Music Therapy With Cancer Affected Children and Their Families

Study Overview
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Brief Summary
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Background: Pediatric oncology patients and their families are in an existentially threatening situation for which music therapy has proven as a cross-linguistic field of action: the creative act of making music offers the possibility of strengthening individual competences and makes socio-psycho-biological conflicts tangible in a very direct way. Although music therapy is an established component of multimodal care and the inclusion of significant others in the therapy setting is recommended, there has been little clinical research on music therapy interaction processes in the family system. The researchers have designed a randomized controlled pilot trial (INMUT) that specifically addresses family interaction in a multi-person setting. Methods: The examiners investigate the efficacy of music therapy interventions involving the parent-child dyad (INMUT-KB, n=16) compared to music therapy interventions involving only the child (MUT-K, n=16) and a waiting group without intervention (WG, n=10). Research questions: 1) Does the parent-child interaction improves in mutual attunement, nonverbal communication, and emotional parental response? 2) Are there effects on quality of life, psychosocial and psychosomatic impairments, and system-related level of functioning? Evaluation tools: Primary goals will be assessed by the music therapy-based Assessment of parent-child interaction (APCI) pre and post. The secondary objectives will be assessed by self-reports in form of the psychometric questionnaires KINDL, Experience in Social Systems Questionnaire (EXIS), Burden Assessment Scale (BAS) and Symptom Checklist-K-9 (SCL-9K) pre, post and follow up. Discussion: The investigators hope for an improvement of the primary and secondary endpoints through participation in music therapy as a basis for a needs-oriented accompaniment of families.

Official Title
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Interaction-focused Music Therapy With Cancer Affected Children and Their Significant Others: a Randomized Controlled Feasibility Study With Subsequent Intervention (INMUT)

Conditions
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Pediatric Cancer

Intervention / Treatment
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* Behavioral: Interaction-focused Music Therapy with Children and Significant Others (INMUT-KB) (exp. group)
* Behavioral: Music Therapy with Children (MUT-K) (exp. group)
* Behavioral: Interaction-focused Music Therapy with Children and Significant Others (WG-KB) (control group)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria, Children: cancer diagnosis inpatient (e.g. GKH) no cognitive and auditory dysfunction Exclusion Criteria, Children: Serious comorbidity with impairment of brain-organic functions BMI<14 serious physical comorbidity that does not allow specific assessment of psychosomatic constructs with certainty withdrawal of informed consent Inclusion Criteria, Important Reference Persons: - e.g. father, mother, siblings Exclusion Criteria, Important Reference Persons: - withdrawal of consent

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interaction-focused Music Therapy with Children and Significant Others (INMUT-KB) (exp. group)<br>Interaction-focused music therapy with children with cancer and their significant others, delivered by trained music therapists | Behavioral: Interaction-focused Music Therapy with Children and Significant Others (INMUT-KB) (exp. group)<br>* Interaction-focused music therapy with children with cancer and their significant others, delivered by trained music therapists.<br>|
| Experimental: Music Therapy with Children (MUT-K) (exp. group)<br>Interaction-focused music therapy with children with cancer without the involvement of significant others, delivered by trained music therapists. | Behavioral: Music Therapy with Children (MUT-K) (exp. group)<br>* Interaction-focused music therapy with children with cancer without the involvement of significant others, delivered by trained music therapists.<br>|
| Experimental: Interaction-focused Music Therapy with Children and Significant Others (WG-KB) (control group)<br>Study participants randomized to this group receive the intervention INMUT 10 weeks after the experimental groups. | Behavioral: Interaction-focused Music Therapy with Children and Significant Others (WG-KB) (control group)<br>* Study participants randomized to this group receive the intervention INMUT 10 weeks after the experimental groups.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Parent-Child Interaction (APCI) | The APCI captures child-reference interaction using mutual attunement, nonverbal communication, and emotional parental response. The diagnostic music therapy intervention sessions are conducted and evaluated by external, blinded, APCI-certified raters. | Baseline, Change in 10th hour of intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| KINDL-Children/YouthVersion, Modul Oncology | The KINDL uses 40 items to assess the psychological well-being, social relationships, physical functioning, and daily activities during the daily activities within the last week. | Baseline, Change in 10th hour of intervention, Change in 3 months after intervention | 
| Symptom Checklist-K-9 (SCL-9k) | The Short Form Symptom Checklist (SCL-9k) captures impairment using 9 statements about somatization, obsessiveness, social insecurity, depressiveness, anxiety, aggressiveness, phobic anxiety, paranoia, and psychoticism. | Baseline, Change in 10th hour of intervention, Change in 3 months after intervention | 
| Experience in Social Systems Questionnaire (EXIS) | EXIS, the Questionnaire on Experience in Private Social Systems, measures on basis of 12 items the degree of belonging, autonomy, accord, and confidence in the social system described as important within the past 2 weeks. | Baseline, Change in 10th hour of intervention, Change in 3 months after intervention | 
| Burden Assessment Scale (BAS) | The BAS uses 19 items to survey personal stress, feelings of guilt, the need to interrupt and postpone important matters, and a changed and altered perspective of time in relation to the symptoms displayed by the ill relatives within the last 6 months. | Baseline, Change in 10th hour of intervention, Change in 3 months after intervention | 
| Wittener Ressources Questionnaire (WIRF) | WIRF captures resources on the basis of three domains of coping with general life experiences, difficult situations in the past, and current problems, using 12 items each. We will use the domain of coping with general life esperiences. | Baseline, Change in 10th hour of intervention, Change in 3 months after intervention | 
| Goal Attainement Scale (GAS) | GAS captures in free text the subjective goals of children and their significant others. These are classified using the Bern Inventory for Therapy (BIT-T): (1) coping with specific problems and symptoms, (2) interpersonal goals, (3) well-being, (4) existential issues, (5) personal growth, (6) residual category. | Baseline, Change in 10th hour of intervention, Change in 3 months after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pediatrics oncology, music therapy, children, family, significant others