Speech, Language Developmental Delay From Hearing LossNCT05749315
Comparative Effects of Play Based Therapy and Functional Communication Training in Speech-language Delayed Children
A study testing Play Based Therapy and Functional Communication Training in people with Speech, Language Developmental Delay From Hearing Loss, run by Sehat Medical Complex at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 6 years
- Conditions the study is for
- Speech, Language Developmental Delay From Hearing Loss
- What is being tested?
- Play Based Therapy and Functional Communication Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 13 Dec 2022to May 2023
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Participants with comorbidity of behavioral disorder, Autism \& ADHD
Who cannot join
- Patient with comorbidity of syndromes ( downs syndrome, treacher Collin syndrome, hunter syndrome , Williams Syndrome, kabuki syndrome etc )
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Sehat Medical Complex, Lahore
Lahore, Punjab Province, 55201
Waseem Javaid, 04235410037, info.hw@smc.uol.edu.pk
About this study
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.
Read the 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.
- Being tested
- Play Based Therapy, Functional Communication Training
- Keywords
- Play based therapy, Functional communication training
- Medical subject headings
- Speech
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Play Based TherapyOther
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.
Functional Communication TrainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Group A Speech Language Delayed Children Receives: Other: Play Based Therapy |
| Group B | Active comparator | Group B Speech Language Delayed Children Receives: Other: Functional Communication Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speech Questionnaire
The Speech Questionnaire: an Assessment of Functional Language Ability. International Rehabilitation Medicine.
Measured: Change from baseline at 3rd Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2023
- Study start13 Dec 2022
- Primary completionApr 2023 (estimated)
- Study completionMay 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Speech, Language Developmental Delay From Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sehat Medical Complex
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Waseem Javaid, Sehat Medical Complex
- Investigators
- Momina Mehmood, Principal investigator, University of Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05749315
- Sponsor's protocol ID
- Muniba001-09
- Status last verified
- Feb 2023
- First submitted
- 19 Feb 2023
- Last updated
- 1 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No