The Experiences of Children and Caregivers Given PICU Storybooks

NCT04041401 | Completed

• 1 other identifier: SPON 2018 021 FHMS
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.To assess the acceptability and feasibility of a study design aimed at evaluating the efficacy of a newly developed intervention for children and their caregivers following discharge from PICU
2. 2.To assess the acceptability of the newly developed 'storybook intervention'

Conditions

PTSD; Critical Illness; Depression; Anxiety; Quality of Life

Keywords

paediatric intensive care unit; intervention; PTSD; storybook; Narrative; Feasibility; Case-series

Outcome Measures

Primary Outcomes (5)

• Recruitment and retention rate

  Percentage of participants approached, recruited and retained.

  6 months

• Questionnaire completion rate

  Percentage of questionnaires administered that were completed.

  6 months

• Success rate of intervention delivery within 4-6 weeks post-discharge

  Proportion of storybooks given to family within 6 weeks

  6 months

• 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

• 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 Outcomes (7)

• Post-traumatic Adjustment Screen (parent participants)

  24 hours

• Work and Social Adjustment scale (parent participants; change being assessed)

  24 hours, 1 month, 3 months and 6 months

• Paediatric Quality of Life (PedsQL) (child participants; change being assessed)

  24 hours, 1 month, 3 months and 6 months

• Strength and Difficulties Questionnaire (SDQ) (child participants; change being assessed)

  24 hours, 1 month, 3 months and 6 months

• The Hospital Anxiety and Depression Scale (HADS) (for parent participants; change being assessed)

  24 hours, 1 month, 3 months and 6 months

Study Arms (1)

Children and their Caregivers

Children following discharge from PICU and their caregivers receiving a storybook intervention.

Other: PICU storybook

Interventions

PICU storybook OTHER

Narrative and developmentally appropriate intervention

Children and their Caregivers

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Critically ill patients and their caregivers admitted to the PICU at St George's Hospital PICU.

You may qualify if:

• Parent-child dyads where the child has been admitted to the St Georges Hospital PICU during the recruitment phase.
• At time of discharge, the parent is at least 18 years old, and the child is between 3 and 15 years old with an assumed cognitive ability of at least 3 years.
• Child's admission was at least 24 hours in duration.

You may not qualify if:

• The child's admission was due to a non-accidental injury or they are known to be the subject of safeguarding concerns within their family;
• Either the parent or child has a severe visual impairment, or the parent is unable to read.
• The child is 'Looked after'/in foster care.
• The child is discharged from PICU to end of life care.
• Either the parent or child is participating in other intervention research for PICU survivors, is in receipt of psychological therapy in relation to the admission, or has already received a storybook about this most recent PICU admission.

Sponsors & Collaborators

• University of Surrey: lead
• St George's University Hospitals NHS Foundation Trust: collaborator

Study Sites (1)

St George's Hospital

Tooting, SW17 0QT, United Kingdom

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Critical Illness; Depression; Anxiety Disorders; Narration

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Communication

Study Officials

• Dr Ellie Atkins

  St George's Hospital Paediatric Psychology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2019
• First Posted: August 1, 2019
• Study Start: June 5, 2019
• Primary Completion: January 29, 2020
• Study Completion: February 28, 2020
• Last Updated: December 19, 2023

Record last verified: 2023-12

Locations

GB (1)