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| Name | Class |
|---|---|
| Children of St Mary's Intensive Care | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Psycho-educational intervention | Experimental | Psycho-education |
|
| Treatment as usual | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Psycho-education | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Impact of Events Scale (IES) | Validated measure of post-traumatic stress symptoms in the parent. | 3-6 months post discharge from PICU |
| Hospital Anxiety and Depression Scale (HADS) | Validated measure of anxiety and depression in the parent. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elena Garralda, M.D. | Imperial College London | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26715482 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Psycho-educational Intervention | Psycho-education 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. |
| FG001 | Treatment as Usual | There is no existing standard follow up for parents of children discharged from PICU. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Psycho-educational Intervention | Received psycho-educational intervention. |
| BG001 | Treatment as Usual | There is no existing standard follow up for parents of children discharged from PICU. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | Number of criteria successfully met | 3-6 months post discharge from PICU |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Psycho-educational Intervention | Received psycho-educational intervention. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor Elena Garralda | Imperial College London | +44 (0)20 3312 6085 | e.garralda@imperial.ac.uk |
| ID | Term |
|---|---|
| D016638 | Critical Illness |
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010549 | Personal Satisfaction |
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|
| 3-6 months post discharge from PICU |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG000 |
| Intervention |
There were six feasibility criteria related to the intervention, covering aspects of the timing of the intervention, compliance, and evaluation. |
| OG001 | Study Design | There were also six feasibility criteria related to the study design, covering recruitment/ participation rate, acceptability of procedures, loss to follow-up rate, and the time-scale of data collection. |
|
|
| Secondary | Impact of Events Scale (IES) | Validated measure of post-traumatic stress symptoms in the parent. | Not Posted | 3-6 months post discharge from PICU | Participants |
| Secondary | Hospital Anxiety and Depression Scale (HADS) | Validated measure of anxiety and depression in the parent. | Not Posted | 3-6 months post discharge from PICU | Participants |
| 0 |
| 22 |
| 0 |
| 22 |
| EG001 | Treatment as Usual | There is no existing standard follow up for parents of children discharged from PICU. | 0 | 9 | 0 | 9 |
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| D001519 | Behavior |