Cognitive Impairment
Conditions
Keywords
palliative care, pediatrics, music therapy
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.
Interventions
BEHAVIORALSongwriting with licensed music therapist
Song selected by parent-child dyad with recordings of physiologic components (i.e. heartbeat, breathing)
Sponsors
Vanderbilt University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
7 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intervention feasibility and recruitment log | throughout study completion, an average of 1 year | Number of enrolled participants who complete all phases of study |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
| 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 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. |
| 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. |
| 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 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. |
| 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. |
| 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. |
| 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. |
Countries
United States
Outcome results
None listed