Autism Spectrum Disorder (ASD)NCT07170163
Navigating the Transition to Adulthood: A Dual Language Mobile App for Latino Youth With ASD and Their Families
A study testing ¡Iniciando! mHealth App in people with Autism Spectrum Disorder (ASD), run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Autism Spectrum Disorder (ASD)
- What is being tested?
- ¡Iniciando! mHealth App
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2026to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Antonio Pagán, PhD, 713-486-2700, Antonio.Pagan@uth.tmc.edu
Ronald Acierno, PhD, (713) 486-2863, Ronald.Acierno@uth.tmc.edu
About this study
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)
- Being tested
- ¡Iniciando! mHealth App
- Keywords
- mHealth app
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
¡Iniciando! mHealth AppBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| ¡Iniciando! mHealth App | Experimental | Not described Receives: Behavioral: ¡Iniciando! mHealth App |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants recruited
Measured: 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
Measured: end of study (about 3 months after baseline)
Time taken for recruitment of participants
Measured: end of study (about 3 months after baseline)
Number of participants that completed the study
Measured: 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.
Measured: 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.
Measured: 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
Measured: end of study (about 3 months after baseline)
Treatment Adherence as assessed by the number of completed sessions
Measured: end of study (about 3 months after baseline)
Treatment Adherence as assessed by the homework completion rate
Measured: end of study (about 3 months after baseline)
Treatment Adherence as assessed by the number of participants that drop out
Measured: end of study (about 3 months after baseline)
Treatment Adherence as assessed by the time spent on homework
Measured: end of study (about 3 months after baseline)
Time-used on the mHealth app
Measured: end of study (about 3 months after baseline)
Percentage of modules completed on the mHealth app
Measured: end of study (about 3 months after baseline)
Frequencies of goal setting on the mHealth app
Measured: 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
Measured: 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
Measured: 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
Measured: 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
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
Measured: 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
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
Measured: 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)
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
Measured: 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
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
Measured: 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)
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
Measured: baseline (+/-1 month), 6 weeks later (+/-1 month), and 12 weeks later ((+/-1 month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2025
- Study start1 Aug 2026 (estimated)
- Primary completion31 Mar 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum Disorder (ASD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Antonio Pagan, The University of Texas Health Science Center, Houston
- Investigators
- Antonio Pagán, PhD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07170163
- Sponsor's protocol ID
- HSC-MS-25-0519
- Other IDs
- 1R03HD119485
- Status last verified
- Jul 2026
- First submitted
- 5 Sep 2025
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Navigating the Transition to Adulthood: A Dual Language Mobile App for Latino Youth With ASD and Their Families
- ClinicalTrials.gov ID
- NCT07170163
- Acronym / sponsor ID
- HSC-MS-25-0519
- Conditions
- Autism Spectrum Disorder (ASD)
- Keywords
- mHealth app
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 12 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ¡Iniciando! mHealth App | Experimental | Behavioral: ¡Iniciando! mHealth App |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ¡Iniciando! mHealth AppParticipants 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). | Behavioural | ¡Iniciando! mHealth App |
Primary outcome
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)
Participants maybe recruited from the following : UTHealth Houston Community Health Workers Social Media advertisements Private clinics
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)
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)
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.
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
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)
Treatment Adherence as assessed by the time spent on homework
Time frame: end of study (about 3 months after baseline)
Time-used on the mHealth app
Time frame: 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)
Frequencies of goal setting on the mHealth app
Time frame: 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
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
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
5 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Antonio Pagán, PhD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ¡Iniciando! mHealth App in people with Autism Spectrum Disorder (ASD), run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Antonio Pagán, PhD ((713) 486-2700, Antonio.Pagan@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants recruited (time frame: end of study (about 3 months after baseline)). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.