Stammer Mental and Behavioural Disorders Stuttering, stammering
Conditions
Interventions
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 re
Sponsors
Benetalk Ltd
Eligibility
Sex/Gender
All
Age
8 Years to 12 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 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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
England, United Kingdom
Contacts
Public ContactRonan Miller
Outcome results
None listed