About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Adapted Visual Safety Plan for Autistic Youth (VSP-AY) to Address Self-harm, Suicidal Ideation, and Suicide Behaviors
BehavioralThe Visual Safety Plan for Autistic Youth (VSP-AY) is an autism-adapted suicide prevention tool delivered as a visual card-based system with supporting materials. The intervention includes two main sections: intrapersonal strategies (recognizing warning signs, internal coping skills) and interpersonal strategies (social contacts, professional resources, means safety). VSP-AY uses visual cards with color-coding to guide the safety planning process. Participants choose where to begin, accommodating individual preferences and processing styles. Each component offers multiple phrasing options and includes concrete examples drawn from autistic individuals with lived experience, making content accessible and relevant. Supporting materials include: writing sheets where participants document their personalized strategies; communication cards for different settings (home, school, community) with explicit guidance on what to do and what not to do during suicidal crisis moments; visual supports
Treatment groups
Trial outcomes
Primary outcomes
Feasibility as Measured by Recruitment, Completion, and Dropout Rates
Feasibility is evaluated through three key parameters that assess whether the study can be successfully conducted and whether a future definitive trial is warranted: recruitment rate, completion rate, and dropout rate. Together, these metrics provide essential information about the practicality of conducting a larger-scale efficacy trial. Recruitment rate is calculated as the number of participants recruited divided by the number of eligible individuals approached. Detailed tracking includes the number screened, meeting criteria, approached, consenting, and reasons for non-participation. A target of 60% or higher indicates successful recruitment feasibility. Completion rate is calculated as the percentage of enrolled participants completing all procedures (baseline, post-intervention, and follow-up assessments). Tracking includes partial completion patterns to identify where attrition occurs. A target of 70% or higher indicates acceptable retention. Dropout rate is calculated as the p
Acceptability
Acceptability is evaluated through both quantitative and qualitative methods to comprehensively assess stakeholder perspectives on the Visual Safety Plan for Autistic Youth intervention. Satisfaction questionnaires adapted from the Client Satisfaction Questionnaire assess perceived quality, helpfulness, whether the intervention met participant needs, and willingness to recommend the intervention to others or use it again. These questionnaires are administered to youth participants, their caregivers, and mental health professionals who delivered the intervention. Scores range from 8 to 32, with higher scores indicating greater satisfaction.
Acceptability
Semi-structured interviews are conducted with purposive samples of youth participants, caregivers, and professionals to explore experiences in depth. Interview topics include overall experiences with the intervention, perceived benefits and helpful aspects, challenges or difficulties encountered, barriers to implementation, and suggestions for improvement. Interviews are analyzed using a collaborative, reflexive thematic analysis conducted by autistic and non-autistic researchers to identify key themes regarding acceptability and user experience.
Secondary outcomes
Preliminary Effectiveness of Suicidal Ideation
Suicidal ideation is assessed using the Columbia Suicide Severity Rating Scale (C-SSRS), a clinician-administered structured interview that evaluates the severity and intensity of suicidal thoughts. The severity subscale assesses the highest level of ideation endorsed over the past two weeks, ranging from passive wish to be dead without specific suicidal thoughts, through increasingly severe levels including non-specific active suicidal thoughts, suicidal thoughts with a method but without intent, suicidal intent without a specific plan, and suicidal intent with a specific plan. Scores range from 0 (no suicidal ideation) to 5 (active suicidal ideation with specific plan and intent), with higher scores indicating more severe ideation. The intensity subscale assesses frequency, duration, controllability, deterrents, and reasons for ideation. The C-SSRS also evaluates suicidal behavior including actual attempts, interrupted attempts, aborted attempts, and preparatory acts.
Preliminary Effectiveness of Non-Suicidal Self-Injury
Non-suicidal self-injury is assessed using the Non-Suicidal Self-Injury Assessment Tool (NSSI-AT), which evaluates deliberate self-harm behaviors without suicidal intent. The tool assesses the presence and frequency of NSSI behaviors over the past two weeks, specific methods used such as cutting, scratching, burning, hitting oneself, head-banging, picking at skin or wounds, or interfering with wound healing. The assessment also examines the functions or motivations for NSSI including affect regulation, self-punishment, anti-dissociation, interpersonal influence, anti-suicide, or sensation seeking, as well as contextual factors such as typical locations on the body and situations that precede NSSI episodes. Lower frequency counts indicate improvement in self-injury behaviors.
Preliminary Effectiveness of
Depression symptoms are assessed using the Children's Depression Inventory 2nd Edition Self-Report Short Form (CDI 2:SR), a standardized 12-item measure designed for youth aged 7-17 years. The measure evaluates depressive symptoms over the past two weeks across cognitive, affective, and behavioral domains. Each item presents three statements representing increasing severity of a symptom, with participants selecting the statement that best describes their experience. The CDI 2:SR generates three scores: the Emotional Problems subscale, assessing sadness, hopelessness, and anhedonia; the Functional Problems subscale, assessing interpersonal difficulties and school problems; and the Total Depression score, combining all items. Raw scores are converted to T-scores based on age and gender norms, with a mean of 50 and standard deviation of 10. T-scores of 60 or above (84th percentile) indicate elevated symptoms, and T-scores of 70 or above (98th percentile) indicate very elevated symptoms.
Sponsors and contacts
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College of Management Academic Studies
Lead sponsor
Geha Mental Health Center
Collaborator
University of Haifa
Collaborator
Tel Aviv University
Collaborator
Reichman University
Collaborator
University of Nottingham
Collaborator
La Trobe University
Collaborator
Deakin University
Collaborator
Bournemouth University
Collaborator
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