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Suitability of a Self-report Questionnaire to Assess Adaptive Functioning for Persons With Intellectual Disability

Primary Purpose

Mild Intellectual Disability, Borderline Intellectual Functioning

Status
Active
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Adaptive functioning self-report questionnaire
Adaptive functioning self-report questionnaire - adapted
Sponsored by
Koraal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Mild Intellectual Disability focused on measuring self-report questionnaires, inclusive diagnostics, easy-read language, adaptive functioning

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Koraal

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental

Arm Description

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.

Outcomes

Primary Outcome Measures

Text comprehension - HyTeC T0
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.
Text comprehension - HyTeC T1
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.
Text comprehension - missings T0
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.
Text comprehension - missings 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.
Text comprehension - cognitive interviews T0
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).
Text comprehension - cognitive interviews T1
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).

Secondary Outcome Measures

Self-reported Adaptive Functioning - original ABAS-3 scores
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.
Self-reported Adaptive Functioning - adapted ABAS-3 scores
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).
Informant-reported Adaptive Functioning - adapted ABAS-3 scores
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.
Self-reported Adaptive functioning - SCAF
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.

Full Information

First Posted
March 15, 2023
Last Updated
October 11, 2023
Sponsor
Koraal
Collaborators
University of Amsterdam, Zuyd University of Applied Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05857592
Brief Title
Suitability of a Self-report Questionnaire to Assess Adaptive Functioning for Persons With Intellectual Disability
Official Title
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 Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 1, 2023 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
November 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Koraal
Collaborators
University of Amsterdam, Zuyd University of Applied Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
In the proposed study, the investigators aim to investigate whether the existing ABAS-3 self-report questionnaire is suitable to be completed meaningfully by individuals who are perceived as having mild intellectual disability (55<IQ<85) based on cognitive impairment. Based on the participants' experiences and researchers' expertise, the investigators develop a 'more inclusive' self-report version. The investigators then look at the extent to which participants indicate that they understand this version better, based on user experiences and limited psychometric research. In doing so, the investigators also compare the outcomes of the self-report and informant-report variant.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Intellectual Disability, Borderline Intellectual Functioning
Keywords
self-report questionnaires, inclusive diagnostics, easy-read language, adaptive functioning

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
A mixed-method repeated-measures design will be used: data are collected using both qualitative and quantitative methods at two points in time (before and after adaptation) from the same participants.
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Adaptive functioning self-report questionnaire
Intervention Description
A self-report questionnaire for assessing level of adaptive functioning
Intervention Type
Diagnostic Test
Intervention Name(s)
Adaptive functioning self-report questionnaire - adapted
Intervention Description
A self-report questionnaire for assessing level of adaptive functioning, adapted to the communication level of the participant
Primary Outcome Measure Information:
Title
Text comprehension - HyTeC T0
Description
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.
Time Frame
At baseline (T0)
Title
Text comprehension - HyTeC T1
Description
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.
Time Frame
Approximately 8 weeks after baseline (T1)
Title
Text comprehension - missings T0
Description
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.
Time Frame
At baseline (T0)
Title
Text comprehension - missings T1
Description
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.
Time Frame
Approximately 8 weeks after baseline (T1)
Title
Text comprehension - cognitive interviews T0
Description
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).
Time Frame
At baseline (T0)
Title
Text comprehension - cognitive interviews T1
Description
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).
Time Frame
Approximately 8 weeks after baseline (T1)
Secondary Outcome Measure Information:
Title
Self-reported Adaptive Functioning - original ABAS-3 scores
Description
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.
Time Frame
At baseline (T0)
Title
Self-reported Adaptive Functioning - adapted ABAS-3 scores
Description
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).
Time Frame
Approximately 8 weeks after baseline (T1)
Title
Informant-reported Adaptive Functioning - adapted ABAS-3 scores
Description
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.
Time Frame
Approximately 8 weeks after baseline (T1)
Title
Self-reported Adaptive functioning - SCAF
Description
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.
Time Frame
At baseline (T0)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roel Kooijmans, MSc
Organizational Affiliation
Koraal
Official's Role
Principal Investigator
Facility Information:
Facility Name
Koraal
City
Sittard
State/Province
L
ZIP/Postal Code
6130 PC
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Study data are highly specific for this study and not relevant for sharing with other researchers, except for validation of results in exceptional circumstances. When required, relevant data will be made available upon request to reviewers or auditors, subject to privacy regulations. Only anonymized data will be shared.
Citations:
Citation
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.
Results Reference
background

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Suitability of a Self-report Questionnaire to Assess Adaptive Functioning for Persons With Intellectual Disability

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