Intellectual DisabilityNCT02099773
Support Staff-client Interactions With Augmentative and Alternative Communication
An observational study of Intellectual Disability, run by Universitaire Ziekenhuizen KU Leuven at 3 sites in Belgium.
Trial summary
This exploratory and observational study focuses on adults with an intellectual disability (ID) and their support workers. Two groups of clients are observed: clients using Key Word Signing, and clients using aided Augmentative and Alternative Communication (AAC). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Intellectual Disability
- How many people
- 40 participants
- Where
- 3 sitesBelgium
- Study dates
- Mar 2014to May 2017
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Support workers who work in residential facilities or day-centres for adults with intellectual disability, in Flanders.
Who may be able to join
- uses AAC with client
- client has congenital intellectual disability
- supports client for at least 6 months
Who cannot join
- client has dementia symptoms
- client has severe, non-corrected visual impairment
- client has diagnosed autism
Trial locations and contacts
3 sites in 1 country.
Belgium3 sites
KULeuven
Leuven, Flanders
Katholieke Universiteit Leuven
Leuven, Vlaams-Brabant, 3000
KULeuven
Leuven, Vlaams-Brabant, 3000
About this study
Official title: Support Staff's Interactions With Adults With Intellectual Disability Who Use Augmentative and Alternative Communication
This exploratory and observational study focuses on adults with an intellectual disability (ID) and their support workers. Two groups of clients are observed: clients using Key Word Signing, and clients using aided Augmentative and Alternative Communication (AAC). Approximately half of adults with ID is estimated to experience communication difficulties. AAC supports them in their daily communication aiming at optimal participation in society. Current communication models, such as Participation Model (Beukelman \& Mirenda, 2005) and International Classification of Functioning, Disability and Health (WHO, 2001), regard both client-related and environmental factors as important elements of communication. A substantial part of the environmental factors is made up of the communication partners' characteristics. In daycare and residential services for adults with ID the support worker is an important communication partner .
Read the detailed description
This study aims to:
- with regard to teaching Key Word Signing (KWS), a specific form of AAC, to support workers: Analyse the relation between training method, support workers' attitude, and short and long term sign knowledge.
- with regard to the use of manual signs in everyday communication between support workers and adults with ID:
- Identity the support workers' characteristics that may influence the quality/quantity of the communication between adults with ID who use manual signs and their support worker.
- Analyse the nature of this influence as well as any possible interaction effects with the clients' characteristics.
- Assess whether an existing instrument, designed for measuring interactions between parents and children with cerebral palsy using AAC, may be used with adults client and support workers.
- Conditions
- Intellectual Disability
- Keywords
- AAC, support worker, direct care staff, intellectual disability, learning disability, communication, adults
- Medical subject headings
- Intellectual Disability, Learning Disabilities, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| support workers & AAC users | Support workers who use KeyWordSigning in the communication with their client who has an intellectual disability | |
| support workers & KWS users | Support workers who use aided AAC in the communication with their client who has an intellectual disability |
What is being measured
The primary outcome is the main question the study is designed to answer.
Signing rate of support workers and individuals with intellectual disabilities
Proportion: number of signed utterances divided by total number (spoken + exclusively spoken) of utterances
Measured: Three observation sessions over period of 2 weeks per participant, 2 years for all participants
Sign imitation rate support workers and individuals with intellectual disabilities
Proportion: number of manual sign imitations divided by total number manual signs produced
Measured: Three observation sessions over period of 2 weeks per participant, 2 years for all participants
Secondary outcomes (3)
Explicit Attitude of direct care staff towards manual signs
Self-developed survey with subscales (Likert response): scaled score
Measured: One testing per participant, over period of 6 months for all participants
Implicit Attitude of direct care staff working in towards manual signs
Single-Category Implicit Association Test scores
Measured: One testing per participant, over period of 6 months for all participants
Communicative functions of individuals with intellectual disabilities
Proportion of responses/acknowledgement versus all communicative functions (responses/acknowledgements as well as initiations)
Measured: Three observation sessions over period of 2 weeks per participant, 2 years for all participants
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionDec 2016
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intellectual DisabilityStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ellen Rombouts, PhD cand., Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02099773
- Sponsor's protocol ID
- S56517
- Status last verified
- Nov 2017
- First submitted
- 24 Mar 2014
- Last updated
- 11 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Support Staff's Interactions With Adults With Intellectual Disability Who Use Augmentative and Alternative Communication
- ClinicalTrials.gov ID
- NCT02099773
- Acronym / sponsor ID
- S56517
- Conditions
- Intellectual Disability
- Keywords
- AAC, support worker, direct care staff, intellectual disability, learning disability, communication, adults
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Mar 2014 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 31 Mar 2014 (estimated)
- 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.
This exploratory and observational study focuses on adults with an intellectual disability (ID) and their support workers. Two groups of clients are observed: clients using Key Word Signing, and clients using aided Augmentative and Alternative Communication (AAC). Approximately half of adults with ID is estimated to experience communication difficulties. AAC supports them in their daily communication aiming at optimal participation in society. Current communication models, such as Participation Model (Beukelman \& Mirenda, 2005) and International Classification of Functioning, Disability and Health (WHO, 2001), regard both client-related and environmental factors as important elements of communication. A substantial part of the environmental factors is made up of the communication partners' characteristics. In daycare and residential services for adults with ID the support worker is an important communication partner .
Detailed description
This study aims to:
- with regard to teaching Key Word Signing (KWS), a specific form of AAC, to support workers: Analyse the relation between training method, support workers' attitude, and short and long term sign knowledge.
- with regard to the use of manual signs in everyday communication between support workers and adults with ID:
- Identity the support workers' characteristics that may influence the quality/quantity of the communication between adults with ID who use manual signs and their support worker.
- Analyse the nature of this influence as well as any possible interaction effects with the clients' characteristics.
- Assess whether an existing instrument, designed for measuring interactions between parents and children with cerebral palsy using AAC, may be used with adults client and support workers.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| support workers & AAC users | – | –Support workers who use KeyWordSigning in the communication with their client who has an intellectual disability |
| support workers & KWS users | – | –Support workers who use aided AAC in the communication with their client who has an intellectual disability |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Support workers who work in residential facilities or day-centres for adults with intellectual disability, in Flanders.
Key inclusion criteria (3 listed)
- uses AAC with client
- client has congenital intellectual disability
- supports client for at least 6 months
Key exclusion criteria (3 listed)
- client has dementia symptoms
- client has severe, non-corrected visual impairment
- client has diagnosed autism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Signing rate of support workers and individuals with intellectual disabilities
Time frame: Three observation sessions over period of 2 weeks per participant, 2 years for all participants
Proportion: number of signed utterances divided by total number (spoken + exclusively spoken) of utterances
Sign imitation rate support workers and individuals with intellectual disabilities
Time frame: Three observation sessions over period of 2 weeks per participant, 2 years for all participants
Proportion: number of manual sign imitations divided by total number manual signs produced
3 secondary outcomes
Explicit Attitude of direct care staff towards manual signs
Time frame: One testing per participant, over period of 6 months for all participants
Implicit Attitude of direct care staff working in towards manual signs
Time frame: One testing per participant, over period of 6 months for all participants
Communicative functions of individuals with intellectual disabilities
Time frame: Three observation sessions over period of 2 weeks per participant, 2 years for all participants
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 11 Dec 2017.
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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.
Ellen Rombouts, PhD cand. principal investigator
KU Leuven
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intellectual Disability, run by Universitaire Ziekenhuizen KU Leuven at 3 sites in Belgium.
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 3 inclusion and 3 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 11 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium. 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?
Signing rate of support workers and individuals with intellectual disabilities (time frame: Three observation sessions over period of 2 weeks per participant, 2 years for all participants). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Dec 2017; AzTrials last refreshed its copy on 27 Oct 2026.