- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05749315
Comparative Effects of Play Based Therapy and Functional Communication Training in Speech-language Delayed Children
February 19, 2023 updated by: Waseem Javaid, Sehat Medical Complex
The purpose of this study is to compare the play based therapy and functional communication training in speech-language delayed children 2-6 years old.
This study will highlight the most effective intervention or therapy for Speech & Language Delayed Children.
The Randomized clinical trial study will be conducted in clinic, sehat medical complex, with children who will have the diagnosis of speech and language delay.
These individual will be diagnose by a speech therapist (more than 2 years experience in the field) with PORTAGE guide to early education .
A group of children will be given play based therapy and the other group of children will be given functional communication training.
Participants' assessments of SLD will be made using the Portage Guide to Early Education.
It will take three months of sessions 5 days in a week, lasting 20 to 30 minutes.
The Progress of both therapies will be seen and assessed through structured questionnaire that which technique is more effective.
The individual will be assess through Speech Questionnaire on base line and after 3 months session program.
Study Overview
Status
Recruiting
Intervention / Treatment
Detailed Description
Speech is the verbal production of language, whereas language is the conceptual processing of communication.
Language includes receptive language (understanding) and expressive language (the ability to convey information, feelings, thoughts, and ideas).
Language is commonly thought of in its spoken form, but may also include a visual form, such as American Sign Language.
Speech and language delay in children is associated with increased difficulty with reading, writing, attention, and socialization.
In children not meeting the expected milestones for speech and language, a comprehensive developmental evaluation is essential, because atypical language development can be a secondary characteristic of other physical and developmental problems that may first manifest as language problems.
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Imran Ghafoor
- Phone Number: 03344292887
- Email: imran.ghafoor64@gamil.com
Study Locations
-
-
Punjab
-
Lahore, Punjab, Pakistan, 55201
- Recruiting
- Sehat Medical Complex, Lahore
-
Contact:
- Waseem Javaid
- Phone Number: 04235410037
- Email: info.hw@smc.uol.edu.pk
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years to 6 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Participants with comorbidity of behavioral disorder, Autism & ADHD
Exclusion Criteria:
- Patient with comorbidity of syndromes ( downs syndrome, treacher Collin syndrome, hunter syndrome , Williams Syndrome, kabuki syndrome etc )
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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 |
|---|---|
|
Active Comparator: Group A
Group A Speech Language Delayed Children
|
Participants' assessments of SLD will be made using the Portage Guide to Early Education.
It will take three months of sessions 5 days a week, lasting 20 to 30 minutes.
The individual will be asses through Speech Questionnaire on base line and after 3 months session program.
The Progress of both therapies will be seen that which technique is more effective.
|
|
Active Comparator: Group B
Group B Speech Language Delayed Children
|
Participants' assessments of SLD will be made using the Portage Guide to Early Education.
It will take three months of sessions 5 days a week, lasting 20 to 30 minutes.
The individual will be asses through Speech Questionnaire on base line and after 3 months session program.
The Progress of both therapies will be seen that which technique is more effective.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Speech Questionnaire
Time Frame: Change from baseline at 3rd Month
|
The Speech Questionnaire: an Assessment of Functional Language Ability.
International Rehabilitation Medicine.
|
Change from baseline at 3rd Month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Momina Mehmood, University of Lahore
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 13, 2022
Primary Completion (Anticipated)
April 1, 2023
Study Completion (Anticipated)
May 1, 2023
Study Registration Dates
First Submitted
February 19, 2023
First Submitted That Met QC Criteria
February 19, 2023
First Posted (Actual)
March 1, 2023
Study Record Updates
Last Update Posted (Actual)
March 1, 2023
Last Update Submitted That Met QC Criteria
February 19, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Muniba001-09
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.