SUPPORT: Supporting Caregivers with a mobile app for children who stammer aged 8–12 years
| ISRCTN | ISRCTN60636241 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN60636241 |
| IRAS number | 333572 |
| Secondary identifying numbers | CPMS 58389, NIHR206439 |
- Submission date
- 24/07/2025
- Registration date
- 05/08/2025
- Last edited
- 05/08/2025
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
This study is exploring a new mobile app called Super Penguin, designed to support families of children who stammer. The app was co-created with parents 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. The 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 8 to 12 years 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 four months later, and again five months after that. The study fits around normal NHS therapy appointments and lasts up to 11 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?
July 2025 to July 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
Public, Scientific, Principal Investigator
Flat 7 Foxgrove House
Foxgrove Road
Beckenham
BR3 5AR
United Kingdom
| Phone | +44 2080500402 |
|---|---|
| ronan@benetalk.com |
Study information
| Study design | Interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Internet/virtual |
| Study type | Treatment |
| Scientific title | The SUPPORT Study: Supporting Caregivers with a mobile app for children who stammer aged 8–12 years: 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 8-12 years old who stammer |
| Study acronym | SUPPORT |
| 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: 1. Usability, Safety and Acceptability: To assess the safety, usability and acceptability of the SuperPenguin app among caregivers and SLTs. 2. Caregiver Engagement: To evaluate caregiver engagement with the app. 3. Caregiver confidence and anxiety reduction. 4. Intervention fidelity: to assess whether the intervention has been delivered to caregivers the way it was anticipated. 5. Economic viability: To make a preliminary assessment of the economic viability of SuperPenguin implementation into NHS pathways. |
| Ethics approval(s) |
Submitted 14/07/2025, London - Brent Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 2071048131; brent.rec@hra.nhs.uk), ref: 25/PR/0918 |
| Health condition(s) or problem(s) studied | Stammer |
| Intervention | This project is a multi-centre, two-arm, mixed-methods, open-label randomised controlled feasibility study. We will recruit 34 parents or main caregivers of 8- to 12-year-old children 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 11 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 four months later—or sooner if therapy finishes early—and (4) five 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 type | Behavioural |
| Primary outcome measure | Feasibility outcomes: 1. Eligibility rate is measured using screening logs at baseline 2. Approach rate is measured using site recruitment logs at baseline 3. Consent rate is measured using consent forms at baseline 4. Randomisation rate is measured using trial database records at baseline 5. Completion rate of outcome measures is measured using questionnaire return logs at baseline, therapy start, 4 months post-therapy start, and 9 months post-therapy start 6. Participation rate is measured using trial database records at baseline and throughout the study duration 7. App usage is measured using SuperPenguin app analytics (time spent and modules completed) throughout the study duration 8. Treatment allocation adherence is measured using trial database records throughout the study duration 9. Reasons for non-randomisation and dropouts are measured using site logs and participant feedback throughout the study duration |
| Secondary outcome measures | 1. Caregiver confidence is 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 are 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 is 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 are measured using the Resource Use Questionnaire at therapy start, 4 months post-therapy start, and 9 months post-therapy start 5. Therapy outcomes are 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 is measured using the mHealth App Usability Questionnaire (MAUQ) at 4 months post-therapy start 7. App usability and acceptability are measured using semi-structured interviews with caregivers and SLTs at around 9 months 8. Child confidence and communication experiences are measured using semi-structured interviews with children at around 9 months 9. Economic viability is 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 is measured using adverse event logs and device-related event reports throughout the study duration |
| Overall study start date | 14/07/2025 |
| Completion date | 30/06/2027 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 8 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 34; UK Sample Size: 34 |
| Key inclusion criteria | Main 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 practice. Their child is 8-12 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 8-12 years 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 criteria | Main feasibility study: 1. Caregivers are unable to provide informed consent. Are unable or unwilling to complete study assessments in English. 2. Families with more than one child who stammers, 8-12 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 enrolment | 22/09/2025 |
| Date of final enrolment | 30/06/2026 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Fieldhead Hospital
Ouchthorpe Lane
Wakefield
WF1 3SP
United Kingdom
110-120 Eureka Park
Eureka Business Park
Ashford
TN25 4AZ
United Kingdom
Kingston upon Thames
KT2 7QB
United Kingdom
Sponsor information
Industry
Flat 7 Foxgrove House
Beckenham
BR3 5AR
England
United Kingdom
| Phone | +44 2080500402 |
|---|---|
| ronan@benetalk.com |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date |
Editorial Notes
24/07/2025: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).
