Family-Centered Songwriting in Pediatric Palliative Care

Cognitive Impairment Clinical Trial

Official title:

A Pilot Study to Evaluate the Feasibility of Family-Centered Songwriting in Pediatric Palliative Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04198038
• Other study ID #: 191557
• Status: Completed
• Phase: N/A
• Start date: March 11, 2020
• Est. completion date: June 30, 2021

Study information

• Verified date: September 2021
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment

Intervention

Behavioral:
• Songwriting with licensed music therapist
Song selected by parent-child dyad with recordings of physiologic components (i.e. heartbeat, breathing)

Locations

Country	Name	City	State
United States	Monroe Carell, Jr. Children's Hospital at Vanderbilt	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intervention feasibility and recruitment log	Number of enrolled participants who complete all phases of study	throughout study completion, an average of 1 year
Secondary	Parent Proxy Sleep Disturbance Short Form	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.	Will be obtained at Time 1 (baseline, at recruitment) and at Time 2 (at completion of intervention, estimated at 3-4weeks following baseline)
Secondary	Parent Proxy Physical Stress Experiences	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.	Will be obtained at Time 1 (baseline, at recruitment) and at Time 2 (at completion of intervention, estimated at 3-4weeks following baseline)
Secondary	Parent Proxy Psychological Stress Experiences	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.	Will be obtained at Time 1 (baseline, at recruitment) and at Time 2 (at completion of intervention, estimated at 3-4weeks following baseline)
Secondary	Parent Proxy Anxiety	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.	Will be obtained at Time 1 (baseline, at recruitment) and at Time 2 (at completion of intervention, estimated at 3-4weeks following baseline)
Secondary	Parent Proxy Depressive Symptoms	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.	Will be obtained at Time 1 (baseline, at recruitment) and at Time 2 (at completion of intervention, estimated at 3-4weeks following baseline)
Secondary	Family Relationships	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.	Will be obtained at Time 1 (baseline, at recruitment) and at Time 2 (at completion of intervention, estimated at 3-4weeks following baseline)
Secondary	Parent Anxiety	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.	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.)
Secondary	Parent Sleep Disturbance	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.	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.)
Secondary	Parental Perceived Stress (NIH Toolbox)	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.	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.)
Secondary	Parent Satisfaction	Parents report satisfaction with songwriting intervention with qualitative responses.	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.)
Secondary	Change in cortisol levels	Salivary cortisol obtained from parent and child buccal swabs.	Before and after each songwriting intervention session throughout study completion, an average of 1 year