SUPPORT: Supporting caregivers with a mobile app for children who stammer aged under 8 years old

ISRCTN ISRCTN11672383
DOI https://doi.org/10.1186/ISRCTN11672383
Integrated Research Application System (IRAS) 333389
Central Portfolio Management System (CPMS) 58386
National Institute for Health and Care Research (NIHR) 206439
Sponsor Benetalk Ltd
Funder National Institute for Health and Care Research
Submission date
18/03/2026
Registration date
23/03/2026
Last edited
23/03/2026
Recruitment status
Recruiting
Overall study status
Ongoing
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
This study is exploring a new mobile app called SuperPenguin, designed to support families of children who stammer. The app was co-created with parents of children who stammer and speech and language therapists and is meant to be used alongside regular NHS speech and language therapy. It offers personalised exercises and resources to help parents feel more confident in supporting their child's communication and aims to reduce stress and anxiety. This study will help researchers decide whether to run a larger trial in the future and how best to do that across the UK.

Who can participate?
Parents or main caregivers of children aged under 8 years old who have been referred for NHS speech and language therapy for stammering and are assessed as needing therapy.

What does the study involve?
Participants will be asked to complete online questionnaires at four different times: before therapy starts, when therapy begins, about 2 months later, and again 3 months after that. The study fits around normal NHS therapy appointments and lasts up to 7 months from the time of consent.

What are the possible benefits and risks of participating?
The app may help parents feel more confident and less stressed when supporting their child's communication. There are minimal risks, though some users might find the app frustrating or difficult to use. Support will be available to help with any issues.

Where is the study run from?
BeneTalk Ltd (UK).

When is the study starting and how long is it expected to run for?
March 2026 to June 2027.

Who is funding the study?
National Institute for Health and Care Research (NIHR) (UK).

Who is the main contact?
Dr Ronan Miller, ronan@benetalk.com

Contact information

Dr Trish Holch
Principal investigator

Chief Investigator, Leeds Beckett University
-
LS1 3HE
United Kingdom

ORCiD logo 0000-0002-4255-8315
+44 0113 812 4950
t.holch@leedsbeckett.ac.uk
Kirsty Brown
Public, Scientific

Clinical trial manager, Derby Clinical Trials Support Unit, Medical School, Office 5033. Royal Derby Hospital
Derby
DE22 3DT
United Kingdom

kirsty.brown69@nhs.net

Study information

Primary study designInterventional
AllocationRandomized controlled trial
MaskingBlinded (masking used)
ControlActive
AssignmentParallel
PurposeTreatment
Participant information sheet 49227_PIS Under 8's_V2.0_06Feb2026.pdf
Scientific titleThe SUPPORT Study: Supporting Caregivers with a mobile app for children who stammer aged under 8 years old: A mixed method, randomised controlled, open label, multi-centre study to investigate the feasibility and acceptance of the Super Penguin mobile application plus usual care compared to usual care alone in families of children aged under 8 years old years old who stammer
Study acronymThe SUPPORT Study - Under 8's (WP6)
Study objectives Primary objective
To evaluate the feasibility of the SuperPenguin app as an adjunct to standard NHS speech and language therapy for caregivers of children who stammer (CWS).

Secondary objectives
a. Usability, Safety and Acceptability: To assess the safety, usability and acceptability of the SuperPenguin app among caregivers and SLTs. 
b. Caregiver Engagement: To evaluate caregiver engagement with the app. 
c. Caregiver confidence and anxiety reduction.  
d. Intervention fidelity: to assess whether the intervention has been delivered to caregivers the way it was anticipated.  
e. Economic viability:  To make a preliminary assessment of the economic viability of SuperPenguin implementation into NHS pathways. 
Ethics approval(s)

Approved 26/02/2026, South West - Cornwall and Plymouth Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 0207 104 8071; cornwallandplymouth.rec@hra.nhs.uk), ref: 26/SW/0014

Health condition(s) or problem(s) studiedSpecialty: Children, Primary sub-specialty: General Paediatrics; Health Category: Neurological; Disease/Condition: Behavioural and emotional disorders with onset usually occurring in childhood and adolescence
InterventionThis project is a multi-centre, two-arm, mixed-methods, open-label randomised controlled feasibility study. The study will recruit 34 parents or main caregivers of children aged under 8 years old who have been referred to NHS speech-and-language therapy (SLT) for stammering. After giving consent, each caregiver is randomly allocated—by computer, in a 1:1 ratio—to either (a) a control group that follows standard NHS SLT only or (b) an intervention group that follows the same NHS SLT plus receives free access to the SuperPenguin mobile app, which provides practical activities and guidance for supporting their child at home. Because families will know whether they are using the app, there is no blinding.

Participation in the study will be for a maximum of 7 months and fits entirely around normal SLT appointments; no extra clinic visits are added. Caregivers complete the same online questionnaires at four points: (1) up to two months before therapy begins (baseline and randomisation), (2) on the day therapy starts, (3) roughly two months later—or sooner if therapy finishes early—and (4) three months after that. The questionnaires cover parental confidence (PPRS), therapy goals (SFBT), quality of life (EQ-5D-3L) and service-use costs; the child’s SLT also records a routine rating (TOMs) at points 2-4. Intervention-group parents complete one additional usability survey (MAUQ) about the app. Alongside these quantitative measures, an embedded qualitative study will invite up to 10 caregivers, 10 children and 10 SLTs to take part in voluntary Microsoft Teams interviews (30–45 minutes) to explore the app’s usability, acceptability and the practicality of the study procedures; some participants may have a follow-up chat later.
Intervention typeDevice
PhaseNot Applicable
Drug / device / biological / vaccine name(s)SuperPenguin mobile app
Primary outcome measure(s)
  1. Feasibility outcomes: Eligibility rate measured using screening logs at baseline
  2. Feasibility outcomes: Approach rate measured using site recruitment logs at baseline
  3. Feasibility outcomes: Consent rate measured using consent forms at baseline
  4. Feasibility outcomes: Randomisation rate measured using trial database records at baseline
  5. Feasibility outcomes: Completion rate of outcome measures measured using questionnaire return logs at baseline, therapy start, 4 months post-therapy start, and 9 months post-therapy start
  6. Feasibility outcomes: Participation rate measured using trial database records at baseline and throughout the study duration
  7. Feasibility outcomes: App usage measured using SuperPenguin app analytics (time spent and modules completed) at the study duration
  8. Feasibility outcomes: Treatment allocation adherence measured using trial database records at the study duration
  9. Feasibility outcomes: Reasons for non-randomisation and dropouts measured using site logs and participant feedback at the study duration
Key secondary outcome measure(s)
  1. Caregiver confidence measured using the Palin Parent Rating Scales (PPRS) at baseline, therapy start, 4 months post-therapy start, and 9 months post-therapy start
  2. Therapy goals measured using the Solution Focused Brief Therapy (SFBT) questionnaire at baseline, therapy start, 4 months post-therapy start, and 9 months post-therapy start
  3. Quality of life measured using the EQ-5D-3L questionnaire at baseline, therapy start, 4 months post-therapy start, and 9 months post-therapy start
  4. Service-use costs measured using the Resource Use Questionnaire at therapy start, 4 months post-therapy start, and 9 months post-therapy start
  5. Therapy outcomes measured using the Dysfluency Therapy Outcome Measures (TOMs) at therapy start, 4 months post-therapy start, and 9 months post-therapy start
  6. App usability measured using the mHealth App Usability Questionnaire (MAUQ) at 4 months post-therapy start
  7. App usability and acceptability measured using semi-structured interviews with caregivers and SLTs at around 9 months
  8. Child confidence and communication experiences measured using semi-structured interviews with children at around 9 months
  9. Economic viability measured using the EQ-5D-3L and Resource Use Questionnaire at therapy start, 4 months post-therapy start, and 9 months post-therapy start
  10. Safety measured using adverse event logs and device-related event reports at the study duration
Completion date30/06/2027

Eligibility

Participant type(s)
Age groupMixed
Lower age limit8 Years
Upper age limit65 Years
SexAll
Target sample size at registration34
Key inclusion criteriaMain feasibility study:
1. Caregivers must be 18 years or over
2. Their child has been referred for speech and language therapy for stammering and has been assessed as requiring access to speech and language therapy in line with usual NHS practice. Their child is under 8 years old.

Qualitative interviews:
1. Caregivers are taking part in the feasibility study and have been randomised to access the app. Are able to conduct online interviews in English.
2. Speech and language therapists who have randomised participants to access the app and can complete an online interview in English.
3. Children aged under 8 years old whose caregiver has been randomised to access the app. Are able to conduct an adult-led speaking activity in English. Has been referred for speech and language therapy support for stammering.
Key exclusion criteriaMain feasibility study:
1. Caregivers are unable to provide informed consent.
2. Are unable or unwilling to complete study assessments in English.
3. Families with more than one child who stammers, under 8 years old, and both have been referred for therapy.

Qualitative interviews:
1. Caregivers are unable to give informed consent.
2. Speech and language therapists who are unable to give informed consent.
3. Children whose caregiver has not provided informed consent for their participation in the interviews.
Date of first enrolment23/03/2026
Date of final enrolment31/08/2026

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centres

Fieldhead Hospital
Ouchthorpe Lane
Wakefield
WF1 3SP
England
Kent Community Health NHS Foundation Trust
Trinity House
110-120 Eureka Park
Eureka Business Park
Ashford
TN25 4AZ
England
Kingston and Richmond NHS Foundation Trust
Galsworthy Road
Kingston upon Thames
KT2 7QB
England
Kent Community Health NHS Foundation Trust
Trinity House
110-120 Eureka Park
Eureka Business Park
Ashford
TN25 4AZ
England

Results and Publications

Individual participant data (IPD) Intention to shareYes
IPD sharing planThe datasets generated and/or analysed during the current study are stored in non-public repositories and are available from the Sponsor upon reasonable request.
Contact for Access:
Requests should be directed to the study Sponsor, BeneTalk Ltd., via email to speak@superpenguin.com.
Repository / Storage Location:
The quantitative dataset is securely held in a validated electronic data capture system managed by the Derby Clinical Trials Support Unit (DCTSU).
The qualitative dataset (anonymised transcripts) is archived in the non-public Leeds Beckett University (LBU) Research Data Repository.
The integrated, final dataset will be held by the Sponsor (BeneTalk Ltd).
Type of Data Available:
Anonymised Individual Participant Data (IPD) will be shared. This includes the full quantitative dataset (demographics, PPRS, SFBT, TOMs, MAUQ, EQ5D-3L, Resource Use Questionnaires) and the fully anonymised qualitative interview transcripts.
Availability Timeline:
Data will be available for request 12 months after the publication of the study's main findings and will remain available for a period of 5 years.
Access Criteria:
Data will be shared with bona fide researchers at academic or non-commercial institutions for the purpose of ethically approved, non-commercial secondary research. A legally binding Data Sharing Agreement (DSA) must be executed before any data is transferred.
Access Mechanism:
Researchers must submit a formal written proposal outlining their research plan and ethical approval. Requests will be reviewed by a Data Access Committee, with final approval from the Joint Controllers (BeneTalk Ltd and Leeds Beckett University).
Consent and Anonymisation:
Consent for sharing anonymised data for future research was obtained from all participants.
The dataset will be fully anonymised by removing all direct identifiers (e.g., names, NHS number, contact details) and key indirect identifiers to minimise the risk of re-identification.
Ethical or Legal Restrictions:
The use of the data is strictly governed by the terms of the Data Sharing Agreement, which prohibits any attempt to re-identify participants. All data sharing will comply with UK GDPR and the Data Protection Act 2018.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Participant information sheet version 2.0 06/02/2026 23/03/2026 No Yes
Study website 23/03/2026 No No

Additional files

49227_PIS Under 8's_V2.0_06Feb2026.pdf
Participant information sheet

Editorial Notes

18/03/2026: Study's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).

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