Improving Outcomes After PICU Admission: A Pilot Study
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Purpose
- 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 | Intervention |
|---|---|
|
Critical Illness |
Other: Psycho-education |
| Study Type: | Interventional |
| 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-8; child version) [ Time Frame: 3-6 months post discharge from PICU ] [ Designated as safety issue: No ]Validated measure of post-traumatic stress symptoms in the child.
- Strength and Difficulties Questionnaire (SDQ; parent rated) [ Time Frame: 3-6 months post discharge from PICU ] [ Designated as safety issue: No ]Validated measure of general psychiatric adjustment in the child
- Child Sleep Habits Questionnaire (CSHQ; parent rated) [ Time Frame: 3-6 months post discharge from PICU ] [ Designated as safety issue: No ]Validated measure of sleep disturbance in the child.
- Child Education Progress (teacher rated) [ Time Frame: 3-6 months post discharge from PICU ] [ Designated as safety issue: No ]Non-validated standardised questionnaire to assess educational progress in the child.
- 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.
- Parental Stressor Scale: PICU (PSS:PICU) [ Time Frame: Baseline (at hospital discharge) ] [ Designated as safety issue: No ]Validated measure of level of parental stress experienced whilst child was admitted to PICU.
| Estimated Enrollment: | 36 |
| Study Start Date: | November 2012 |
| Estimated Study Completion Date: | October 2013 |
| Estimated Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Psycho-educational 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.
|
| No Intervention: Treatment as usual |
Detailed 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.
Eligibility| Ages Eligible for Study: | 4 Years to 16 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Lorraine C Als, BSc., PhD | +44 203 312 1145 | l.als@imperial.ac.uk |
| United Kingdom | |
| St Mary's Hospital | Recruiting |
| London, United Kingdom, W2 1NY | |
| Contact: Simon Nadel s.nadel@imperial.ac.uk | |
| Principal Investigator: | Elena Garralda, M.D., FRCPsych, FRCPCH | Imperial College London |
More Information
No publications provided
| Responsible Party: | Imperial College London |
| ClinicalTrials.gov Identifier: | NCT01737021 History of Changes |
| Other Study ID Numbers: | CRO2015 |
| Study First Received: | November 1, 2012 |
| Last Updated: | May 10, 2013 |
| Health Authority: | United Kingdom: Research Ethics Committee |
Keywords provided by Imperial College London:
|
PICU Critical illness Outcomes Mental health |
Education Randomized Controlled Trial (RCT) Pilot Feasibility |
Additional relevant MeSH terms:
|
Critical Illness Disease Attributes Pathologic Processes |
ClinicalTrials.gov processed this record on May 19, 2013