title: Feasibility of a Trial on Improvisational Music Therapy for Children with Autism Spectrum Disorder.
abstract: BACKGROUND
  To conduct generalizable, rigorously designed, adequately powered trials investigating music therapy and other complex interventions, it is essential that study procedures are feasible and acceptable for participants. To date, only limited evidence on feasibility of trial designs and strategies to facilitate study implementation is available in the music therapy literature.
  
  
  OBJECTIVE
  Using data from a subsample of a multi-center RCT on improvisational music therapy (IMT) for autism spectrum disorder (ASD), this study aims to evaluate feasibility of study procedures, evaluate safety, document concomitant treatment, and report consistency of individuals' trends over time in chosen outcome measures.
  
  
  METHODS
  Children with ASD aged between 4 years, 0 months, and 6 years, 11 months, were randomly assigned to one of three conditions: one (low intensity) vs. three weekly IMT sessions (high intensity) for five months vs. standard care. Feasibility was evaluated by examining recruitment, implementation of study conditions, assessment procedures, blinding, and retention; we also evaluated safety, concomitant treatment, and consistency of changes in standardized scales completed by blinded assessors and parents before and 5 months after randomization.
  
  
  RESULTS
  Within this subsample (n = 15), recruitment rates, session attendance in the high-intensity condition, and consistency between outcome measures were lower than expected. Session attendance in the low-intensity and control conditions, treatment fidelity, measurement completion, blinding, retention, and safety met a priori thresholds for feasibility.
  
  
  CONCLUSIONS
  By discussing strategies to improve recruitment and to minimize potential burden on study participants, referrers, and researchers, this study helps build knowledge about designing and implementing trials successfully.
authors.affiliation: Aalborg University, Denmark; GAMUT - Grieg Academy Music Therapy Research Centre, Uni Research Health, Bergen, Norway Aalborg University, DenmarkGAMUT - Grieg Academy Music Therapy Research Centre, Uni Research Health, Bergen, NorwayGAMUT - Grieg Academy Music Therapy Research Centre, Uni Research Health, Bergen, Norway monika.geretsegger@uni.no.
authors.forename: Monika
authors.initials: M
authors.lastname: Geretsegger
authors.affiliation: Aalborg University, Denmark; GAMUT - Grieg Academy Music Therapy Research Centre, Uni Research Health, Bergen, Norway Aalborg University, DenmarkGAMUT - Grieg Academy Music Therapy Research Centre, Uni Research Health, Bergen, NorwayGAMUT - Grieg Academy Music Therapy Research Centre, Uni Research Health, Bergen, Norway.
authors.forename: Ulla
authors.initials: U
authors.lastname: Holck
authors.affiliation: Aalborg University, Denmark; GAMUT - Grieg Academy Music Therapy Research Centre, Uni Research Health, Bergen, Norway Aalborg University, DenmarkGAMUT - Grieg Academy Music Therapy Research Centre, Uni Research Health, Bergen, NorwayGAMUT - Grieg Academy Music Therapy Research Centre, Uni Research Health, Bergen, Norway.
authors.forename: Łucja
authors.initials: Ł
authors.lastname: Bieleninik
authors.affiliation: Aalborg University, Denmark; GAMUT - Grieg Academy Music Therapy Research Centre, Uni Research Health, Bergen, Norway Aalborg University, DenmarkGAMUT - Grieg Academy Music Therapy Research Centre, Uni Research Health, Bergen, NorwayGAMUT - Grieg Academy Music Therapy Research Centre, Uni Research Health, Bergen, Norway.
authors.forename: Christian
authors.initials: C
authors.lastname: Gold
mesh_terms: D001317:Austria; D000067877:Autism Spectrum Disorder / Q000628:therapy*; D002648:Child; D002675:Child, Preschool; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008297:Male; D009147:Music Therapy / Q000379:methods*; D010290:Parents; D010865:Pilot Projects; D016896:Treatment Outcome
keywords: complex intervention; feasibility; internal pilot; retention