Autism - Children's Improvisational Music Therapy Evaluation

Официальное название

A Randomised Controlled Trial on the Effectiveness of Improvisational Music Therapy for Autistic Children Aged 7 - 11 [Autism-CHIME Trial].

Обзор

The goal of this clinical trial is to evaluate the effectiveness of individual sessions of improvisational music therapy for autistic children aged 7 - 11. Researchers will compare the impact of adding improvisational music therapy to usual care alone for autistic children over a 12-week period. Participants will be randomly assigned to one of the following two conditions: the Improvisational Music Therapy (intervention) Group or the support as usual (control) Group. The aim is to achieve seven overarching objectives: 1. To determine whether 12 weeks of individual sessions of improvisational music therapy in addition to support as usual is superior to support as usual alone in improving social communication in autistic children. 2. To examine whether 12 weeks of individual sessions of improvisational music therapy in addition to support as usual is superior to support as usual alone in improving communication skills in autistic children. 3. To examine whether 12 weeks of individual sessions of improvisational music therapy in addition to support as usual is superior to support as usual alone in reducing psychosocial problems in autistic children. 4. To examine whether 12 weeks of individual sessions of improvisational music therapy in addition to support as usual is superior to support as usual alone in improving wellbeing of autistic children. 5. To examine whether 12 weeks of individual sessions of improvisational music therapy in addition to support as usual is superior to support as usual alone in improving adaptive functioning in autistic children. 6. To examine whether 12 weeks of individual sessions of improvisational music therapy in addition to support as usual is superior to support as usual alone in improving anxiety in autistic children. 7. To examine whether the therapeutic relationship predicts the development of social, communication and language skills among autistic children.

Подробное описание

Co-Chief Investigators Professor Simon Baron-Cohen Dr Carrie Allison Dr David M. Greenberg Dr. Jonathan Pool

Co-Investigators Dr Artur Jaschke

Advisor Emeritus Professor Helen Odell-Miller Dr. Claire Howlin

The Autism-CHIME trial is designed as a rigorous Randomised Controlled Trial (RCT) of individual sessions of improvisational music therapy with autistic children. The trial will be conducted in mainstream and special schools located in Cambridgeshire, Peterborough, London, and the South and East of England. The number of schools involved will depend on the number of eligible children willing to participate, with a minimum of 5-10 children per school.

Enrolled participants will undergo 1:1 block randomisation, to either support as usual plus improvisational music therapy sessions (intervention arm) or support as usual (control arm). Randomisation will occur after the baseline assessments have been completed. Participants will be stratified based on the version of the Brief Observation of Social Communication Change (BOSCC) that they are allocated (primary outcome measure): (1) Minimally Verbal, (2) Phrase Speakers, or (3) Fluent Speakers, so that there are equal numbers in each group, and that the control group and experimental group are balanced.

Data will be collected at different time points during the trial:

The first data collection point (T1) will be collected prior to randomisation (to establish eligibility to participate and assess baseline functioning), and at the primary endpoint T2 (13 weeks after randomisation; end of intervention) and the secondary endpoint T3 will be 39 weeks post-randomisation (i.e. 6 months after the end of music therapy).

The trial will finish after the final follow-up data collection from the participants is completed.

Вмешательства

• Поведенческое Improvisational Music Therapy
  The therapist engages with the child by playing and sharing musical instruments, and/or sings while being attuned to the child's behaviour and expression. Various improvisational techniques are employed to engage the child. There are opportunities for pulse, rhythmic, dynamic or melodic patterns, and timbre to be mirrored, reinforced, or complemented, which allows for moments of synchronization between the therapist and the child, giving the child's musical expressions a pragmatic meaning within

Первичные конечные точки

• Absolute change of the total score of the Brief Observation of Social Communication Change (BOSCC). One of three versions of the BOSCC will be used depending on the child's level of verbal communication. [Срок оценки: Baseline and at the end of intervention (13 weeks after randomisation).]

Вторичные конечные точки (8)

• Absolute change of the total score of the BOSCC. [Срок оценки: Baseline and 39 weeks after randomisation.]
• Absolute change of the total score of the Children's Communication Checklist-2 to test improvement in communication skills. [Срок оценки: Baseline, 13 and 39 weeks after randomisation.]
• Absolute change of the total score of the Strengths and Difficulties Questionnaire to test improvement in psychosocial difficulties [Срок оценки: Baseline, 13 and 39 weeks after randomisation.]
• Absolute change of the total score of the Young Child Outcome Rating Scale (YCORS) as a measure of wellbeing. [Срок оценки: Baseline, 13 and 39 weeks after randomisation.]
• Absolute change of the total score of the Vineland-3 Domain level parent/caregiver form to test improvement in adaptive functioning. [Срок оценки: Baseline, 13 and 39 weeks after randomisation.]
• Absolute change of the total score of the Parent-Rated Anxiety Scale (PRAS) for Youth with Autism Spectrum Disorder (ASD) as a measure of anxiety. [Срок оценки: Baseline, 13 and 39 weeks after randomisation.]
• Association between the therapeutic relationship and the development of social, communication and language skills. [Срок оценки: Weeks 1 and 12]
• Absolute change of the total score of the Music Therapy Communication and Social Interaction Scale (MTCSI) (or Music Engagement Scale, MES) based on video recordings. [Срок оценки: Weeks 1 and 12.]

Критерии участия

Критерии включения

• Aged 7 to 11 years.
• A clinical diagnosis of autism made by a qualified professional according to the International Classification of Diseases (ICD) 10th Revision criteria. Confirmed by a copy of the clinical report detailing the diagnosis (if available) or verified verbally by the child's parents.
• Parents/guardians must give informed consent for their children to be enrolled in the trial.
• Parents/guardians must be willing for the music therapy sessions and BOSCC assessments to be video recorded for monitoring and research purpose
• Participants must be willing to attend two music therapy sessions per week for the duration of the trial.
• Non-verbal children may be included

Критерии исключения

• Received regular individual music therapy in the preceding year as this would be likely to have a strong influence on the course of therapy.
• Severe hearing deficit as this would alter the aim, course, and implementation of therapy.
• Caregivers that are unable to attend for the psychological assessments with their child.
• Caregivers without a basic understanding of English.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Великобритания · 2 центра

• Anglia Ruskin University — Cambridge
• Autism Research Centre — Cambridge

Публикации

• Levitin, D. J. This is your brain on music: The science of a human obsession. vi, 314 (Dutton/Penguin Books, 2006).
• Savage PE, Loui P, Tarr B, Schachner A, Glowacki L, Mithen S, Fitch WT. Music as a coevolved system for social bonding. Behav Brain Sci. 2020 Aug 20;44:e59. doi: 10.1017/S0140525X20000333. PMID 32814608
• Sharda M, Tuerk C, Chowdhury R, Jamey K, Foster N, Custo-Blanch M, Tan M, Nadig A, Hyde K. Music improves social communication and auditory-motor connectivity in children with autism. Transl Psychiatry. 2018 Oct 23;8(1):231. doi: 10.1038/s41398-018-0287-3. PMID 30352997
• American Music Therapy Association (AMTA). https://www.musictherapy.org/.
• Diagnostic and statistical manual of mental disorders: DSM-5TM, 5th ed. xliv, 947 (American Psychiatric Publishing, Inc., 2013). doi:10.1176/appi.books.9780890425596.
• Kanner L. Autistic disturbances of affective contact. Acta Paedopsychiatr. 1968;35(4):100-36. No abstract available. PMID 4880460
• Stegemann T, Geretsegger M, Phan Quoc E, Riedl H, Smetana M. Music Therapy and Other Music-Based Interventions in Pediatric Health Care: An Overview. Medicines (Basel). 2019 Feb 14;6(1):25. doi: 10.3390/medicines6010025. PMID 30769834
• Lim HA, Draper E. The effects of music therapy incorporated with applied behavior analysis verbal behavior approach for children with autism spectrum disorders. J Music Ther. 2011 Winter;48(4):532-50. doi: 10.1093/jmt/48.4.532. PMID 22506303

Идентификаторы

NCT: NCT06016621 · PRE.2022.077 · ETH2223-3184

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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