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Completed

NCT Number: NCT04665479

Digital-storytelling Intervention for Rural-dwelling Children

The overall purpose of this study is to test the feasibility of a web-based storytelling intervention for rural-dwelling children (ages 8-17) with serious advanced illnesses.

There is a growing need for home-based end-of-life and palliative care for children with serious illnesses. While palliative care interventions offered in home settings are significantly lacking, the problems are magnified by substantial gaps in access to palliative care for rural populations. Web-based recruitment and intervention methods have the potential to access hard-to-reach rural populations and provide a cost-effective health care. In particular, legacy-making (i.e., actions/behaviors aimed at being remembered) is one strategy to help decrease suffering and improve psychosocial outcomes for children with serious illness and end of life needs. Storytelling has successfully documented child legacies and may be an ideal format for children. Guided by our existing, web-based digital storytelling intervention and previous work, this project will offer a remotely-delivered legacy-making intervention to rural-dwelling children with diverse serious, advanced health conditions and their parents.

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Key information

Conditions

Pediatrics

Age range

8 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232, United States

About this study

Background: Nearly 1 million children between the ages of 8 and 17 years worldwide are estimated to be in need of palliative care. These children and their parents are at substantial risk for suffering and long-term morbidity. Pediatric palliative care interventions have primarily focused on children with cancer, despite children with cancer only representing 30 to 40% of patients receiving pediatric palliative care services. Despite parents preferring that children with serious illnesses die at home, nearly two-thirds of children die in hospital or care facilities. The need for home-based end-of-life and palliative care is critical for this vulnerable population, yet interventions offered in home settings are significantly lacking. Risks are magnified by substantial gaps in access to palliative care for rural populations. Challenges to care for rural-dwelling children with serious illnesses and their caregivers include lack of pediatric-focused local healthcare resources; need to move residence; disruption to family life; missed school; financial burdens from missed work and costs associated with food, gas, and housing; and a lack of communication between urban and rural healthcare providers. Thus, the burden for children with serious illnesses and their parents may be greater for those living in rural versus urban communities.

Legacy-making (i.e., actions/behaviors aimed at being remembered) is one strategy to help decrease suffering and improve psychosocial outcomes for individuals with serious illness and end of life needs. Storytelling has successfully documented child legacies and may be an ideal format for children. Our interdisciplinary team, rooted in nursing's unique perspective, has successfully developed and tested a digital storytelling intervention in pediatric oncology. Parents reported that the intervention facilitated "conversations with [ill child] that I otherwise wouldn't have had." One parent said, "This project was really a neat way for [ill child] to express himself…. He loved picking out photos and thinking about his favorites…. we worked together, and it really did create a bond." Research in this field has yet to expand outside of oncology or to rural settings, and we have significantly modified our existing digital storytelling intervention based on parent input to further increase its effect. In the proposed project, guided by our conceptual framework based on our previous work and existing theory, our goal is to expand to non-cancer pediatric patients and determine the feasibility of our newly adapted intervention for rural-dwelling children with diverse serious, advanced conditions and their parents.

Objective/Hypothesis: The overall purpose of this study is to test the feasibility of a web-based storytelling intervention for rural-dwelling children (ages 8-17) with serious advanced illnesses.

Specific aims are to: (1) determine feasibility and acceptability of a digital storytelling intervention for rural-dwelling children with serious illness; (2) determine the feasibility of data collection procedures, and (3) determine child and parent perceptions of the benefits of storytelling.

Study Design: One group pre- and post-test clinical trial design will be used. A total of 30 children with any progressively declining (acute or chronic) life-threatening diagnosis per parent report (aged 8 to 17) and their primary parent caregivers will be recruited via Facebook (N=30 dyads; 60 total participants). Dyads will participate in a nurse-delivered intervention that will guide children to create electronic digital storyboards about themselves during 6 sessions over 6 weeks. A trained nurse will deliver sessions averaging 1 hour each via Zoom. Dyads will receive a final digital story that plays in a cinematic format. Participants will be asked to complete baseline and post-intervention measures, attempting to assess following outcome variables: (a) child psychological distress, (b) parent psychological distress, (c) parent-child communication, (d) family relationships, and (e) program satisfaction.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

for Children:

  • any progressively declining (acute or chronic) life-threatening diagnosis per parent report
  • living in a rural area based on the Federal Office of Rural Health Policy criteria (https://www.hrsa.gov/rural-health/about-us/definition/datafiles.html)
  • speak and understand English

Inclusion criteria

for Parents:

  • 18 years of age and older
  • child's primary parent caregiver
  • speak and understand English
  • living in a rural area based on the Federal Office of Rural Health Policy criteria (https://www.hrsa.gov/rural-health/about-us/definition/datafiles.html)

Exclusion criteria

  • currently live outside of the United States or live in a non-rural area
  • have any cognitive impairment(s) per parent report
  • do not have internet access and/or electronic devices (e.g., laptop, desktop computer, mobile phone, tablet PC) required for the study participation

Treatment and study plan

Web-based legacy-making intervention through digital storytelling

Other

A child-parent dyad will participate in a nurse-delivered intervention that will guide children to create electronic digital storyboards about themselves during 6 sessions over 6 weeks.

Primary outcomes

  1. Change in PROMIS Pediatric Psychological Distress - Short Form

    Time frame: Day 0, Day 43

    A 8-item 5-point Likert scale measure ranging from 1 (never) to 5 (always) to assess children's psychological distress.

  2. Change in PROMIS Pediatric Anxiety - Short Form

    Time frame: Day 0, Day 43

    A 8-item 5-point Likert scale measure ranging from 1 (never) to 5 (almost always) to assess children's anxiety.

  3. Change in PROMIS Pediatric Depressive Symptom - Short Form

    Time frame: Day 0, Day 43

    A 8-item 5-point Likert scale measure ranging from 1 (never) to 5 (almost always) to assess children's depressive symptoms.

  4. Change in PROMIS Pediatric Meaning and Purpose - Short Form

    Time frame: Day 0, Day 43

    A 8-item 5-point Likert scale measure ranging from 1 (not at all) to 5 (very much) to assess children's perception of meaning and purpose of life.

  5. Change in NIH Toolbox Perceived Stress Survey

    Time frame: Day 0, Day 43

    A 10-item 5-point Likert scale measure ranging from 1 (never) to 5 (very often) to assess parents' perceived stress in the past month.

  6. Change in PROMIS Anxiety - Short Form

    Time frame: Day 0, Day 43

    A 8-item 5-point Likert scale measure ranging from 1 (never) to 5 (always) to assess parents' anxiety.

  7. Change in PROMIS Depression- Short Form

    Time frame: Day 0, Day 43

    A 8-item 5-point Likert scale measure ranging from 1 (never) to 5 (always) to assess parents' depression.

  8. Change in PROMIS Meaning and Purpose - Short Form

    Time frame: Day 0, Day 43

    A 8-item 5-point Likert scale measure ranging from 1 (strongly disagree) to 5 (strongly agree) to assess parents' perception of meaning and purpose of life.

  9. Change in Parent-Adolescent Communication Scale

    Time frame: Day 0, Day 43

    A 20-item 5-point Likert scale measure ranging from 1 (strongly disagree) to 5 (strongly agree) to assess quality of parent-adolescent communication.

  10. Change in PROMIS Pediatric Family Relationships - Short Form

    Time frame: Day 0, Day 43

    A 8-item 5-point Likert scale measure ranging from 1 (never) to 5 (always) to assess children's perception of family relationships.

  11. Satisfaction Survey

    Time frame: Day 43

    A 16-item survey to assess participants' satisfaction of the intervention program. Ten 7-point Likert scale items assess satisfaction, and 6 items assess perceived benefits of the intervention.

Sponsors and collaborators

Lead sponsor

Vanderbilt University

Other

Collaborators

  • Rita & Alex Hillman Foundation

Registry information

Official study title

Web-based Digital-storytelling Intervention for Rural-dwelling Children With Life-threatening Conditions

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 11, 2020
Registry last updated
Feb 27, 2023

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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