An interventional study of Interaction-focused Music Therapy with Children and Significant Others (INMUT-KB) (exp. group) and Music Therapy with Children (MUT-K) (exp. group) in Pediatric Cancer, sponsored by University of Witten/Herdecke. Recruiting at 3 sites in Germany. Open to participants aged 5 Years to 13 Years. Per ClinicalTrials.gov, last updated 2024-05-09.
Sponsored by University of Witten/Herdecke · Not applicable, Interventional, and Treatment
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.
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Inclusion Criteria, Children:
Exclusion Criteria, Children:
Inclusion Criteria, Important Reference Persons:
Exclusion Criteria, Important Reference Persons:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
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)
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)
Interaction-focused music therapy with children with cancer and their significant others, delivered by trained music therapists.
Interaction-focused music therapy with children with cancer without the involvement of significant others, delivered by trained music therapists.
Study participants randomized to this group receive the intervention INMUT 10 weeks after the experimental groups.
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.
Time frame: Baseline, Change in 10th hour of intervention
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, Change in 10th hour of intervention, Change in 3 months after intervention
Plan to share: No
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University of Witten/Herdecke