Navigating the Transition to Adulthood: A Dual Language Mobile App for Latino Youth With ASD and Their Families
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Treatment Adherence as assessed by the time spent on homework
研究概览
简要总结
The purpose of this study is to determine useability and satisfaction characteristics,product usage data,methodological feasibility parameters and feasibility metrics of the mHealth app adapted intervention on the mental health, quality of life, and adaptive functioning of Latino transition aged young adults with ASD and their parents.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Latino young adults with ASD ASD with a score of 15 or greater on the Social Communication Questionnaire-Lifetime (SCQ-L)
- •meets Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR), criteria for ASD based on a DSM-5-TR ASD symptom checklist
- •previous diagnosis of ASD from a licensed mental health or medical professional(f they have not been diagnosed by a licensed mental health or medical professional, a complete a diagnostic evaluation will be conducted, using semi-structured interviews, questionnaires, the autism diagnostic interview-revised (ADI-R), and the Autism Diagnostic Observation Schedule, Second Edition (ADOS-2) to confirm ASD diagnosis)
- •above the "moderate" cut off for symptoms of anxiety or depression( Depression and anxiety symptoms will be assessed via the Patient Health Questionnaire-9 (PHQ-9) and the Generalized Anxiety Disorder-7 (GAD-7)
- •Spanish-speaking parents
排除标准
- •low intelligence quotient (IQ) score (Verbal IQ < 70) on the verbal IQ on Kaufman Brief Intelligence Test Second Edition (KBIT-2)
- •psychotic as determined by the Structured clinical interview for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM5): Research Version (SCID-5-RV), or are actively suicidal with an active plan.
- •substance abuse
研究组 & 干预措施
¡Iniciando! mHealth App
干预措施: ¡Iniciando! mHealth App (Behavioral)
结局指标
主要结局
Treatment Adherence as assessed by the time spent on homework
时间窗: end of study (about 3 months after baseline)
Time-used on the mHealth app
时间窗: end of study (about 3 months after baseline)
Percentage of modules completed on the mHealth app
时间窗: end of study (about 3 months after baseline)
Frequencies of goal setting on the mHealth app
时间窗: end of study (about 3 months after baseline)
Treatment Adherence as assessed by the homework completion rate
时间窗: end of study (about 3 months after baseline)
Number of participants that completed the study
时间窗: end of study (about 3 months after baseline)
Treatment Adherence as assessed by the number of participants that drop out
时间窗: end of study (about 3 months after baseline)
Differences in outcome expectancy as assessed by the treatment credibility scales
时间窗: end of study (about 3 months after baseline)
this is a 6 item questionnaire and each is scored from 1-9, maximum score would be 54, higher score indicating better outcome
Number of participants recruited
时间窗: end of study (about 3 months after baseline)
Time taken for recruitment of participants
时间窗: end of study (about 3 months after baseline)
Source of participants
时间窗: end of study (about 3 months after baseline)
Participants maybe recruited from the following : UTHealth Houston Community Health Workers Social Media advertisements Private clinics
Usability as measured by the User Version of the Mobile Application Rating Scale (uMARS)
时间窗: end of study (about 3 months after baseline)
This is a 20 item questionnaire and each item is rated on a 5-point Likert scale, scores range from 1(inadequate) to 5(excellent) with higher scores indicating better usability.
Usability as Measured by the System Usability Scale (SUS)
时间窗: end of study (about 3 months after baseline)
The System Usability Scale (SUS) is a validated 10-item questionnaire . Each item is rated on a 5-point Likert scale (1 = strongly disagree to 5 = strongly agree). Scores are converted to a total SUS score ranging from 0 to 100, with higher scores indicating better usability. A score above 68 is generally considered above average usability.
Treatment Adherence as assessed by the number of completed sessions
时间窗: end of study (about 3 months after baseline)
Acceptability of Intervention as assessed by the Acceptability of Intervention Measure (AIM
时间窗: end of study (about 3 months after baseline)
This is a 4 item questionnaire and each is scored form 1( completely disagree) to 5 (completely agree) for a maximum score of 20, higher score indicating better outcome
Intervention Appropriateness as assessed by the Intervention Appropriateness Measure (IAM)
时间窗: end of study (about 3 months after baseline)
This is a 4 item questionnaire and each is scored form 1( completely disagree) to 5 (completely agree) for a maximum score of 20, higher score indicating better outcome
Feasibility of Intervention as assessed by the Feasibility of Intervention Measure (FIM)
时间窗: end of study (about 3 months after baseline)
This is a 4 item questionnaire and each is scored form 1( completely disagree) to 5 (completely agree) for a maximum score of 20, higher score indicating better outcome
次要结局
- Change in depression as assessed by the Patient Health Questionnaire-9 (PHQ-9) for depressive symptoms(baseline (+/-1 month), 6 weeks later (+/-1 month), and 12 weeks later ((+/-1 month))
- Change in anxiety as assessed by the Generalized Anxiety Disorder-7 (GAD-7) for anxiety symptoms(baseline (+/-1 month), 6 weeks later (+/-1 month), and 12 weeks later ((+/-1 month))
- Change in adaptive functioning as assessed by the Adaptive Behavior Assessment System, Third Edition (ABAS-3)(baseline (+/-1 month), 6 weeks later (+/-1 month), and 12 weeks later ((+/-1 month))
- Change in quality of life as assessed by the Autism Spectrum Quality of Life (ASQoL) questionnaire(baseline (+/-1 month), 6 weeks later (+/-1 month), and 12 weeks later ((+/-1 month))
- Change in quality of life as assessed by the Spanish World Health Organization Quality of Life Brief Version (WHOQOL-BREF)(baseline (+/-1 month), 6 weeks later (+/-1 month), and 12 weeks later ((+/-1 month))
研究者
Antonio Pagan
Post Doctoral Fellow
The University of Texas Health Science Center, Houston