Direct versus Indirect Treatment for Preschool Children who Stutter: The RESTART Randomized Trial

Abstract

ObjectiveStuttering 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.MethodsIn 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.ResultsPercentage 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.ConclusionsDirect 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.Trial Registrationisrctn.org ISRCTN24362190

After the RESTART trial: six guidelines for clinical trials of early stuttering intervention

“…The primary trial outcome was a dichotomous measure of ‘the percentage of non‐stuttering children at 18 months,’ ‘operationalized as ≤1.5% syllables stuttered’ (de Sonneville‐Koedoot et al . : 4). The outcome was obtained from three 10–15‐min audio recordings after the start of treatment from beyond‐clinic speaking situations.…”

“…Secondary outcomes established no evidence of any outcome differences between the two treatments: ‘most outcome measures were slightly in favor of the direct approach (LP), but the few significant interaction terms were deemed negligible due to their small effect sizes’ (de Sonneville‐Koedoot et al . : 11). The %SS secondary outcome is shown in Figure .…”

“…The scope of this issue is not clear in the report, with the only indication being that 28% of children in Lidcombe Program arm and 35% of children in the RESTART‐DCM arm ‘were still on treatment’ (de Sonneville‐Koedoot et al . : 11). Regardless, it seems self‐evident that a fundamental feature of pragmatic clinical trials is that treatments are evaluated in their entireties.…”

The Pathogenesis, Assessment and Treatment of Speech Fluency Disorders

“…• In children, strong evidence supports the Lidcombe method, which is based on the principle of operant learning and is delivered in constant collaboration with the parents (28)(29)(30)(31). Fluent speech is positively reinforced, and if stuttering events occur these are gently corrected.…”

“…This should be used in children aged 3-6. Strong evidence supporting this approach comes from a single Dutch study (30). Medication treatments shall not be used (strong negative evidence [32]).…”