Critical Illness
Conditions
Keywords
PICU, Critical illness, Outcomes, Mental health, Education, Randomized Controlled Trial (RCT), Pilot, Feasibility
Brief 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. Explore the effects of the intervention on parent and child psychological outcomes 3-6 months post discharge from PICU; 4. Explore the effects of parental stress experienced during PICU admission on the effectiveness of the intervention; 5. 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.
Interventions
OTHERPsycho-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.
Sponsors
Children of St Mary's Intensive Care
Imperial College London
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 16 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Number of Feasibility Criteria Successfully Met | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Impact of Events Scale (IES) | 3-6 months post discharge from PICU | Validated measure of post-traumatic stress symptoms in the parent. |
| Hospital Anxiety and Depression Scale (HADS) | 3-6 months post discharge from PICU | Validated measure of anxiety and depression in the parent. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Psycho-educational Intervention Received psycho-educational intervention. | 17 |
| Treatment as Usual There is no existing standard follow up for parents of children discharged from PICU. | 6 |
| Total | 23 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 5 | 3 |
Baseline characteristics
| Characteristic | Psycho-educational Intervention | Treatment as Usual | Total |
|---|---|---|---|
| Age, Continuous | 6.00 years | 9.00 years | 6.00 years |
| Sex: Female, Male Female | 10 Participants | 3 Participants | 13 Participants |
| Sex: Female, Male Male | 7 Participants | 3 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 22 | 0 / 9 |
| serious Total, serious adverse events | 0 / 22 | 0 / 9 |
Outcome results
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.
Time frame: 3-6 months post discharge from PICU
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention | The Number of Feasibility Criteria Successfully Met | 3 Number of criteria successfully met |
| Study Design | The Number of Feasibility Criteria Successfully Met | 1 Number of criteria successfully met |
Secondary
Hospital Anxiety and Depression Scale (HADS)
Validated measure of anxiety and depression in the parent.
Time frame: 3-6 months post discharge from PICU
Secondary
Impact of Events Scale (IES)
Validated measure of post-traumatic stress symptoms in the parent.
Time frame: 3-6 months post discharge from PICU