NCT04400071

Biology and Benefits of Music Play and Stories for Kids/Parents During ALL Treatment

Biologic Mechanisms and Dosing of Active Music Engagement in Children With Acute Lymphoblastic Leukemia and Parents

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 192 (actual)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: 3 Years – 8 Years
• Healthy volunteers: Not accepted

Summary

Music therapy has become a standard palliative care service in many pediatric and adult hospitals; however, a majority of music therapy research has focused on the use of music to improve psychosocial dimensions of health, without considering biological dimensions. This study builds on prior work examining the psychosocial mechanisms of action underlying an Active Music Engagement (AME) intervention, designed to help manage emotional distress and improve positive health outcomes in young children with cancer and parents, by examining its effects on biomarkers of stress and immune function. The purposes of this two group, randomized controlled trial are to examine biological mechanisms of effect and dose-response relationships of AME on child/parent stress during the consolidation phase of Acute Lymphoblastic Leukemia (ALL) treatment. Specific aims are to: Aim 1. Establish whether AME lowers child and parent cortisol during ALL treatment. Aim 2. Examine cortisol as a mediator of AME effects on child and parent outcomes during ALL treatment. Aim 3 (exploratory). Examine the dose-response relationship of AME on child and parent cortisol during ALL treatment. Findings will provide a more holistic understanding about how active music interventions work to mitigate cancer-related stress and its potential to improve immune function, with direct implications for the evidence-based use of music to improve health.

Detailed description

Music therapy has become a standard palliative care service in many pediatric and adult hospitals. However, a majority of music therapy research has focused on the use of music to improve psychosocial dimensions of health, without considering biological dimensions. In addition, few studies have examined dose-response relationships. Cancer treatment is an inherently stressful experience, and a significant number of young children and parents (caregivers) experience persistent, interrelated emotional distress and poor quality of life. Many parents also experience traumatic stress symptoms because of their child's cancer diagnosis and treatment. The investigators previously tested an Active Music Engagement (AME) intervention that uses active music play to diminish stressful attributes of cancer treatment to help manage emotional/traumatic distress experienced by young children (ages 3-8) and parents and improve quality of life. A recent AME trial is examining psychosocial mechanisms of action responsible for change in child/parent outcomes. The current study expands on this work by examining AME's effects on several biomarkers to provide a more holistic understanding about how active music interventions work to mitigate cancer-related stress and its potential to improve immune function. The purposes of this two group, randomized controlled trial are to examine biological mechanisms of effect and dose-response relationships of AME on child/parent stress during the consolidation phase of Acute Lymphoblastic Leukemia (ALL) treatment. Specific aims are to: 1) establish whether AME lowers child and parent cortisol, 2) examine cortisol as a mediator of AME effects on child and parent outcomes, and 3) examine the dose-response relationship of AME on child and parent cortisol. Child/parent dyads (n=250) will be stratified (by age, site, ALL risk level) and randomized in blocks of four to AME or attention control. Each group will receive one 45-minute session during weekly clinic visits for the duration of ALL consolidation (4 weeks standard risk; 8 weeks high risk). Parents will complete measures at baseline and following the last study session. Child and parent salivary cortisol samples will be taken pre and post-session for the first 4 AME or attention control sessions. Child blood samples will be reserved from routine blood draws prior to sessions 1 and 4 (all participants) and session 8 (high risk participants). Linear mixed models will be used to estimate AME's effect on child and parent cortisol. Examining child and parent cortisol as mediators of AME effects on child and parent outcomes will be performed in an ANCOVA setting, fitting the appropriate mediation models using MPlus and then testing indirect effects using the percentile bootstrap approach to estimate the indirect effect. Graphical plots and non-linear repeated measures models will be used to examine the dose-response relationship of AME on child and parent cortisol.

Conditions

• Acute Lymphoblastic Leukemia, Pediatric
• Pediatric Cancer

Interventions

Type	Name	Description
BEHAVIORAL	Active Music Engagement	Weekly 45-minute sessions with a board-certified music therapist delivered during weekly clinic visits for the consolidation phase of ALL treatment. Children with standard risk ALL will receive 4 sessions over 4 weeks. Children with high risk ALL will receive 8 sessions over 8 weeks. Sessions are delivered in a private setting during regularly scheduled clinic appointments. During the first visit, parent and child will receive information on how they can use music play activities to help manage distress 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 subsequent visits the music therapist will lead parent and child through the music play activities, answer questions, and make suggestions for using these activities in the hospital and at home.
BEHAVIORAL	Audio Storybooks	Weekly 45-minute sessions with a trained provider delivered during weekly clinic visits for the consolidation phase of ALL treatment. Children with standard risk ALL will receive 4 sessions over 4 weeks. Children with high risk ALL will receive 8 sessions over 8 weeks. Sessions are delivered in a private setting during regularly scheduled clinic appointments. Each session children/parents will choose and listen to one of three illustrated children's books with audio-recorded narration.

Timeline

• Start date: 2020-08-07
• Primary completion: 2025-04-11
• Completion: 2025-04-11
• First posted: 2020-05-22
• Last updated: 2025-06-26

Locations

4 sites across 1 country: United States