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Completed

NCT Number: NCT04198038

Family-Centered Songwriting in Pediatric Palliative Care

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

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Key information

Conditions

Cognitive Impairment Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders

Age range

7 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Monroe Carell, Jr. Children's Hospital at Vanderbilt

Nashville, Tennessee, 37212, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Songwriting with licensed music therapist

Behavioral

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

Primary outcomes

  1. Intervention feasibility and recruitment log

    Time frame: throughout study completion, an average of 1 year

    Number of enrolled participants who complete all phases of study

Secondary outcomes

  1. Parent Proxy Sleep Disturbance Short Form

    Time frame: 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.

  2. Parent Proxy Physical Stress Experiences

    Time frame: 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.

  3. Parent Proxy Psychological Stress Experiences

    Time frame: 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.

  4. Parent Proxy Anxiety

    Time frame: 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.

  5. Parent Proxy Depressive Symptoms

    Time frame: 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.

  6. Family Relationships

    Time frame: 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.

  7. Parent Anxiety

    Time frame: 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.

  8. Parent Sleep Disturbance

    Time frame: 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.

  9. Parental Perceived Stress (NIH Toolbox)

    Time frame: 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.

  10. Parent Satisfaction

    Time frame: 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.

  11. Change in cortisol levels

    Time frame: Before and after each songwriting intervention session throughout study completion, an average of 1 year

    Salivary cortisol obtained from parent and child buccal swabs.

Sponsors and collaborators

Lead sponsor

Vanderbilt University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 13, 2019
Registry last updated
Sep 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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