Navigating the Transition to Adulthood: A Dual Language Mobile App for Latino Youth With ASD and Their Families

NCT07170163 | Not Yet Recruiting

• 2 other identifiers: HSC-MS-25-05191R03HD119485
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Autism Spectrum Disorder (ASD)

Keywords

mHealth app

Outcome Measures

Primary Outcomes (17)

• Number of participants recruited

  end of study (about 3 months after baseline)

• Source of participants

  Participants maybe recruited from the following : UTHealth Houston Community Health Workers Social Media advertisements Private clinics

  end of study (about 3 months after baseline)

• Time taken for recruitment of participants

  end of study (about 3 months after baseline)

• Number of participants that completed the study

  end of study (about 3 months after baseline)

• Usability as measured by the User Version of the Mobile Application Rating Scale (uMARS)

  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.

  end of study (about 3 months after baseline)

• Usability as Measured by the System Usability Scale (SUS)

  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.

  end of study (about 3 months after baseline)

• Differences in outcome expectancy as assessed by the treatment credibility scales

  this is a 6 item questionnaire and each is scored from 1-9, maximum score would be 54, higher score indicating better outcome

  end of study (about 3 months after baseline)

• Treatment Adherence as assessed by the number of completed sessions

  end of study (about 3 months after baseline)

• Treatment Adherence as assessed by the homework completion rate

  end of study (about 3 months after baseline)

• Treatment Adherence as assessed by the number of participants that drop out

  end of study (about 3 months after baseline)

• Treatment Adherence as assessed by the time spent on homework

  end of study (about 3 months after baseline)

• Time-used on the mHealth app

  end of study (about 3 months after baseline)

• Percentage of modules completed on the mHealth app

  end of study (about 3 months after baseline)

• Frequencies of goal setting on the mHealth app

  end of study (about 3 months after baseline)

• Acceptability of Intervention as assessed by the Acceptability of Intervention Measure (AIM

  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

  end of study (about 3 months after baseline)

• Intervention Appropriateness as assessed by the Intervention Appropriateness Measure (IAM)

  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

  end of study (about 3 months after baseline)

• Feasibility of Intervention as assessed by the Feasibility of Intervention Measure (FIM)

  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

  end of study (about 3 months after baseline)

Secondary Outcomes (5)

• 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)

Study Arms (1)

¡Iniciando! mHealth App

EXPERIMENTAL

Behavioral: ¡Iniciando! mHealth App

Interventions

¡Iniciando! mHealth App BEHAVIORAL

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).

¡Iniciando! mHealth App

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Antonio Pagán, PhD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Antonio Pagán, PhD

CONTACT

(713) 486-2700; Antonio.Pagan@uth.tmc.edu

Ronald Acierno, PhD

CONTACT

(713) 486-2863; Ronald.Acierno@uth.tmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post Doctoral Fellow

Study Record Dates

• First Submitted: September 5, 2025
• First Posted: September 12, 2025
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)