Improving Outcomes After PICU Admission: A Pilot Study
- Evaluate the feasibility and acceptability of an information based intervention delivered to parents following their child's admission to paediatric intensive care;
- Evaluate the feasibility and acceptability of the study design and procedures;
- Explore the effects of the intervention on parent and child psychological outcomes 3-6 months post discharge from PICU;
- Explore the effects of parental stress experienced during PICU admission on the effectiveness of the intervention;
- To provide data that, combined with results from other studies, could inform the sample size for a future multi-site RCT.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||A Psycho-educational Intervention to Improve Family Mental Health and Child Educational Outcomes Following Admission to PICU: A Pilot Study|
- The Number of Feasibility Criteria Successfully Met [ Time Frame: 3-6 months post discharge from PICU ] [ Designated as safety issue: No ]
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.
- Impact of Events Scale (IES) [ Time Frame: 3-6 months post discharge from PICU ] [ Designated as safety issue: No ]Validated measure of post-traumatic stress symptoms in the parent.
- Hospital Anxiety and Depression Scale (HADS) [ Time Frame: 3-6 months post discharge from PICU ] [ Designated as safety issue: No ]Validated measure of anxiety and depression in the parent.
|Study Start Date:||November 2012|
|Study Completion Date:||July 2014|
|Primary Completion Date:||July 2014 (Final data collection date for primary outcome measure)|
Experimental: Psycho-educational intervention
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: Treatment as usual|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01737021
|Principal Investigator:||Elena Garralda, M.D.||Imperial College London|