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

NCT07333014 | Not Yet Recruiting

• 1 other identifier: VSP-AY-2025-Pilot
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Autism Spectrum Disorder; Depression; Suicidal Ideation; Suicidal Behavior; Self-Injurious Behavior

Keywords

Autistic adolescents; Visual safety plan; Self-harm; NSSI; Mental health intervention

Outcome Measures

Primary Outcomes (3)

• 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

  Through study completion, approximately 12 months

• 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.

  Post-intervention (T1, approximately 8-12 weeks) and one-month follow-up (T2)

• 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.

  Post-intervention (T1, approximately 8-12 weeks)

Secondary Outcomes (3)

• Preliminary Effectiveness of Suicidal Ideation

  Baseline (T0), Post-intervention (T1, approximately 8-12 weeks), and One-month follow-up (T2)

• Preliminary Effectiveness of Non-Suicidal Self-Injury

  Baseline (T0), Post-intervention (T1, approximately 8-12 weeks), and One-month follow-up (T2)

• Preliminary Effectiveness of

  Baseline (T0), Post-intervention (T1, approximately 8-12 weeks), and One-month follow-up (T2)

Study Arms (2)

An Interventional study VSP-AY

EXPERIMENTAL

Participants receive the Visual Safety Plan for Autistic Youth (VSP-AY) intervention in addition to treatment as usual. VSP-AY is an autism-adapted safety planning tool incorporating linguistic modifications (concrete language, explicit examples), visual supports (color-coding, progressive revelation), and developmental appropriateness for adolescents.

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

No Intervention: Treatment as Usual

NO INTERVENTION

Participants receive standard mental health care at Geha Mental Health Center without the VSP-AY intervention.

Interventions

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

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, 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

An Interventional study VSP-AY

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• College of Management Academic Studies: lead
• 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

Study Sites (1)

Geha Mental Health Center

Petah Tikva, 4910002, Israel

Location

Related Links

• Related Info

MeSH Terms

Conditions

Autism Spectrum Disorder; Suicidal Ideation; Self-Injurious Behavior; Depression

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Suicide; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD. Senior Lecturer Rank

Study Record Dates

• First Submitted: December 17, 2025
• First Posted: January 12, 2026
• Study Start (Estimated): July 30, 2026
• Primary Completion (Estimated): July 30, 2029
• Study Completion (Estimated): July 30, 2029
• Last Updated: January 12, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)