INMUT: Music Therapy With Cancer Affected Children and Their Families

Sponsor
University of Witten/Herdecke (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05534282
Collaborator
Heidehof Foundation Stuttgart (Other), Community Hospital Herdecke (Other), Nordoff/Robbins Music Therapy Center Witten (Other), Interprofessional Graduate Programm in Integrative Medicine IGIM (Other)
52
3
23

Study Details

Study Description

Brief Summary

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 (MUT-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.

Condition or Disease Intervention/Treatment Phase
  • 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 (INMUT-KB) (control group)
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
52 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Interaction-focused Music Therapy With Cancer Affected Children and Their Significant Others: a Randomized Controlled Feasibility Study With Subsequent Intervention (INMUT)
Anticipated Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Aug 31, 2024
Anticipated Study Completion Date :
Nov 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Interaction-focused Music Therapy with Children and Significant Others (INMUT-KB) (exp. group)

Interaction-focused Nordoff/Robbins 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 Nordoff/Robbins music therapy with children with cancer and their significant others, delivered by trained music therapists.

Experimental: Music Therapy with Children (MUT-K) (exp. group)

Interaction-focused Nordoff/Robbins 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)
Interaction-focused Nordoff/Robbins music therapy with children with cancer without the involvement of significant others, delivered by trained music therapists.

Experimental: Interaction-focused Music Therapy with Children and Significant Others (INMUT-KB) (control 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 (INMUT-KB) (control group)
Study participants randomized to this group receive the intervention INMUT 10 weeks after the experimental groups.

Outcome Measures

Primary Outcome Measures

  1. Assessment of Parent-Child Interaction (APCI) [Baseline, Change in 10th hour of intervention]

    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.

Secondary Outcome Measures

  1. KINDL-Children/YouthVersion, Modul Oncology [Baseline, Change in 10th hour of intervention, Change in 3 months after intervention]

    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.

  2. Symptom Checklist-K-9 (SCL-9k) [Baseline, Change in 10th hour of intervention, Change in 3 months after intervention]

    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.

  3. Experience in Social Systems Questionnaire (EXIS) [Baseline, Change in 10th hour of intervention, Change in 3 months after intervention]

    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.

  4. Burden Assessment Scale (BAS) [Baseline, Change in 10th hour of intervention, Change in 3 months after intervention]

    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.

  5. Wittener Ressources Questionnaire (WIRF) [Baseline, Change in 10th hour of intervention, Change in 3 months after intervention]

    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.

  6. Goal Attainement Scale (GAS) [Baseline, Change in 10th hour of intervention, Change in 3 months after intervention]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Years to 12 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Witten/Herdecke
  • Heidehof Foundation Stuttgart
  • Community Hospital Herdecke
  • Nordoff/Robbins Music Therapy Center Witten
  • Interprofessional Graduate Programm in Integrative Medicine IGIM

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Constance Boyde, cand. Dr., University of Witten/Herdecke
ClinicalTrials.gov Identifier:
NCT05534282
Other Study ID Numbers:
  • INMUT
First Posted:
Sep 9, 2022
Last Update Posted:
Sep 9, 2022
Last Verified:
Sep 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Constance Boyde, cand. Dr., University of Witten/Herdecke

Study Results

No Results Posted as of Sep 9, 2022