TerminatedNot Applicable

READYorNot[TM] Brain-Based Disabilities Trial

Stopped: The planned sample size was 264; 43 participants completed follow-up. With significant start-up delays and recruitment curtailed by the COVID-19 pandemic, the limited feasibility to recruit our sample ultimately led to the early stop of the trial.

Canada52 participantsStarted 2020-06-22

Plain-language summary

The purpose of this study is to find out if there is a benefit to using the MyREADY Transition\[TM\] BBD App for brain-based disabilities, compared to not using it. To do this, some of the participants in this study will use the MyREADY Transition\[TM\] BBD App and others will not use the App. Everyone will continue to get the same care they have been getting (their usual care). The study team wants to see how youth will use the MyREADY Transition\[TM\] BBD App as they are getting ready to leave the children's hospital or children's treatment centre. And, they want to see if it will help youth to be knowledgeable about their own health. The study team hopes to see youth taking steps to develop the skills so they become better managers of their health. For example, this would include knowing about their medication or knowing when to ask for help from parents/caregivers and health care providers.

Who can participate

Age range

15 Years – 17 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: * Youth with chronological age between 15 and 17 years of age (i.e. before 18th birthday), in one of the four Canadian study regions (Alberta, Ontario, Quebec, Maritimes), followed in pediatric care and for whom a discharge from pediatric care is planned but not for at least 6 months. * A diagnosis of one of the following neurological brain-based disabilities: autism spectrum disorder, cerebral palsy, epilepsy, spina bifida, or fetal alcohol spectrum disorder. * Cognitive ability to provide informed consent and the ability to read and understand English or French. * Access to internet and a smartphone, iPad/tablet or desktop computer. * TRANSITION-Q score \>40 (as a screen to define a minimum threshold for transition readiness based on earlier work). Exclusion Criteria: * Youth is in "acute crisis" with unstable physical or mental health that would interfere with the ability to participate in the study. * Sensory impairments, such as uncorrected vision or hearing loss, which interfere with use of the App intervention. * Enrolled in a potentially confounding trial (e.g., a different transition intervention study).

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

Transition Readiness Assessment Questionnaire (TRAQ) Change

Timeframe: Baseline and 6-Month Visit

Trial details

NCT IDNCT03852550

SponsorMcMaster University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-05-22

Results submitted2024-07-15

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