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Completed

NCT Number: NCT01737021

Improving Outcomes After PICU Admission: A Pilot Study

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.

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Key information

Conditions

Critical Illness Behavior Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms Personal Satisfaction Psychological Well-Being

Age range

4 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Impact of Events Scale (IES)

    Time frame: 3-6 months post discharge from PICU

    Validated measure of post-traumatic stress symptoms in the parent.

  2. Hospital Anxiety and Depression Scale (HADS)

    Time frame: 3-6 months post discharge from PICU

    Validated measure of anxiety and depression in the parent.

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Collaborators

  • Children of St Mary's Intensive Care

Registry information

Official study title

A Psycho-educational Intervention to Improve Family Mental Health and Child Educational Outcomes Following Admission to PICU: A Pilot Study

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Nov 29, 2012
Registry last updated
May 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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