Overview

This trial is active, not recruiting.

Condition critical illness
Treatment psycho-education
Sponsor Imperial College London
Collaborator Children of St Mary's Intensive Care
Start date November 2012
End date June 2014
Trial size 36 participants
Trial identifier NCT01737021, CRO2015

Summary

1. Evaluate the feasibility and acceptability of an information based intervention delivered to parents following their child's admission to paediatric intensive care;

2. Evaluate the feasibility and acceptability of the study design and procedures;

3. Explore the effects of the intervention on parent and child psychological outcomes 3-6 months post discharge from PICU;

4. Explore the effects of parental stress experienced during PICU admission on the effectiveness of the intervention;

5. To provide data that, combined with results from other studies, could inform the sample size for a future multi-site RCT.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose supportive care
Arm
(Experimental)
Psycho-education
psycho-education
The information given to parents will cover expected reactions that follow a PICU admission; how parents can help their child cope with these reactions; how to recognise warning signs; and sign-posting of appropriate follow-up services (if relevant). There will also be a follow-up telephone call to reinforce the information and to support parents in putting it in to practice, if appropriate.
(No Intervention)

Primary Outcomes

Measure
The number of feasibility criteria successfully met
time frame: 3-6 months post discharge from PICU

Secondary Outcomes

Measure
Impact of Events Scale (IES-8; child version)
time frame: 3-6 months post discharge from PICU
Strength and Difficulties Questionnaire (SDQ; parent rated)
time frame: 3-6 months post discharge from PICU
Child Sleep Habits Questionnaire (CSHQ; parent rated)
time frame: 3-6 months post discharge from PICU
Child Education Progress (teacher rated)
time frame: 3-6 months post discharge from PICU
Impact of Events Scale (IES)
time frame: 3-6 months post discharge from PICU
Hospital Anxiety and Depression Scale (HADS)
time frame: 3-6 months post discharge from PICU
Parental Stressor Scale: PICU (PSS:PICU)
time frame: Baseline (at hospital discharge)

Eligibility Criteria

Male or female participants from 4 years up to 16 years old.

Inclusion Criteria: - Unplanned emergency admissions to PICU for at least 12 hours - Parent or primary carer speaks and can read English Exclusion Criteria: - Child dies whilst on ward - Child discharged with a terminal illness - Child has had multiple PICU admission in the past - Staff feel it is inappropriate to approach family - Family live overseas

Additional Information

Official title A Psycho-educational Intervention to Improve Family Mental Health and Child Educational Outcomes Following Admission to PICU: A Pilot Study
Principal investigator Elena Garralda, M.D.
Description Most children are now expected to make a complete medical recovery following admission to PICU. However, research suggests that some children will go on to develop psychological difficulties, such as problems with emotions, behaviour, and learning. In addition, parents themselves may suffer with emotional difficulties. Although the follow-up of survivors is recommended, there are currently no specific guidelines in place. Intervention in the early stages of recovery could help families pull through without long lasting after-effects.
Trial information was received from ClinicalTrials.gov and was last updated in March 2014.
Information provided to ClinicalTrials.gov by Imperial College London.