PediatricsNCT04665479
Digital-storytelling Intervention for Rural-dwelling Children
A study testing Web-based legacy-making intervention through digital storytelling in people with Pediatrics, run by Vanderbilt University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Pediatrics
- What is being tested?
- Web-based legacy-making intervention through digital storytelling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Feb 2021to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232
About this study
Official title: Web-based Digital-storytelling Intervention for Rural-dwelling Children With Life-threatening Conditions
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.
Read the detailed description
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.
- Conditions
- Pediatrics
- Being tested
- Web-based legacy-making intervention through digital storytelling
- Keywords
- Pediatric Palliative Care, Digital Storytelling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-based legacy-making intervention through digital storytellingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Web-based legacy-making intervention through digital storytelling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 43
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2020
- Study start12 Feb 2021
- Primary completion30 Jun 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PediatricsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- One group pre- and post-test clinical trial design
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Collaborators
- Rita & Alex Hillman Foundation
- Responsible party
- Principal investigator, Terrah Akard, Vanderbilt University
- Investigators
- Terrah Akard, PhD, Principal investigator, Vanderbilt University School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04665479
- Sponsor's protocol ID
- 123456
- Status last verified
- Feb 2023
- First submitted
- 22 Oct 2020
- Last updated
- 27 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: There are no tangible resources to share at this time as the intervention is in testing phases. We plan to make the intervention available for sharing in the future, upon completed testing. Therefore, data is the only resource available for sharing. The proposed research will produce data with 30 rural-dwelling children with serious health conditions-parent dyads. The final data set will contain demographic information and children/parent responses on psychological distress, family relationship, and communication.
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Web-based Digital-storytelling Intervention for Rural-dwelling Children With Life-threatening Conditions
- ClinicalTrials.gov ID
- NCT04665479
- Acronym / sponsor ID
- 123456
- Conditions
- Pediatrics
- Keywords
- Pediatric Palliative Care, Digital Storytelling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Collaborators
- Rita & Alex Hillman Foundation
- Study start
- 12 Feb 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 11 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- One group pre- and post-test clinical trial design
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Web-based legacy-making intervention through digital storytellingA 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. |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
- 18 years of age and older
- child's primary parent caregiver
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Web-based legacy-making intervention through digital storytellingA 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. | Other | Intervention group |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2023.
- Individual participant dataSharing planned: Yes. There are no tangible resources to share at this time as the intervention is in testing phases. We plan to make the intervention available for sharing in the future, upon completed testing. Therefore, data is the only resource available for sharing. The proposed research will produce data with 30 rural-dwelling children with serious health conditions-parent dyads. The final data set will contain demographic information and children/parent responses on psychological distress, family relationship, and communication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Terrah Akard, PhD principal investigator
Vanderbilt University School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Web-based legacy-making intervention through digital storytelling in people with Pediatrics, run by Vanderbilt University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in PROMIS Pediatric Psychological Distress - Short Form (time frame: Day 0, Day 43). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2023.