NCT02099773

Brief 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). 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 .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2014

Typical duration for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

March 24, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 31, 2014

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

December 11, 2017

Status Verified

November 1, 2017

Enrollment Period

2.8 years

First QC Date

March 24, 2014

Last Update Submit

December 7, 2017

Conditions

Keywords

AACsupport workerdirect care staffintellectual disabilitylearning disabilitycommunicationadults

Outcome Measures

Primary Outcomes (2)

  • Signing rate of support workers and individuals with intellectual disabilities

    Proportion: number of signed utterances divided by total number (spoken + exclusively spoken) of utterances

    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

    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

    One testing per participant, over period of 6 months for all participants

  • Implicit Attitude of direct care staff working in towards manual signs

    One testing per participant, over period of 6 months for all participants

  • Communicative functions of individuals with intellectual disabilities

    Three observation sessions over period of 2 weeks per participant, 2 years for all participants

Study Arms (2)

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

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Support workers who work in residential facilities or day-centres for adults with intellectual disability, in Flanders.

You may qualify if:

  • uses AAC with client
  • client has congenital intellectual disability
  • supports client for at least 6 months

You may not qualify if:

  • client has dementia symptoms
  • client has severe, non-corrected visual impairment
  • client has diagnosed autism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

KULeuven

Leuven, Flanders, Belgium

Location

Katholieke Universiteit Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

KULeuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

MeSH Terms

Conditions

Intellectual DisabilityLearning DisabilitiesCommunication

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental DisordersCommunication DisordersBehavior

Study Officials

  • Ellen Rombouts, PhD cand.

    KU Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2014

First Posted

March 31, 2014

Study Start

March 1, 2014

Primary Completion

December 1, 2016

Study Completion

May 1, 2017

Last Updated

December 11, 2017

Record last verified: 2017-11

Locations