Millard S K, Murphy S, Barton G, Rixon L, Shepstone L, Sims E, Joffe V
The Michael Palin Centre, Whittington Hospital NHS Trust, London, UK.
University of Befordshire, UK.
J Fluency Disord. 2025 Jun;84:106114. doi: 10.1016/j.jfludis.2025.106114. Epub 2025 Mar 1.
Despite a clear need for and evidence-based therapy for some children who stutter aged 8-14, there is no high-level evidence of effectiveness, with Speech and Language Therapists rating knowledge and confidence low. One programme which might address these needs, increase availability of services and improve outcomes, is Palin Stammering Therapy for School aged Children (Palin STSC(8-14)).
To investigate the feasibility of conducting a definitive randomised controlled trial comparing Palin STSC(8-14) with usual treatment. Objectives were to establish: recruitment and retention rates; appropriateness of the outcome measures; acceptability of the research and Palin STSC(8-14) therapy; treatment fidelity; and, appropriateness of the cost-effectiveness measures.
A two-arm, cluster-randomised trial, with randomisation of therapists, stratified by service. Children aged 8;0-14;11, and their parent(s), were allocated to therapist and completed questionnaires pre-therapy and six months later. Assessments were selected for their potential to measure or predict therapy outcome. Therapists completed measures at the start and end of the trial. A process analysis was conducted, incorporating semi-structured interviews and treatment fidelity examination.
Recruitment targets were exceeded (Children n = 67; SLTs n = 37). Research processes were largely acceptable, as was Palin STSC(8-14) therapy. Treatment fidelity was high, with SLT adherence at 85.7 % Mean number of sessions per child for Palin STSC(8-14) was 6.9 compared to 3.5 for usual treatment.
The feasibility targets were met. Based on recruitment, retention and adherence rates and our outcome measures, a full-scale randomised controlled trial appears feasible and warranted to assess the effectiveness of Palin STSC(8-14).
尽管8至14岁口吃儿童显然需要循证治疗，但目前尚无关于疗效的高级别证据，言语和语言治疗师对相关知识和信心的评价较低。一项可能满足这些需求、增加服务可及性并改善治疗效果的方案是学龄儿童佩林口吃治疗法（Palin STSC(8 - 14)）。
调查开展一项将Palin STSC(8 - 14)与常规治疗进行比较的确定性随机对照试验的可行性。目标是确定：招募率和保留率；结局指标的适用性；研究及Palin STSC(8 - 14)治疗的可接受性；治疗依从性；以及成本效益指标的适用性。
一项双臂整群随机试验，治疗师随机分组，按服务机构分层。年龄在8岁0个月至14岁11个月的儿童及其父母被分配给治疗师，并在治疗前和六个月后完成问卷调查。选择评估指标是因其具有测量或预测治疗效果的潜力。治疗师在试验开始和结束时完成测量。进行了一项过程分析，包括半结构化访谈和治疗依从性检查。
超过了招募目标（儿童n = 67；言语和语言治疗师n = 37）。研究过程在很大程度上是可接受的，Palin STSC(8 - 14)治疗也是如此。治疗依从性很高，言语和语言治疗师的依从率为85.7%。Palin STSC(8 - 14)治疗中每个儿童的平均治疗次数为6.9次，而常规治疗为3.5次。
达到了可行性目标。基于招募、保留和依从率以及我们的结局指标，开展一项全面的随机对照试验似乎可行且有必要，以评估Palin STSC(8 - 14)的有效性。
