Mechanisms of Active Music Engagement to Improve Health Outcomes of Children With Cancer and Parents

NCT ID: NCT03085927

Last Updated: 2021-11-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 137 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-26
• Study Completion Date: 2020-04-06

Brief Summary

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.

Conditions

Cancer

Keywords

music therapy; neoplasms; play; children; parents

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Arm 1-Active Music Engagement

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.

Group Type: EXPERIMENTAL

Active Music Engagement

Intervention Type: BEHAVIORAL

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

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.

Group Type: EXPERIMENTAL

Audio Storybooks

Intervention Type: BEHAVIORAL

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.

Interventions

Active Music Engagement

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.

Intervention Type: BEHAVIORAL

Audio Storybooks

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Children ages 3-8 years inclusive.
• Expected treatment course for at least 3 days to receive chemotherapy and/or radiation therapy.
• A consistent parent who can be present for all sessions.

Exclusion Criteria

• Child and/or parent do not speak English.
• Child has a significant cognitive impairment that hinders participation (based on physician judgment).

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Healthcare of Atlanta

OTHER

Sponsor Role: collaborator

Children's Mercy Hospital Kansas City

OTHER

Sponsor Role: collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role: collaborator

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Sheri Robb

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sheri L Robb, PhD

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Locations

Children's Healthcare of Atlanta

Atlanta, Georgia, United States

Riley Hospital for Children

Indianapolis, Indiana, United States

Children's Mercy Hospitals and Clinics

Kansas City, Missouri, United States

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Countries

United States

References

Robb 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.

Reference Type: BACKGROUND

PMID: 18033724 (View on PubMed)

Robb 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.

Reference Type: BACKGROUND

PMID: 27289068 (View on PubMed)

Robb 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.

Reference Type: BACKGROUND

PMID: 10932125 (View on PubMed)

Robb SL, Stegenga K, Perkins SM, Stump TE, Moody KM, Henley AK, MacLean J, Jacob SA, Delgado D, Haut PR. Mediators and Moderators of Active Music Engagement to Reduce Traumatic Stress Symptoms and Improve Well-being in Parents of Young Children With Cancer. Integr Cancer Ther. 2023 Jan-Dec;22:15347354231218266. doi: 10.1177/15347354231218266.

Reference Type: DERIVED

PMID: 38145309 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

R01NR015789

Identifier Type: NIH

Identifier Source: org_study_id

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