Clinical Trials /

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

NCT03085927

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.

Related Conditions:
  • Cancer
Recruiting Status:

Recruiting

Phase:

N/A

Trial Eligibility

Document

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

  • Cancer

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

NameTypeDescriptionInterventions
Arm 1-Active Music EngagementExperimentalThree 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-StorybooksExperimentalThree 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 hospitalization 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:Recruiting
      Lead Sponsor:Indiana University

      Trial Keywords

      • music therapy
      • neoplasms
      • play
      • children
      • parents

      Last Updated

      April 12, 2017