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NCT Number: NCT07170163

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

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.

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Key information

Conditions

Autism Spectrum Disorder (ASD) Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

¡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).

Primary outcomes

  1. Number of participants recruited

    Time frame: end of study (about 3 months after baseline)

  2. Source of participants

    Time frame: end of study (about 3 months after baseline)

    Participants maybe recruited from the following :

    UTHealth Houston Community Health Workers Social Media advertisements Private clinics

  3. Time taken for recruitment of participants

    Time frame: end of study (about 3 months after baseline)

  4. Number of participants that completed the study

    Time frame: end of study (about 3 months after baseline)

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

    Time frame: 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.

  6. Usability as Measured by the System Usability Scale (SUS)

    Time frame: 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.

  7. Differences in outcome expectancy as assessed by the treatment credibility scales

    Time frame: 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

  8. Treatment Adherence as assessed by the number of completed sessions

    Time frame: end of study (about 3 months after baseline)

  9. Treatment Adherence as assessed by the homework completion rate

    Time frame: end of study (about 3 months after baseline)

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

    Time frame: end of study (about 3 months after baseline)

  11. Treatment Adherence as assessed by the time spent on homework

    Time frame: end of study (about 3 months after baseline)

  12. Time-used on the mHealth app

    Time frame: end of study (about 3 months after baseline)

  13. Percentage of modules completed on the mHealth app

    Time frame: end of study (about 3 months after baseline)

  14. Frequencies of goal setting on the mHealth app

    Time frame: end of study (about 3 months after baseline)

  15. Acceptability of Intervention as assessed by the Acceptability of Intervention Measure (AIM

    Time frame: 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

  16. Intervention Appropriateness as assessed by the Intervention Appropriateness Measure (IAM)

    Time frame: 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

  17. Feasibility of Intervention as assessed by the Feasibility of Intervention Measure (FIM)

    Time frame: 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

Secondary outcomes

  1. 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)

    This is a 9 item questionnaire and each is scored from 0(not at all) to 3(nearly every day) for a maximum score of 27, higher number indicating worse outcome

  2. 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)

    This is a 7 item questionnaire and each is scored from 0(not at all) to 4(nearly every day) for a maximum score of 21 , higher score indicating more anxiety

  3. 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)

    This is a 239 item questionnaire and each is scored from 0(is not able to do this behavior) to 3 [(always able to do this behavior)(or almost always)] a higher number indicating better outcome

  4. 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)

    This is a 9 item questionnaire. Each is scored on a 4-point Likert scale from 1(not at all) to 5(totally) ,questions 6,7 and 8 are reverse scored for a maximum score range of 9-36 and higher score indicating better quality of life

  5. 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)

    This is a 26 item questionnaire ,with 4 domains. Each is scored from 1(very poor) to 5(very good) ,questions 3,4 and 26 are reverse scored for a maximum raw score of 120 and higher score indicating better quality of life

Study contacts

Contact information is provided by the study sponsor or research team.

Antonio Pagán, PhD

CONTACT

[email protected]

(713) 486-2700

Ronald Acierno, PhD

CONTACT

[email protected]

(713) 486-2863

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 12, 2025
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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