Family-Centered Songwriting in Pediatric Palliative Care

NCT04198038 | Completed

• 1 other identifier: 191557
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Impairment

Keywords

palliative care; pediatrics; music therapy

Outcome Measures

Primary Outcomes (1)

• Intervention feasibility and recruitment log

  Number of enrolled participants who complete all phases of study

  throughout study completion, an average of 1 year

Secondary Outcomes (11)

• Parent Proxy Sleep Disturbance Short Form

  Will be obtained at Time 1 (baseline, at recruitment) and at Time 2 (at completion of intervention, estimated at 3-4weeks following baseline)

• Parent Proxy Physical Stress Experiences

  Will be obtained at Time 1 (baseline, at recruitment) and at Time 2 (at completion of intervention, estimated at 3-4weeks following baseline)

• Parent Proxy Psychological Stress Experiences

  Will be obtained at Time 1 (baseline, at recruitment) and at Time 2 (at completion of intervention, estimated at 3-4weeks following baseline)

• Parent Proxy Anxiety

  Will be obtained at Time 1 (baseline, at recruitment) and at Time 2 (at completion of intervention, estimated at 3-4weeks following baseline)

• Parent Proxy Depressive Symptoms

  Will be obtained at Time 1 (baseline, at recruitment) and at Time 2 (at completion of intervention, estimated at 3-4weeks following baseline)

Study Arms (1)

cognitively impaired children

EXPERIMENTAL

This is a single-group study; all participants will be offered the songwriting intervention.

Behavioral: Songwriting with licensed music therapist

Interventions

Songwriting with licensed music therapist BEHAVIORAL

Song selected by parent-child dyad with recordings of physiologic components (i.e. heartbeat, breathing)

cognitively impaired children

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• \- None

Sponsors & Collaborators

• Vanderbilt University: lead

Study Sites (1)

Monroe Carell, Jr. Children's Hospital at Vanderbilt

Nashville, Tennessee, 37212, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Terrah Akard, PhD, RN

  Vanderbilt University

  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

Study Record Dates

• First Submitted: December 5, 2019
• First Posted: December 13, 2019
• Study Start: March 11, 2020
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: September 13, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)