Description:
Music therapy, a frequently used arts-based therapy, has become standard palliative care in
many pediatric and adult hospitals; however, few studies have examined the mechanisms by
which music therapy interventions work. This study investigates behavioral, social, and
psychological factors that may explain how an Active Music Engagement (AME) intervention
(i.e., an interactive, music-based play intervention) works to manage emotional distress and
improve positive health outcomes in parents and young children with cancer during treatment.
Findings will provide scientific and clinically relevant practice knowledge to guide delivery
of music therapy as a complementary therapy.
Title
- Brief Title: Mechanisms of Active Music Engagement to Improve Health Outcomes of Children With Cancer and Parents
- Official Title: Mechanisms of Active Music Engagement to Improve Health Outcomes of Children With Cancer and Parents
Clinical Trial IDs
- ORG STUDY ID:
R01NR015789
- NCT ID:
NCT03085927
Conditions
Purpose
Music therapy, a frequently used arts-based therapy, has become standard palliative care in
many pediatric and adult hospitals; however, few studies have examined the mechanisms by
which music therapy interventions work. This study investigates behavioral, social, and
psychological factors that may explain how an Active Music Engagement (AME) intervention
(i.e., an interactive, music-based play intervention) works to manage emotional distress and
improve positive health outcomes in parents and young children with cancer during treatment.
Findings will provide scientific and clinically relevant practice knowledge to guide delivery
of music therapy as a complementary therapy.
Detailed Description
Music therapy, a frequently used arts-based therapy, has become standard palliative care in
many pediatric and adult hospitals; however, few studies have examined mechanisms by which
music therapy interventions work.Based on the Contextual Support Model of Music Therapy, the
investigators developed and tested the Active Music Engagement (AME) intervention,
establishing it as a feasible and acceptable intervention that reduces emotional distress in
young children (ages 3-8) hospitalized for cancer treatment.Emotional distress in young
children with cancer during acute treatment and their parents is a prevalent,persistent
problem associated with physical symptom distress and diminished quality of life and family
function. The music therapist-led AME uses music-based play and parent education/support
(music play resource kit; tip sheets), is easy to implement, and teaches parents/children how
to therapeutically use a familiar activity to manage distress. The purpose of this two group
randomized controlled trial is to identify behavioral, sociological, and psychological
variables contributing to positive outcomes observed in previous AME studies (i.e.,
mediators) and identify for whom the intervention works (i.e., moderators). The investigators
will examine proximal mediators of child engagement and parent-child interaction and distal
mediators of perceived family normalcy, parent confidence (self-efficacy) about their ability
to support their child during treatment, and independent parent/child use of music and play
activities to manage distress during hospitalization. The investigators hypothesize these
factors mediate change in outcomes of child emotional distress, physical symptom distress,
and quality of life; parent emotional/traumatic distress and quality of life; and family
function. Specific aims are to examine: 1) effects of proximal and distal mediators of AME on
young child/parent outcomes; 2) moderators of AME on young child/parent distress; 3) explore
child physical symptom distress (pain, fatigue, nausea) in mediation and moderation models.
Child/parent dyads (n=184) will be stratified by age and randomized in blocks of 6 to AME or
audio-storybooks; each group will receive three 45-minute sessions with a credentialed music
therapist for 3 consecutive days with data collection at baseline, post-intervention, and 30
days later. Mediation effects will be estimated using ANCOVA, fitting appropriate mediation
models using MPlus and then testing indirect effects using the percentile bootstrap approach
to estimate indirect effect. Moderation effects will be tested by including appropriate
interaction terms of the potential moderator with the intervention indicator in our models.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| Arm 1-Active Music Engagement | Experimental | Three 45-minute sessions with a board-certified music therapist delivered over three days. Sessions are delivered in a private setting during in-patient hospitalization. During the first visit, parent and child will receive information on common responses of young children to cancer treatment and how parents can use music play activities to support their child during treatment. The music therapist will lead parent and child in a variety of music play activities. Parent and child will receive a music kit that includes items such as hand-held rhythm instruments, puppets, and a music CD. During the second and third visit the music therapist will lead parent and child child through the music play activities, answer questions, and make suggestions for using these activities in the hospital and at home. | |
| Arm II- Audio-Storybooks | Experimental | Three 45-minute sessions with a board-certified music therapist delivered over three days. Sessions are delivered in a private setting during in-patient hospitalization. Each session children/parents will choose and listen to one of three illustrated children's books with audio recorded narration. | |
Eligibility Criteria
Inclusion Criteria (Child/Parent):
- Children ages 3-8 years inclusive.
- Expected treatment course for at least 3 days to receive chemotherapy.
- A consistent parent who can be present for all sessions.
Exclusion Criteria (Child/Parent):
- Child and/or parent do not speak English.
- Child has a significant cognitive impairment that hinders participation (based on
physician judgment).
| Maximum Eligible Age: | 8 Years |
| Minimum Eligible Age: | 3 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Child and Parent prior distress with hospitalization measured by Prior Illness Experiences Scale (PIES) |
| Time Frame: | Up to 30 days |
| Safety Issue: | |
| Description: | |
Details
| Phase: | N/A |
| Primary Purpose: | Interventional |
| Overall Status: | Completed |
| Lead Sponsor: | Indiana University |
Trial Keywords
- music therapy
- neoplasms
- play
- children
- parents
Last Updated
April 14, 2020
