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Not yet recruiting NCT07333014

Adapted Visual Safety Plan for Autistic Youth (VSP-AY) to Address Self-harm, Suicidal Ideation, and Suicide Behaviors

No phase Interventional Autism Spectrum Disorder Suicidal Ideation Suicidal Behavior Self-Injurious Behavior

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Adapted Visual Safety Plan for Autistic Youth (VSP-AY) to Address Self-harm, Suicidal Ideation, and Suicide Behaviors.
Who it may be relevant to
Registry conditions: Autism Spectrum Disorder, Suicidal Ideation, Suicidal Behavior, Self-Injurious Behavior. Basic parameters: 13 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Israel
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Adapted Visual Safety Plan for Autistic Youth (VSP-AY) to Address Self-harm, Suicidal Ideation, and Suicide Behaviors: : A Pilot Randomized Controlled Trial

Overview

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).

Detailed description

Background Autistic individuals face a significantly higher risk of suicide compared to the general population, with recent meta-analyses consistently showing rates up to three times higher across various groups, including general autistic samples and those without any intellectual disability. Other meta-analytical data indicate pooled prevalence rates of lifetime suicidal ideation at 37.2% and suicide attempts at 15.3% among autistic individuals.

This increased risk is mainly due to co-occurring psychiatric conditions. Autistic individuals with any psychiatric disorder have 3.55 times higher odds of self-harm compared to those without such conditions. These psychiatric conditions are consistently linked to poorer health outcomes, reduced quality of life, and increased suicidal behaviors.

While suicide among autistic adults has received substantial research attention, autistic youth have been less studied. However, emerging evidence shows that this higher risk also applies to younger groups. Epidemiological research indicates that autistic youth aged 10-19 years have 4.27 times higher rates of suicide deaths and 2.83 times higher rates of suicide attempts compared to their non-autistic peers. A Korean study of school-aged children also found increased rates of parent-reported suicidal ideation among those with autism spectrum disorder compared to neurotypical peers. Similarly, a UK cohort study showed that youth with social communication challenges had significantly higher risks for self-harm with suicidal intent, suicidal thoughts, and suicidal plans by age 16, with depressive symptoms at age 12 partly mediating this relationship.

Clinical studies reveal even more worrying patterns. For example, in an outpatient sample of autistic youth (n=103; aged 10-17 years), 83.5% reported lifetime suicidal ideation and 24.3% had attempted suicide. Despite this high risk, suicide prevention interventions tailored specifically for autistic individuals are still rare. Importantly, no specialized tools are currently available for autistic youth. To fill this gap, the current study protocol describes the development of a new Visual Safety Plan for Autistic Youth (VSP-AY) and details the plan to assess its effectiveness with autistic adolescents.

The Safety Planning Intervention (SPI) is an evidence-based suicide prevention tool that offers personalized coping strategies, organized into six key steps: (1) recognizing warning signs, (2) using internal coping skills, (3) engaging in social interactions for distraction, (4) contacting supportive individuals, (5) reaching out to mental health providers, and (6) removing lethal means. SPI has proven effective in reducing suicidal behavior and increasing treatment engagement among non-autistic adults. Given this demonstrated effectiveness, SPI has become a core recommended element of clinical practice when suicidal thoughts or behaviors are present and can be incorporated into treatment protocols or used as a standalone intervention.

However, evidence for its effectiveness among adolescents remains limited. A recent meta-analysis of safety planning interventions in adolescents (n = 1,002) found no significant associations with reductions in suicidal ideation, behavior, or attempts. Despite these mixed findings across age groups, SPI's proven effectiveness in adults, combined with the elevated suicide risk among autistic individuals, underscores the importance of examining whether adapted versions could be similarly effective for autistic populations.

Research further shows that developing interventions for autistic individuals needs adaptation because of differences in communication and information processing. Recent efforts have started to address this, with studies pointing out the unique challenges in safety planning with autistic individuals. This has resulted in autism-adapted safety plans for adults and the development of modified assessment tools designed for this group. However, despite this early progress with autistic adults, no evidence-based safety planning interventions have been created or tested specifically for autistic youth.

This gap is particularly concerning, as adolescents display distinctive characteristics regarding suicidal behaviors that differ from adults. Adolescent suicide attempts are often more impulsive, typically involve less lethal methods, and are marked by intentions that are less serious and lethal than those of adults. Additionally, caregiver involvement is crucial in adolescent safety planning, as active parental participation is vital to the process. Yet research indicates that half of autistic youth do not disclose suicidal thoughts to caregivers, while bullying, teasing, and depression emerge as primary precipitants of suicidal behaviors. Together, these findings highlight the need for adaptations that not only address suicide-specific risk factors but also align with the linguistic and visual processing preferences of autistic youth.

Evidence from studies with autistic adults further highlights the need for language adaptations in safety planning. Autistic adults often struggle to identify and express emotions, which requires additional support to effectively engage with safety planning materials. Research also stresses the importance of clear and concrete language to help identify coping strategies. Additionally, terminology changes have been shown to lower distress and improve accessibility, such as reframing "reasons for living" into "what is important to me?" Overall, these findings show that linguistic adaptations are a crucial step in developing effective safety planning interventions for autistic populations.

In addition to these language modifications, research consistently shows that autistic youth respond more effectively to visual stimuli than to verbal communication. Visual channels enable clearer comprehension and more efficient information processing. Visual supports also promote predictability and structure, helping autistic youth create an organized learning environment that reduces anxiety levels. These findings align with recommendations from suicide prevention specialists, who emphasize the importance of visual adaptations in safety planning interventions for autistic youth. Incorporating visual elements into SPI may therefore enhance accessibility, clarity, and engagement, particularly in moments of crisis.

The current research advances the field in two critical ways. First, it focuses specifically on autistic youth aged 13-21 years, a highly vulnerable population that requires tailored interventions. Second, it introduces comprehensive adaptations that integrate both language modifications and visual supports-elements that have not yet been fully combined in existing interventions for this group. The absence of evidence-based SPIs that systematically incorporate both linguistic and visual adaptations represents a key barrier to addressing self-harm and suicidal thoughts and behaviors in autistic youth. This gap underscores the urgent need for developing and evaluating the Visual Safety Plan for Autistic Youth (VSP-AY). The section below describes the co-development process of VSP-AY, which has been completed to enable evaluation of this intervention in the current study.

Intervention Development International Collaboration and Theoretical Framework VSP-AY development resulted from an international partnership involving Israeli researchers and collaborators from the University of Nottingham (UK), La Trobe University, Deakin University (Australia), and Bournemouth University (UK). The development followed the Knowledge-to-Action framework and participatory research principles, with autistic individuals serving as equal partners throughout. The Israeli team formed the Collaborative Research Group for Mental Health and Suicide Prevention among Autistic People, which includes both non-autistic researchers and autistic community experts with lived experience, who act as co-leaders in all research activities. Each project functions through co-leadership pairs-one autistic and one non-autistic researcher-with shared decision-making and joint authorship.

Qualitative Co-development The investigators conducted in-depth interviews with 26 participants: autistic adults with experience of suicide or self-harm (n=16), mental health professionals working with autistic youth (n=10), and parents of autistic youth with a history of suicide or self-harm (n=3). Participants reviewed the UK-developed Autism Adapted Safety Plan (AASP) and provided detailed feedback on clarity, terminology, gaps, and expected responses.

Visual Design Co-development The research team partnered with the Design Department at the College of Management Academic Studies. Design students received comprehensive training on autism characteristics, therapeutic context, suicide prevention principles, and the linguistically adapted protocol. Students participated in iterative design cycles, incorporating feedback from autistic community members, researchers, and supervising designers, resulting in three optimized visual concepts for final selection by an expanded stakeholder group. The development of VSP-AY was based on this multi-stage qualitative process. The current study protocol now focuses on evaluating the finalized Visual Safety Plan for Autistic Youth (VSP-AY) through a pilot randomized controlled trial with two main objectives: (1) to assess its feasibility, usability, and acceptability; and (2) to examine its effectiveness in supporting utilization during crises and in reducing self-injurious and suicidal behaviors among autistic youth.

This study is a pilot randomized controlled trial (RCT) of a visual suicide prevention tool, the Visual Safety Plan for Autistic Youth (VSP-AY). The trial will be conducted in partnership with Geha Mental Health Center, which offers comprehensive mental health services in central Israel and includes both inpatient and outpatient units for adolescents. The center receives many referrals for youth experiencing suicidal thoughts, behaviors, and self-harm, with a significant portion of these involving autistic youth. This makes Geha an ideal setting for recruiting the target population.

Study Design and Methods Setting and Participants The study will recruit 90 autistic youth (45 per group: VSP-AY intervention vs. treatment as usual) through mental health professionals from various disciplines-including psychiatrists, psychologists, social workers, and art therapists-who work directly with autistic youth experiencing suicidal thoughts, behaviors, or self-harm. Eligible participants will be aged 13-18 years (matching the age range served by Geha Mental Health Center's adolescent units), have a formal autism diagnosis, and have experienced suicidal thoughts or behaviors within the past six months. Participants must be able to engage in the study intellectually (either verbally or in writing), not be at imminent risk of suicide, and have adequate family support. Exclusion criteria include immediate suicide risk requiring inpatient care, active psychotic or manic symptoms, and lack of family support as known to social services. Informed consent will be obtained from parents, and assent from adolescents, using documentation designed to be accessible for autistic participants.

Assessments Outcomes are evaluated at three timepoints: baseline (T0) before randomization, post-intervention (T1) when treatment ends (usually 8-12 weeks), and one-month follow-up (T2). Assessments are scheduled prior to regular therapy appointments to reduce burden.

Primary Outcomes - Feasibility Recruitment rate (number recruited divided by approached; target ≥60%), completion rate (percentage completing all procedures; target ≥70%), and dropout rate (percentage withdrawing; target ≤30%). Detailed tracking includes reasons for non-participation, non-completion, and dropout.

Primary Outcomes - Acceptabilit

Interventions

  • Behavioral Adapted Visual Safety Plan for Autistic Youth (VSP-AY) to Address Self-harm, Suicidal Ideation, and Suicide Behaviors
    The 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, accommodati

Primary outcome measures

  • Feasibility as Measured by Recruitment, Completion, and Dropout Rates [Time frame: Through study completion, approximately 12 months]
  • Acceptability [Time frame: Post-intervention (T1, approximately 8-12 weeks) and one-month follow-up (T2)]
  • Acceptability [Time frame: Post-intervention (T1, approximately 8-12 weeks)]
Secondary outcome measures (3)
  • Preliminary Effectiveness of Suicidal Ideation [Time frame: Baseline (T0), Post-intervention (T1, approximately 8-12 weeks), and One-month follow-up (T2)]
  • Preliminary Effectiveness of Non-Suicidal Self-Injury [Time frame: Baseline (T0), Post-intervention (T1, approximately 8-12 weeks), and One-month follow-up (T2)]
  • Preliminary Effectiveness of [Time frame: Baseline (T0), Post-intervention (T1, approximately 8-12 weeks), and One-month follow-up (T2)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

Israel · 1 center
  • Geha Mental Health Center — Petah Tikva

Identifiers

NCT: NCT07333014 · VSP-AY-2025-Pilot

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗