Shifting perspectives and transformative change: Parent perspectives of an active music engagement intervention for themselves and their child with cancer.

BACKGROUND: Children with cancer (ages 3-8 years) and their parents experience significant, interrelated distress associated with cancer treatment. Active music engagement (AME) uses music-based play and shared music-making to mitigate this distress. To advance our understanding about how AME works and its essential features, we interviewed parents who received the AME intervention as part of a multi-site mechanistic trial. The purpose of this qualitative analysis was to describe parents' experiences of AME for themselves and their child and to better understand how the intervention worked to lower parent-child distress. PROCEDURE: We conducted a total of 43 interviews with parents/caregivers, and purposively analyzed all interviews from underrepresented groups based on race/ethnicity and parent role. We used thematic analysis and achieved thematic redundancy after analyzing 28 interviews. RESULTS: The following statement summarizes resulting themes: Music therapists skillfully use AME to create a safe and healthy space (Theme 1), where parents/children have transformative experiences (Theme 2) that lead to learning and enactment (Theme 3) of new skills that counteract suffering (Theme 4) through empowerment, connectedness, and sustained relief. CONCLUSIONS: This work elucidates how AME works to counteract stressful qualities of cancer treatment. As parents witnessed positive and transformative changes in their child, they experienced relief and reported shifts in their perspective about cancer treatment. This led to learning and use of music as a coping strategy that extended beyond therapist-led sessions. Accessible, music-based interventions, like AME, offer a developmentally appropriate and effective way to support parents and young children during treatment.

Pilot Randomized Trial of Active Music Engagement Intervention Parent Delivery for Young Children With Cancer.

Objectives: To examine the feasibility/acceptability of a parent-delivered Active Music Engagement (AME + P) intervention for young children with cancer and their parents. Secondary aim to explore changes in AME + P child emotional distress (facial affect) and parent emotional distress (mood; traumatic stress symptoms) relative to controls. Methods: A pilot two-group randomized trial was conducted with parents/children (ages 3-8 years) receiving AME + P ( n = 9) or attention control ( n = 7). Feasibility of parent delivery was assessed using a delivery checklist and child engagement; acceptability through parent interviews; preliminary outcomes at baseline, postintervention, 30 days postintervention. Results: Parent delivery was feasible, as they successfully delivered AME activities, but interviews indicated parent delivery was not acceptable to parents. Emotional distress was lower for AME + P children, but parents derived no benefit. Conclusions: Despite child benefit, findings do not support parent delivery of AME + P.

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.

BACKGROUND: Music therapy is a standard palliative care service in many pediatric and adult hospitals; however, most 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 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 (caregivers), by examining its effects on biomarkers of stress and immune function. METHODS: This two-group randomized controlled trial (R01NR019190) is designed to examine biological mechanisms of effect and dose-response relationships of AME on child/parent stress during the consolidation phase of Acute B- or T-cell Lymphoblastic Leukemia (ALL) and T-cell Lymphoblastic Lymphoma (TLyLy) treatment. Child/parent dyads (n = 228) are stratified (by age, site, risk level) and randomized in blocks of four to the AME or attention control condition. Each group receives one session (30-minutes AME; 20-minutes control) during weekly clinic visits (4 weeks standard risk B-cell ALL; 8 weeks high risk B-cell ALL/T-cell ALL/TLyLy). Parents complete questionnaires at baseline and post-intervention. Child/parent salivary cortisol samples are taken pre- and post-session (sessions 1-4). Child blood samples are reserved from routine draws before sessions 1 and 4 (all participants) and session 8 (high risk participants). We will use linear mixed models to estimate AME's effect on child/parent cortisol. Examining child/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. Graphical plots and non-linear repeated measures models will be used to examine dose-response relationship of AME on child/parent cortisol. DISCUSSION: During pediatric cancer treatment there are special challenges that must be considered when measuring cortisol and immune function. In this manuscript we discuss how we addressed three specific challenges through our trial design. Findings from this trial will increase mechanistic understanding of the effects of active music interventions on multiple biomarkers and understanding of dose-response effects, with direct implications for clinical practice. TRIAL REGISTRATION: ClinicalTrials.gov: NCT04400071.

Mediators and Moderators of Active Music Engagement to Reduce Traumatic Stress Symptoms and Improve Well-being in Parents of Young Children With Cancer.

OBJECTIVE: This trial examined the effects of proximal/distal mediators and moderators of an Active Music Engagement (AME) intervention on young child/parent distress, quality of life, and family function outcomes. METHODS: Child/parent dyads (n = 125) were randomized to AME or Audio-storybooks attention control condition. Each group received 3 sessions with a credentialed music therapist for 3 consecutive days with data collection at baseline, post-intervention (T2), and 30-days later (T3). Potential proximal mediators included within session child and parent engagement. Potential distal mediators included changes in perceived family normalcy, parent self-efficacy, and independent use of play materials. Potential moderators included parent/child distress with prior hospitalizations, parent traumatic stress screener (PCL-6), and child age. Outcomes included child emotional distress and quality of life; parent emotion, traumatic stress symptoms (IES-R), well-being; and family function. Mediation effects were estimated using ANCOVA, with indirect effects estimated using the percentile bootstrap approach. Moderation effects were tested by including appropriate interaction terms in models. RESULTS: No significant mediation effects were observed. Child distress with prior hospitalizations moderated AME effects for IES-R intrusion subscale scores at T2 (P = .01) and avoidance subscale scores at T3 (P = .007). Traumatic stress screener scores (PCL-6) moderated intervention effects for IES-R hyperarousal subscale scores at T2 (P = .01). There were no moderation effects for child age. CONCLUSIONS: AME is a promising intervention for mitigating traumatic stress symptoms and supporting well-being in parents of children with cancer, particularly for parents who screen high for traumatic stress and whose children are more highly distressed with hospitalization.

Implementing NIH Behavior Change Consortium Treatment Fidelity Recommendations in a Multi-Site Randomized Controlled Trial of an Active Music Engagement Intervention for Young Children with Cancer and Parents.

Treatment fidelity is the use of methodological strategies to monitor and enhance reliability and validity of behavioral intervention trials. Despite availability of guidelines and checklists, treatment fidelity remains underreported, hindering evaluation, interpretation, and cross-study comparisons. Treatment fidelity is particularly important for music interventions given the inherent complexity of musical stimuli and flexibility required for tailored delivery. The purpose of this paper is to define and describe treatment fidelity strategies for our trial of a music-based play intervention for young children with cancer and parents grounded in the NIH Behavior Change Consortium Treatment Fidelity Recommendations. We report strategies for all 5 areas: study design, training providers, delivery of treatment, receipt of treatment, and enactment of treatment skills. We also discuss 4 challenges our team encountered, including: (1) standardizing live music delivery, (2) defining boundaries for tailored intervention delivery, (3) managing extended time between participants, and (4) minimizing risk for bias. This paper expands on current fidelity literature and may provide a working model for other investigators examining dyadic and/or active music interventions.

Randomized Clinical Trial of a Self-care and Communication Intervention for Parents of Adolescent/Young Adults Undergoing High-Risk Cancer Treatment: A Report From the Children's Oncology Group.

BACKGROUND: Parents of adolescents and young adults (AYAs) with cancer offer primary support to their children and often experience their own high levels of distress, affecting parent-AYA communication and quality of life. OBJECTIVE: To reduce parent distress and improve communication during high-risk cancer treatment, we examined efficacy of a self-care and communication intervention for parents and indirect benefit for AYAs receiving a therapeutic music video (TMV) intervention. METHODS: In this study, we conducted a multisite, randomized controlled trial with AYAs and parents enrolled as dyads (n = 110). Parents were randomized to intervention or low-dose control; all AYAs received TMV. Data collection occurred at baseline, 2 weeks post intervention (T2), and 90 days post intervention (T3). RESULTS: There were no significant between-group differences on primary outcomes for parents or AYAs. We did find significant differences favoring the parent intervention group on parenting confidence at T2 and marginally better outcomes for family adaptability/cohesion at T3. Both groups exhibited significant within-group improvement for parent distress (state anxiety, T3; perceived stress, T2 and T3; mood, T3), state anxiety (T2) intervention only, and family strengths control group only. Qualitative data demonstrate the parent intervention raised self-awareness and parent confidence in the short term. CONCLUSION: Parents found their intervention helpful. Absence of significant results may be due to short intervention duration, need for tailored content, underpowered sample, and potential indirect parent benefit from AYA participation in TMV. The parent intervention did not provide an indirect benefit for AYAs. IMPLICATIONS FOR NURSING: Parents identified their own need for communication and support from nurses. Nurses can optimize AYA care by attending to parent needs through supportive listening and encouraging self-care.

Active Music Engagement and Cortisol as an Acute Stress Biomarker in Young Hematopoietic Stem Cell Transplant Patients and Caregivers: Results of a Single Case Design Pilot Study.

This paper reports the results of a single case design pilot study of a music therapy intervention [the Active Music Engagement (AME)] for young children (age 3.51 to 4.53 years) undergoing hematopoietic stem cell transplantation (HCST) and their caregivers. The primary aims of the study were to determine feasibility/acceptability of the AME intervention protocol and data collection in the context of HCST. Secondary aims were to examine caregivers' perceptions of the benefit of AME and whether there were changes in child and caregiver cortisol levels relative to the AME intervention. Results indicated that the AME could be implemented in this context and that data could be collected, though the collection of salivary cortisol may constitute an additional burden for families. Nevertheless, data that were collected suggest that families derive benefit from the AME, which underscores the need for devising innovative methods to understand the neurophysiological impacts of the AME.

Cortisol as an Acute Stress Biomarker in Young Hematopoietic Cell Transplant Patients/Caregivers: Active Music Engagement Protocol.

Objective: Primary aims of the proposed protocol are to determine the feasibility/acceptability of the active music engagement intervention protocol during hematopoietic stem cell transplantation (HSCT) and clinical feasibility/acceptability of the biological sample collection schedule. Design: The authors propose a single-case, alternating treatment design to compare levels of child and caregiver cortisol in blood and saliva collected on alternating days, when the dyad receives and does not receive AME sessions. Included are the scientific rationale for this design and detailed intervention and sample collection schedules based on transplant type. Setting/Location: Pediatric inpatient HSCT unit. Subjects: Eligible participants are dyads of children 3-8 years old, hospitalized for HSCT, and their caregiver. Children with malignant and nonmalignant conditions will be eligible, regardless of transplant type. Intervention: AME intervention is delivered by a board-certified music therapist who tailors music-based play experiences to encourage active engagement in, and independent use of, music play to manage the inter-related emotional distress experienced by children and their caregivers during HSCT. Dyads will receive two 45-min AME sessions each week during hospitalization. Outcome Measures: Eight collections of blood (child) and saliva (child/caregiver) will be performed for cortisol measurement. The authors will also collect self-report and caregiver proxy measures for dyad emotional distress, quality of life, and family function. At study conclusion, qualitative caregiver interviews will be conducted. Results: Planned analyses will be descriptive and evaluate the feasibility of participant recruitment, cortisol collection, planned evaluations, and AME delivery. Analysis of qualitative interviews will be used to gain an understanding about the ease/burden of biological sample collection and any perceived benefit of AME. Conclusions: Behavioral intervention studies examining biological mechanisms of action in pediatric transplant populations are rare. Findings will provide important information about the feasibility/acceptability of collecting cortisol samples during a high-intensity treatment and advance understanding about the use of active music interventions to mitigate child/caregiver distress during the transplant period.

Music Therapist Experiences of a Randomized Controlled Trial as Clinician Researchers.

Music therapy clinicians bring an important perspective to the design and conduct of clinically meaningful studies. Unfortunately, there continue to be roadblocks that hinder clinician involvement in research and the development of successful partnerships between academic researchers and practicing clinicians. To help grow clinician involvement, it is important that research teams share their experiences. As such, the purpose of this qualitative study was to share music therapists' perspectives about their experience of working as a research clinician on a large multisite randomized controlled trial. 10 board-certified music therapists provided written responses to 6 data-generating questions about: (a) reasons for participating, (b) perceived challenges and benefits, (c) experiences of quality assurance monitoring, (d) professional growth, (e) value of research, and (f) advice for clinicians considering research involvement. Using thematic content analysis, we identified primary themes and subthemes for each question (20 themes; 30 subthemes). Qualitative analysis revealed not only common challenges, such as reconciling clinical and research responsibilities, but also benefits, including continued professional growth, greater understanding of research processes, and research participation as a way to advocate and advance the profession. Finally, for clinicians interested in becoming involved in research, therapists noted the importance of having workplace support from a mentor, supervisor, and/or administrator; seeking out available resources; and knowing roles and responsibilities before initiating research involvement. Findings offer important insight and recommendations to support the involvement of clinicians in research and support further exploration of clinician involvement in dissemination efforts to improve translation and uptake of research into practice.