Critical IllnessNCT01737021
Improving Outcomes After PICU Admission: A Pilot Study
A study testing Psycho-education in people with Critical Illness, run by Imperial College London.
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. Read more about this study
- Who is it for?
- Ages 4 to 16 years
- Conditions the study is for
- Critical Illness
- What is being tested?
- Psycho-education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- No sites listed yet
- Study dates
- Nov 2012to Jul 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Unplanned emergency admissions to PICU for at least 12 hours
- Parent or primary carer speaks and can read English
Who cannot join
- 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
About this study
Official title: A Psycho-educational Intervention to Improve Family Mental Health and Child Educational Outcomes Following Admission to PICU: 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.
Read the 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.
- Conditions
- Critical Illness
- Being tested
- Psycho-education
- Keywords
- PICU, Critical illness, Outcomes, Mental health, Education, Randomized Controlled Trial (RCT), Pilot, Feasibility
- Medical subject headings
- Critical Illness, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psycho-educationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Psycho-educational intervention | Experimental | Psycho-education Receives: Other: Psycho-education |
| Treatment as usual | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3-6 months post discharge from PICU
Secondary outcomes (2)
Impact of Events Scale (IES)
Validated measure of post-traumatic stress symptoms in the parent.
Measured: 3-6 months post discharge from PICU
Hospital Anxiety and Depression Scale (HADS)
Validated measure of anxiety and depression in the parent.
Measured: 3-6 months post discharge from PICU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Children of St Mary's Intensive Care
- Responsible party
- Sponsor
- Investigators
- Elena Garralda, M.D., Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01737021
- Sponsor's protocol ID
- CRO2015
- Status last verified
- Apr 2022
- First submitted
- 1 Nov 2012
- Last updated
- 11 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Als LC, Nadel S, Cooper M, Vickers B, Garralda ME. A supported psychoeducational intervention to improve family mental health following discharge from paediatric intensive care: feasibility and pilot randomised controlled trial. BMJ Open. 2015 Dec 29;5(12):e009581. doi: 10.1136/bmjopen-2015-009581.
PubMed 26715482
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Psycho-educational Intervention to Improve Family Mental Health and Child Educational Outcomes Following Admission to PICU: A Pilot Study
- ClinicalTrials.gov ID
- NCT01737021
- Acronym / sponsor ID
- CRO2015
- Conditions
- Critical Illness
- Keywords
- PICU, Critical illness, Outcomes, Mental health, Education, Randomized Controlled Trial (RCT), Pilot, Feasibility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Children of St Mary's Intensive Care
- Study start
- Nov 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 29 Nov 2012 (estimated)
- Results
- Posted 15 May 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psycho-educational intervention | Experimental | Other: Psycho-educationPsycho-education |
| Treatment as usual | No intervention | – |
Who may qualify
- Ages
- 4 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Unplanned emergency admissions to PICU for at least 12 hours
- Parent or primary carer speaks and can read English
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psycho-educationThe 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. | Other | Psycho-educational intervention |
Primary outcome
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.
2 secondary outcomes
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26715482Als LC, Nadel S, Cooper M, Vickers B, Garralda ME. A supported psychoeducational intervention to improve family mental health following discharge from paediatric intensive care: feasibility and pilot randomised controlled trial. BMJ Open. 2015 Dec 29;5(12):e009581. doi: 10.1136/bmjopen-2015-009581.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elena Garralda, M.D. principal investigator
Imperial College London
Questions about this trial
What is this clinical trial studying?
A study testing Psycho-education in people with Critical Illness, run by Imperial College London.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 May 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Number of Feasibility Criteria Successfully Met (time frame: 3-6 months post discharge from PICU). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01737021, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2022; AzTrials last refreshed its copy on 31 Oct 2026.