Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1R03HD119485 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ¡Iniciando! mHealth App | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ¡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). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants recruited | 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 | end of study (about 3 months after baseline) |
| Time taken for recruitment of participants | end of study (about 3 months after baseline) | |
| Number of participants that completed the study | 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. | 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. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | baseline (+/-1 month), 6 weeks later (+/-1 month), and 12 weeks later ((+/-1 month) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Antonio Pagán, PhD | Contact | (713) 486-2700 | Antonio.Pagan@uth.tmc.edu | |
| Ronald Acierno, PhD | Contact | (713) 486-2863 | Ronald.Acierno@uth.tmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Antonio Pagán, PhD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
Not provided
| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| end of study (about 3 months after baseline) |
| Treatment Adherence as assessed by the number of completed sessions | end of study (about 3 months after baseline) |
| Treatment Adherence as assessed by the homework completion rate | end of study (about 3 months after baseline) |
| Treatment Adherence as assessed by the number of participants that drop out | end of study (about 3 months after baseline) |
| Treatment Adherence as assessed by the time spent on homework | end of study (about 3 months after baseline) |
| Time-used on the mHealth app | end of study (about 3 months after baseline) |
| Percentage of modules completed on the mHealth app | end of study (about 3 months after baseline) |
| Frequencies of goal setting on the mHealth app | 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 | 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 | 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 | end of study (about 3 months after baseline) |
| 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 | 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 | 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 | 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 | baseline (+/-1 month), 6 weeks later (+/-1 month), and 12 weeks later ((+/-1 month) |