¡Iniciando! mHealth App for ASD

Overseen By Antonio Pagán, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center, Houston

Disqualifiers: Low IQ, Psychotic, Suicidal, Substance abuse

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a mobile health app designed to help young Latino adults with autism spectrum disorder (ASD) improve their mental health, quality of life, and daily skills. The researchers seek to evaluate the app's usability and user satisfaction. Suitable candidates for this trial include individuals with a previous ASD diagnosis, those experiencing anxiety or depression, and those with Spanish-speaking parents. As an unphased trial, participants can contribute to pioneering research that may enhance support for the Latino ASD community.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the ¡Iniciando! mHealth App is safe?

Research has shown that the ¡Iniciando! mHealth App is being tested primarily for ease of use and satisfaction among Latino young adults with Autism Spectrum Disorder (ASD) and their parents. Specific information on side effects or problems with this app is not available. However, mobile health apps generally have very few side effects, as they are digital tools rather than medicines or medical procedures.

This study does not focus on testing the app's safety due to its digital nature, which suggests that most people should find it comfortable to use. For those considering joining the study, it's important to know that mHealth apps are designed to help users manage their health conditions and typically do not involve physical risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The ¡Iniciando! mHealth App is unique because it provides a digital, interactive approach to supporting individuals with Autism Spectrum Disorder (ASD). Unlike traditional therapies that often require in-person sessions, this app offers a convenient and accessible way for users to receive support and track progress right from their smartphones. Researchers are excited about this treatment because it leverages technology to offer personalized interventions and real-time feedback, potentially increasing engagement and effectiveness for users. Additionally, the app could make support more widely available, especially for those who have limited access to traditional therapy options.

What evidence suggests that the ¡Iniciando! mHealth App is effective for improving mental health and quality of life in Latino young adults with ASD?

Research shows that mobile health (mHealth) apps can assist people with Autism Spectrum Disorder (ASD), particularly in supporting parents and enhancing communication. The ¡Iniciando! mHealth App, used by participants in this trial, aims to improve mental health, quality of life, and daily functioning for young adults with ASD and their parents. Although few studies focus specifically on ¡Iniciando!, mHealth apps in general have shown promise in addressing similar needs. These apps provide easy-to-access support and resources, which may enhance daily living skills and overall well-being. Initial findings suggest that users often find these apps helpful and satisfying, leading to positive outcomes. ^{2 3 6 7 8}

Who Is on the Research Team?

Antonio Pagán, PhD

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

This trial is for Latino young adults with Autism Spectrum Disorder (ASD) transitioning to adulthood and their families. Participants must be able to use a mobile app designed to support mental health, quality of life, and adaptive functioning.

Inclusion Criteria

Spanish-speaking parents

Latino young adults with ASD with a score of 15 or greater on the Social Communication Questionnaire-Lifetime (SCQ-L)

Meets DSM-5-TR criteria for ASD based on a DSM-5-TR ASD symptom checklist

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 (DSM-5): Research Version (SCID-5-RV), or are actively suicidal with an active plan

Substance abuse

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the mHealth app to assess usability, satisfaction, and feasibility metrics

12 weeks

Regular app usage and assessments

Follow-up

Participants are monitored for changes in mental health, quality of life, and adaptive functioning

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ¡Iniciando! mHealth App

Trial Overview The study tests the ¡Iniciando! mHealth App's usability, satisfaction levels, usage data, methodological feasibility, and its impact on mental health and daily living skills of Latino youth with ASD during their transition to adulthood.

How Is the Trial Designed?

Group I: ¡Iniciando! mHealth App Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

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

Collaborator

Trials

2,103

Recruited

2,760,000+

Citations

1. withpower.com withpower.com/trial/phase-autism-spectrum-disorder-5-2026-ce80c

¡Iniciando! mHealth App for ASD · Info for Participants Trial Overview The study tests the ¡Iniciando! mHealth App's usability, satisfaction levels, usage data, methodological feasibility, and its impact on mental ...

2. ichgcp.net ichgcp.net/clinical-trials-registry/NCT07170163

¡Iniciando! mHealth App in Autism Spectrum Disorder (ASD ... The purpose of this study is to determine useability and satisfaction characteristics,product usage data,methodological feasibility parameters and ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9062798/

mHealth apps delivering early intervention to support parents ... This review aims to identify the mhealth apps delivering early intervention to support parents of children with autism spectrum disorders (ASD).

4. arxiv.org arxiv.org/html/2509.18716v1

Content and Quality Analysis of mHealth Apps for Feeding ... Conclusion: There is a critical shortage of mHealth apps for feeding difficulties in children with ASD that are both evidence-based and of high ...

5. ui.adsabs.harvard.edu ui.adsabs.harvard.edu/abs/2025arXiv250918716C/abstract

Content and Quality Analysis of mHealth Apps for Feeding ... ... Autism Spectrum Disorder (ASD), and 46% to 89% experience significant feeding difficulties. Mobile health applications (mHealth apps) have emerged as a ...

6. reporter.nih.gov reporter.nih.gov/search/lhNYoH7hxkymaXrH2xF4-g/project-details/11212144

Project Details Aim 1b involves rigorous accessibility, usability, and quality testing of the mHealth app with Latino young adults with ASD and their parents. This will include ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36053590/

mHealth apps delivering early intervention to support ... This review aims to identify the mhealth apps delivering early intervention to support parents of children with autism spectrum disorders (ASD).

8. arxiv.org arxiv.org/abs/2509.18716

Content and Quality Analysis of mHealth Apps for Feeding ... Background: Approximately 1 in 100 children worldwide are diagnosed with Autism Spectrum Disorder (ASD), and 46% to 89% experience significant ...