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

Abstract

Background The Rotterdam Evaluation Study of Stuttering Therapy randomized trial (RESTART) was seminal, comparing the Lidcombe Program with RESTART Demands and Capacities Model‐based treatment (RESTART‐DCM) for pre‐school age children who stutter. Aims To critique the methods of the RESTART trial to develop guidelines for its systematic replication and extension. Beyond that, to contribute to the refinement of existing methodological guidelines for early stuttering intervention. Method The discussion is organized around methodological issues of primary outcomes, treatment completion, clinician allegiance, treatment fidelity, age exclusions and no‐treatment control reasoning. Main Contribution We recommend six methodological guidelines to guide future clinical trials comparing the Lidcombe Program with RESTART‐DCM, which can be applied to clinical trials of other early stuttering intervention methods: (1) incorporate a continuous measure of primary outcome; (2) ensure that all children in clinical trials have completed treatment; (3) eliminate potential bias due to clinician allegiance; (4) establish treatment fidelity within and beyond the clinic; (5) include children younger than 3 years in clinical trials; and (6) establish an estimate of treatment effect size at some stage of treatment development. Conclusion In addition to guiding future clinical research comparing RESTART‐DCM and Lidcombe Program treatment, these recommendations may extend to influence positively other treatment developments for early stuttering.

Early Childhood Professionals' Management of Young Children Who Stutter: A Cross-Sectional Study

“…Common responses reported by early childhood professionals during their initial contact with parents who report that their child is stuttering varied between groups. A "wait and see" approach was reported by many public health nurses and preschool teachers while, as expected, very few SLPs reported that they use this approach as current management recommendations advocate for intervention to de delivered as close as possible to stuttering onset (see Onslow & Lowe, 2019). Based on data collected it is unknown what professional's motives for recommending a "wait and see" approach were or how long they recommended this approach for.…”

“…For those children who do not recover, early intervention can foster the development of positive communication attitudes and build resilience in CWS against potential negative reactions they may experience from listeners (Byrd & Donaher, 2018;de Sonneville-Koedoot et al, 2015). The promising effectiveness of early intervention coupled with the knowledge that children as young as 3 years of age can be socially and emotionally affected by stuttering (McAllister, 2016) therefore reinforces the critical need for all children to receive effective care as close as possible to stuttering onset (Onslow & Lowe, 2019).…”