title: Direct versus Indirect Treatment for Preschool Children who Stutter: The RESTART Randomized Trial.
abstract: OBJECTIVE
  Stuttering is a common childhood disorder. There is limited high quality evidence regarding options for best treatment. The aim of the study was to compare the effectiveness of direct treatment with indirect treatment in preschool children who stutter.
  
  
  METHODS
  In this multicenter randomized controlled trial with an 18 month follow-up, preschool children who stutter who were referred for treatment were randomized to direct treatment (Lidcombe Program; n = 99) or indirect treatment (RESTART-DCM treatment; n = 100). Main inclusion criteria were age 3-6 years, ≥3% syllables stuttered (%SS), and time since onset ≥6 months. The primary outcome was the percentage of non-stuttering children at 18 months. Secondary outcomes included stuttering frequency (%SS), stuttering severity ratings by the parents and therapist, severity rating by the child, health-related quality of life, emotional and behavioral problems, and speech attitude.
  
  
  RESULTS
  Percentage of non-stuttering children for direct treatment was 76.5% (65/85) versus 71.4% (65/91) for indirect treatment (Odds Ratio (OR), 0.6; 95% CI, 0.1-2.4, p = .42). At 3 months, children treated by direct treatment showed a greater decline in %SS (significant interaction time x therapy: β = -1.89; t(282.82) = -2.807, p = .005). At 18 months, stuttering frequency was 1.2% (SD 2.1) for direct treatment and 1.5% (SD 2.1) for indirect treatment. Direct treatment had slightly better scores on most other secondary outcome measures, but no differences between treatment approaches were significant.
  
  
  CONCLUSIONS
  Direct treatment decreased stuttering more quickly during the first three months of treatment. At 18 months, however, clinical outcomes for direct and indirect treatment were comparable. These results imply that at 18 months post treatment onset, both treatments are roughly equal in treating developmental stuttering in ways that surpass expectations of natural recovery. Follow-up data are needed to confirm these findings in the longer term.
  
  
  BACKGROUND
  isrctn.org ISRCTN24362190.
authors.affiliation: Institute of Health Policy and Management, Erasmus University Rotterdam, Rotterdam, the Netherlands; Speech and Hearing Center, Department of Otorhinolaryngology, Sophia Children's Hospital, Erasmus University Medical Center, Rotterdam, the Netherlands.
authors.forename: Caroline
authors.initials: C
authors.lastname: de Sonneville-Koedoot
authors.affiliation: Institute of Health Policy and Management, Erasmus University Rotterdam, Rotterdam, the Netherlands.
authors.forename: Elly
authors.initials: E
authors.lastname: Stolk
authors.affiliation: Department of Linguistics, Radboud University Nijmegen, Nijmegen, the Netherlands.
authors.forename: Toni
authors.initials: T
authors.lastname: Rietveld
authors.affiliation: Speech and Hearing Center, Department of Otorhinolaryngology, Sophia Children's Hospital, Erasmus University Medical Center, Rotterdam, the Netherlands.
authors.forename: Marie-Christine
authors.initials: MC
authors.lastname: Franken
mesh_terms: D001521:Behavior Therapy; D002648:Child; D002675:Child, Preschool; D018479:Early Intervention, Educational; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D011788:Quality of Life; D013068:Speech Production Measurement; D013070:Speech Therapy; D013342:Stuttering / Q000523:psychology / Q000628:therapy*; D016896:Treatment Outcome