Adapted Visual Safety Plan for Autistic Youth (VSP-AY) to Address Self-harm, Suicidal Ideation, a… (NCT07333014) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Adapted Visual Safety Plan for Autistic Youth (VSP-AY) to Address Self-harm, Suicidal Ideation, and Suicide Behaviors
Israel90 participantsStarted 2026-07-30
Plain-language summary
This pilot randomized controlled trial will recruit 90 autistic adolescents aged 13-18 years with recent suicidal thoughts or behaviors from Geha Mental Health Center in Israel. Participants will be randomly assigned in a 1:1 ratio to either (1) the intervention group receiving the Visual Safety Plan for Autistic Youth (VSP-AY) plus standard care, or (2) the control group receiving treatment as usual without VSP-AY. Mental health professionals delivering VSP-AY will complete a 6-hour training with ongoing supervision throughout the study. Outcomes will be assessed at three timepoints: baseline (T0), immediately post-intervention (T1), and one-month follow-up (T2). The study will evaluate feasibility through recruitment and completion rates, acceptability through satisfaction questionnaires and qualitative interviews, and preliminary effectiveness through standardized measures of suicidal ideation (Columbia Suicide Severity Rating Scale), non-suicidal self-injury (NSSI-AT), and depression (Children's Depression Inventory).
Who can participate
Age range
13 Years – 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:
* Aged 13-18 years
* Formal diagnosis of autism spectrum disorder
* Experienced suicidal ideation or behavior within the past six months
* Able to engage in the study intellectually, either verbally or in writing
* Not at imminent risk of suicide requiring immediate hospitalization
* Have adequate family support
* Able to attend appointments at Geha Mental Health Center
* Parent or legal guardian willing to provide informed consent
* Adolescent willing to provide assent
Exclusion Criteria:
* Immediate suicide risk requiring inpatient hospitalization
* Active psychotic symptoms that prevent meaningful engagement
* Active manic symptoms that prevent meaningful engagement
* Insufficient Hebrew language proficiency to engage with study materials
* Lack of family support, as documented by social services
* Current participation in conflicting intervention studies
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
Feasibility as Measured by Recruitment, Completion, and Dropout Rates
Timeframe: Through study completion, approximately 12 months
2
Acceptability
Timeframe: Post-intervention (T1, approximately 8-12 weeks) and one-month follow-up (T2)
3
Acceptability
Timeframe: Post-intervention (T1, approximately 8-12 weeks)