Mild Intellectual DisabilityNCT05857592
Improving the Cognitive Accessibility of Self-reports for People With ID
A study testing Adaptive functioning self-report questionnaire and Adaptive functioning self-report questionnaire - adapted in people with Mild Intellectual Disability and Borderline Intellectual Functioning, run by Koraal at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mild Intellectual Disability, Borderline Intellectual Functioning
- What is being tested?
- Adaptive functioning self-report questionnaire and Adaptive functioning self-report questionnaire - adapted
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jul 2023to 1 May 2024
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Severe physical or sensory impairment limiting ability to participate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adapting Self-report Instruments for People With Intellectual Disability to Improve Cognitive Accessibility - a Cognitive Interview Study
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.
- Being tested
- Adaptive functioning self-report questionnaire, Adaptive functioning self-report questionnaire - adapted
- Keywords
- self-report questionnaires, inclusive diagnostics, easy-read language, adaptive functioning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adaptive functioning self-report questionnaireDiagnostic test
A self-report questionnaire for assessing level of adaptive functioning
Adaptive functioning self-report questionnaire - adaptedDiagnostic test
A self-report questionnaire for assessing level of adaptive functioning, adapted to the communication level of the participant
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Adaptive functioning self-report questionnaire; Diagnostic Test: Adaptive functioning self-report questionnaire - adapted |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scoring comprehension - T0
Degree to which the qualitative information provided by the participant aligns with the self-reported score on the original version of the ABAS-3 (Adaptive Behaviour Assessment System - Third Edition) questionnaire. Outcomes are 0, scores align, -1, scores are lower than answer would suggest, +1, score is higher than answer would suggest.
Measured: At baseline (T0)
Scoring comprehension - T1
Degree to which the qualitative information provided by the participant aligns with the self-reported score on the original version of the ABAS-3 (Adaptive Behaviour Assessment System - Third Edition) questionnaire. Outcomes are 0, scores align, -1, scores are lower than answer would suggest, +1, score is higher than answer would suggest.
Measured: Approximately 8 weeks after baseline (T1)
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). Terms and concepts that were misinterpreted, participant utterings of confusion of statements of difficulty
Measured: At baseline (T0)
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). Terms and concepts that were misinterpreted, participant utterings of confusion of statements of difficulty.
Measured: Approximately 8 weeks after baseline (T1)
Comprehension of instructions - cognitive interviews T0
Level of verbal understanding of the instructions in the questionnaire - original version of the ABAS-3 (Adaptive Behaviour Assessment System - Third Edition). Number of elements that were correctly identiefied (out of possible 10).
Measured: At baseline (T0)
Comprehension of instructions - cognitive interviews T1
Level of verbal understanding of the instructions in the questionnaire - adapted version of the ABAS-3 (Adaptive Behaviour Assessment System - Third Edition). Number of elements that were correctly identiefied (out of possible 10).
Measured: Approximately 8 weeks after baseline (T1)
Overall difficulty score - T0
Likert scale rating of the overall difficulty of items of original version of the ABAS-3 (Adaptive Behaviour Assessment System - Third Edition) by participants (from 1. very easy - 5. very difficult)
Measured: At baseline (T0)
Overall difficulty score - T1
Likert scale rating of the overall difficulty of items of adapted version of the ABAS-3 (Adaptive Behaviour Assessment System - Third Edition) by participants (from 1. very easy - 5. very difficult)
Measured: Approximately 8 weeks after baseline (T1)
Secondary outcomes (5)
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.
Measured: At baseline (T0)
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).
Measured: Approximately 8 weeks after baseline (T1)
Informant-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.
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.
Measured: 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.
Measured: Approximately 8 weeks after baseline (T1)
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.
Measured: At baseline (T0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2023
- Study start1 Jul 2023
- Primary completion31 Oct 2023
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mild Intellectual DisabilityStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Koraal
- Sponsor type
- University, hospital or other
- Collaborators
- University of Amsterdam, Zuyd University of Applied Sciences
- Responsible party
- Principal investigator, Roel Kooijmans, University of Amsterdam
- Investigators
- Roel Kooijmans, MSc, Principal investigator, Koraal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05857592
- Sponsor's protocol ID
- Koraal-ABAS-Kooijmans
- Status last verified
- Oct 2024
- First submitted
- 15 Mar 2023
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
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 at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adapting Self-report Instruments for People With Intellectual Disability to Improve Cognitive Accessibility - a Cognitive Interview Study
- ClinicalTrials.gov ID
- NCT05857592
- Acronym / sponsor ID
- Koraal-ABAS-Kooijmans
- Keywords
- self-report questionnaires, inclusive diagnostics, easy-read language, adaptive functioning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- KoraalUniversity, hospital or other
- Collaborators
- University of Amsterdam, Zuyd University of Applied Sciences
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 12 May 2023 (actual)
- 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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Diagnostic Test: Adaptive functioning self-report questionnaire, Diagnostic Test: Adaptive functioning self-report questionnaire - adaptedPersons 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Severe physical or sensory impairment limiting ability to participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adaptive functioning self-report questionnaireA self-report questionnaire for assessing level of adaptive functioning | Diagnostic test | Experimental |
| Adaptive functioning self-report questionnaire - adaptedA self-report questionnaire for assessing level of adaptive functioning, adapted to the communication level of the participant | Diagnostic test | Experimental |
Primary outcome
Scoring comprehension - T0
Time frame: At baseline (T0)
Degree to which the qualitative information provided by the participant aligns with the self-reported score on the original version of the ABAS-3 (Adaptive Behaviour Assessment System - Third Edition) questionnaire. Outcomes are 0, scores align, -1, scores are lower than answer would suggest, +1, score is higher than answer would suggest.
Scoring comprehension - T1
Time frame: Approximately 8 weeks after baseline (T1)
Degree to which the qualitative information provided by the participant aligns with the self-reported score on the original version of the ABAS-3 (Adaptive Behaviour Assessment System - Third Edition) questionnaire. Outcomes are 0, scores align, -1, scores are lower than answer would suggest, +1, score is higher than answer would suggest.
Text comprehension - cognitive interviews T0
Time frame: At baseline (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). Terms and concepts that were misinterpreted, participant utterings of confusion of statements of difficulty
Text comprehension - cognitive interviews T1
Time frame: Approximately 8 weeks after baseline (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). Terms and concepts that were misinterpreted, participant utterings of confusion of statements of difficulty.
Comprehension of instructions - cognitive interviews T0
Time frame: At baseline (T0)
Level of verbal understanding of the instructions in the questionnaire - original version of the ABAS-3 (Adaptive Behaviour Assessment System - Third Edition). Number of elements that were correctly identiefied (out of possible 10).
Comprehension of instructions - cognitive interviews T1
Time frame: Approximately 8 weeks after baseline (T1)
Level of verbal understanding of the instructions in the questionnaire - adapted version of the ABAS-3 (Adaptive Behaviour Assessment System - Third Edition). Number of elements that were correctly identiefied (out of possible 10).
Overall difficulty score - T0
Time frame: At baseline (T0)
Likert scale rating of the overall difficulty of items of original version of the ABAS-3 (Adaptive Behaviour Assessment System - Third Edition) by participants (from 1. very easy - 5. very difficult)
Overall difficulty score - T1
Time frame: Approximately 8 weeks after baseline (T1)
Likert scale rating of the overall difficulty of items of adapted version of the ABAS-3 (Adaptive Behaviour Assessment System - Third Edition) by participants (from 1. very easy - 5. very difficult)
5 secondary outcomes
Self-reported Adaptive Functioning - original ABAS-3 scores
Time frame: At baseline (T0)
Self-reported Adaptive Functioning - adapted ABAS-3 scores
Time frame: Approximately 8 weeks after baseline (T1)
Informant-reported Adaptive Functioning - original ABAS-3 scores
Time frame: At baseline (T0)
Informant-reported Adaptive Functioning - adapted ABAS-3 scores
Time frame: Approximately 8 weeks after baseline (T1)
Self-reported Adaptive functioning - SCAF
Time frame: At baseline (T0)
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 7 Aug 2026.
- BackgroundKooijmans, 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.
- Individual participant dataSharing planned: No. 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.
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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.
Roel Kooijmans, MSc principal investigator
Koraal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adaptive functioning self-report questionnaire and Adaptive functioning self-report questionnaire - adapted in people with Mild Intellectual Disability and Borderline Intellectual Functioning, run by Koraal at 1 site in Netherlands.
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 4 inclusion and 1 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 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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?
Scoring comprehension - T0 (time frame: At baseline (T0)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05857592, which also lists 1 linked publication.
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 7 Aug 2026.