CompletedNot Applicable

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

Netherlands20 participantsStarted 2023-07-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Scoring comprehension - T0

Timeframe: At baseline (T0)

Scoring comprehension - T1

Timeframe: Approximately 8 weeks after baseline (T1)

Text comprehension - cognitive interviews T0

Timeframe: At baseline (T0)

Text comprehension - cognitive interviews T1

Timeframe: Approximately 8 weeks after baseline (T1)

Comprehension of instructions - cognitive interviews T0

Timeframe: At baseline (T0)

Comprehension of instructions - cognitive interviews T1

Timeframe: Approximately 8 weeks after baseline (T1)

Overall difficulty score - T0

Timeframe: At baseline (T0)

Trial details

NCT IDNCT05857592

SponsorKoraal

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-10-31

View on ClinicalTrials.gov More Mild Intellectual Disability trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Scoring comprehension - T0

Timeframe: At baseline (T0)

Scoring comprehension - T1

Timeframe: Approximately 8 weeks after baseline (T1)

Text comprehension - cognitive interviews T0

Timeframe: At baseline (T0)

Text comprehension - cognitive interviews T1

Timeframe: Approximately 8 weeks after baseline (T1)

Comprehension of instructions - cognitive interviews T0

Timeframe: At baseline (T0)

Comprehension of instructions - cognitive interviews T1

Timeframe: Approximately 8 weeks after baseline (T1)

Overall difficulty score - T0

Timeframe: At baseline (T0)