Digital-storytelling Intervention for Rural-dwelling Children

NCT04665479 | Completed

• 1 other identifier: 123456
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pediatrics

Keywords

Pediatric Palliative Care; Digital Storytelling

Outcome Measures

Primary Outcomes (11)

• Change in PROMIS Pediatric Psychological Distress - Short Form

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

  Day 0, Day 43

• Change in PROMIS Pediatric Anxiety - Short Form

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

  Day 0, Day 43

• Change in PROMIS Pediatric Depressive Symptom - Short Form

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

  Day 0, Day 43

• Change in PROMIS Pediatric Meaning and Purpose - Short Form

  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.

  Day 0, Day 43

• Change in NIH Toolbox Perceived Stress Survey

  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.

  Day 0, Day 43

• Change in PROMIS Anxiety - Short Form

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

  Day 0, Day 43

• Change in PROMIS Depression- Short Form

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

  Day 0, Day 43

• Change in PROMIS Meaning and Purpose - Short Form

  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.

  Day 0, Day 43

• Change in Parent-Adolescent Communication Scale

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

  Day 0, Day 43

• Change in PROMIS Pediatric Family Relationships - Short Form

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

  Day 0, Day 43

• Satisfaction Survey

  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.

  Day 43

Study Arms (1)

Intervention group

EXPERIMENTAL

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 as a dyad. 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.

Other: Web-based legacy-making intervention through digital storytelling

Interventions

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.

Intervention group

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University: lead
• Rita & Alex Hillman Foundation: collaborator

Study Sites (1)

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232, United States

Location

Study Officials

• Terrah Akard, PhD

  Vanderbilt University School of Nursing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: One group pre- and post-test clinical trial design

Study Record Dates

• First Submitted: October 22, 2020
• First Posted: December 11, 2020
• Study Start: February 12, 2021
• Primary Completion: June 30, 2022
• Study Completion: December 31, 2022
• Last Updated: February 27, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data will be available for sharing no later than the publication date of the main results from the final dataset. Data will be disclosed without a specific deadline.
• Access Criteria: The data will be shared with anyone who is interested in this study. We especially seek to make our data available to the community of scientists interested in pediatric palliative care, specifically related to rural-dwelling children with life-threatening conditions and their parents.

Locations

US (1)