ट्रायल रडार AI | ||
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क्लिनिकल ट्रायल NCT06577623 के लिए ऑटिज़्म स्पेक्ट्रम विकार, ऑटिज़्म वर्तमान में भर्ती जारी 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
In-Person Mindfulness-based Intervention for Adolescents with Autism Spectrum Disorder and Their Caregivers
चिकित्सा परीक्षण का विवरण मुख्य रूप से अंग्रेजी में उपलब्ध है। हालाँकि, ट्रायल रडार AI मदद कर सकता है! बस 'परीक्षण समझाएं' पर क्लिक करें और अपनी चुनी हुई भाषा में परीक्षण की जानकारी देखें और चर्चा करें।
क्लिनिकल परीक्षण NCT06577623 एक हस्तक्रियात्मक चिकित्सकीय अध्ययन है जो ऑटिज़्म स्पेक्ट्रम विकार, ऑटिज़्म से जुड़ा हुआ है। परीक्षण वर्तमान में भर्ती जारी चल रहा है। इसकी शुरुआत 14 अगस्त 2024 को हुई थी, और इसमें कुल 28 प्रतिभागियों के नामांकन की योजना है। Southwest Autism Research & Resource Center इस परीक्षण का नेतृत्व कर रहे हैं और इसके 1 दिसंबर 2026 तक पूरा होने की उम्मीद है। ClinicalTrials.gov वेबसाइट पर यह जानकारी 30 अगस्त 2024 को अंतिम बार अपडेट की गई थी।
संक्षिप्त सारांश
Adolescents with ASD often have co-occurring mental health symptoms like stress, anxiety, and depression. The investigators are conducting this research study to develop interventions for adolescents with ASD that will improve co-occurring mental health symptoms.
विस्तृत विवरण
Adolescents with ASD and their parents will complete a 3-hour in-person screening visit to determine eligibility for the study.
Adolescents with ASD and their caregivers will participate in an 8-week mindfulness-based group intervention that meets once weekly at SARRC in Phoenix, Arizona. Each meeting will last approximately 2-hours. Teens and parents/caregivers will have separate meetings with separate group leaders but will reunite for approximately 15-minutes as a larger group to review home practice for the upcoming week. Teens and parents will each be given a free 1-year subscription to Ten Percent Happier, a commercially available mobile app focused on mindfulness meditations. Each week teens will be assigned home practice, which means we will ask participants to practice mindfulness meditation every day. The investigators will recommend specific meditations and activities to complete, but participants will have access to all mindfulness meditations on the Ten Percent Happier app.
Teens and caregivers will be asked to complete questionnaires assessing things like mood, anxiety, quality of life, mindfulness in day-to-day life, and their perception of the intervention. These questionnaires will be done immediately before the intervention, immediately after completing the intervention, and at 2-month follow-up.
आधिकारिक शीर्षक
In-Person Mindfulness-based Intervention for Adolescents with Autism Spectrum Disorder and Their Caregivers
चिकित्सीय स्थितियाँ
ऑटिज़्म स्पेक्ट्रम विकारऑटिज़्मअन्य अध्ययन आईडी
- 00016672b
NCT नंबर
अध्ययन प्रारंभ तिथि (वास्तविक)
2024-08-14
अंतिम अद्यतन प्रकाशित
2024-08-30
अध्ययन की समाप्ति तिथि (अनुमानित)
2026-12
नामांकन (अनुमानित)
28
अध्ययन प्रकार
हस्तक्रियात्मक
चरण
निर्दिष्ट नहीं
स्थिति
भर्ती जारी
प्राथमिक उद्देश्य
उपचार
डिज़ाइन आवंटन
निर्दिष्ट नहीं
हस्तक्षेप मॉडल
एकल समूह
अंधकरण
कोई नहीं (खुलें लेबल)
समूह/हस्तक्षेप
| प्रतिभागी समूह/हाथ | हस्तक्षेप/इलाज |
|---|---|
प्रयोगात्मकMINDful TIME group 8-week mindfulness-based intervention for adolescents with ASD and their caregivers. Weekly meetings will be held in-person and will last approximately 2-hours. Adolescents and their caregivers will be asked to engage in home practice outside of group meetings | MINDFUL TIME Group-based psychoeducational mindfulness-based intervention. |
प्राथमिक परिणाम माप
द्वितीयक परिणाम माप
| परिणाम माप | माप विवरण | समय सीमा |
|---|---|---|
Mean Change from Baseline in Children's Depression Inventory (CDI) Scores | Parent-report measure of adolescent depressive symptoms. Scores range from 30 to 90 with higher scores indicating higher levels of depression symptoms. | Post-intervention (8 weeks); 2-month follow-up |
Mean Change from Baseline in Multidimensional Anxiety Scale for Children (MASC) Scores | Parent-report measure of adolescent anxiety symptoms. Scores range from 30 to 90 with higher scores indicating higher levels of anxiety symptoms. | Post-intervention (8 weeks); 2-month follow-up |
Mean Change from Baseline in Child and Adolescent Mindfulness Measure (CAMM) Scores | Adolescent-report measure of mindfulness. Scores range from 0 to 40 with higher scores indicating higher levels of mindfulness. | Post-intervention (8 weeks); 2-month follow-up |
| परिणाम माप | माप विवरण | समय सीमा |
|---|---|---|
Mean Change from Baseline in Beck Youth Inventories (BYI) Scores | Adolescent-report measure of depression. Scores range from 0 to 90, with higher scores indicating higher levels of depression. | Post-intervention (8 weeks); 2-month follow-up |
Mean Change from Baseline in World Health Organization-Five Wellbeing Index (WHO-5) Scores | Adolescent-report measure on current well-being. Scores range from 0 to 100, with higher scores indicating better quality of life. | Post-intervention (8 weeks); 2-month follow-up |
Mean Change from Baseline in Adaptive Behavior Assessment System (ABAS-3) Scores | Parent-report measure of adolescent adaptive skills across the lifespan. Scores range from 40 to 120, with higher scores indicating better adaptive skills. | Post-intervention (8 weeks); 2-month follow-up |
Mean Change from Baseline in Behavior Rating Inventory of Executive Function (BRIEF) Scores | Parent-report measure of adolescent executive function and self-regulation. Scores range from 30 to 90, with higher scores indicating higher levels of executive dysfunction. | Post-intervention (8 weeks); 2-month follow-up |
Mean Change from Baseline in Five Facets Mindfulness Questionnaire (FFMQ) Scores | Adolescent-report measure of mindfulness on observation, description, aware actions, non-judgmental inner experience, and non-reactivity. Factor scores range from 1 to 5, with higher scores indicating higher levels of mindfulness. | Post-intervention (8 weeks); 2-month follow-up |
Mean Change from Baseline in Stress Index for Parents of Adolescents (SIPA) Scores | Parent-report measure of the relationship of parenting stress to adolescent characteristics, parent characteristics, the quality of the adolescent-parent interactions, and stressful life circumstances. Percentile scores range from 0 to 99, with higher scores indicating higher levels of parenting stress. | Post-intervention (8 weeks); 2-month follow-up |
Mean Change from Baseline in Social Responsiveness Scale (SRS-2) Scores | Parent-report measure of adolescent presence and severity of social impairment within autism spectrum. T-scores range from 30 to \> 90 with higher scores indicating greater social impairment. | Post-intervention (8 weeks); 2-month follow-up |
पात्रता मानदंड
अध्ययन के लिए पात्र आयु
बच्चा, वयस्क
अध्ययन के लिए न्यूनतम आयु
13 Years
अध्ययन के लिए पात्र लिंग
सभी
- Adolescents must be ages 13 to 18 years
- Formal clinical or educational ASD diagnosis confirmed by the study team (i.e., review of the formal diagnostic or educational report)
- Must be able to attend at least 7 of the 8 in-person group meetings
- English speaking: Adolescents and their parent/caregivers must be English-speaking because the screening and behavioral measures are in English, as well as the intervention content
- Non-verbal participants will be excluded to ensure test compliance and increase sample homogeneity.
- Participants with IQ scores <70 will be excluded because the intervention was developed for individuals without intellectual disabilities.
- Participants with a physical disability or co-occurring condition that may prevent participation in the weekly group meetings (e.g., selective mutism; aggressive behavior; inability to participate in a 90-minute video conference meeting each week)
- Participants who report active suicidal ideation
Southwest Autism Research & Resource Centerएरिजोना स्टेट विश्वविद्यालयअध्ययन केंद्रीय संपर्क
संपर्क: Nicole Matthews, Ph.D., 480-582-9499, [email protected]
1 1 देशों में अध्ययन स्थल
Arizona
Southwest Autism Research and Resource Center, Phoenix, Arizona, 85006, United States
Nicole Matthews, Ph.D., संपर्क, 480-582-9499, [email protected]
Nicole Matthews, Ph.D, संपर्क, 480-582-9499, [email protected]
Nicole Matthews, Ph.D, संपर्क
भर्ती जारी