Trial Outcomes & Findings for Mechanisms of Active Music Engagement to Improve Health Outcomes of Children With Cancer and Parents (NCT NCT03085927)

NCT ID: NCT03085927

Last Updated: 2021-11-11

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 137 participants
• Primary outcome timeframe: Time 2(post-session 3 on day 3) and Time 3 (30-days post-session 3, approximately 33 days)
• Results posted on: 2021-11-11

Participant Flow

Participants were recruited as dyads (child/parent) at 4 sites from September of 2016 through February of 2020. The first participant was enrolled on September 26, 2016 and the last participant was enrolled on February 20, 2020.

Participants in this study were enrolled as a dyad (child/parent). Totals listed below represent the numbers of dyads enrolled. One dyad of the 137 total dyads enrolled came off study prior to completing baseline measures due to the child's toxicity/side effects of cancer treatment.

Participant milestones

Measure	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.	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.
Overall Study STARTED	69	67
Overall Study Study Sessions	65	63
Overall Study Time 2 Measures	65	62
Overall Study COMPLETED	63	61
Overall Study NOT COMPLETED	6	6

Reasons for withdrawal

Measure	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.	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.
Overall Study Withdrawal by Subject	1	4
Overall Study Lost to Follow-up	3	1
Overall Study Death	1	0
Overall Study Child Toxicity/Side Effects of Treatment	1	0
Overall Study Dyad Became Ineligible	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Arm 1-Active Music Engagement (Children) n=69 Participants 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 (Children) n=67 Participants 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.	Arm 1-Active Music Engagement (Parents) n=69 Participants 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 (Parents) n=67 Participants 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.	Total n=272 Participants Total of all reporting groups
Age, Categorical <=18 years	69 Participants n=5 Participants	67 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	136 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	68 Participants n=5 Participants	67 Participants n=4 Participants	135 Participants n=21 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Sex: Female, Male Female	29 Participants n=5 Participants	31 Participants n=7 Participants	58 Participants n=5 Participants	61 Participants n=4 Participants	179 Participants n=21 Participants
Sex: Female, Male Male	40 Participants n=5 Participants	36 Participants n=7 Participants	11 Participants n=5 Participants	6 Participants n=4 Participants	93 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	8 Participants n=5 Participants	13 Participants n=7 Participants	6 Participants n=5 Participants	12 Participants n=4 Participants	39 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	58 Participants n=5 Participants	52 Participants n=7 Participants	59 Participants n=5 Participants	52 Participants n=4 Participants	221 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants	3 Participants n=4 Participants	12 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	3 Participants n=21 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants	1 Participants n=4 Participants	8 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants	7 Participants n=7 Participants	8 Participants n=5 Participants	7 Participants n=4 Participants	29 Participants n=21 Participants
Race (NIH/OMB) White	46 Participants n=5 Participants	46 Participants n=7 Participants	48 Participants n=5 Participants	52 Participants n=4 Participants	192 Participants n=21 Participants
Race (NIH/OMB) More than one race	11 Participants n=5 Participants	12 Participants n=7 Participants	7 Participants n=5 Participants	3 Participants n=4 Participants	33 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	7 Participants n=21 Participants
Region of Enrollment United States	69 participants n=5 Participants	67 participants n=7 Participants	69 participants n=5 Participants	67 participants n=4 Participants	272 participants n=21 Participants
Family Normalcy	NA score on a scale STANDARD_DEVIATION NA • n=5 Participants	NA score on a scale STANDARD_DEVIATION NA • n=7 Participants	36.0 score on a scale STANDARD_DEVIATION 10.5 • n=5 Participants	37.1 score on a scale STANDARD_DEVIATION 9.7 • n=4 Participants	36.6 score on a scale STANDARD_DEVIATION 10.1 • n=21 Participants
Parent Self Efficacy	NA score on a scale STANDARD_DEVIATION NA • n=5 Participants	NA score on a scale STANDARD_DEVIATION NA • n=7 Participants	78.3 score on a scale STANDARD_DEVIATION 10.0 • n=5 Participants	80.1 score on a scale STANDARD_DEVIATION 11.3 • n=4 Participants	79.2 score on a scale STANDARD_DEVIATION 10.7 • n=21 Participants
Child Emotional Distress	NA score on a scale STANDARD_DEVIATION NA • n=5 Participants	NA score on a scale STANDARD_DEVIATION NA • n=7 Participants	28.6 score on a scale STANDARD_DEVIATION 14.1 • n=5 Participants	28.6 score on a scale STANDARD_DEVIATION 12.8 • n=4 Participants	28.6 score on a scale STANDARD_DEVIATION 13.4 • n=21 Participants
Child Quality of Life	NA score on a scale STANDARD_DEVIATION NA • n=5 Participants	NA score on a scale STANDARD_DEVIATION NA • n=7 Participants	70.2 score on a scale STANDARD_DEVIATION 14.7 • n=5 Participants	71.1 score on a scale STANDARD_DEVIATION 13.3 • n=4 Participants	70.6 score on a scale STANDARD_DEVIATION 14.0 • n=21 Participants
Parent Emotional and Traumatic Distress	NA score on a scale STANDARD_DEVIATION NA • n=5 Participants	NA score on a scale STANDARD_DEVIATION NA • n=7 Participants	51.6 score on a scale STANDARD_DEVIATION 28.3 • n=5 Participants	52.8 score on a scale STANDARD_DEVIATION 29.3 • n=4 Participants	52.2 score on a scale STANDARD_DEVIATION 28.7 • n=21 Participants
Stress Symptoms	NA score on a scale STANDARD_DEVIATION NA • n=5 Participants	NA score on a scale STANDARD_DEVIATION NA • n=7 Participants	3.4 score on a scale STANDARD_DEVIATION 2.7 • n=5 Participants	3.6 score on a scale STANDARD_DEVIATION 2.5 • n=4 Participants	3.5 score on a scale STANDARD_DEVIATION 2.6 • n=21 Participants
Parent Quality of Life	NA score on a scale STANDARD_DEVIATION NA • n=5 Participants	NA score on a scale STANDARD_DEVIATION NA • n=7 Participants	47.2 score on a scale STANDARD_DEVIATION 11.0 • n=5 Participants	48.0 score on a scale STANDARD_DEVIATION 9.5 • n=4 Participants	47.6 score on a scale STANDARD_DEVIATION 10.2 • n=21 Participants
Family Function	NA score on a scale STANDARD_DEVIATION NA • n=5 Participants	NA score on a scale STANDARD_DEVIATION NA • n=7 Participants	3.9 score on a scale STANDARD_DEVIATION 0.5 • n=5 Participants	3.8 score on a scale STANDARD_DEVIATION 0.6 • n=4 Participants	3.9 score on a scale STANDARD_DEVIATION 0.5 • n=21 Participants

PRIMARY outcome

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

Population: Parent and child participants were enrolled as a dyad. Parents completed all outcome measures for self and for their child as proxy. Arm 1 had 2 parents who did not complete Time 3 measures leaving only 63 participants for analysis. Arm 2 had one parent who did not complete T2 measures leaving 60 participants for analysis.

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.

Outcome measures

Measure	Arm 1-Active Music Engagement n=65 Participants 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 n=61 Participants 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.
Family Normalcy Perspective - Family Management Measure (FaMM) Time 2	35.3 score on a scale Standard Deviation 9.8	36.2 score on a scale Standard Deviation 9.5
Family Normalcy Perspective - Family Management Measure (FaMM) Time 3	34.8 score on a scale Standard Deviation 10.1	34.3 score on a scale Standard Deviation 8.7

PRIMARY outcome

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

Population: Parent and child participants were enrolled as a dyad. Parents completed all outcome measures for self and for their child as proxy. Arm 1 had 2 parents who did not complete Time 3 measures leaving only 63 participants for analysis. Arm 2 had one parent who did not complete T2 measures leaving 60 participants for analysis.

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.

Outcome measures

Measure	Arm 1-Active Music Engagement n=65 Participants 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 n=61 Participants 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.
Parent Self-Efficacy - Parental Beliefs Scale (PBS). Time 2	79.0 score on a scale Standard Deviation 9.8	81.9 score on a scale Standard Deviation 11.4
Parent Self-Efficacy - Parental Beliefs Scale (PBS). Time 3	81.1 score on a scale Standard Deviation 10.7	84.3 score on a scale Standard Deviation 9.7

PRIMARY outcome

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

Population: Parent and child participants were enrolled as a dyad. Parents completed all outcome measures for self and for their child as proxy. Arm 1 had 2 parents who did not complete Time 3 measures leaving only 63 participants for analysis. Arm 2 had one parent who did not complete T2 measures leaving 60 participants for analysis.

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.

Outcome measures

Measure	Arm 1-Active Music Engagement n=65 Participants 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 n=61 Participants 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.
Child Emotional Distress - Child Health Questionnaire (CHQ) Time 2	23.3 score on a scale Standard Deviation 12.0	24.0 score on a scale Standard Deviation 13.9
Child Emotional Distress - Child Health Questionnaire (CHQ) Time 3	24.1 score on a scale Standard Deviation 11.1	22.2 score on a scale Standard Deviation 11.1

PRIMARY outcome

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

Population: Parent and child participants were enrolled as a dyad. Parents completed all outcome measures for self and for their child as proxy. Arm 1 had 2 parents who did not complete Time 3 measures leaving only 63 participants for analysis. Arm 2 had one parent who did not complete T2 measures leaving 60 participants for analysis.

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.

Outcome measures

Measure	Arm 1-Active Music Engagement n=65 Participants 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 n=61 Participants 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.
Child Quality of Life - KINDL. Time 2	67.6 score on a scale Standard Deviation 13.1	69.1 score on a scale Standard Deviation 15.7
Child Quality of Life - KINDL. Time 3	70.6 score on a scale Standard Deviation 14.7	71.7 score on a scale Standard Deviation 15.7

PRIMARY outcome

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

Population: Parent and child participants were enrolled as a dyad. Parents completed all outcome measures for self and for their child as proxy. Arm 1 had 2 parents who did not complete Time 3 measures leaving only 63 participants for analysis. Arm 2 had one parent who did not complete T2 measures leaving 60 participants for analysis.

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.

Outcome measures

Measure	Arm 1-Active Music Engagement n=65 Participants 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 n=61 Participants 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.
Parent Emotional and Traumatic Stress Symptoms - Profile of Mood States-Short Form (POMS). Time 2	38.0 score on a scale Standard Deviation 22.6	42.1 score on a scale Standard Deviation 25.6
Parent Emotional and Traumatic Stress Symptoms - Profile of Mood States-Short Form (POMS). Time 3	42.9 score on a scale Standard Deviation 29.2	43.4 score on a scale Standard Deviation 28.4

PRIMARY outcome

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

Population: Parent and child participants were enrolled as a dyad. Parents completed all outcome measures for self and for their child as proxy. Arm 1 had 2 parents who did not complete Time 3 measures leaving only 63 participants for analysis. Arm 2 had one parent who did not complete T2 measures leaving 60 participants for analysis.

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.

Outcome measures

Measure	Arm 1-Active Music Engagement n=65 Participants 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 n=61 Participants 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.
Parent Emotional and Traumatic Stress Symptoms - Impact of Events Scale-Revised (IES-R) Time 2	2.5 score on a scale Standard Deviation 2.2	2.5 score on a scale Standard Deviation 2.2
Parent Emotional and Traumatic Stress Symptoms - Impact of Events Scale-Revised (IES-R) Time 3	4.7 score on a scale Standard Deviation 4.7	4.9 score on a scale Standard Deviation 4.6

PRIMARY outcome

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

Population: Parent and child participants were enrolled as a dyad. Parents completed all outcome measures for self and for their child as proxy. Arm 1 had 2 parents who did not complete Time 3 measures leaving only 63 participants for analysis. Arm 2 had one parent who did not complete T2 measures leaving 60 participants for analysis.

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.

Outcome measures

Measure	Arm 1-Active Music Engagement n=65 Participants 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 n=61 Participants 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.
Parent Quality of Life - Index of Well Being. Time 2	47.6 score on a scale Standard Deviation 10.1	47.9 score on a scale Standard Deviation 10.3
Parent Quality of Life - Index of Well Being. Time 3	48.2 score on a scale Standard Deviation 10.9	46.9 score on a scale Standard Deviation 11.2

PRIMARY outcome

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

Population: Parent and child participants were enrolled as a dyad. Parents completed all outcome measures for self and for their child as proxy. Arm 1 had 2 parents who did not complete Time 3 measures leaving only 63 participants for analysis. Arm 2 had one parent who did not complete T2 measures leaving 60 participants for analysis.

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.

Outcome measures

Measure	Arm 1-Active Music Engagement n=65 Participants 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 n=61 Participants 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.
Family Function - Family Adaptability and Cohesion Scale (FACES II). Time 2	35.3 score on a scale Standard Deviation 9.8	36.2 score on a scale Standard Deviation 9.5
Family Function - Family Adaptability and Cohesion Scale (FACES II). Time 3	34.8 score on a scale Standard Deviation 10.1	34.3 score on a scale Standard Deviation 8.7

Adverse Events

Arm 1 Parent-Active Music Engagement

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm II Parent- Audio-Storybooks

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm 1 Child-Active Music Engagement

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Arm II Child-Audio Storybooks

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Sheri Robb, MT-BC

Indiana University School of Nursing

Phone: 317-274-3152

Email: shrobb@iu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place