Hearing Impaired ChildrenNCT04962828
Inter Disciplinary Approach to Vocabulary Development in Hearing Impairment
A study testing Vocabulary based intervention- Non Collaborative and Vocabulary based intervention - Collaborative in people with Hearing Impaired Children, run by Riphah International University at 1 site in Pakistan.
Trial summary
The research aims to address to address the role of interdisciplinary working between professionals in the field of speech and language pathology/therapy. There is considerable evidence to state that when professionals work in collaboration with each other on particular goals that the outcomes are more favorable… Read more about this study
- Who is it for?
- Ages 6 to 11 years
- Conditions the study is for
- Hearing Impaired Children
- What is being tested?
- Vocabulary based intervention- Non Collaborative and Vocabulary based intervention - Collaborative
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 sitePakistan
- Study dates
- 24 May 2021to 26 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 6 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Hearing impaired children from 6 to 11 years of age who have severe unilateral or bilateral hearing loss from birth and for whom Urdu has their first language. There hearing age is at least one year. Their parents were not hearing impaired. Children used hearing aids. Unilateral \& bilateral hearing impaired children were equally distributed.
Who cannot join
- Children who did not present with HI as their main diagnosis or may have other co-morbid conditions.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Aghosh Special Children's School
Kharian, Punjab Province, 46000
About this study
Official title: The Effect Of An Inter Disciplinary Approach On Vocabulary Development in Children With Hearing Impairment; A Randomized Control Trial
The research aims to address to address the role of interdisciplinary working between professionals in the field of speech and language pathology/therapy. There is considerable evidence to state that when professionals work in collaboration with each other on particular goals that the outcomes are more favorable, functional and beneficial for the child.
Read the detailed description
The aim of the current research is to devise a joint interventional program between the speech and language pathologist and teachers in order to support their comprehension and expression of functional vocabulary. This study was devised as there is a gap in collaborative working by professionals in Pakistan. Often therapy is provided through a medical model of taking the child outside the class for one to one sessions. There is lack of lack of collaborative goal planning. This is particularly true for children who are in hearing impairment centres.
In Pakistan, the prevalence of all hearing loss in rural Pakistan has been estimated to be 7.9%, in a general population setting. The high prevalence rates are a source of concern. The impact of hearing impairment manifests itself in many ways. As is evident from the studies carried out on the impact of hearing impairment on vocabulary skills and speech-language and communication difficulties in general of children and adolescents, that these difficulties if not identified in a timely manner will affect later schooling and educational attainment. Vocabulary knowledge is a key predictor of reading comprehension, which is essential for academic progress.
In the field of early intervention and early childhood special education caregiver involvement has been documented as important. Speech, language and communication needs (SLCN) are prevalent among primary school-aged children. Collaboration between speech and language therapists (SLTs) and teachers is beneficial for supporting children's communication skills. Findings from an Australian study suggests that change to service delivery needs to be considered at an individual, interpersonal and organizational level to enable better outcomes for children with SLCN and increased support for their families and the professionals who work with them.
Hence, timely identification and management plays a pivotal role. It is critical that therapy is provided in a manner as to generalize learnt skills. Research described speech therapy services as largely happening outside of the classroom such as removing individuals or small groups from the classroom for intervention sessions ('pull out') or that involve the speech-language pathologist indirectly affecting the child's educational program by providing modeling or coaching to relevant educators in the use of strategies to promote specific skills ('consultation').
There is no denying that collaborative working is essential. A study comparing improvement on a specific study measure designed on selected vocabulary in 12 classrooms with 3 conditions: (1) Pull-out - 50-minute group or one to one sessions for twelve weeks. (2) Classroom-based - Weekly 40-minute lessons for 12 weeks (3) Collaborative - Weekly 40-minute SLP-teacher planned and team taught lessons for 12 weeks. The results suggested evidence for the benefits of collaborative working such as the ability to discuss, design and plan between the teacher and SLP, resulting in greater outcomes and facilitating generalization of the activities in students who require it the most. The study sheds light on the need for such collaboration and provides evidence sums for further research to address similar outcomes in Pakistan.
- Conditions
- Hearing Impaired Children
- Being tested
- Vocabulary based intervention- Non Collaborative, Vocabulary based intervention - Collaborative
- Keywords
- Hearing Impairment, Language Intervention, Interdisciplinary working
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vocabulary based intervention- Non CollaborativeOther
Also called Language Intervention, Language Intervention for Hearing Impairment, Total Communication
List of 10 words functional words Therapy 3 times a week for 20 minutes Duration = 9 weeks Only with SLP
Vocabulary based intervention - CollaborativeOther
Also called Language Therapy, Inter-disciplinary working
List of 10 words functional words Therapy 3 times a week for 20 minutes Duration = 9 weeks With SLP and to be reinforced by teachers in class over the week
| Study group | Role | What they receive |
|---|---|---|
| Collaboration group | Experimental | This group of children will have targets and vocabulary that has been designed collaboratively and then the therapist and teacher both reinforce the vocabulary during the week Receives: Other: Vocabulary based intervention - Collaborative |
| Non-collaborative group | Active comparator | This group of children will have targets and vocabulary that has been designed collaboratively but they will only be practiced with the therapist during the week Receives: Other: Vocabulary based intervention- Non Collaborative |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vocabulary List
There will be 10 functional words that will be designed post collaboration with the teachers. The list will accommodate 6 Ling sounds and will be implemented with both groups. The participants will be tested on the list pre-intervention and post intervention. Scoring will be based on binary responses such as correct and incorrect responses. Any further responses will be addressed qualitatively.
Measured: 9th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2021
- Study start24 May 2021
- Primary completion26 Jul 2021 (estimated)
- Study completion26 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Hearing Impaired ChildrenStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ayesha Butt, PhD, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04962828
- Sponsor's protocol ID
- REC/00973
- Status last verified
- Jul 2021
- First submitted
- 10 Jul 2021
- Last updated
- 15 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers
Publications
Mathers C, Smith A, Concha M. Global Burden Of Hearing Loss In The Year 2000. Global Burden Of Disease. 2000;18(4):1-30.
McGregor KK, Oleson J, Bahnsen A, Duff D. Children with developmental language impairment have vocabulary deficits characterized by limited breadth and depth. Int J Lang Commun Disord. 2013 May-Jun;48(3):307-19. doi: 10.1111/1460-6984.12008. Epub 2013 Feb 25.
PubMed 23650887Suleman S, Mcfarlane La, Pollock K, Schneider P, Leroy C, Skoczylas M. Collaboration: More Than
Ebbels SH, McCartney E, Slonims V, Dockrell JE, Norbury CF. Evidence-based pathways to intervention for children with language disorders. Int J Lang Commun Disord. 2019 Jan;54(1):3-19. doi: 10.1111/1460-6984.12387. Epub 2018 Apr 25.
PubMed 29696726Wilson L, McneillBc, Gillon Gt. Understanding The Effectiveness Of Student Speech-Language Pathologists And Student Teachers Co-Working During Inter-Professional School Placements. Child Language Teaching And Therapy. 2019 Jun;35(2):125-43.( 7)
Lowe H, Henry L, Joffe VL. The Effectiveness of Classroom Vocabulary Intervention for Adolescents With Language Disorder. J Speech Lang Hear Res. 2019 Aug 15;62(8):2829-2846. doi: 10.1044/2019_JSLHR-L-18-0337. Epub 2019 Jul 24.
PubMed 31339808Glover A, Mccormack J, Smith-Tamaray M. Collaboration Between Teachers And Speech And Language Therapists: Services For Primary School Children With Speech, Language And Communication Needs. Child Language Teaching And Therapy. 2015 Oct;31(3):363-82.
Murray E, McCabe P, Ballard KJ. A comparison of two treatments for childhood apraxia of speech: methods and treatment protocol for a parallel group randomised control trial. BMC Pediatr. 2012 Aug 3;12:112. doi: 10.1186/1471-2431-12-112.
PubMed 22863021Spencer TD, Petersen DB, Adams JL. Tier 2 Language Intervention for Diverse Preschoolers: An Early-Stage Randomized Control Group Study Following an Analysis of Response to Intervention. Am J Speech Lang Pathol. 2015 Nov;24(4):619-36. doi: 10.1044/2015_AJSLP-14-0101.
PubMed 26125951Thomas DC, McCabe P, Ballard KJ. Combined clinician-parent delivery of rapid syllable transition (ReST) treatment for childhood apraxia of speech. Int J Speech Lang Pathol. 2018 Dec;20(7):683-698. doi: 10.1080/17549507.2017.1316423. Epub 2017 Apr 26.
PubMed 28443686
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of An Inter Disciplinary Approach On Vocabulary Development in Children With Hearing Impairment; A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT04962828
- Acronym / sponsor ID
- REC/00973
- Conditions
- Hearing Impaired Children
- Keywords
- Hearing Impairment, Language Intervention, Interdisciplinary working
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 24 May 2021 (actual)
- Primary completion
- 26 Jul 2021 (estimated)
- Study completion
- 26 Jul 2021 (estimated)
- First posted
- 15 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The research aims to address to address the role of interdisciplinary working between professionals in the field of speech and language pathology/therapy. There is considerable evidence to state that when professionals work in collaboration with each other on particular goals that the outcomes are more favorable, functional and beneficial for the child.
Detailed description
The aim of the current research is to devise a joint interventional program between the speech and language pathologist and teachers in order to support their comprehension and expression of functional vocabulary. This study was devised as there is a gap in collaborative working by professionals in Pakistan. Often therapy is provided through a medical model of taking the child outside the class for one to one sessions. There is lack of lack of collaborative goal planning. This is particularly true for children who are in hearing impairment centres.
In Pakistan, the prevalence of all hearing loss in rural Pakistan has been estimated to be 7.9%, in a general population setting. The high prevalence rates are a source of concern. The impact of hearing impairment manifests itself in many ways. As is evident from the studies carried out on the impact of hearing impairment on vocabulary skills and speech-language and communication difficulties in general of children and adolescents, that these difficulties if not identified in a timely manner will affect later schooling and educational attainment. Vocabulary knowledge is a key predictor of reading comprehension, which is essential for academic progress.
In the field of early intervention and early childhood special education caregiver involvement has been documented as important. Speech, language and communication needs (SLCN) are prevalent among primary school-aged children. Collaboration between speech and language therapists (SLTs) and teachers is beneficial for supporting children's communication skills. Findings from an Australian study suggests that change to service delivery needs to be considered at an individual, interpersonal and organizational level to enable better outcomes for children with SLCN and increased support for their families and the professionals who work with them.
Hence, timely identification and management plays a pivotal role. It is critical that therapy is provided in a manner as to generalize learnt skills. Research described speech therapy services as largely happening outside of the classroom such as removing individuals or small groups from the classroom for intervention sessions ('pull out') or that involve the speech-language pathologist indirectly affecting the child's educational program by providing modeling or coaching to relevant educators in the use of strategies to promote specific skills ('consultation').
There is no denying that collaborative working is essential. A study comparing improvement on a specific study measure designed on selected vocabulary in 12 classrooms with 3 conditions: (1) Pull-out - 50-minute group or one to one sessions for twelve weeks. (2) Classroom-based - Weekly 40-minute lessons for 12 weeks (3) Collaborative - Weekly 40-minute SLP-teacher planned and team taught lessons for 12 weeks. The results suggested evidence for the benefits of collaborative working such as the ability to discuss, design and plan between the teacher and SLP, resulting in greater outcomes and facilitating generalization of the activities in students who require it the most. The study sheds light on the need for such collaboration and provides evidence sums for further research to address similar outcomes in Pakistan.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Collaboration group | Experimental | Other: Vocabulary based intervention - CollaborativeThis group of children will have targets and vocabulary that has been designed collaboratively and then the therapist and teacher both reinforce the vocabulary during the week |
| Non-collaborative group | Active comparator | Other: Vocabulary based intervention- Non CollaborativeThis group of children will have targets and vocabulary that has been designed collaboratively but they will only be practiced with the therapist during the week |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Hearing impaired children from 6 to 11 years of age who have severe unilateral or bilateral hearing loss from birth and for whom Urdu has their first language. There hearing age is at least one year. Their parents were not hearing impaired. Children used hearing aids. Unilateral \& bilateral hearing impaired children were equally distributed.
Key exclusion criteria (1 listed)
- Children who did not present with HI as their main diagnosis or may have other co-morbid conditions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vocabulary based intervention- Non CollaborativeAlso: Language Intervention, Language Intervention for Hearing Impairment, Total CommunicationList of 10 words functional words Therapy 3 times a week for 20 minutes Duration = 9 weeks Only with SLP | Other | Non-collaborative group |
| Vocabulary based intervention - CollaborativeAlso: Language Therapy, Inter-disciplinary workingList of 10 words functional words Therapy 3 times a week for 20 minutes Duration = 9 weeks With SLP and to be reinforced by teachers in class over the week | Other | Collaboration group |
Primary outcome
Vocabulary List
Time frame: 9th week
There will be 10 functional words that will be designed post collaboration with the teachers. The list will accommodate 6 Ling sounds and will be implemented with both groups. The participants will be tested on the list pre-intervention and post intervention. Scoring will be based on binary responses such as correct and incorrect responses. Any further responses will be addressed qualitatively.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2021.
- BackgroundMathers C, Smith A, Concha M. Global Burden Of Hearing Loss In The Year 2000. Global Burden Of Disease. 2000;18(4):1-30.
- Background: PubMed 23650887McGregor KK, Oleson J, Bahnsen A, Duff D. Children with developmental language impairment have vocabulary deficits characterized by limited breadth and depth. Int J Lang Commun Disord. 2013 May-Jun;48(3):307-19. doi: 10.1111/1460-6984.12008. Epub 2013 Feb 25.
- BackgroundSuleman S, Mcfarlane La, Pollock K, Schneider P, Leroy C, Skoczylas M. Collaboration: More Than
- Background: PubMed 29696726Ebbels SH, McCartney E, Slonims V, Dockrell JE, Norbury CF. Evidence-based pathways to intervention for children with language disorders. Int J Lang Commun Disord. 2019 Jan;54(1):3-19. doi: 10.1111/1460-6984.12387. Epub 2018 Apr 25.
- BackgroundWilson L, McneillBc, Gillon Gt. Understanding The Effectiveness Of Student Speech-Language Pathologists And Student Teachers Co-Working During Inter-Professional School Placements. Child Language Teaching And Therapy. 2019 Jun;35(2):125-43.( 7)
- Background: PubMed 31339808Lowe H, Henry L, Joffe VL. The Effectiveness of Classroom Vocabulary Intervention for Adolescents With Language Disorder. J Speech Lang Hear Res. 2019 Aug 15;62(8):2829-2846. doi: 10.1044/2019_JSLHR-L-18-0337. Epub 2019 Jul 24.
- BackgroundGlover A, Mccormack J, Smith-Tamaray M. Collaboration Between Teachers And Speech And Language Therapists: Services For Primary School Children With Speech, Language And Communication Needs. Child Language Teaching And Therapy. 2015 Oct;31(3):363-82.
- Background: PubMed 22863021Murray E, McCabe P, Ballard KJ. A comparison of two treatments for childhood apraxia of speech: methods and treatment protocol for a parallel group randomised control trial. BMC Pediatr. 2012 Aug 3;12:112. doi: 10.1186/1471-2431-12-112.
- Background: PubMed 26125951Spencer TD, Petersen DB, Adams JL. Tier 2 Language Intervention for Diverse Preschoolers: An Early-Stage Randomized Control Group Study Following an Analysis of Response to Intervention. Am J Speech Lang Pathol. 2015 Nov;24(4):619-36. doi: 10.1044/2015_AJSLP-14-0101.
- Background: PubMed 28443686Thomas DC, McCabe P, Ballard KJ. Combined clinician-parent delivery of rapid syllable transition (ReST) treatment for childhood apraxia of speech. Int J Speech Lang Pathol. 2018 Dec;20(7):683-698. doi: 10.1080/17549507.2017.1316423. Epub 2017 Apr 26.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers
Related trials for Hearing Impaired Children
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Recruiting
BEARS Training Package to Maximise Hearing Abilities in Older Children and Teenagers With Bilateral Cochlear Implants
Hearing Loss, Sensorineural, Hearing Loss
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayesha Butt, PhD principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vocabulary based intervention- Non Collaborative and Vocabulary based intervention - Collaborative in people with Hearing Impaired Children, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Waqar Amjad, PhD (03335348846, waqar.ahmad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vocabulary List (time frame: 9th week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04962828, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2021; AzTrials last refreshed its copy on 6 Nov 2026.