- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05857592
Suitability of a Self-report Questionnaire to Assess Adaptive Functioning for Persons With Intellectual Disability
How to Improve the Possibilities for Self-reporting Adaptive Functioning for Persons With Mild Intellectual Disability or Borderline Intellectual Functioning With the ABAS-3?
Study Overview
Status
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Roel Kooijmans, MSc
- Phone Number: +31620352292
- Email: rkooijmans@koraal.nl
Study Contact Backup
- Name: Xavier Moonen, Professor
- Phone Number: +31655107583
- Email: x.m.h.moonen@uva.nl
Study Locations
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L
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Sittard, L, Netherlands, 6130 PC
- Koraal
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Contact:
- Roel Kooijmans, MSc
- Phone Number: +31620352292
- Email: rkooijmans@koraal.nl
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Contact:
- Patricia Marcic
- Phone Number: +31648127025
- Email: pmarcic@koraal.nl
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 18 years or older
- Last known Total Intelligence Quotient (TIQ) 55 - 85
- Receiving support from a care organization for persons with ID.
- A care worker who knows the participant for at least a year and knows him well enough tot complete the informant version of the ABAS-3 is available.
Exclusion Criteria:
• Severe physical or sensory impairment limiting ability to participate.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental
Persons with Mild Intellectual Disability (MID) or Borderline Intellectual Functioning (BIF) complete the ABAS-3 in assisted form on two occasions: the original version the first time and an adapted version after a few weeks.
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A self-report questionnaire for assessing level of adaptive functioning
A self-report questionnaire for assessing level of adaptive functioning, adapted to the communication level of the participant
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Text comprehension - HyTeC T0
Time Frame: At baseline (T0)
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Level of verbal understanding of instructions and questions in the ABAS-3 (Adaptive Behaviour Assessment System - Third Edition) questionnaire - results from HyTeC-cloze tests.
The HyTeC-cloze (Hybrid Text Comprehension cloze) is a test to assess the level of text comprehension for a body of text.
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At baseline (T0)
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Text comprehension - HyTeC T1
Time Frame: Approximately 8 weeks after baseline (T1)
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Level of verbal understanding of instructions and questions in an adapted version of the ABAS-3 (Adaptive Behaviour Assessment System - Third Edition) questionnaire - results from HyTeC-cloze tests.
The HyTeC-cloze (Hybrid Text Comprehension cloze) is a test to assess the level of text comprehension for a body of text.
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Approximately 8 weeks after baseline (T1)
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Text comprehension - missings T0
Time Frame: At baseline (T0)
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Level of verbal understanding of questions in the ABAS-3 (Adaptive Behaviour Assessment System - Third Edition) questionnaire.
Outcomes are 1.
number of missing (unscored) items (min 0 - max 30), 2. number of 'don't know' answers (min 0 - max 30) and 3. a composite score of 1 and 2.
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At baseline (T0)
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Text comprehension - missings T1
Time Frame: Approximately 8 weeks after baseline (T1)
|
Level of verbal understanding of questions in an adapted version of the ABAS-3 (Adaptive Behaviour Assessment System - Third Edition) questionnaire.
Outcomes are 1.
number of missing (unscored) items (min 0 - max 30), 2. number of 'don't know' answers (min 0 - max 30) and 3. a composite score of 1 and 2.
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Approximately 8 weeks after baseline (T1)
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Text comprehension - cognitive interviews T0
Time Frame: At baseline (T0)
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Level of verbal understanding of questions in the questionnaire - qualitative analysis of answers from cognitive interviews during assessment of the ABAS-3 (Adaptive Behaviour Assessment System - Third Edition).
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At baseline (T0)
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Text comprehension - cognitive interviews T1
Time Frame: Approximately 8 weeks after baseline (T1)
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Level of verbal understanding of questions in the questionnaire - qualitative analysis of answers from cognitive interviews during assessment of an adapted version of the ABAS-3 (Adaptive Behaviour Assessment System - Third Edition).
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Approximately 8 weeks after baseline (T1)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self-reported Adaptive Functioning - original ABAS-3 scores
Time Frame: At baseline (T0)
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The ABAS-3 (Adaptive Behaviour Assessment System - Third Edition) is an observational scale that measures adaptive behaviour.
Both self-report and informant report versions are available.
In the context of the current study, a 30-item abbreviated version is used.
Composite scores are calculated: a total score and three domain scores (conceptual, social and practical domain).
Scores range from 0-90 for the total scale and 0-30 for each domain scale.
Higher scores indicate better adaptive functioning.
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At baseline (T0)
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Self-reported Adaptive Functioning - adapted ABAS-3 scores
Time Frame: Approximately 8 weeks after baseline (T1)
|
The ABAS-3 (Adaptive Behaviour Assessment System - Third Edition) is an observational scale that measures adaptive behaviour. Both self-report and informant report versions are available. In the context of the current study, a 30-item abbreviated version is used. Composite scores are calculated: a total score and three domain scores (conceptual, social and practical domain). Scores range from 0-90 for the total scale and 0-30 for each domain scale. Higher scores indicate better adaptive functioning. The second time participants complete the ABAS (approximately 8 weeks after baseline, T1), an adapted version is used, with language and design adapted to the comprehension level of participants according to the outcomes at baseline (T0). |
Approximately 8 weeks after baseline (T1)
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Informant-reported Adaptive Functioning - adapted ABAS-3 scores
Time Frame: Approximately 8 weeks after baseline (T1)
|
The ABAS-3 (Adaptive Behaviour Assessment System - Third Edition) is an observational scale that measures adaptive behaviour. Both self-report and informant report versions are available. In the context of the current study, a 30-item abbreviated version is used. Composite scores are calculated: a total score and three domain scores (conceptual, social and practical domain). Scores range from 0-90 for the total scale and 0-30 for each domain scale. Higher scores indicate better adaptive functioning. For the informant-report an adapted version of the original is used; the adaptations for the self-report version are replicated for the informant version. |
Approximately 8 weeks after baseline (T1)
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Self-reported Adaptive functioning - SCAF
Time Frame: At baseline (T0)
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The SCAF (Screener for Adaptive Functioning) is a screening questionnaire for adaptive functioning for individuals who may have MID or BIF.
The SCAF yields a total AF score (min 0 - max 24), with higher scores indicating better adaptive functioning.
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At baseline (T0)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Roel Kooijmans, MSc, Koraal
Publications and helpful links
General Publications
- Kooijmans, R., Mercera, G., Langdon, P. E., & Moonen, X. (2022). The adaptation of self-report measures to the needs of people with intellectual disabilities: A systematic review. Clinical Psychology: Science and Practice.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Koraal-ABAS-Kooijmans
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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