Interventions

Follow up Clinic for High risk participants OTHER

Families where either or both parents are screened to be at risk of PTSD or depression are randomised in a 1:1 ratio to the intervention or control arm. Those in the intervention arm will receive an offer of a follow up clinic two months post discharge, staffed by the unit Clinical Psychologist, a PICU doctor and PICU nurse. Those in the control arm will not be offered a follow up clinic.

Follow up Clinic

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All parents of children admitted to paediatric intensive care for over 12 hours.

You may not qualify if:

• Parents deemed unsuitable for the study by the responsible consultant. This will include families where a child's condition is suspected to result from non-accidental injury or where withdrawal of care is being discussed due to a child's critical condition. Families will be excluded if their child died during or after admission, as these families are already followed up routinely.

Sponsors & Collaborators

• University Hospitals Bristol and Weston NHS Foundation Trust: lead

Study Sites (1)

Bristol Royal Hospital for Children

Bristol, BS2 8BJ, United Kingdom

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Sarah Goodwin

  University Hospitals Bristol and Weston NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

• Victoria Samuel

  University Hospitals Bristol and Weston NHS Foundation Trust

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist Registrar

Study Record Dates

• First Submitted: June 21, 2012
• First Posted: June 26, 2012
• Study Start: December 1, 2011
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: November 27, 2020

Record last verified: 2020-11

Locations

GB (1)