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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-25
SponsorThe University of Texas Health Science Center, Houston

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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 design

Design model

Single group

Treatments tested in this trial

  • ¡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).

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: ¡Iniciando! mHealth AppExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of participants recruited

Time frame
end of study (about 3 months after baseline)
2

Source of participants

Participants maybe recruited from the following : UTHealth Houston Community Health Workers Social Media advertisements Private clinics

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

Secondary outcomes

1

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

Time frame
baseline (+/-1 month), 6 weeks later (+/-1 month), and 12 weeks later ((+/-1 month)
2

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

Time frame
baseline (+/-1 month), 6 weeks later (+/-1 month), and 12 weeks later ((+/-1 month)
3

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

Time frame
baseline (+/-1 month), 6 weeks later (+/-1 month), and 12 weeks later ((+/-1 month)
4

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

Time frame
baseline (+/-1 month), 6 weeks later (+/-1 month), and 12 weeks later ((+/-1 month)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The University of Texas Health Science Center, Houston

Lead sponsor

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

Collaborator

This trial is not recruiting at the moment. You can still explore other options: