Improving Outcomes After PICU Admission: A Pilot Study
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|ClinicalTrials.gov Identifier: NCT01737021|
Recruitment Status : Completed
First Posted : November 29, 2012
Results First Posted : May 15, 2015
Last Update Posted : May 15, 2015
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Critical Illness||Other: Psycho-education||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (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|
|Study Start Date :||November 2012|
|Actual Primary Completion Date :||July 2014|
|Actual Study Completion Date :||July 2014|
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|
- The Number of Feasibility Criteria Successfully Met [ Time Frame: 3-6 months post discharge from PICU ]
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 ]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 ]Validated measure of anxiety and depression in the parent.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01737021
|Principal Investigator:||Elena Garralda, M.D.||Imperial College London|