ट्रायल रडार AI | ||
|---|---|---|
क्लिनिकल ट्रायल NCT07333014 (VSP-AY) के लिए ऑटिज़्म स्पेक्ट्रम विकार, आत्मघाती विचार, आत्मघाती व्यवहार, आत्म-क्षतिकारक व्यवहार, अवसाद वर्तमान में अभी भर्ती शुरू नहीं है। सभी विवरणों के लिए क्लिनिकल ट्रायल रडार कार्ड दृश्य और AI खोज उपकरण देखें, या यहाँ कुछ भी पूछें। | ||
एक परीक्षण फ़िल्टर मानदंडों से मेल खाता है
कार्ड दृश्य
Adapted Visual Safety Plan for Autistic Youth (VSP-AY) to Address Self-harm, Suicidal Ideation, and Suicide Behaviors 90 रैंडमाइज़्ड किशोरावस्था
चिकित्सा परीक्षण का विवरण मुख्य रूप से अंग्रेजी में उपलब्ध है। हालाँकि, ट्रायल रडार AI मदद कर सकता है! बस 'अध्ययन समझाएं' पर क्लिक करें और अपनी चुनी हुई भाषा में परीक्षण की जानकारी देखें और चर्चा करें।
क्लिनिकल ट्रायल NCT07333014 (VSP-AY) एक हस्तक्रियात्मक चिकित्सकीय अध्ययन है जो ऑटिज़्म स्पेक्ट्रम विकार, आत्मघाती विचार, आत्मघाती व्यवहार, आत्म-क्षतिकारक व्यवहार, अवसाद से जुड़ा हुआ है। परीक्षण वर्तमान में अभी भर्ती शुरू नहीं चल रहा है। इसमें 90 प्रतिभागियों को शामिल करने की योजना है और प्रतिभागियों का नामांकन 30 जुलाई 2026 से शुरू होगा। College of Management Academic Studies इस परीक्षण का नेतृत्व कर रहे हैं और इसके 30 जुलाई 2029 तक पूरा होने की उम्मीद है। ClinicalTrials.gov वेबसाइट पर यह जानकारी 12 जनवरी 2026 को अंतिम बार अपडेट की गई थी।
संक्षिप्त सारांश
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. ...और दिखाएँ
विस्तृत विवरण
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...और दिखाएँ
आधिकारिक शीर्षक
Adapted Visual Safety Plan for Autistic Youth (VSP-AY) to Address Self-harm, Suicidal Ideation, and Suicide Behaviors: : A Pilot Randomized Controlled Trial
स्वास्थ्य स्थितियां
ऑटिज़्म स्पेक्ट्रम विकारआत्मघाती विचारआत्मघाती व्यवहारआत्म-क्षतिकारक व्यवहारअवसादअन्य अध्ययन आईडी
- VSP-AY
- VSP-AY-2025-Pilot
NCT नंबर
अध्ययन प्रारंभ तिथि (वास्तविक)
2026-07-30
अंतिम अद्यतन प्रकाशित
2026-01-12
अध्ययन की समाप्ति तिथि (अनुमानित)
2029-07-30
नामांकन (अनुमानित)
90
अध्ययन प्रकार
हस्तक्रियात्मक
चरण
निर्दिष्ट नहीं
स्थिति
अभी भर्ती शुरू नहीं
प्रमुख शब्द
Autistic adolescents
Visual safety plan
Self-harm
NSSI
Mental health intervention
Visual safety plan
Self-harm
NSSI
Mental health intervention
प्राथमिक उद्देश्य
अन्य
डिज़ाइन आवंटन
यादृच्छिक
हस्तक्षेप मॉडल
समानांतर
अंधकरण
कोई नहीं (खुला लेबल)
समूह/हस्तक्षेप
| प्रतिभागी समूह/शाखा | हस्तक्षेप/उपचार |
|---|---|
प्रयोगात्मकAn Interventional study VSP-AY 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. | 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 gu...और दिखाएँ |
कोई हस्तक्षेप नहींNo Intervention: Treatment as Usual Participants receive standard mental health care at Geha Mental Health Center without the VSP-AY intervention. | निर्दिष्ट नहीं |
प्राथमिक परिणाम माप
द्वितीयक परिणाम माप
| परिणाम माप | माप विवरण | समय सीमा |
|---|---|---|
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) |
| परिणाम माप | माप विवरण | समय सीमा |
|---|---|---|
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. | Baseline (T0), Post-intervention (T1, approximately 8-12 weeks), and One-month follow-up (T2) |
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. | Baseline (T0), Post-intervention (T1, approximately 8-12 weeks), and One-month follow-up (T2) |
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. | Baseline (T0), Post-intervention (T1, approximately 8-12 weeks), and One-month follow-up (T2) |
भागीदारी सहायक
पात्रता मानदंड
अध्ययन के लिए पात्र आयु
बच्चा, वयस्क
अध्ययन के लिए न्यूनतम आयु
13 Years
अध्ययन के लिए पात्र लिंग
सभी
- 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
- 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
- ⚕️Geha...
अध्ययन उत्तरदायी पक्ष
Ella Sarel-Mahlev, मुख्य अन्वेषक, PhD. Senior Lecturer Rank, College of Management Academic Studies
कोई संपर्क डेटा नहीं।
1 1 देशों में अध्ययन स्थान
Geha Mental Health Center, Petah Tikva, 4910002, Israel
Ella Sarel Mahlev, संपर्क, +972504848533, [email protected]