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临床试验/NCT07333014
NCT07333014尚未招募不适用

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

College of Management Academic Studies1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2026年7月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
90
试验地点
1
主要终点
Feasibility as Measured by Recruitment, Completion, and Dropout Rates

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
13 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

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.

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

No Intervention: Treatment as Usual

No Intervention

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

结局指标

主要结局

Feasibility as Measured by Recruitment, Completion, and Dropout Rates

时间窗: Through study completion, approximately 12 months

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

时间窗: Post-intervention (T1, approximately 8-12 weeks)

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.

Acceptability

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

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.

次要结局

  • 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))

研究者

发起方
College of Management Academic Studies
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ella Sarel-Mahlev

PhD. Senior Lecturer Rank

College of Management Academic Studies

研究点 (1)

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