Ignite Creation Date:
2025-12-25 @ 5:06 AM
Ignite Modification Date:
2025-12-26 @ 4:10 AM
Study NCT ID:
NCT03085927
Status:
COMPLETED
Last Update Posted:
2021-11-11
First Post:
2017-02-27
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Mechanisms of Active Music Engagement to Improve Health Outcomes of Children With Cancer and Parents
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'shrobb@iu.edu', 'phone': '317-274-3152', 'title': 'Dr. Sheri Robb, MT-BC', 'organization': 'Indiana University School of Nursing'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '33 days (Time 1 through Time 3)', 'description': 'The child in the child/parent dyad passed away before Time 3 therefore we took the dyad off study and did not collect Time 3 data.', 'eventGroups': [{'id': 'EG000', 'title': 'Arm 1 Parent-Active Music Engagement', 'description': '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.', 'otherNumAtRisk': 69, 'deathsNumAtRisk': 69, 'otherNumAffected': 0, 'seriousNumAtRisk': 69, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Arm II Parent- Audio-Storybooks', 'description': "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.\n\nAudio 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.", 'otherNumAtRisk': 67, 'deathsNumAtRisk': 67, 'otherNumAffected': 0, 'seriousNumAtRisk': 67, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Arm 1 Child-Active Music Engagement', 'description': '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.', 'otherNumAtRisk': 69, 'deathsNumAtRisk': 69, 'otherNumAffected': 0, 'seriousNumAtRisk': 69, 'deathsNumAffected': 1, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Arm II Child-Audio Storybooks', 'description': "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.\n\nAudio 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.", 'otherNumAtRisk': 67, 'deathsNumAtRisk': 67, 'otherNumAffected': 0, 'seriousNumAtRisk': 67, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Family Normalcy Perspective - Family Management Measure (FaMM)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1-Active Music Engagement', 'description': '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.'}, {'id': 'OG001', 'title': 'Arm II- Audio-Storybooks', 'description': "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."}], 'classes': [{'title': 'Time 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '35.3', 'spread': '9.8', 'groupId': 'OG000'}, {'value': '36.2', 'spread': '9.5', 'groupId': 'OG001'}]}]}, {'title': 'Time 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '34.8', 'spread': '10.1', 'groupId': 'OG000'}, {'value': '34.3', 'spread': '8.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Time 2(post-session 3 on day 3) and Time 3 (30-days post-session 3, approximately 33 days)', 'description': "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.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Parent Self-Efficacy - Parental Beliefs Scale (PBS).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1-Active Music Engagement', 'description': '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.'}, {'id': 'OG001', 'title': 'Arm II- Audio-Storybooks', 'description': "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."}], 'classes': [{'title': 'Time 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '79.0', 'spread': '9.8', 'groupId': 'OG000'}, {'value': '81.9', 'spread': '11.4', 'groupId': 'OG001'}]}]}, {'title': 'Time 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '81.1', 'spread': '10.7', 'groupId': 'OG000'}, {'value': '84.3', 'spread': '9.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Time 2(post-session 3 on day 3) and Time 3 (30-days post-session 3, approximately 33 days)', 'description': "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.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Child Emotional Distress - Child Health Questionnaire (CHQ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1-Active Music Engagement', 'description': '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.'}, {'id': 'OG001', 'title': 'Arm II- Audio-Storybooks', 'description': "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."}], 'classes': [{'title': 'Time 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23.3', 'spread': '12.0', 'groupId': 'OG000'}, {'value': '24.0', 'spread': '13.9', 'groupId': 'OG001'}]}]}, {'title': 'Time 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '24.1', 'spread': '11.1', 'groupId': 'OG000'}, {'value': '22.2', 'spread': '11.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Time 2(post-session 3 on day 3) and Time 3 (30-days post-session 3, approximately 33 days)', 'description': '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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Child Quality of Life - KINDL.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1-Active Music Engagement', 'description': '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.'}, {'id': 'OG001', 'title': 'Arm II- Audio-Storybooks', 'description': "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."}], 'classes': [{'title': 'Time 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '67.6', 'spread': '13.1', 'groupId': 'OG000'}, {'value': '69.1', 'spread': '15.7', 'groupId': 'OG001'}]}]}, {'title': 'Time 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '70.6', 'spread': '14.7', 'groupId': 'OG000'}, {'value': '71.7', 'spread': '15.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Time 2(post-session 3 on day 3) and Time 3 (30-days post-session 3, approximately 33 days)', 'description': '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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Parent Emotional and Traumatic Stress Symptoms - Profile of Mood States-Short Form (POMS).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1-Active Music Engagement', 'description': '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.'}, {'id': 'OG001', 'title': 'Arm II- Audio-Storybooks', 'description': "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."}], 'classes': [{'title': 'Time 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '38.0', 'spread': '22.6', 'groupId': 'OG000'}, {'value': '42.1', 'spread': '25.6', 'groupId': 'OG001'}]}]}, {'title': 'Time 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '42.9', 'spread': '29.2', 'groupId': 'OG000'}, {'value': '43.4', 'spread': '28.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Time 2(post-session 3 on day 3) and Time 3 (30-days post-session 3, approximately 33 days)', 'description': '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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Parent Emotional and Traumatic Stress Symptoms - Impact of Events Scale-Revised (IES-R)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1-Active Music Engagement', 'description': '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.'}, {'id': 'OG001', 'title': 'Arm II- Audio-Storybooks', 'description': "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."}], 'classes': [{'title': 'Time 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.5', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '2.2', 'groupId': 'OG001'}]}]}, {'title': 'Time 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.7', 'spread': '4.7', 'groupId': 'OG000'}, {'value': '4.9', 'spread': '4.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Time 2(post-session 3 on day 3) and Time 3 (30-days post-session 3, approximately 33 days)', 'description': '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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Parent Quality of Life - Index of Well Being.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1-Active Music Engagement', 'description': '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.'}, {'id': 'OG001', 'title': 'Arm II- Audio-Storybooks', 'description': "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."}], 'classes': [{'title': 'Time 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '47.6', 'spread': '10.1', 'groupId': 'OG000'}, {'value': '47.9', 'spread': '10.3', 'groupId': 'OG001'}]}]}, {'title': 'Time 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '48.2', 'spread': '10.9', 'groupId': 'OG000'}, {'value': '46.9', 'spread': '11.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Time 2(post-session 3 on day 3) and Time 3 (30-days post-session 3, approximately 33 days)', 'description': '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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Family Function - Family Adaptability and Cohesion Scale (FACES II).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1-Active Music Engagement', 'description': '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.'}, {'id': 'OG001', 'title': 'Arm II- Audio-Storybooks', 'description': "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."}], 'classes': [{'title': 'Time 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '35.3', 'spread': '9.8', 'groupId': 'OG000'}, {'value': '36.2', 'spread': '9.5', 'groupId': 'OG001'}]}]}, {'title': 'Time 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '34.8', 'spread': '10.1', 'groupId': 'OG000'}, {'value': '34.3', 'spread': '8.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Time 2(post-session 3 on day 3) and Time 3 (30-days post-session 3, approximately 33 days)', 'description': '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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm 1-Active Music Engagement', 'description': '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.'}, {'id': 'FG001', 'title': 'Arm II- Audio-Storybooks', 'description': "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."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Numbers listed reflect child/parents in a dyad. Arm 1=138 individuals Arm 2=134', 'achievements': [{'groupId': 'FG000', 'numSubjects': '69'}, {'groupId': 'FG001', 'numSubjects': '67'}]}, {'type': 'Study Sessions', 'comment': 'Arm 1=130 individuals Arm 2=126 individuals', 'achievements': [{'comment': 'Off Study reasons:\n\nChild toxicity/side effects (n=1) Dyad withdrew (n=1) Dyad lost to follow-up (n=2)', 'groupId': 'FG000', 'numSubjects': '65'}, {'comment': 'Off Study reasons:\n\nDyad withdrew (n=3) Dyad became ineligible (n=1)', 'groupId': 'FG001', 'numSubjects': '63'}]}, {'type': 'Time 2 Measures', 'comment': 'Arm 1=130 individuals Arm 2=124 individuals', 'achievements': [{'groupId': 'FG000', 'numSubjects': '65'}, {'comment': 'Off Study reasons:\n\nDyad withdrew (n=1)', 'groupId': 'FG001', 'numSubjects': '62'}]}, {'type': 'COMPLETED', 'comment': 'Arm 1=126 individuals Arm 2=122 individuals', 'achievements': [{'comment': 'Off Study reasons:\n\nDeath of child (n=1) Dyad lost to follow up (n=1)', 'groupId': 'FG000', 'numSubjects': '63'}, {'comment': 'Off Study reason:\n\nDyad lost to follow up (n=1)', 'groupId': 'FG001', 'numSubjects': '61'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Child Toxicity/Side Effects of Treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Dyad Became Ineligible', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': '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.', 'preAssignmentDetails': "Participants in this study were enrolled as a dyad (child/parent). Totals listed below represent the numbers of dyads enrolled.\n\nOne 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."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}, {'value': '67', 'groupId': 'BG003'}, {'value': '272', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm 1-Active Music Engagement (Children)', 'description': '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.'}, {'id': 'BG001', 'title': 'Arm II- Audio-Storybooks (Children)', 'description': "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."}, {'id': 'BG002', 'title': 'Arm 1-Active Music Engagement (Parents)', 'description': '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.'}, {'id': 'BG003', 'title': 'Arm II- Audio-Storybooks (Parents)', 'description': "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."}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '69', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '136', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}, {'value': '67', 'groupId': 'BG003'}, {'value': '135', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '61', 'groupId': 'BG003'}, {'value': '179', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '93', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '39', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}, {'value': '52', 'groupId': 'BG003'}, {'value': '221', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '29', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}, {'value': '52', 'groupId': 'BG003'}, {'value': '192', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '33', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '69', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}, {'value': '67', 'groupId': 'BG003'}, {'value': '272', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Family Normalcy', 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Measures completed by parents once for dyads (parent + child).', 'groupId': 'BG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Measures completed by parents once for dyads (parent + child).', 'groupId': 'BG001'}, {'value': '36.0', 'spread': '10.5', 'groupId': 'BG002'}, {'value': '37.1', 'spread': '9.7', 'groupId': 'BG003'}, {'value': '36.6', 'spread': '10.1', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': "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.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Parent Self Efficacy', 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Measures completed by parents for each dyad (parent + child)', 'groupId': 'BG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Measures completed by parents for each dyad (parent + child)', 'groupId': 'BG001'}, {'value': '78.3', 'spread': '10.0', 'groupId': 'BG002'}, {'value': '80.1', 'spread': '11.3', 'groupId': 'BG003'}, {'value': '79.2', 'spread': '10.7', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': "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.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Child Emotional Distress', 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Measures completed by parents once for each dyad (parent + child)', 'groupId': 'BG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Measures completed by parents once for each dyad (parent + child)', 'groupId': 'BG001'}, {'value': '28.6', 'spread': '14.1', 'groupId': 'BG002'}, {'value': '28.6', 'spread': '12.8', 'groupId': 'BG003'}, {'value': '28.6', 'spread': '13.4', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': '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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Child Quality of Life', 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Measures completed by parents once for each dyad (parent + child).', 'groupId': 'BG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Measures completed by parents once for each dyad (parent + child).', 'groupId': 'BG001'}, {'value': '70.2', 'spread': '14.7', 'groupId': 'BG002'}, {'value': '71.1', 'spread': '13.3', 'groupId': 'BG003'}, {'value': '70.6', 'spread': '14.0', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': '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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Parent Emotional and Traumatic Distress', 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Measures completed by parents once for dyads (parent + child).', 'groupId': 'BG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Measures completed by parents once for dyads (parent + child).', 'groupId': 'BG001'}, {'value': '51.6', 'spread': '28.3', 'groupId': 'BG002'}, {'value': '52.8', 'spread': '29.3', 'groupId': 'BG003'}, {'value': '52.2', 'spread': '28.7', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': '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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Stress Symptoms', 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Measures completed by parents once for dyads (parent + child).', 'groupId': 'BG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Measures completed by parents once for dyads (parent + child).', 'groupId': 'BG001'}, {'value': '3.4', 'spread': '2.7', 'groupId': 'BG002'}, {'value': '3.6', 'spread': '2.5', 'groupId': 'BG003'}, {'value': '3.5', 'spread': '2.6', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': '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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Parent Quality of Life', 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Measures completed by parents once for each dyad (parent + child).', 'groupId': 'BG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Measures completed by parents once for each dyad (parent + child).', 'groupId': 'BG001'}, {'value': '47.2', 'spread': '11.0', 'groupId': 'BG002'}, {'value': '48.0', 'spread': '9.5', 'groupId': 'BG003'}, {'value': '47.6', 'spread': '10.2', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': '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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Family Function', 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Measures completed by parents once for each dyad (parent + child).', 'groupId': 'BG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Measures completed by parents once for each dyad (parent + child).', 'groupId': 'BG001'}, {'value': '3.9', 'spread': '0.5', 'groupId': 'BG002'}, {'value': '3.8', 'spread': '0.6', 'groupId': 'BG003'}, {'value': '3.9', 'spread': '0.5', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': '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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Parents and Children were enrolled as dyads and engaged in sessions together. Some of the outcome measures reflect the children, some the parents, and some both members of the dyad.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-10-16', 'size': 716682, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-04-29T15:11', 'hasProtocol': True}, {'date': '2018-12-07', 'size': 196007, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2020-04-08T18:45', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 137}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2020-04-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-15', 'studyFirstSubmitDate': '2017-02-27', 'resultsFirstSubmitDate': '2021-04-29', 'studyFirstSubmitQcDate': '2017-03-15', 'lastUpdatePostDateStruct': {'date': '2021-11-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-10-15', 'studyFirstPostDateStruct': {'date': '2017-03-21', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-11-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Family Normalcy Perspective - Family Management Measure (FaMM)', 'timeFrame': 'Time 2(post-session 3 on day 3) and Time 3 (30-days post-session 3, approximately 33 days)', 'description': "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."}, {'measure': 'Parent Self-Efficacy - Parental Beliefs Scale (PBS).', 'timeFrame': 'Time 2(post-session 3 on day 3) and Time 3 (30-days post-session 3, approximately 33 days)', 'description': "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."}, {'measure': 'Child Emotional Distress - Child Health Questionnaire (CHQ)', 'timeFrame': 'Time 2(post-session 3 on day 3) and Time 3 (30-days post-session 3, approximately 33 days)', 'description': '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.'}, {'measure': 'Child Quality of Life - KINDL.', 'timeFrame': 'Time 2(post-session 3 on day 3) and Time 3 (30-days post-session 3, approximately 33 days)', 'description': '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.'}, {'measure': 'Parent Emotional and Traumatic Stress Symptoms - Profile of Mood States-Short Form (POMS).', 'timeFrame': 'Time 2(post-session 3 on day 3) and Time 3 (30-days post-session 3, approximately 33 days)', 'description': '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.'}, {'measure': 'Parent Emotional and Traumatic Stress Symptoms - Impact of Events Scale-Revised (IES-R)', 'timeFrame': 'Time 2(post-session 3 on day 3) and Time 3 (30-days post-session 3, approximately 33 days)', 'description': '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.'}, {'measure': 'Parent Quality of Life - Index of Well Being.', 'timeFrame': 'Time 2(post-session 3 on day 3) and Time 3 (30-days post-session 3, approximately 33 days)', 'description': '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.'}, {'measure': 'Family Function - Family Adaptability and Cohesion Scale (FACES II).', 'timeFrame': 'Time 2(post-session 3 on day 3) and Time 3 (30-days post-session 3, approximately 33 days)', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['music therapy', 'neoplasms', 'play', 'children', 'parents'], 'conditions': ['Cancer']}, 'referencesModule': {'references': [{'pmid': '18033724', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '27289068', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '10932125', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '38145309', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria (Child/Parent):\n\n* Children ages 3-8 years inclusive.\n* Expected treatment course for at least 3 days to receive chemotherapy and/or radiation therapy.\n* A consistent parent who can be present for all sessions.\n\nExclusion Criteria (Child/Parent):\n\n* Child and/or parent do not speak English.\n* Child has a significant cognitive impairment that hinders participation (based on physician judgment).'}, 'identificationModule': {'nctId': 'NCT03085927', 'acronym': 'PINPOINT', 'briefTitle': 'Mechanisms of Active Music Engagement to Improve Health Outcomes of Children With Cancer and Parents', 'organization': {'class': 'OTHER', 'fullName': 'Indiana University'}, 'officialTitle': 'Mechanisms of Active Music Engagement to Improve Health Outcomes of Children With Cancer and Parents', 'orgStudyIdInfo': {'id': 'R01NR015789', 'link': 'https://reporter.nih.gov/quickSearch/R01NR015789', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1-Active Music Engagement', 'description': '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.', 'interventionNames': ['Behavioral: Active Music Engagement']}, {'type': 'EXPERIMENTAL', 'label': 'Arm II- Audio-Storybooks', 'description': "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.", 'interventionNames': ['Behavioral: Audio Storybooks']}], 'interventions': [{'name': 'Active Music Engagement', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Arm 1-Active Music Engagement']}, {'name': 'Audio Storybooks', 'type': 'BEHAVIORAL', 'description': "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.", 'armGroupLabels': ['Arm II- Audio-Storybooks']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': "Children's Healthcare of Atlanta", 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Riley Hospital for Children', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '64155', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': "Children's Mercy Hospitals and Clinics", 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Sheri L Robb, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Indiana University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indiana University', 'class': 'OTHER'}, 'collaborators': [{'name': "Children's Healthcare of Atlanta", 'class': 'OTHER'}, {'name': "Children's Mercy Hospital Kansas City", 'class': 'OTHER'}, {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Sheri Robb', 'investigatorAffiliation': 'Indiana University'}}}}