Feasibility Study of the Storytelling Through Music Intervention with Bereaved Parents

NCT06047808 | Completed

• 1 other identifier: STUDY00004111
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

The death of a child, at any age, is considered one of the most stressful life events a person can experience. In 2020, 11,050 children (under 15 years), 5,000 adolescents (15-19 years) and 60,000 young adults (20-39 years) were estimated to be diagnosed with cancer in the US. While the five-year survival is better for children than adults, over 10,000 children, adolescents, and young adults die from cancer in the US each year.1 Bereaved parents often experience intense and lasting psychological distress resulting in significantly higher morbidity and mortality compared to non-bereaved parents. Twenty-five percent of bereaved parents report new diagnoses of illnesses including prediabetes, anxiety and sleep disorders. Bereaved parents also experience psychological distress such as anxiety, post-traumatic stress disorder, and grief-related depressive symptoms that continue to be significant for years after a child's death. A recent study showed that nearly 33% of bereaved parents suffered from prolonged grief five years after their loss.6 Physiologically, studies show increased cortisol, immune, endocrine, and cardio biomarkers in people with prolonged grief. The death of a child can also affect family and social relationships resulting in decreased communication, feelings of isolation, absence of close social relationships and increased marital strain and divorce. The purpose of this randomized controlled pilot study is to evaluate the feasibility of implementing a six-week multi-dimensional intervention, Storytelling Through Music (STM), with parents of children who have died from cancer. STM combines multiple modalities of expression (storytelling, writing, and music) to facilitate loss- and restoration-oriented coping by creating a legacy piece (self-written story paired with song) to facilitate continuing bonds with the deceased and find meaning.

Conditions

Pediatric Cancer; Grief; Well-Being, Psychological; Coping Strategies; Bereavement

Outcome Measures

Primary Outcomes (3)

• Study Feasibility

  Feasibility will be evaluated by tracking the percentage of participants screened and enrolled. The study will be deemed feasible with a 60% enrollment rate.

  Immediately post-intervention (6 weeks)

• Intervention Feasibility

  Feasibility will be evaluated by tracking the average number of sessions the participants complete. This intervention will be deemed feasible if 85% of the intervention is completed.

  Immediately post-intervention (6 weeks)

• Intervention Acceptability

  An additional primary endpoint is acceptability. Acceptability will be evaluated with semi-structured interview questions to understand the participant's perception of intervention delivery and content, as well as the perceived impact.

  Immediately post-intervention (6 weeks)

Secondary Outcomes (9)

• Mean Change from Baseline in Anxiety Scores at 6 weeks and 10 weeks

  Immediately post-intervention and 1-month post-intervention

• Mean Change from Baseline in Depression Scores at 6 weeks and 10 weeks

  Immediately post-intervention and 1-month post-intervention

• Mean Change from Baseline in Quality of Life Scores at 6 weeks and 10 weeks

  Immediately post-intervention and 1-month post-intervention

• Mean Change from Baseline in Sleep Disturbance Scores at 6 weeks and 10 weeks

  Immediately post-intervention and 1-month post-intervention

• Mean Change from Baseline in Loneliness Scores at 6 weeks and 10 weeks

  Immediately post-intervention and 1-month post-intervention

Study Arms (2)

Storytelling Through Music

EXPERIMENTAL

Participants will be randomized to either the "Storytelling Through Music" (STM) experimental arm or the waitlist control arm. STM is a six-week intervention that utilizes storytelling, reflective writing, self-care skills (i.e., breathing exercises, meditation, self-compassion, body scans), and songwriting. The intervention is delivered online and in a group setting. Online delivery provides convenience to participants, and the group setting provides an environment of people with shared experiences, which has been shown to decrease social isolation and feelings of being alone in their emotional experience. By the end of the intervention, participants will have written a short story and a song based on their story.

Behavioral: Storytelling Through Music

Waitlist Control

NO INTERVENTION

Participants will receive the same "Storytelling Through Music" intervention once data collection from the experimental arm is complete.

Interventions

Storytelling Through Music BEHAVIORAL

"Storytelling Through Music" is a six-week expressive arts intervention.

Storytelling Through Music

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>18 years old
• able to read and speak English
• bereaved parent of a child who died from cancer (ages\<39 years)
• child's death \>6 months and \<5 years before study initiation
• access to the internet and computer.

You may not qualify if:

• do not have the technological requirements for Zoom interviews and REDCap surveys.

Sponsors & Collaborators

• University of Texas at Austin: lead

Study Sites (1)

University of Texas at Austin

Austin, Texas, 78712, United States

Location

MeSH Terms

Conditions

Neoplasms; Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Study Officials

• Carolyn Phillips, PhD

  University of Texas at Austin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 6, 2023
• First Posted: September 21, 2023
• Study Start: May 1, 2023
• Primary Completion: July 30, 2024
• Study Completion: July 30, 2024
• Last Updated: March 13, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)