A Crisis Prevention Program for Youth With Autism (NCT05681143) | Clinical Trial Compass
CompletedNot Applicable
A Crisis Prevention Program for Youth With Autism
United States61 participantsStarted 2023-02-01
Plain-language summary
Mental health crises involve acute psychiatric states, such as aggression and/or self-injury, which can result in harm to self or others. There is evidence to suggest that 20% to 25% of autistic children are at risk of a mental health crises, however no crisis prevention programs exist for autistic children. The goal of this project is to evaluate, via a randomized design, a novel crisis prevention program.
Who can participate
Age range
3 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:
* Have a child with autism
* The child must be 3-17 years of age
* Caregivers must score \<=13 on the Crisis Prevention Index (CPI)
* The child must have some behavioral concerns (e.g., aggression, property destruction, elopement, tantrums), as listed on section 2 of the MCAS-R.
* The child must have an MCAS-R Acuity score of at most 19
* The child must be actively seen by a medical or mental health professional within the last six months
Exclusion Criteria:
* The child has any suicidal thoughts or behaviors
* The child is enrolled in another treatment study
* The child is enrolled in the RUBI parent training program, offered at the Center for Autism and Related Disorders at Kennedy Krieger
* Caregivers has a hearing or language impairment
* Caregiver does not have consistent access to the internet
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
1
Change in The Crisis Prevention Index scores
Timeframe: baseline, 4 weeks, 8 weeks
Trial details
NCT IDNCT05681143
SponsorHugo W. Moser Research Institute at Kennedy Krieger, Inc.