Improving Outcomes After PICU Admission: A Pilot Study

Critical Illness Clinical Trial

Official title:

A Psycho-educational Intervention to Improve Family Mental Health and Child Educational Outcomes Following Admission to PICU: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01737021
• Other study ID #: CRO2015
• Status: Completed
• Phase: N/A
• Start date: November 2012
• Est. completion date: July 2014

Study information

• Verified date: April 2022
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness

Intervention

Other:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Imperial College London	Children of St Mary's Intensive Care

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Number of Feasibility Criteria Successfully Met	Feasibility success criteria have been defined a priori for the intervention and study design. There are six feasibility criteria related to the intervention, covering aspects of the timing of the intervention, compliance, and evaluation. There are also six feasibility criteria related to the study design, covering recruitment rate; participation rate; acceptability of procedures; attrition rate; and the time-scale of data collection.; Dependent on the number of criteria successfully met, the following classification will be used: "*" 0-2/6 criteria met - Stop; intervention and/or study design not feasible. "*" 3-4/6 criteria met - Continue with modifications; feasible intervention and/or study design with modifications.; "*" 5/6 criteria met - Continue without modifications, but monitor closely; feasible intervention and/or study design with close monitoring.; "*" 6/6 criteria met - Continue without modifications; feasible intervention and/or study design as is.	3-6 months post discharge from PICU
Secondary	Impact of Events Scale (IES)	Validated measure of post-traumatic stress symptoms in the parent.	3-6 months post discharge from PICU
Secondary	Hospital Anxiety and Depression Scale (HADS)	Validated measure of anxiety and depression in the parent.	3-6 months post discharge from PICU