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

NCT ID: NCT07170163

Last Updated: 2025-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-06-01

Study Completion Date

2027-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Autism Spectrum Disorder (ASD)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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¡Iniciando! mHealth App

Group Type EXPERIMENTAL

¡Iniciando! mHealth App

Intervention Type 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).

Interventions

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¡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).

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

NIH

Sponsor Role collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Antonio Pagan

Post Doctoral Fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Antonio Pagán, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

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The University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status

Countries

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United States

Central Contacts

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Antonio Pagán, PhD

Role: CONTACT

(713) 486-2700

Ronald Acierno, PhD

Role: CONTACT

(713) 486-2863

Facility Contacts

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Antonio Pagán, PhD

Role: primary

(713) 486-2700

Ronald Acierno, PhD

Role: backup

(713) 486-2863

Other Identifiers

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1R03HD119485

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HSC-MS-25-0519

Identifier Type: -

Identifier Source: org_study_id

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