Clinical trial NCT04198038: Family-Centered Songwriting in Pediatric Palliative Care
Official title: A Pilot Study to Evaluate the Feasibility of Family-Centered Songwriting in Pediatric Palliative Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Impairment
Keywords: palliative care
pediatrics
music therapy
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
First posted: 2019-12-13
Enrollment: 25
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study evaluates the feasibility and efficacy of a family-centered songwriting intervention for cognitively-impaired children referred to a palliative care service.

Detailed description: Music-based interventions have previously been shown to reduce psychological distress in children with life-threatening conditions. However, children with cognitive impairment are frequently excluded from these studies. Our study will evaluate the efficacy a family-centered songwriting intervention for the following outcomes: child psychological and physical symptoms, parent psychological distress, and family environment.

Following recruitment, parent-child dyads will undergo 4 sessions with a licensed music therapist (anticipated to last 1 hour each). During these sessions, families and their children will select a song and engage in a songwriting process which includes various physiologic sounds from the child (i.e. heart rate, breathing). At the conclusion of these four sessions, a music DVD will be produced and delivered to the family.

Eligibility criteria: Inclusion Criteria:

* children ages 7-17 years
* cognitive impairment (T-score of 40 or below on the PROMIS Parent-Proxy Cognitive Function)
* receiving palliative/complex care
* progressively declining disease
* ability to hear.
* parents 18 years of age and older
* parent without cognitive impairment
* parent able to speak/understand English

Exclusion Criteria:

- None

Primary outcomes:
measure: Intervention feasibility and recruitment log
timeFrame: throughout study completion, an average of 1 year
Secondary outcomes:
measure: Parent Proxy Sleep Disturbance Short Form
timeFrame: Will be obtained at Time 1 (baseline, at recruitment) and at Time 2 (at completion of intervention, estimated at 3-4weeks following baseline)
measure: Parent Proxy Physical Stress Experiences
timeFrame: Will be obtained at Time 1 (baseline, at recruitment) and at Time 2 (at completion of intervention, estimated at 3-4weeks following baseline)
measure: Parent Proxy Psychological Stress Experiences
timeFrame: Will be obtained at Time 1 (baseline, at recruitment) and at Time 2 (at completion of intervention, estimated at 3-4weeks following baseline)
measure: Parent Proxy Anxiety
timeFrame: Will be obtained at Time 1 (baseline, at recruitment) and at Time 2 (at completion of intervention, estimated at 3-4weeks following baseline)
measure: Parent Proxy Depressive Symptoms
timeFrame: Will be obtained at Time 1 (baseline, at recruitment) and at Time 2 (at completion of intervention, estimated at 3-4weeks following baseline)
measure: Family Relationships
timeFrame: Will be obtained at Time 1 (baseline, at recruitment) and at Time 2 (at completion of intervention, estimated at 3-4weeks following baseline)
measure: Parent Anxiety
timeFrame: Will be obtained at Time 1 (baseline, at recruitment), at Time 2 (at completion of intervention, estimated at 3-4weeks following baseline), and at Time 3 (one month following death of child, if death of child occurs during study period.)
measure: Parent Sleep Disturbance
timeFrame: Will be obtained at Time 1 (baseline, at recruitment), at Time 2 (at completion of intervention, estimated at 3-4weeks following baseline), and at Time 3 (one month following death of child, if death of child occurs during study period.)
measure: Parental Perceived Stress (NIH Toolbox)
timeFrame: Will be obtained at Time 1 (baseline, at recruitment), at Time 2 (at completion of intervention, estimated at 3-4weeks following baseline), and at Time 3 (one month following death of child, if death of child occurs during study period.)
measure: Parent Satisfaction
timeFrame: Will be obtained at Time 2 (at completion of intervention, estimated at 3-4weeks following baseline), and at Time 3 (one month following death of child, if death of child occurs during study period.)
measure: Change in cortisol levels
timeFrame: Before and after each songwriting intervention session throughout study completion, an average of 1 year
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Monroe Carell, Jr. Children's Hospital at Vanderbilt
state: Tennessee
Study officials:
affiliation: Vanderbilt University
name: Terrah Akard, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References: