Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000874213
Ethics application status
Approved
Date submitted
14/05/2018
Date registered
23/05/2018
Date last updated
19/05/2021
Date data sharing statement initially provided
19/05/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Teaching Adults with Developmental Disability to Use an iPad for Communication Purposes
Scientific title
Evaluating an iPad-based Augmentative and Alternative Communication Intervention on Frequency of Requesting Responses Among Adults with Developmental Disabilities
Secondary ID [1] 294869 0
None
Universal Trial Number (UTN)
U1111-1205-7688
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Developmental Disability 307819 0
Severe Communication Impairment 307820 0
Condition category
Condition code
Mental Health 306866 306866 0 0
Learning disabilities
Neurological 306867 306867 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Augmentative and Alternative Communication (AAC) intervention involves teaching individuals to use non-speech modes of communication, such as using manual signs, picture-based communication boards, or computer-based speech-generating devices. AAC intervention is indicated for individuals who have limited speech and language development, a temporary loss of speech, and/or unintelligible speech. Many individuals with developmental disabilities (e.g., intellectual disability, autism spectrum disorder, and/or cerebral palsy) lack speech and are therefore candidates for learning to use an AAC device. AAC intervention for individuals with developmental disabilities can begin be teaching individuals to use AAC to first recruit the attention of a listener and then make a request of that listener. The present intervention involves teaching adults with developmental disabilities to use AAC to first recruit the attention of a listener and then make a request of that listener. The AAC device will involve the use of an Apple iPad with a special application (i.e., Proloquo2Go® software) that allows the iPad to be used as a picture-based speech-generating device. Each participant will be provided with an iPad that will be configured with two picture symbols. One symbol will be a line drawing picture showing the outline of a person. Tapping this symbol will result in corresponding synthetic speech output (i.e., Excuse me. Can I talk to you?). The other symbol will be a line drawing picture of a preferred item, such as a line drawing of a water glass or a apple. Tapping these symbols will result in corresponding synthetic speech output (i.e., Can I have a drink of water please? or Can I have an apple please?). The intervention will involve creating opportunities for communication by having a listener present but not attending and then teaching the person to tap the two line drawings to first recruit the listener's attention and then request a preferred item from that listener. The instructional procedures will involve using the least amount of physical guidance necessary to assist the person in tapping the symbols and then fading out the need for prompting by waiting 10 seconds before prompting. The intervention will be delivered by the lead researcher and two university students who will be serving as research assistants. The mode of delivery will be individuals, face to face and one-on-one teaching sessions that will each last 10 minutes. It is anticipated that from 30 to 40 such sessions will be required for the participants to reach proficiency with the iPad-based AAC device. Sessions will occur 1-2 days per week for approximately 20-30 weeks. The duration of the intervention will be decided based on the level of proficiency shown by the participants. Specifically, intervention will continue until participants obtain the 80 to 100% correct level for three successive sessions. The intervention will be delivered in the participant's residential care facility. During each session, data will be collected on the number of opportunities that were conduction and the for each opportunity we will record whether the person use the iPad to communication independently or if the person had to be prompted. For each session, we will graph the percentage of opportunities with independent use of the iPad and continue intervention until the 80 to 100% level is reached and maintained over at least 3 successive sessions. The interventionist will record these data using pen and paper data sheets. Reliability of data collection will be assessed by an independent observer on at least 20% of the sessions. Procedural fidelity using a checklist of the procedural steps will be assessed by the ndependent observer on at least 20% of the sessions. We also plan to conduct a follow-up session, which would be identical to an intervention session, at 3 and/or 6 months post-intervention provided that the participant is available.
Intervention code [1] 301181 0
Treatment: Devices
Intervention code [2] 301182 0
Treatment: Other
Comparator / control treatment
No control Group. Each participant will serve as his or her own control by first participating in a baseline phase in which they will have the device, but will not receive the response prompting procedure. Baseline will involve from 3 to 7, 10-min sessions conducted 1-2 times per week. The decision regarding the number of baseline sessions (3 to 7) will depend the level performance shown by the participants during baseline. A stable baseline (0% correct) would result in the person receiving only 3 baseline session. However, if there is variability ion the baseline data then additional baseline sessions will be conducted until a stable trend is obtained. A stage trend is defined as no more than a 20% change over three successive sessions. The study involves the use of single-case experimental designs in which each participant will proceed from a baseline phase to a subsequent intervention phase. The baseline phase serves as a control against which to evaluate the effects of the intervention.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 305857 0
Percentage of opportunities during which there was independent and correct use of the iPad-based communication device to recruit the attention of the listener. This outcome is assessed by the researchers counting whether or not the person made an independent and correct response for each opportunity and then calculating a percentage of opportunities with an independent and correct response for each teaching session that is conducted.
Timepoint [1] 305857 0
The primary outcome [1] variable will be measured as they occur during each 10 minute baseline and intervention session. In addition, we also plan to collect the same data during a follow-up session. We plan to conduct follow-up sessions at 3 and/or 6 months post-intervention provided that the participant is available.
Primary outcome [2] 305906 0
The percentage of opportunities during which the participant uses the iPad to make a request for a preferred item. This outcome is assessed by the researchers counting whether or not the person made an independent and correct response for each opportunity and then calculating a percentage of opportunities with an independent and correct response for each teaching session that is conducted.
Timepoint [2] 305906 0
The primary outcome [2] variable will be measured as they occur during each 10 minute baseline and intervention session. In addition, we also plan to collect the same data during a follow-up session. We plan to conduct follow-up sessions at 3 and/or 6 months post-intervention provided that the participant is available.
Secondary outcome [1] 346815 0
Percentage of opportunities during which the participant required a response prompt in order to use the iPad to recruit the listener's attention. This outcome is assessed by the researchers counting whether or not the person made an independent and correct response for each opportunity and then calculating a percentage of opportunities with an independent and correct response for each teaching session that is conducted.
Timepoint [1] 346815 0
Data on secondary outcome [1] will be collected as these prompts are provided within each 10 minute baseline and intervention session. In addition, we also plan to collect the same data during a follow-up session. We plan to conduct follow-up sessions at 3 and/or 6 months post-intervention provided that the participant is available.
Secondary outcome [2] 346998 0
Percentage of opportunities during which the participant required a response prompt in order to use the iPad to make a request for a preferred item. This outcome is assessed by the researchers counting whether or not the person made an independent and correct response for each opportunity and then calculating a percentage of opportunities with an independent and correct response for each teaching session that is conducted.
Timepoint [2] 346998 0
Data on secondary outcome [2] will be collected as these prompts are provided within each 10 minute baseline and intervention session. In addition, we also plan to collect the same data during a follow-up session. We plan to conduct follow-up sessions at 3 and/or 6 months post-intervention provided that the participant is available.

Eligibility
Key inclusion criteria
1. 18 years of age or older.
2. Diagnosis of developmental disability; specifically intellectual disability, autism spectrum disorder, and/ore cerebral palsy).
3. Severe communication impairment as evidenced by having 10 or less spoken words.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Advanced communication ability as evidenced by having more than 10 spoken words.
2. Already using AAC to recruit attention and request objects.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
The study involves the use of single-case experimental designs in which each participant will proceed from a baseline phase to a subsequent intervention phase. The baseline phase serves as a control against which to evaluate the effects of the intervention. A minimum of three participants is needed to provide sufficient evidence of a replicable intervention effect.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The efficacy of the treatment will be determined by calculating the percentage of non-overlapping data points between the baseline and intervention phases.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
4/06/2018
Actual
25/05/2018
Date of last participant enrolment
Anticipated
2/07/2018
Actual
1/06/2018
Date of last data collection
Anticipated
30/08/2019
Actual
10/04/2019
Sample size
Target
4
Accrual to date
Final
4
Recruitment outside Australia
Country [1] 10396 0
New Zealand
State/province [1] 10396 0
Wellington

Funding & Sponsors
Funding source category [1] 299456 0
University
Name [1] 299456 0
School of Education, Victoria Univesity of Wellington
Country [1] 299456 0
New Zealand
Primary sponsor type
Individual
Name
Jeff Sigafoos
Address
Jeff Sigafoos
School of Education
Victoria University of Wellington
Kelburn Campus, PO Box 600
Kelburn Parade, Murphy Bldg., Level 8
Wellington, New Zealand, 6140
Country
New Zealand
Secondary sponsor category [1] 298754 0
None
Name [1] 298754 0
Address [1] 298754 0
Country [1] 298754 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300362 0
Health and Disability Ethics Committee
Ethics committee address [1] 300362 0
Ethics committee country [1] 300362 0
New Zealand
Date submitted for ethics approval [1] 300362 0
24/11/2017
Approval date [1] 300362 0
06/04/2018
Ethics approval number [1] 300362 0
17/NTA/260

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2688 2688 0 0
/AnzctrAttachments/375087-Approval LetterHDEC - Letter - 17NTA260 Approved FULL Application.pdf (Ethics approval)

Contacts
Principal investigator
Name 83406 0
Prof Jeff Sigafoos
Address 83406 0
School of Education,
Victoria University of Wellington,
Room 808, Murphy Building, Kelburn Parade,
Wellington, New Zealand, 6140


Country 83406 0
New Zealand
Phone 83406 0
+64-4-463 9772
Fax 83406 0
Email 83406 0
[email protected]
Contact person for public queries
Name 83407 0
Jeff Sigafoos
Address 83407 0
School of Education,
Victoria University of Wellington,
Room 808, Murphy Building, Kelburn Parade,
Wellington, New Zealand, 6140
Country 83407 0
New Zealand
Phone 83407 0
+64-4-463 9772
Fax 83407 0
Email 83407 0
[email protected]
Contact person for scientific queries
Name 83408 0
Jeff Sigafoos
Address 83408 0
School of Education,
Victoria University of Wellington,
Room 808, Murphy Building, Kelburn Parade,
Wellington, New Zealand, 6140


Country 83408 0
New Zealand
Phone 83408 0
+64-4-463 9772
Fax 83408 0
Email 83408 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Graphed data on number of responses made during each session.
When will data be available (start and end dates)?
From publication of the study with no end date determined.
Available to whom?
To reviewers.
Available for what types of analyses?
percentage of non-overlapping data points (PND) from baseline to intervention phases.
How or where can data be obtained?
By submitting a supplementary file when the manuscript is submitted for publication.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.