Co-creating SuperPenguin, a novel digital therapeutic solution for families with children who stammer to improve speech therapy outcomes and service efficiency within NHS: Product development, clinical feasibility, and economic assessment.

Research question Can the addition of a co-designed novel digital therapeutic solution for stammering to NHS speech therapy services be acceptable and feasible for parents/carers, clinical staff, and children?

Background Stammering is a neurodevelopmental speech disorder that disrupts speech fluency and negatively impacts quality of life, social and professional development, and parental mental health.

It occurs in 5-8% of children, typically between 2 and 6-years old, and persists after puberty in 1-2% of the general population. The male-to-female ratio is 4 to 1 [1].

Early intervention for Children who Stammer (CWS) is key, but in the UK access to treatment in the National Health Service (NHS) is severely restricted and with long waiting lists [2].

CWS care varies across the NHS, although it often occurs indirectly through parents/carers supported by Speech-Language Therapists (SLTs). Parents/carers learn to reduce anxiety and shame in CWS while encouraging communication.

No digital solutions exist to provide ongoing support to parents/carers of CWS, and an unmet clinical need exists to help CWS and their families improve outcomes and prevent relapses or mental health complications. Objectives Develop SuperPenguin (TRL7) addressing the needs of CWS, parents/carers, and SLTs.

Perform randomised controlled feasibility study with parents/carers of children under 8 old and those aged 8-12 to assess the feasibility and acceptability of SuperPenguin in the NHS and to inform a definitive randomised controlled trial (RCT). Evaluate the regulatory and economic viability to develop a commercial and effective NHS adoption plan.

Methods Data from semi-structured interviews and focus groups (with both SLTs and parents/carers) will drive SuperPenguin development. Three Develop-Build-Test-Learn cycles for each age group will be completed to ensure acceptability and reliability.

A 2-arm randomised clinical feasibility study will be conducted across 3 NHS sites, recruiting parents/carers of CWS (n=68). Outcome measures include feasibility outcomes, and Palin Parent Rating Scales (PPRS).

A preliminary analysis of the economic viability, value proposition, and Digital Technology Assessment Criteria for SuperPenguin will guide the development of a commercialisation/NHS adoption plan, as well as a regulatory roadmap to ensure SuperPenguin is compliant with UKCA/CE mark requirements (post-project).

Timelines for delivery For parents/carers of children under 8 (months) For parents/carers of children aged 8-12 (months) Product development 18 12 Recruitment 6 9 Feasibility study 7 11 Dissemination, project studies reports and commercialisation plan 5 4 36 36 Impact and Dissemination This project can positively impact NHS stammering pathways by addressing a significant unmet need, reducing demands on NHS services, and providing a more cost-effective treatment across the UK.

Furthermore, the technology behind SuperPenguin may be developed to address other speech therapy conditions to benefit more patients.

Findings will contribute to the evidence base regarding digital solutions for speech therapy and will be disseminated in scientific journals and through engaged charity partners.