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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03085927

Acronym

PINPOINT

Enrollment

137

Registered

2017-03-21

Start date

2016-09-26

Completion date

2020-04-06

Last updated

2021-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Keywords

music therapy, neoplasms, play, children, parents

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.

Interventions

BEHAVIORALActive 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.

BEHAVIORALAudio 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

3 Years to 8 Years

Healthy volunteers

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).

Design outcomes

Primary

Measure	Time frame	Description
Family Normalcy Perspective - Family Management Measure (FaMM)	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.
Parent Self-Efficacy - Parental Beliefs Scale (PBS).	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.
Child Emotional Distress - Child Health Questionnaire (CHQ)	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.
Child Quality of Life - KINDL.	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.
Parent Emotional and Traumatic Stress Symptoms - Profile of Mood States-Short Form (POMS).	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.
Parent Emotional and Traumatic Stress Symptoms - Impact of Events Scale-Revised (IES-R)	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.
Parent Quality of Life - Index of Well Being.	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.
Family Function - Family Adaptability and Cohesion Scale (FACES II).	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.

Countries

United States

Participant flow

Recruitment details

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.

Pre-assignment details

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.

Participants by arm

Arm	Count
Arm 1-Active Music Engagement (Children) 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.	69
Arm II- Audio-Storybooks (Children) 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.	67
Arm 1-Active Music Engagement (Parents) 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.	69
Arm II- Audio-Storybooks (Parents) 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.	67
Total	272

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Child Toxicity/Side Effects of Treatment	1	0
Overall Study	Death	1	0
Overall Study	Dyad Became Ineligible	0	1
Overall Study	Lost to Follow-up	3	1
Overall Study	Withdrawal by Subject	1	4

Baseline characteristics

Characteristic	Arm II- Audio-Storybooks (Children)	Arm 1-Active Music Engagement (Children)	Arm 1-Active Music Engagement (Parents)	Arm II- Audio-Storybooks (Parents)	Total
Age, Categorical <=18 years	67 Participants	69 Participants	0 Participants	0 Participants	136 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants
Age, Categorical Between 18 and 65 years	0 Participants	0 Participants	68 Participants	67 Participants	135 Participants
Child Emotional Distress	NA score on a scale	NA score on a scale	28.6 score on a scale STANDARD_DEVIATION 14.1	28.6 score on a scale STANDARD_DEVIATION 12.8	28.6 score on a scale STANDARD_DEVIATION 13.4
Child Quality of Life	NA score on a scale	NA score on a scale	70.2 score on a scale STANDARD_DEVIATION 14.7	71.1 score on a scale STANDARD_DEVIATION 13.3	70.6 score on a scale STANDARD_DEVIATION 14
Ethnicity (NIH/OMB) Hispanic or Latino	13 Participants	8 Participants	6 Participants	12 Participants	39 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	52 Participants	58 Participants	59 Participants	52 Participants	221 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants	3 Participants	4 Participants	3 Participants	12 Participants
Family Function	NA score on a scale	NA score on a scale	3.9 score on a scale STANDARD_DEVIATION 0.5	3.8 score on a scale STANDARD_DEVIATION 0.6	3.9 score on a scale STANDARD_DEVIATION 0.5
Family Normalcy	NA score on a scale	NA score on a scale	36.0 score on a scale STANDARD_DEVIATION 10.5	37.1 score on a scale STANDARD_DEVIATION 9.7	36.6 score on a scale STANDARD_DEVIATION 10.1
Parent Emotional and Traumatic Distress	NA score on a scale	NA score on a scale	51.6 score on a scale STANDARD_DEVIATION 28.3	52.8 score on a scale STANDARD_DEVIATION 29.3	52.2 score on a scale STANDARD_DEVIATION 28.7
Parent Quality of Life	NA score on a scale	NA score on a scale	47.2 score on a scale STANDARD_DEVIATION 11	48.0 score on a scale STANDARD_DEVIATION 9.5	47.6 score on a scale STANDARD_DEVIATION 10.2
Parent Self Efficacy	NA score on a scale	NA score on a scale	78.3 score on a scale STANDARD_DEVIATION 10	80.1 score on a scale STANDARD_DEVIATION 11.3	79.2 score on a scale STANDARD_DEVIATION 10.7
Race (NIH/OMB) American Indian or Alaska Native	1 Participants	0 Participants	0 Participants	2 Participants	3 Participants
Race (NIH/OMB) Asian	0 Participants	3 Participants	4 Participants	1 Participants	8 Participants
Race (NIH/OMB) Black or African American	7 Participants	7 Participants	8 Participants	7 Participants	29 Participants
Race (NIH/OMB) More than one race	12 Participants	11 Participants	7 Participants	3 Participants	33 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants	2 Participants	2 Participants	2 Participants	7 Participants
Race (NIH/OMB) White	46 Participants	46 Participants	48 Participants	52 Participants	192 Participants
Region of Enrollment United States	67 participants	69 participants	69 participants	67 participants	272 participants
Sex: Female, Male Female	31 Participants	29 Participants	58 Participants	61 Participants	179 Participants
Sex: Female, Male Male	36 Participants	40 Participants	11 Participants	6 Participants	93 Participants
Stress Symptoms	NA score on a scale	NA score on a scale	3.4 score on a scale STANDARD_DEVIATION 2.7	3.6 score on a scale STANDARD_DEVIATION 2.5	3.5 score on a scale STANDARD_DEVIATION 2.6

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk
deaths Total, all-cause mortality	0 / 69	0 / 67	1 / 69	0 / 67
other Total, other adverse events	0 / 69	0 / 67	0 / 69	0 / 67
serious Total, serious adverse events	0 / 69	0 / 67	0 / 69	0 / 67

Outcome results

Primary

Child Emotional Distress - Child Health Questionnaire (CHQ)

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.