Comparative Effects of Play Based Therapy and Functional Communication Training in Speech-language Delayed Children
Primary Purpose
Speech, Language Developmental Delay From Hearing Loss
Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Play Based Therapy
Functional Communication Training
Sponsored by
About this trial
This is an interventional treatment trial for Speech, Language Developmental Delay From Hearing Loss focused on measuring Play based therapy, Functional communication training
Eligibility Criteria
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 )
Sites / Locations
- Sehat Medical Complex, LahoreRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group A
Group B
Arm Description
Group A Speech Language Delayed Children
Group B Speech Language Delayed Children
Outcomes
Primary Outcome Measures
Speech Questionnaire
The Speech Questionnaire: an Assessment of Functional Language Ability. International Rehabilitation Medicine.
Secondary Outcome Measures
Full Information
NCT ID
NCT05749315
First Posted
February 19, 2023
Last Updated
February 19, 2023
Sponsor
Sehat Medical Complex
1. Study Identification
Unique Protocol Identification Number
NCT05749315
Brief Title
Comparative Effects of Play Based Therapy and Functional Communication Training in Speech-language Delayed Children
Official Title
Comparative Effects of Play Based Therapy and Functional Communication Training in Speech-language Delayed Children
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 13, 2022 (Actual)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
May 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sehat Medical Complex
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Speech, Language Developmental Delay From Hearing Loss
Keywords
Play based therapy, Functional communication training
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Active Comparator
Arm Description
Group A Speech Language Delayed Children
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
Group B Speech Language Delayed Children
Intervention Type
Other
Intervention Name(s)
Play Based Therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Functional Communication Training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Speech Questionnaire
Description
The Speech Questionnaire: an Assessment of Functional Language Ability. International Rehabilitation Medicine.
Time Frame
Change from baseline at 3rd Month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 )
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Imran Ghafoor
Phone
03344292887
Email
imran.ghafoor64@gamil.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Momina Mehmood
Organizational Affiliation
University of Lahore
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sehat Medical Complex, Lahore
City
Lahore
State/Province
Punjab
ZIP/Postal Code
55201
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Waseem Javaid
Phone
04235410037
Email
info.hw@smc.uol.edu.pk
12. IPD Sharing Statement
Learn more about this trial
Comparative Effects of Play Based Therapy and Functional Communication Training in Speech-language Delayed Children
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