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

July 8, 2026 updated by: Antonio Pagan, The University of Texas Health Science Center, Houston
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ¡Iniciando! mHealth App
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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of participants recruited
Time Frame: end of study (about 3 months after baseline)
end of study (about 3 months after baseline)
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
end of study (about 3 months after baseline)
Time taken for recruitment of participants
Time Frame: end of study (about 3 months after baseline)
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)
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)
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)
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.
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)
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
Time Frame: end of study (about 3 months after baseline)
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)
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)
end of study (about 3 months after baseline)
Treatment Adherence as assessed by the time spent on homework
Time Frame: end of study (about 3 months after baseline)
end of study (about 3 months after baseline)
Time-used on the mHealth app
Time Frame: end of study (about 3 months after baseline)
end of study (about 3 months after baseline)
Percentage of modules completed on the mHealth app
Time Frame: end of study (about 3 months after baseline)
end of study (about 3 months after baseline)
Frequencies of goal setting on the mHealth app
Time Frame: end of study (about 3 months after baseline)
end of study (about 3 months after baseline)
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
end of study (about 3 months after baseline)
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
end of study (about 3 months after baseline)
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
end of study (about 3 months after baseline)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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)
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
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)
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
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)
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
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)
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
baseline (+/-1 month), 6 weeks later (+/-1 month), and 12 weeks later ((+/-1 month)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Texas Health Science Center, Houston

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Antonio Pagán, PhD, The University of Texas Health Science Center, Houston

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 5, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 5, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 12, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HSC-MS-25-0519
  • 1R03HD119485 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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