- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07820982
DEVELOPMENT OF TRAINING PROTOCOL AND APPLICATION FOR SPEECH LANGUAGE PATHOLOGISTS ON TELETHERAPY: A CONTEMPORARY APPROACH TO SPEECH LANGUAGE THERAPY
The goal of this mixed-methods study is to develop and evaluate a teletherapy training protocol and a dedicated teletherapy application for Speech-Language Pathologists (SLPs) in Pakistan. It will also assess the effectiveness, usability, and acceptability of these tools among SLPs and patients receiving speech-language therapy services. The main questions it aims to answer are:
Can a standardized teletherapy training protocol be developed and validated for Speech-Language Pathologists? Can a teletherapy application improve the delivery and effectiveness of speech-language therapy services? What are the perceptions, experiences, and satisfaction levels of SLPs and patients regarding teletherapy? Does the use of the developed protocol and application improve the quality and accessibility of speech-language therapy services?
Researchers will assess the effectiveness of the developed protocol and application by comparing outcomes before and after implementation among Speech-Language Pathologists and patients receiving teletherapy services.
Participants will:
Complete questionnaires regarding teletherapy practices, satisfaction, effectiveness, and challenges.
Participate in structured interviews to share experiences and perceptions of teletherapy.
Contribute to the development and validation of a teletherapy training protocol through expert consultation.
Use the developed teletherapy application for speech and language intervention. Participate in evaluations to assess the effectiveness, usability, and acceptability of the protocol and application.
The expected outcome of the study is the development of a validated teletherapy protocol and a comprehensive teletherapy application that can standardize telepractice and improve the accessibility and quality of speech-language pathology services in Pakistan.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Teletherapy has emerged as an important mode of service delivery in speech-language pathology, particularly following the COVID-19 pandemic. Although teletherapy has been increasingly adopted worldwide, many Speech-Language Pathologists (SLPs) continue to face challenges related to the absence of standardized training, limited technological resources, and inconsistent clinical practices. In Pakistan, teletherapy services are being utilized by practitioners; however, there is currently no validated training protocol or comprehensive teletherapy application specifically designed to support speech-language pathology services.
This study aims to develop a standardized teletherapy training protocol and a dedicated teletherapy application for Speech-Language Pathologists. The study will employ a mixed-methods approach involving quantitative surveys and qualitative interviews with practicing SLPs to identify current teletherapy practices, challenges, training needs, and recommendations. Findings from these phases will be used to develop a protocol through expert consensus using the Delphi technique.
The proposed protocol will address essential operational and ethical aspects of teletherapy, including clinician competencies, client eligibility, technology requirements, service delivery procedures, documentation practices, privacy and confidentiality, informed consent, and quality assurance measures. Following protocol development, a teletherapy application will be designed to facilitate the delivery of speech and language intervention services for a range of communication disorders.
The psychometric properties of the developed protocol, including validity and reliability, will be evaluated. Subsequently, the protocol and application will be implemented in clinical practice to assess their effectiveness, usability, and acceptability among both clinicians and service recipients. Outcome measures will focus on user satisfaction, perceived effectiveness, feasibility, and the overall quality of teletherapy service delivery.
The anticipated outcome of this research is the establishment of an evidence-based framework for teletherapy in speech-language pathology, supported by a practical digital application. The findings are expected to contribute to the standardization of teletherapy practices, enhance access to speech-language services, and support the integration of telepractice into routine clinical care in Pakistan and similar healthcare settings.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
• The inclusion criteria will include Speech Language Pathologists from Pakistan that are actively involved in the profession.
- Speech language pathologists with minimum qualification of undergraduate degree in Speech language pathology and licensed SLP's working with patients through teletherapy mode will be included in the study.
- SLP's dealing with speech, language and communication problems will be included in the study.
- The patients or their guardians currently receiving speech language pathology services.
- Any age range of patients or guardians will be included in the study.
Exclusion Criteria:
• The exclusion criteria will not involve seminars or academic activities; it will not consider the therapeutic interventions used by other counselling or session-based therapists i.e., psychologists.
- Patients with psychological, visual impairment, physical limitations, and medical conditions such as cancer and other long-term diseases will be excluded from the study.
- The patients with swallowing disorder are excluded in the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: App-supported teletherapy
Speech and language therapy delivered through weekly live video sessions with a speech-language pathologist trained in the study teletherapy protocol, supported by the TeleSpeech application for home practice.
One 30-45 minute session per week for 12 weeks plus a home programme assigned in the application and practised on five days per week.
Delivered in the participant's home or a quiet room at the site.
|
Speech and language therapy delivered by a speech-language pathologist through scheduled live video sessions, supported by the TeleSpeech progressive web application for home practice.
One 30 to 45 minute individual session per week for 12 weeks, delivered in the participant's home or in a quiet room at the site where the family prefers that.
Between sessions, a home programme is assigned in the application by the treating therapist and practised on five days per week.
Therapy content and targets are individualised.
The treating therapist has completed the study teletherapy training protocol.
Adherence is captured automatically by the application, which timestamps each login, activity and completion, and session attendance is logged.
|
|
Active Comparator: Usual in-person therapy
Standard face-to-face speech and language therapy as currently delivered at the site by a speech-language pathologist in usual practice.
One 30-45 minute session per week for 12 weeks plus a paper home programme practised on five days per week.
Delivered in the clinic.
|
Standard face-to-face speech and language therapy as currently delivered at the participating site by a speech-language pathologist in usual practice.
One 30 to 45 minute individual session per week for 12 weeks, delivered in the clinic.
Between sessions, a home programme is given to the family on paper and practised on five days per week.
Therapy content and targets are individualised as in usual practice.
Adherence is recorded in a paper diary returned at each session, and attendance is logged from site records.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Goal Attainment Scaling (GAS) T-score
Time Frame: Baseline and 12 weeks after randomisation (change from baseline to 12 weeks)
|
Goal Attainment Scaling is a criterion-referenced method in which three to five individually agreed therapy goals are set with the participant and family before randomisation and scaled from -2 (much less than expected) to +2 (much more than expected), with 0 as the expected level of attainment.
Goals are not revised after randomisation.
Attainment is rated at 12 weeks by an outcome assessor masked to allocation and converted to a standardised T-score.
Higher scores indicate greater attainment of individually agreed communication goals.
The outcome reported is the change in T-score from baseline to 12 weeks, analysed by analysis of covariance with the baseline value, site and diagnostic group as covariates.
Non-inferiority of app-supported teletherapy will be concluded if the lower bound of the two-sided 95% confidence interval for the between-arm difference lies above the pre-specified margin..
|
Baseline and 12 weeks after randomisation (change from baseline to 12 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adherence to the prescribed home practice programme
Time Frame: Weekly over the 12-week intervention period
|
The proportion of prescribed home-practice days on which practice was completed, over the 12-week intervention period, expressed as a percentage.
In the app-supported teletherapy arm this is derived from timestamps recorded automatically by the application.
In the usual in-person therapy arm it is derived from a paper practice diary returned at each session.
The difference in measurement method between arms is recognised and is reported as a limitation
|
Weekly over the 12-week intervention period
|
|
Proportion of scheduled therapy sessions attended
Time Frame: Over the 12-week intervention period
|
The number of therapy sessions attended as a proportion of the number scheduled over the 12-week intervention period, expressed as a percentage, taken from site attendance records in both arms.
A session is counted as attended if it began, whatever its duration.
|
Over the 12-week intervention period
|
|
Client Satisfaction Questionnaire (CSQ-8) score
Time Frame: 12 weeks after randomisation
|
Participant or caregiver satisfaction with the therapy received, measured on the eight-item Client Satisfaction Questionnaire.
Total scores range from 8 to 32, with higher scores indicating greater satisfaction.
Self-reported, or reported by the caregiver where the participant is a child or is unable to self-report.
|
12 weeks after randomisation
|
|
System Usability Scale (SUS) score
Time Frame: 12 weeks after randomisation
|
Usability of the TeleSpeech application, measured on the ten-item System Usability Scale.
Scores range from 0 to 100, with higher scores indicating better perceived usability.
Collected from participants or caregivers in the app-supported teletherapy arm only, as participants in the usual in-person therapy arm do not use the application.
|
12 weeks after randomisation
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC-UOL-/574/08/24
- University of Cyberjaya (Registry Identifier: University of Cyberjaya)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.