DESIGN: A UK arm of the multicentre international ‘TIME-A’ study. The study is a three arm, parallel group, researcher-blind, randomised trial. SETTING: NHS community paediatric and children’s mental health services in six sites: Bedfordshire, Cambridge and Peterborough, and three London boroughs. TARGET POPULATION: Children aged 4 to 7 years old, who have autism spectrum disorder (ASD) and are in contact with primary or secondary care NHS services. INCLUSION CRITERIA: i) Aged between 4:0 and 6:11 ii) Have a clinical diagnosis of autism spectrum disorder iii) Meet diagnostic criteria for ASD on the Autism Diagnostic Observation Schedule [1] and on two of three domains of the Autism Diagnostic Interview-Revised (ADI-R) [2] iv) Main carer provides written informed consent. EXCLUSION CRITERIA: i) Severe sensory impairment (blindness or deafness). (ii) Already receiving music therapy or has done so in the past. HEALTH TECHNOLOGIES BEING ASSESSED: Improvisational music therapy. We have selected this form of music therapy as it is the type that is most widely used in the NHS for children with ASD, and evidence from small-scale trials suggests it is effective [3-6]. All those in the trial will receive enhanced treatment as usual: in addition to usual care from primary and secondary care, parents/ guardians will receive three counselling sessions delivered over a five month period. These sessions will be delivered by experienced clinicians who receive regular supervision, and will comprise psychoeducation, information about support organisations and support in coping with current problems in accordance with national guidelines [7]. In addition to this, those in one of the two active treatment arms of the trial will be offered either: Low-intensity music therapy: weekly sessions for five months, or High-intensity music therapy: sessions three times a week for five months. All music therapy sessions will last 30 minutes, and be delivered by trained music therapists who have experience of working with children with ASD and are registered with the Health Care Professions Council. Therapists will deliver improvisational music therapy in accordance with consensus guidelines which have been developed from practice in previous studies [3-6]. This approach involves therapists attuning to the child’s behaviour through improvisational techniques, including making co-improvised music. While engaging in joint musical activities the child is offered opportunities to develop and enhance their communication skills, including affect sharing, imitation, joint attention and turn-taking, all of which are associated with later development of social competency [8,9]. To ensure treatment fidelity, therapists will be asked to document and video-record the sessions. Notes will be used during monthly supervision sessions and video-recordings will be monitored by the lead music therapist in the study. MEASUREMENT OF COST AND OUTCOMES: At baseline we will establish eligibility using the Autism Diagnostic Interview-Revised (ADI-R) [2] and assess the child’s level of cognitive ability using the Kaufman Assessment Battery for Children [10]. The primary outcome measure is the severity of autism symptoms measured using the social communication algorithm which is derived from the ADOS [1] which will be assessed by a trained researcher who is masked to allocation status. We have selected this measure because of its strong psychometric properties, including sensitivity to change [1] and because it has been widely used in other randomised trials of children with autism [11-13]. Secondary outcomes are: 1) Social Responsiveness Scale [14] - a carer based assessment of the severity of autism spectrum symptoms that has high inter-rater and test-retest reliability [15-16]. 2) The Short-Form Parenting Stress index [17]. A widely used measure of difficulties in parent-child interactions. 3) Warwick and Edinburgh Mental Wellbeing Scale, a short validated measure of parental mental well-being [33]. 4) Resource use, using an amended version of the using the Child and Adolescent Service Use Schedule (CA-SUS) and the Carer Service Use Schedule (CARER-SUS), which will embed an amended version of the Children and Adolescent Mental Health Services Receipt Inventory- European Version [18]. These measures include questions on a broad range of health, education and social costs. The economic evaluation will be conducted from the societal perspective, covering service use and any productivity losses. Unit costs will be attached to resource use, using the best available estimates of marginal opportunity cost, to obtain a cost per participant over the entire period of the trial. All outcome measures will be assessed at baseline, five and 12 months after randomisation. STUDY LOGISTICS: For details of recruitment, please see Flow Diagram. Study participants will be randomised by a remote service (based in Norway) using an allocation ratio of 1:1:2 (high intensity music therapy: low intensity music therapy: control treatment). We will use block randomisation with randomised block sizes of 4 or 8. SAMPLE SIZE: A sample of 235 patients would provide 90% power to detect a medium effect size of the intervention on the social communication scale of the ADOS score at 12 months with a 5% level of statistical significance. To take account of clustering and loss to follow-up we must recruit 300 children and their families. To achieve this sample the TIME-A team are seeking 100 recruits in the UK. This sample will be large enough to ensure that the total sample required for the main TIME-A study is achieved, as well as providing valuable information about the impact of this intervention in the NHS. TIMETABLE: Lead-in period: obtain ethical approval, recruitment of research staff. Months 1-3: Publicise trial, train therapists and research assistants. Months 4-15: Recruit participants (at a rate of 4.2 participants per researcher per month) Months 9-27: Collect follow up data. Months 28-30: Analyse data and implement dissemination plan. EXPERTISE IN THE TEAM: The proposal is submitted by a multidisciplinary team that includes experts in autism, music therapy, clinical trials, psychology, child psychiatry, statistics health economics, and a parent of a child with autism.
Interagency Autism Coordinating Committee (IACC)
Autism Research Database (AFD)
