NCT07820982

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
7mo left

Started Sep 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress7%
Sep 2026Apr 2027

First Submitted

Initial submission to the registry

September 9, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 15, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

September 20, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2027

Last Updated

September 23, 2026

Status Verified

January 1, 2026

Enrollment Period

6 months

First QC Date

September 9, 2026

Last Update Submit

September 19, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in Goal Attainment Scaling (GAS) T-score

    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 Outcomes (4)

  • Adherence to the prescribed home practice programme

    Weekly over the 12-week intervention period

  • Proportion of scheduled therapy sessions attended

    Over the 12-week intervention period

  • Client Satisfaction Questionnaire (CSQ-8) score

    12 weeks after randomisation

  • System Usability Scale (SUS) score

    12 weeks after randomisation

Study Arms (2)

App-supported teletherapy

EXPERIMENTAL

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.

Behavioral: App-supported teletherapy

Usual in-person therapy

ACTIVE COMPARATOR

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.

Behavioral: Usual in-person speech and language therapy

Interventions

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.

App-supported teletherapy

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.

Usual in-person therapy

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Language Therapy

Intervention Hierarchy (Ancestors)

Rehabilitation of Speech and Language DisordersRehabilitationAftercareContinuity of Patient CarePatient CareTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2026

First Posted

September 15, 2026

Study Start

September 20, 2026

Primary Completion (Estimated)

March 20, 2027

Study Completion (Estimated)

April 20, 2027

Last Updated

September 23, 2026

Record last verified: 2026-01