Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Recruitment and retention rate |
Percentage of participants approached, recruited and retained. |
6 months |
|
Primary |
Questionnaire completion rate |
Percentage of questionnaires administered that were completed. |
6 months |
|
Primary |
Success rate of intervention delivery within 4-6 weeks post-discharge |
Proportion of storybooks given to family within 6 weeks |
6 months |
|
Primary |
Acceptability of intervention and research participation: qualitative interview |
Child and parent reported qualitative interview data regarding acceptability of intervention and research design in the first three months. |
3 months |
|
Primary |
Acceptability of intervention and research participation: qualitative interview |
Child and parent reported qualitative interview data regarding acceptability of intervention and research design over six months. |
6 months |
|
Secondary |
Post-traumatic Adjustment Screen (parent participants) |
This is a brief measure consisting of 10 items that ask parents to rate the extent to which they experienced factors relating to before, during or after their child's intensive care unit stay. Each item is rated on a 5 point scale, from 0= not at all to 4=totally. Scores are summed to provide a total (0- 40), with totals above 16 indicating risk of post-traumatic stress. |
24 hours |
|
Secondary |
Work and Social Adjustment scale (parent participants; change being assessed) |
This is a five-item measure assessing functional impairment in relation to work, home management, social leisure activities, private leisure activities, and family and relationships. Each item is rated on a nine-point scale ranging from 0 (no impairment) to 8 (severe impairment) and all items scores are added together to give a total score indicating mild (0-9), moderate (10-19) or severe (20-40) impairment. |
24 hours, 1 month, 3 months and 6 months |
|
Secondary |
Paediatric Quality of Life (PedsQL) (child participants; change being assessed) |
The PedsQL is a 23-item generic measure of health-related quality of life divided into four dimensions (Physical, Emotional, Social, School) designed for 2-18 year olds. It is available in four separate versions for ages 2-4, 5-7, 8-12 and 12-18 year olds (self-report versions available for children 8 years and above). Each item is rated on a 5-pint scale from 0=never, to 4=almost always, where 0= a score of 100, 1= score of 75, 2=score of 50, 3=score of 25 and 4= score of 0. Scores from different items can be summed to compute two Summary Scores (the Psychosocial Health Summary Score and the Physical Health Summary Score), or all can be summed to provide a total score. Higher scores indicate better health related quality of life. |
24 hours, 1 month, 3 months and 6 months |
|
Secondary |
Strength and Difficulties Questionnaire (SDQ) (child participants; change being assessed) |
The SDQ comprises of 25 questions on psychological attributes, divided into five 5-item symptom subscales: Conduct Problems, Peer relationships, Emotional Symptoms, Hyperactivity-Inattention, and Prosocial Behaviour. Items are rated on 3-point scale (0= not true, 1= somewhat true, 2= certainly true) and summed to provide total scores for each scale. |
24 hours, 1 month, 3 months and 6 months |
|
Secondary |
The Hospital Anxiety and Depression Scale (HADS) (for parent participants; change being assessed) |
This is a self-report scale containing two 7- item Likert subscales to assess the presence of symptoms of anxiety and depression. Items are rated on a scale from 0-3, with higher scores indicating greater symptom severity. Items are combined and summed to give a total score for anxiety and a total score for depression symptoms. |
24 hours, 1 month, 3 months and 6 months |
|
Secondary |
The PTSD (post traumatic stress disorder) Checklist for DSM (diagnostic statistical manual) 5 (PCL5) (for parent participants; change being assessed) |
This is a 20-item self-report measure in which participants rate how much they are bothered by symptoms of PTSD on a 5-point scale (0 = "Not at all" to 4 = "Extremely"). A total symptom severity score (range - 0-80) can be obtained by summing the scores for each of the 20 items, with scores of 33-80 indicating clinical levels of symptoms. |
1 month, 3 months and 6 months |
|
Secondary |
The Child revised Impact of Events Scale - 8 (CRIES-8) (For child participants; change being assessed) |
This is an 8-item self report measure in which participants rate how much they experience symptoms of PTSD on a 4-point scale (0= not at all, 1=rarely, 3=sometimes, 5=often). Scores are added together to give a total score (0-40), with scores over 17 suggestive of clinical levels of symptoms. |
1 month, 3 months and 6 months |
|