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Efficacy of AAC for Functional Communication

Primary Purpose

Learning Disabilities, Cerebral Palsy, Down Syndrome

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Rhymes
Individual Items in Rhymes
Objects
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Learning Disabilities focused on measuring AAC, Functional Communication, Group intervention

Eligibility Criteria

4 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Children with special needs
  • Children not currently using any AAC

Exclusion Criteria:

  • Children with any co-morbid conditions.

Sites / Locations

  • Riphah Child Development Centre & Step to Learn School

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Rhymes, Individual Items in Rhymes, Objects

Arm Description

Existing method Post intervention

Outcomes

Primary Outcome Measures

Self designed Questionnaire
Self designed questionnaire to address choice making in objects, pictures and symbols in three activities Rhymes, Items in Rhymes and Objects

Secondary Outcome Measures

Full Information

First Posted
October 6, 2020
Last Updated
March 30, 2021
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT04583332
Brief Title
Efficacy of AAC for Functional Communication
Official Title
Efficacy of Using Augmentative Alternative Communication for Functional Communication in Group Activities
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
December 15, 2020 (Actual)
Study Completion Date
December 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Learning Disabilities, Cerebral Palsy, Down Syndrome
Keywords
AAC, Functional Communication, Group intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Pre-post experimental study
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rhymes, Individual Items in Rhymes, Objects
Arm Type
Other
Arm Description
Existing method Post intervention
Intervention Type
Other
Intervention Name(s)
Rhymes
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Individual Items in Rhymes
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Objects
Intervention Description
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.
Primary Outcome Measure Information:
Title
Self designed Questionnaire
Description
Self designed questionnaire to address choice making in objects, pictures and symbols in three activities Rhymes, Items in Rhymes and Objects
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Children with special needs Children not currently using any AAC Exclusion Criteria: Children with any co-morbid conditions.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayesha K Butt, PhD
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Riphah Child Development Centre & Step to Learn School
City
Rawalpindi
State/Province
Punjab
ZIP/Postal Code
46000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31013673
Citation
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.
Results Reference
background
PubMed Identifier
31238158
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
18663107
Citation
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).
Results Reference
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Citation
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.
Results Reference
background
PubMed Identifier
24819024
Citation
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.
Results Reference
background
PubMed Identifier
25058915
Citation
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.
Results Reference
background
Citation
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.
Results Reference
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Efficacy of AAC for Functional Communication

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