Learning DisabilitiesNCT04583332
Efficacy of AAC for Functional Communication
A study testing Rhymes, Individual Items in Rhymes and Objects in people with Learning Disabilities and Cerebral Palsy, run by Riphah International University at 1 site in Pakistan.
Trial summary
There is a considerable number children who are unable to speak, and our currently not being provided with any AAC options in their therapeutic facilities. The study aims to identify the current practice being employed with these children and then provide an AAC intervention for choice making with in group activities… Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Learning Disabilities, Cerebral Palsy, Down Syndrome
- What is being tested?
- Rhymes, Individual Items in Rhymes and Objects
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2020to 15 Dec 2020
- 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 4 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children with special needs
- Children not currently using any AAC
Who cannot join
- Children with any co-morbid conditions.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Riphah Child Development Centre & Step to Learn School
Rawalpindi, Punjab Province, 46000
About this study
Official title: Efficacy of Using Augmentative Alternative Communication for Functional Communication in Group Activities
There is a considerable number children who are unable to speak, and our currently not being provided with any AAC options in their therapeutic facilities. The study aims to identify the current practice being employed with these children and then provide an AAC intervention for choice making with in group activities in the existing system, where the child is enrolled. Currently there is no indigenous evidence of AAC being employed effectively with these children. A pre- assessment will be carried out to establish the level of communication of the children. Intervention will be provided in a group for 6 weeks, three days a week, as these children already attend these groups.
Read the detailed description
The study is a novel approach to intervention in Pakistan. There are currently no such studies conducted on intervention using AAC use in Pakistan. The objective of the the study are as follows
- To compare establish current practices with AAC for choice making in group activities.
- To determine the frequency of choice making in structured group activities.
Hypothesis:
Null Hypothesis:
The use of augmentative alternative communication does not increase functional communication in group activities.
Alternative Hypothesis:
The use of augmentative alternative communication increases functional communication in group activities.
Study Setting: Step to Learn School
Assessment: An assessment will be carried out using the online Communication Matrix to establish baseline communication skills of all the children. The children will also be assessed informally for their current means of communication in existing group activity at baseline, mid level (3 weeks) and at the end of the study (6 weeks).
Intervention: Intervention will (3 days a week for 6 weeks) be provided through objects, picture cards placed on a choice board. The choice will be given for Rhymes, Individual Rhymes \& Sensory objects. Auditory, visual and tactile prompts will be provided.
- Conditions
- Learning Disabilities, Cerebral Palsy, Down Syndrome
- Being tested
- Rhymes, Individual Items in Rhymes, Objects
- Keywords
- AAC, Functional Communication, Group intervention
- Medical subject headings
- Learning Disabilities, Cerebral Palsy, Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RhymesOther
Participants will be provided with a choice of 3 Nursery rhymes (Wheels on the bus, Old McDonald and Twinkle Twinkle Little Star) Objects pertaining to the 3 rhymes will be placed on a board Children will be given prompts as per their need and will be marked on the type of prompt given.
These children will transit to pictures and Makaton symbols, if they are able to make choices using objects.
Individual Items in RhymesOther
Participants will be provided with a choice of 3 pictures within the initial choice making of the 2 Nursery rhymes (Wheels on the bus and Old McDonald ) Wheels on the Bus will include - mama/wipers/horn McDonalds - cow/dog/cat Objects pertaining to the 3 rhymes will be placed on a board Children will be given prompts as per their need and will be marked on the type of prompt given.
These children will transit to pictures and Makaton symbols, if they are able to make choices using objects.
ObjectsOther
Participants will be provided with 2,3 and 4 sensory objects. Participants will opt for an object by making a choice between these objects, if this is achieved then the child will be moved to picture level and symbol.
| Study group | Role | What they receive |
|---|---|---|
| Rhymes, Individual Items in Rhymes, Objects | Other | Existing method Post intervention Receives: Other: Rhymes; Other: Individual Items in Rhymes; Other: Objects |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self designed Questionnaire
Self designed questionnaire to address choice making in objects, pictures and symbols in three activities Rhymes, Items in Rhymes and Objects
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2020
- Study start1 Jan 2020
- Primary completion15 Dec 2020
- Study completion15 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Learning DisabilitiesStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Pre-post experimental study
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ayesha K Butt, PhD, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04583332
- Sponsor's protocol ID
- REC/00738 Sheeba Sharazi
- Status last verified
- Mar 2021
- First submitted
- 6 Oct 2020
- Last updated
- 2 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Elsahar Y, Hu S, Bouazza-Marouf K, Kerr D, Mansor A. Augmentative and Alternative Communication (AAC) Advances: A Review of Configurations for Individuals with a Speech Disability. Sensors (Basel). 2019 Apr 22;19(8):1911. doi: 10.3390/s19081911.
PubMed 31013673Meinzen-Derr J, Sheldon RM, Henry S, Grether SM, Smith LE, Mays L, Riddle I, Altaye M, Wiley S. Enhancing language in children who are deaf/hard-of-hearing using augmentative and alternative communication technology strategies. Int J Pediatr Otorhinolaryngol. 2019 Oct;125:23-31. doi: 10.1016/j.ijporl.2019.06.015. Epub 2019 Jun 20.
PubMed 31238158Nam S, Kim J, Sparks S. An Overview of Review Studies on Effectiveness of Major AAC Systems for Individuals with Developmental Disabilities Including Autism. Journal of Special Education Apprenticeship. 2018 Jun;7(2):n2.
Schlosser RW, Wendt O. Effects of augmentative and alternative communication intervention on speech production in children with autism: a systematic review. Am J Speech Lang Pathol. 2008 Aug;17(3):212-30. doi: 10.1044/1058-0360(2008/021).
PubMed 18663107Lorah ER, Tincani M, Parnell A. Current trends in the use of handheld technology as a speech-generating device for children with autism. Behavior Analysis: Research and Practice. 2018 Aug;18(3):317.
Waddington H, Sigafoos J, Lancioni GE, O'Reilly MF, van der Meer L, Carnett A, Stevens M, Roche L, Hodis F, Green VA, Sutherland D, Lang R, Marschik PB. Three children with autism spectrum disorder learn to perform a three-step communication sequence using an iPad(R)-based speech-generating device. Int J Dev Neurosci. 2014 Dec;39:59-67. doi: 10.1016/j.ijdevneu.2014.05.001. Epub 2014 May 10.
PubMed 24819024Roche L, Sigafoos J, Lancioni GE, O'Reilly MF, Schlosser RW, Stevens M, van der Meer L, Achmadi D, Kagohara D, James R, Carnett A, Hodis F, Green VA, Sutherland D, Lang R, Rispoli M, Machalicek W, Marschik PB. An evaluation of speech production in two boys with neurodevelopmental disorders who received communication intervention with a speech-generating device. Int J Dev Neurosci. 2014 Nov;38:10-6. doi: 10.1016/j.ijdevneu.2014.07.003. Epub 2014 Jul 21.
PubMed 25058915Stasolla F, De Pace C, Damiani R, Di Leone A, Albano V, Perilli V. Comparing PECS and VOCA to promote communication opportunities and to reduce stereotyped behaviors by three girls with Rett syndrome. Research in Autism Spectrum Disorders. 2014 Oct 1;8(10):1269-78.
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Using Augmentative Alternative Communication for Functional Communication in Group Activities
- ClinicalTrials.gov ID
- NCT04583332
- Acronym / sponsor ID
- REC/00738 Sheeba Sharazi
- Conditions
- Learning Disabilities, Cerebral Palsy, Down Syndrome
- Keywords
- AAC, Functional Communication, Group intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 15 Dec 2020 (actual)
- Study completion
- 15 Dec 2020 (actual)
- First posted
- 12 Oct 2020 (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.
There is a considerable number children who are unable to speak, and our currently not being provided with any AAC options in their therapeutic facilities. The study aims to identify the current practice being employed with these children and then provide an AAC intervention for choice making with in group activities in the existing system, where the child is enrolled. Currently there is no indigenous evidence of AAC being employed effectively with these children. A pre- assessment will be carried out to establish the level of communication of the children. Intervention will be provided in a group for 6 weeks, three days a week, as these children already attend these groups.
Detailed description
The study is a novel approach to intervention in Pakistan. There are currently no such studies conducted on intervention using AAC use in Pakistan. The objective of the the study are as follows
- To compare establish current practices with AAC for choice making in group activities.
- To determine the frequency of choice making in structured group activities.
Hypothesis:
Null Hypothesis:
The use of augmentative alternative communication does not increase functional communication in group activities.
Alternative Hypothesis:
The use of augmentative alternative communication increases functional communication in group activities.
Study Setting: Step to Learn School
Assessment: An assessment will be carried out using the online Communication Matrix to establish baseline communication skills of all the children. The children will also be assessed informally for their current means of communication in existing group activity at baseline, mid level (3 weeks) and at the end of the study (6 weeks).
Intervention: Intervention will (3 days a week for 6 weeks) be provided through objects, picture cards placed on a choice board. The choice will be given for Rhymes, Individual Rhymes \& Sensory objects. Auditory, visual and tactile prompts will be provided.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pre-post experimental study
| Arm | Type | Receives |
|---|---|---|
| Rhymes, Individual Items in Rhymes, Objects | Other | Other: Rhymes, Other: Individual Items in Rhymes, Other: ObjectsExisting method Post intervention |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children with special needs
- Children not currently using any AAC
Key exclusion criteria (1 listed)
- Children with any 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 |
|---|---|---|
| RhymesParticipants will be provided with a choice of 3 Nursery rhymes (Wheels on the bus, Old McDonald and Twinkle Twinkle Little Star) Objects pertaining to the 3 rhymes will be placed on a board Children will be given prompts as per their need and will be marked on the type of prompt given. These children will transit to pictures and Makaton symbols, if they are able to make choices using objects. | Other | Rhymes, Individual Items in Rhymes, Objects |
| Individual Items in RhymesParticipants will be provided with a choice of 3 pictures within the initial choice making of the 2 Nursery rhymes (Wheels on the bus and Old McDonald ) Wheels on the Bus will include - mama/wipers/horn McDonalds - cow/dog/cat Objects pertaining to the 3 rhymes will be placed on a board Children will be given prompts as per their need and will be marked on the type of prompt given. These children will transit to pictures and Makaton symbols, if they are able to make choices using objects. | Other | Rhymes, Individual Items in Rhymes, Objects |
| ObjectsParticipants will be provided with 2,3 and 4 sensory objects. Participants will opt for an object by making a choice between these objects, if this is achieved then the child will be moved to picture level and symbol. | Other | Rhymes, Individual Items in Rhymes, Objects |
Primary outcome
Self designed Questionnaire
Time frame: 6 weeks
Self designed questionnaire to address choice making in objects, pictures and symbols in three activities Rhymes, Items in Rhymes and Objects
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2021.
- Background: PubMed 31013673Elsahar Y, Hu S, Bouazza-Marouf K, Kerr D, Mansor A. Augmentative and Alternative Communication (AAC) Advances: A Review of Configurations for Individuals with a Speech Disability. Sensors (Basel). 2019 Apr 22;19(8):1911. doi: 10.3390/s19081911.
- Background: PubMed 31238158Meinzen-Derr J, Sheldon RM, Henry S, Grether SM, Smith LE, Mays L, Riddle I, Altaye M, Wiley S. Enhancing language in children who are deaf/hard-of-hearing using augmentative and alternative communication technology strategies. Int J Pediatr Otorhinolaryngol. 2019 Oct;125:23-31. doi: 10.1016/j.ijporl.2019.06.015. Epub 2019 Jun 20.
- BackgroundNam S, Kim J, Sparks S. An Overview of Review Studies on Effectiveness of Major AAC Systems for Individuals with Developmental Disabilities Including Autism. Journal of Special Education Apprenticeship. 2018 Jun;7(2):n2.
- Background: PubMed 18663107Schlosser RW, Wendt O. Effects of augmentative and alternative communication intervention on speech production in children with autism: a systematic review. Am J Speech Lang Pathol. 2008 Aug;17(3):212-30. doi: 10.1044/1058-0360(2008/021).
- BackgroundLorah ER, Tincani M, Parnell A. Current trends in the use of handheld technology as a speech-generating device for children with autism. Behavior Analysis: Research and Practice. 2018 Aug;18(3):317.
- Background: PubMed 24819024Waddington H, Sigafoos J, Lancioni GE, O'Reilly MF, van der Meer L, Carnett A, Stevens M, Roche L, Hodis F, Green VA, Sutherland D, Lang R, Marschik PB. Three children with autism spectrum disorder learn to perform a three-step communication sequence using an iPad(R)-based speech-generating device. Int J Dev Neurosci. 2014 Dec;39:59-67. doi: 10.1016/j.ijdevneu.2014.05.001. Epub 2014 May 10.
- Background: PubMed 25058915Roche L, Sigafoos J, Lancioni GE, O'Reilly MF, Schlosser RW, Stevens M, van der Meer L, Achmadi D, Kagohara D, James R, Carnett A, Hodis F, Green VA, Sutherland D, Lang R, Rispoli M, Machalicek W, Marschik PB. An evaluation of speech production in two boys with neurodevelopmental disorders who received communication intervention with a speech-generating device. Int J Dev Neurosci. 2014 Nov;38:10-6. doi: 10.1016/j.ijdevneu.2014.07.003. Epub 2014 Jul 21.
- BackgroundStasolla F, De Pace C, Damiani R, Di Leone A, Albano V, Perilli V. Comparing PECS and VOCA to promote communication opportunities and to reduce stereotyped behaviors by three girls with Rett syndrome. Research in Autism Spectrum Disorders. 2014 Oct 1;8(10):1269-78.
- Individual participant dataSharing planned: No
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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 K 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 Rhymes, Individual Items in Rhymes and Objects in people with Learning Disabilities and Cerebral Palsy, 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 2 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: finished, as of the sponsor's last update on 2 Apr 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self designed Questionnaire (time frame: 6 weeks). 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 NCT04583332, which also lists 8 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 2 Apr 2021.