- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04583332
Efficacy of AAC for Functional Communication
Efficacy of Using Augmentative Alternative Communication for Functional Communication in Group Activities
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Punjab
-
Rawalpindi, Punjab, Pakistan, 46000
- Riphah Child Development Centre & Step to Learn School
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Children with special needs
- Children not currently using any AAC
Exclusion Criteria:
- Children with any co-morbid conditions.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: Rhymes, Individual Items in Rhymes, Objects
Existing method Post intervention
|
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. 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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
6 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ayesha K Butt, PhD, Riphah International University
Publications and helpful links
General 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.
- Meinzen-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.
- Nam 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).
- Lorah 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.
- Roche 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.
- Stasolla 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 record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Congenital Abnormalities
- Brain Damage, Chronic
- Genetic Diseases, Inborn
- Intellectual Disability
- Neurodevelopmental Disorders
- Abnormalities, Multiple
- Chromosome Disorders
- Communication Disorders
- Cerebral Palsy
- Down Syndrome
- Learning Disabilities
Other Study ID Numbers
- REC/00738 Sheeba Sharazi
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Cerebral Palsy
-
Gazi UniversityCompletedCerebral Palsy | Cerebral Palsy, Spastic | Cerebral Palsy Spastic Diplegia | Cerebral Palsy Quadriplegic | Cerebral Palsy, MonoplegicTurkey
-
Northwestern UniversityActive, not recruitingCerebral Palsy | Diplegic Cerebral Palsy | Bilateral Cerebral PalsyUnited States
-
Centre Médico-Chirurgical de Réadaptation des Massues...RecruitingCerebral Palsy, Dyskinetic | Cerebral Palsy, Spastic | Infantile Hemiplegic Cerebral PalsyFrance
-
St Mary's University CollegeUniversity of GloucestershireUnknownCerebral Palsy | Cerebral Palsy Ataxic | Cerebral Palsy, MixedUnited Kingdom
-
Hilde FeysHasselt University; ETH Zurich; Curtin UniversityRecruitingHemiplegic Cerebral Palsy | Cerebral Palsy, SpasticBelgium
-
University of California, San FranciscoNational Institute of Neurological Disorders and Stroke (NINDS); National Institutes...RecruitingDystonic Cerebral Palsy | Dyskinetic Cerebral PalsyUnited States
-
East Carolina UniversityRecruitingHemiplegic Cerebral Palsy | Unilateral Cerebral Palsy | Remote Ischemic ConditioningUnited States
-
MTI UniversityEnrolling by invitationSpastic Diplegic Cerebral PalsyEgypt
-
October 6 UniversityCompletedSpastic Cerebral Palsy | Spastic Hemiplegic Cerebral PalsyEgypt
-
Marmara UniversityUnknownCerebral Palsy, Spastic | Cerebral Palsy, Spastic, DiplegicTurkey