Family-Centered Songwriting in Pediatric Palliative Care

Not Applicable

Completed

• Conditions: Cognitive Impairment
• Interventions: Behavioral: Songwriting with licensed music therapist

• Registration Number: NCT04198038
• Lead Sponsor: Vanderbilt University

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.

Study Timeline

• Study First Submitted: 2019-12-05
• Study First Submitted QC: 2019-12-11
• Study First Posted: 2019-12-13
• Study Start: 2020-03-11
• Primary Completion: 2021-06-30
• Study Completion: 2021-06-30
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-09
• Last Update Posted: 2021-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

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Exclusion Criteria

• None

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
cognitively impaired children	Songwriting with licensed music therapist	This is a single-group study; all participants will be offered the songwriting intervention.

Primary Outcome Measures

Name	Time	Method
Intervention feasibility and recruitment log	throughout study completion, an average of 1 year	Number of enrolled participants who complete all phases of study

Secondary Outcome Measures

Name	Time	Method
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 measures of pediatric physical stress. Includes eight Likert-scale questions. Scores range from 1 to 5; high scores indicate greater burden of physical stress experiences while low scores indicate lower likelihood of physical stress experiences.
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 measures of pediatric anxiety. Includes eight Likert-scale questions with scores ranging from 1 to 5. High scores indicate more frequent child anxiety symptoms while low scores indicate less frequent child anxiety symptoms.
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 measures of pediatric sleep disturbance. Scores range from 1 to 5; high scores indicate presence of disordered sleep symptoms, while low scores indicate absence of disordered sleep symptoms.
Parent Anxiety	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 of parental anxiety symptoms. Includes eight Likert-scale questions with scores ranging from 1 to 5. Higher scores indicate elevation in parental anxiety while lower scores indicate lower levels of parental anxiety.
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)	Parent-proxy measures of pediatric depressive symptoms. Includes six Likert-scale questions with scores ranging from 1-5. High scores indicate more frequent symptoms of pediatric depression, low scores indicate less frequent pediatric depressive symptoms.
Parent Sleep Disturbance	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 of parental sleep disturbance. Includes four Likert-scale questions which range from 1 to 5. High scores indicate higher levels of disordered sleep while low scores indicate lower levels of disordered sleep.
Change in cortisol levels	Before and after each songwriting intervention session throughout study completion, an average of 1 year	Salivary cortisol obtained from parent and child buccal swabs.
Parental Perceived Stress (NIH Toolbox)	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 of parental perception of stress. Includes ten Likert-scale questions with scores ranging from 1 to 5. Higher scores indicate greater levels of parental perceived stress, while lower scores indicate lower levels of parental perceived stress.
Parent Satisfaction	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.)	Parents report satisfaction with songwriting intervention with qualitative responses.
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 measures of pediatric psychological stress. Includes eight questions; scores range from 1 to five; high scores indicate higher level of psychological stress while low scores indicate lower levels of psychological stress.
Family Relationships	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 measures of family relationships symptoms. Includes eight Likert-scale questions which ranges from 1 to 5. High scores indicate higher family functioning and bonding while low scores indicate lower levels of family functioning and bonding.

Trial Locations

Locations (1)

Monroe Carell, Jr. Children's Hospital at Vanderbilt; 🇺🇸 Nashville, Tennessee, United States