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Completed

NCT Number: NCT05857592

Improving the Cognitive Accessibility of Self-reports for People With ID

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.

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Key information

Conditions

Mild Intellectual Disability Borderline Intellectual Functioning

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Koraal

Sittard, L, 6130 PC, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Adaptive functioning self-report questionnaire

Diagnostic Test

A self-report questionnaire for assessing level of adaptive functioning

Adaptive functioning self-report questionnaire - adapted

Diagnostic Test

A self-report questionnaire for assessing level of adaptive functioning, adapted to the communication level of the participant

Primary outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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.

  5. 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).

  6. 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).

  7. 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)

  8. 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)

Secondary outcomes

  1. Self-reported Adaptive Functioning - original ABAS-3 scores

    Time frame: At baseline (T0)

    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.

  2. 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).

  3. Informant-reported Adaptive Functioning - original ABAS-3 scores

    Time frame: At baseline (T0)

    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.

  4. 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.

  5. Self-reported Adaptive functioning - SCAF

    Time frame: At baseline (T0)

    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.

Sponsors and collaborators

Lead sponsor

Koraal

Other

Collaborators

  • University of Amsterdam
  • Zuyd University of Applied Sciences

Registry information

Official study title

Adapting Self-report Instruments for People With Intellectual Disability to Improve Cognitive Accessibility - Putting Guidelines to the Test

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
May 12, 2023
Registry last updated
May 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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