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Efficacy of AAC for Functional Communication

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ClinicalTrials.gov Identifier: NCT04583332
Recruitment Status : Completed
First Posted : October 12, 2020
Last Update Posted : April 2, 2021
Sponsor:
Information provided by (Responsible Party):
Riphah International University

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.

Condition or disease Intervention/treatment Phase
Learning Disabilities Cerebral Palsy Down Syndrome Other: Rhymes Other: Individual Items in Rhymes Other: Objects Not Applicable

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

  1. To compare establish current practices with AAC for choice making in group activities.
  2. 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Pre-post experimental study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Using Augmentative Alternative Communication for Functional Communication in Group Activities
Actual Study Start Date : January 1, 2020
Actual Primary Completion Date : December 15, 2020
Actual Study Completion Date : December 15, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Rhymes, Individual Items in Rhymes, Objects
Existing method Post intervention
Other: Rhymes

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.


Other: Individual Items in Rhymes

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.


Other: 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.




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   4 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Children with any co-morbid conditions.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04583332


Locations
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Pakistan
Riphah Child Development Centre & Step to Learn School
Rawalpindi, Punjab, Pakistan, 46000
Sponsors and Collaborators
Riphah International University
Investigators
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Principal Investigator: Ayesha K Butt, PhD Riphah International University
Publications:
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.
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.
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.

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Responsible Party: Riphah International University
ClinicalTrials.gov Identifier: NCT04583332    
Other Study ID Numbers: REC/00738 Sheeba Sharazi
First Posted: October 12, 2020    Key Record Dates
Last Update Posted: April 2, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Riphah International University:
AAC
Functional Communication
Group intervention
Additional relevant MeSH terms:
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Cerebral Palsy
Down Syndrome
Learning Disorders
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn
Communication Disorders
Neurodevelopmental Disorders
Mental Disorders