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Completed

NCT Number: NCT03085927

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

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.

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Key information

Conditions

Cancer Neoplasms

Age range

3 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Healthcare of Atlanta, Atlanta, Georgia, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

(Child/Parent):

  • 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/Parent):

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

Treatment and study plan

Active Music Engagement

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.

Audio Storybooks

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.

Primary outcomes

  1. Family Normalcy Perspective - Family Management Measure (FaMM)

    Time frame: Time 2(post-session 3 on day 3) and Time 3 (30-days post-session 3, approximately 33 days)

    Family Normalcy is assessed through The Family Management Measure (FaMM) - Family Life Difficulty Subscale includes 14-items rated on a 5-point Likert-type scale. Subscale items address parents' perceptions of the extent to which having a child with a chronic condition makes family life difficult. Higher values indicate more difficulty managing the condition. Score range 14 - 70.

  2. Parent Self-Efficacy - Parental Beliefs Scale (PBS).

    Time frame: Time 2(post-session 3 on day 3) and Time 3 (30-days post-session 3, approximately 33 days)

    Parent Self-Efficacy is assessed through the Parental Beliefs Scale (PBS) for Hospitalized Children, a 20-item scale that measures parental beliefs about their confidence in anticipating changes in their hospitalized child's behavior and confidence in their parental role during hospitalization. Scores range from 20-100, with higher scores indicating more positive beliefs.

  3. Child Emotional Distress - Child Health Questionnaire (CHQ)

    Time frame: Time 2(post-session 3 on day 3) and Time 3 (30-days post-session 3, approximately 33 days)

    Child Emotional Distress is assessed through the Child Health Questionnaire (CHQ-PF98) Mental Health Subscale (Landgraf et al., 1999). This subscale consists of 16 items rated on a 5-point Likert-scale. Scores range from 16 to 80 with lower scores indicating better mental health.

  4. Child Quality of Life - KINDL.

    Time frame: Time 2(post-session 3 on day 3) and Time 3 (30-days post-session 3, approximately 33 days)

    Child Quality of Life is assessed through the KINDL Questionnaire for Measuring Health-Related Quality of Life in Children. The KINDL consists of 24 parent-report items rated on a 5-point Likert-scale for each subscale. Scores range from 20-100 with higher scores indicating better quality of life.

  5. Parent Emotional and Traumatic Stress Symptoms - Profile of Mood States-Short Form (POMS).

    Time frame: Time 2(post-session 3 on day 3) and Time 3 (30-days post-session 3, approximately 33 days)

    Parent Emotional and Traumatic Distress was assessed through the Profile of Mood States - Short Form (POMS-SF) which measures mood disturbance. There are 37 items which respondents rate on a 5-point Likert scale. Scores range from 0 to 148 with higher scores indicating greater mood disturbance.

  6. Parent Emotional and Traumatic Stress Symptoms - Impact of Events Scale-Revised (IES-R)

    Time frame: Time 2(post-session 3 on day 3) and Time 3 (30-days post-session 3, approximately 33 days)

    Stress Symptoms assessed through the Impact of Events Scale-Revised (IES-R), a 22-item measure that measures traumatic stress symptoms in response to a traumatic event that is specified in the instructions. Parents respond to each item using a 5-point Likert scale. Scores range from 0 to 12 with higher scores indicating greater traumatic stress symptoms.

  7. Parent Quality of Life - Index of Well Being.

    Time frame: Time 2(post-session 3 on day 3) and Time 3 (30-days post-session 3, approximately 33 days)

    Parent Quality of Life is assessed through the Index of Well-being, a 9-item semantic differential scale describing present life using adjective extremes. Scores range from 7 to 63 with higher scores meaning greater well-being.

  8. Family Function - Family Adaptability and Cohesion Scale (FACES II).

    Time frame: Time 2(post-session 3 on day 3) and Time 3 (30-days post-session 3, approximately 33 days)

    Family Function is assessed through the Family Adaptability and Cohesion Scale II (FACES II), a 30-item scale of items rated using a 5-point Likert scale. Scores range from 1 to 5, with higher scores meaning higher family adaptability and cohesion.

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • Children's Healthcare of Atlanta
  • Children's Mercy Hospital Kansas City
  • M.D. Anderson Cancer Center

Registry information

Acronym: PINPOINT

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Mar 21, 2017
Registry last updated
Nov 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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