Not yet recruiting NCT07170163
Navigating the Transition to Adulthood: A Dual Language Mobile App for Latino Youth With ASD and Their Families
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ¡Iniciando! mHealth App.
- Who it may be relevant to
- Registry conditions: Autism Spectrum Disorder (ASD). Basic parameters: 18 years — 25 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Behavioral ¡Iniciando! mHealth App
Participants will undergo 12 weekly, 1-hour virtual group sessions (separate for young adults and parents) and weekly, 30-minute individual virtual coaching sessions for young adults (which parents may attend as appropriate). Participants will also engage with the ¡Iniciando! app modules before and after their virtual group meetings. Throughout the approximately three-month study period, participants will complete (e.g., usability, satisfaction, adherence, app usage data).
Primary outcome measures
- Number of participants recruited [Time frame: end of study (about 3 months after baseline)]
- Source of participants [Time frame: end of study (about 3 months after baseline)]
- Time taken for recruitment of participants [Time frame: end of study (about 3 months after baseline)]
- Number of participants that completed the study [Time frame: end of study (about 3 months after baseline)]
- Usability as measured by the User Version of the Mobile Application Rating Scale (uMARS) [Time frame: end of study (about 3 months after baseline)]
- Usability as Measured by the System Usability Scale (SUS) [Time frame: end of study (about 3 months after baseline)]
- Differences in outcome expectancy as assessed by the treatment credibility scales [Time frame: end of study (about 3 months after baseline)]
- Treatment Adherence as assessed by the number of completed sessions [Time frame: end of study (about 3 months after baseline)]
- Treatment Adherence as assessed by the homework completion rate [Time frame: end of study (about 3 months after baseline)]
- Treatment Adherence as assessed by the number of participants that drop out [Time frame: end of study (about 3 months after baseline)]
Secondary outcome measures (5)
- Change in depression as assessed by the Patient Health Questionnaire-9 (PHQ-9) for depressive symptoms [Time frame: 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 [Time frame: 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) [Time frame: 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 [Time frame: 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) [Time frame: baseline (+/-1 month), 6 weeks later (+/-1 month), and 12 weeks later ((+/-1 month)]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- The University of Texas Health Science Center at Houston — Houston
Identifiers
NCT: NCT07170163 · HSC-MS-25-0519 · 1R03HD119485