Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia, Pediatric | Childhood Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
| Pediatric Cancer | Childhood Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Active Music Engagement | Behavioral | — | UNRESOLVED |
| Audio Storybooks | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Active Music Engagement
- description
- See intervention description.
- interventionNames
- Behavioral: Active Music Engagement
- type
- ACTIVE_COMPARATOR
- label
- Audio Storybooks
- description
- See intervention description.
- interventionNames
- Behavioral: Audio Storybooks
Primary outcomes (7)
- measure
- Change in Child and Parent Stress (Salivary Cortisol)
- timeFrame
- Pre/Post-Sessions 1, 2, 3, and 4 (each session is 7 days apart; each session has a 45 min. duration).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 3 Years
- Maximum age
- 8 Years
Show eligibility criteria text
Inclusion Criteria: * Child is 3 - 8 years of age at time of enrollment * Child has diagnosis of standard or high risk B- or T-cell acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LyLy) * Child is currently receiving induction therapy * One parent (\>18 years of age) can be present for all sessions. Exclusion Criteria: * Child has Ph+ ALL, * Child has Cushing disease, * Child is taking steroid medication for asthma and/or has asthma that is not well controlled, * The parent does not speak English, or * The child has a significant cognitive impairment that might hinder participation (determination made in consultation with attending physician, oncologist, and parents).
References
Publications (4)
- BACKGROUNDRobb SL, Clair AA, Watanabe M, Monahan PO, Azzouz F, Stouffer JW, Ebberts A, Darsie E, Whitmer C, Walker J, Nelson K, Hanson-Abromeit D, Lane D, Hannan A. A non-randomized [corrected] controlled trial of the active music engagement (AME) intervention on children with cancer. Psychooncology. 2008 Jul;17(7):699-708. doi: 10.1002/pon.1301. PMID 18033724
- BACKGROUNDRobb SL, Haase JE, Perkins SM, Haut PR, Henley AK, Knafl KA, Tong Y. Pilot Randomized Trial of Active Music Engagement Intervention Parent Delivery for Young Children With Cancer. J Pediatr Psychol. 2017 Mar 1;42(2):208-219. doi: 10.1093/jpepsy/jsw050. PMID 27289068
- BACKGROUNDRobb SL. The effect of therapeutic music interventions on the behavior of hospitalized children in isolation: developing a contextual support model of music therapy. J Music Ther. 2000 Summer;37(2):118-46. doi: 10.1093/jmt/37.2.118. PMID 10932125
- DERIVEDRobb SL, Russ KA, Holochwost SJ, Stegenga K, Perkins SM, Jacob SA, Henley AK, MacLean JA. Protocol and biomarker strategy for a multi-site randomized controlled trial examining biological mechanisms and dosing of active music engagement in children with acute lymphoblastic leukemia and lymphoma and parents. BMC Complement Med Ther. 2023 Mar 27;23(1):90. doi: 10.1186/s12906-023-03909-w. PMID 36973774