Specialty: Children, Primary sub-specialty: General Paediatrics
Conditions
Interventions
This 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
Sponsors
Benetalk Ltd
Eligibility
Sex/Gender
All
Age
8 Years to 65 Years
Inclusion criteria
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 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.
Exclusion criteria
Exclusion criteria: Main 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility outcomes: Eligibility rate measured using screening logs at baseline;Feasibility outcomes: Approach rate measured using site recruitment logs at baseline;Feasibility outcomes: Consent rate measured using consent forms at baseline;Feasibility outcomes: Randomisation rate measured using trial database records at baseline;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;Feasibility outcomes: Participation rate measured using trial database records at baseline and throughout the study duration;Feasibility outcomes: App usage measured using SuperPenguin app analytics (time spent and modules completed) at the study duration;Feasibility outcomes: Treatment allocation adherence measured using trial database records at the study duration;Feasibility outcomes: Reasons for non-randomisation and dropouts measured using site logs and participant feedback at the study duration | — |
Secondary
| Measure | Time frame |
|---|---|
| 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;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;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;Service-use costs measured using the Resource Use Questionnaire at therapy start, 4 months post-therapy start, and 9 months post-therapy start;Therapy outcomes measured using the Dysfluency Therapy Outcome Measures (TOMs) at therapy start, 4 months post-therapy start, and 9 months post-therapy start;App usability measured using the mHealth App Usability Questionnaire (MAUQ) at 4 months post-therapy start;App usability and acceptability measured using semi-structured interviews with caregivers and SLTs at around 9 months;Child confidence and communication experiences measured using semi-structured interviews with children at around 9 months;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;Safety measured using adverse event logs and device-related event reports at the study duration | — |
Countries
England, United Kingdom
Contacts
Public ContactKirsty Brown
Outcome results
None listed