Autism Spectrum DisorderNCT06107972
Developing a Culturally Adapted Intervention for Latino Youth Transitioning to Adulthood
A study testing Launching! to Adulthood (¡Iniciando! la Adultez) program in people with Autism Spectrum Disorder, 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 evaluate the acceptability, feasibility (e.g., satisfaction, completion rate, barriers to recruitment, treatment fidelity) of the culturally refined Launching! to Adulthood (¡Iniciando! la Adultez) program, to test for a preliminary signal of effect between baseline and post-treatment… Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Launching! to Adulthood (¡Iniciando! la Adultez) program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2024to 31 Dec 2025
- 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
- confirmed case of ASD
- a score of >14 on the Social Communication Questionnaire-Lifetime (SCQ-L110) completed with the mother or father
- meet DSM-5 criteria for ASD based on a Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 ASD symptom checklist
- previous diagnosis of ASD from a licensed mental health or medical professional
- speak English
- have a parent willing to participate
- score >85 on verbal intelligence quotient (IQ) on the Kaufman Brief Intelligence Test (KBIT-2)
Who cannot join
- history of a psychotic disorder or current psychotic symptoms
- suicidal ideation with intent or plan
- current alcohol or other substance use disorder rated severe
- concurrent enrollment in another clinical trial for autism spectrum disorder
- expression of unwillingness to complete study procedures
- For fMRI, unable to undergo fMRI scanning due to metallic devices or objects (cardiac pacemaker or neurostimulator, some artificial joints, metal pins, surgical clips, or other implanted metal parts) or claustrophobic to the scanner.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
The purpose of this study is to evaluate the acceptability, feasibility (e.g., satisfaction, completion rate, barriers to recruitment, treatment fidelity) of the culturally refined Launching! to Adulthood (¡Iniciando! la Adultez) program, to test for a preliminary signal of effect between baseline and post-treatment for the Launching! to Adulthood (¡Iniciando! la Adultez) program and to identify preliminary neural mechanisms of action, including biomarkers of brain structure and connectivity, in terms of treatment response for 15 Latino young adults participating in the ¡Iniciando! therapy program.
Read the detailed description
The Launching! to Adulthood (¡Iniciando! la Adultez) program uses a culturally sensitive therapy program that was translated into Spanish to help Latino young adults with Autism Spectrum Disorder (ASD) who are transitioning to adulthood (18-25 years old) and their parents. The program aims to make the transition to adulthood easier for young adults and their families, and it includes specific cultural values of Latino young adults and their family members. The ¡Iniciando! la adultez program helps autistic young adults manage mental health needs like depression and anxiety and also addresses several areas impacting transition, including mental health barriers, executive functioning, and motivation. The ¡Iniciando! program also helps parents manage their own needs and addresses several areas, including psychoeducation and mental health.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Launching! to Adulthood (¡Iniciando! la Adultez) program
- 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.
Launching! to Adulthood (¡Iniciando! la Adultez) programBehavioural
The program includes cognitive behavioral and acceptance and commitment therapy, with a focus on developing goals during the transition to adulthood through a values framework. After a combined (parents and young adults) 90-minute introductory group meeting in-person, parents and the transition-aged young adults with ASD attend 9 separate, 90-minute weekly group telehealth meetings. Additionally, young adults have weekly personal coaching meetings for 30-minutes to discuss progress toward goals and barriers encountered. Leaders teach transition-aged young adult's skills through various social activities, as well as other skills (e.g., emotion regulation, cognitive diffusion) to help overcome barriers towards their goals. The treatment targets three core factors (i.e., mental health conditions, social skills, and coping with and adapting to stress). Leaders teach parents new parenting skills, knowledge of ASD, and readiness to support their young adult's transition to independent life.
| Study group | Role | What they receive |
|---|---|---|
| Launching! to Adulthood (¡Iniciando! la Adultez) program | Experimental | Not described Receives: Behavioral: Launching! to Adulthood (¡Iniciando! la Adultez) program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in adaptive behavior as assessed by the Adaptive Behaviour Assessment System, Third Edition
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, mid-treatment (5 weeks after baseline) , post-treatment (12 weeks after baseline), 3 month follow up, 6 month follow up
Change in Quality of life as assessed by the Autism Spectrum Quality of Life (ASQoL) questionnaire
This is a 9 item questionnaire. Questions 1-5 and 9 are each scored from 1(not at all) to 5(totally) a higher number indicating better outcome and questions 6-8 are reverse scored from 5(never) to 1(always) a higher score indicating worse outcome
Measured: baseline, mid-treatment (5 weeks after baseline) , post-treatment (12 weeks after baseline), 3 month follow up, 6 month follow up
Change in Anxiety as assessed by the Generalized Anxiety Disorder-7 (GAD7)
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, mid-treatment(5 weeks after baseline) , post-treatment (12 weeks after baseline), 3 month follow up, 6 month follow up
Change in depression as assessed by the Patient Health Questionnaire (PHQ-9)
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, mid-treatment(5 weeks after baseline) , post-treatment (12 weeks after baseline), 3 month follow up, 6 month follow up
Secondary outcomes (4)
Change in caregiver burden as assessed by the Rapid Screen for Caregiver Burden (CBI)
This is a 24 item questionnaire, each item is given a score between 0 (not at all descriptive) and 4 (very descriptive), where higher scores indicate greater caregiver burden
Measured: baseline, mid treatment (5 weeks after baseline) , post-treatment (12 weeks after baseline), 3 month follow up, 6 month follow up
Change in efficacy of coping with life's challenges as assessed by the Coping Self-Efficacy Scale (CSES)
This is a 26 item questionnaire and each is scored on a 11-point scale from 0(cannot do at all)-10 (certain can do) and higher number indicates better outcome
Measured: baseline, mid treatment (5 weeks after baseline) , post-treatment (12 weeks after baseline),3 month follow up, 6 month follow up
Change in stress as assessed by the Riverside Acculturation Stress Inventory (RASI)
This is a 15-item scale and each is scored on a 5-point scale ranging from 1 (strongly disagree) to 5 (strongly agree) higher number indicates worse outcome
Measured: baseline, mid treatment (5 weeks after baseline) , post-treatment (12 weeks after baseline), 3 month follow up, 6 month follow up
Change in goal attainment Goal Attainment Scaling (GAS)
This is scored on a 5-point scale, with the degree of attainment captured for each goal area: If the patient achieves the expected level, this is scored at 0. If they achieve a better than expected outcome this is scored at: +1 (somewhat better) +2 (much better) If they achieve a worse than expected outcome this is scored at: -1 (somewhat worse) or -2 (much worse) Goals may be weighted to take account of the relative importance of the goal to the individual, and/or the anticipated difficulty of achieving it.
Measured: week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, week 9, week 10, week 11, week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study start1 Apr 2024
- Primary completion1 Nov 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- 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
- 56 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- UTHealth Houston Seed Grant and Autism Speaks Fellowship
- Responsible party
- Principal investigator, Antonio Pagan, The University of Texas Health Science Center, Houston
- Investigators
- Antonio Pagan, PhD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06107972
- Sponsor's protocol ID
- HSC-MS-23-0188
- Status last verified
- Aug 2025
- First submitted
- 22 Oct 2023
- Last updated
- 27 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Culturally Adapted Intervention for Latino Youth Transitioning to Adulthood
- ClinicalTrials.gov ID
- NCT06107972
- Acronym / sponsor ID
- HSC-MS-23-0188
- Conditions
- Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 56 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- UTHealth Houston Seed Grant and Autism Speaks Fellowship
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 30 Oct 2023 (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 evaluate the acceptability, feasibility (e.g., satisfaction, completion rate, barriers to recruitment, treatment fidelity) of the culturally refined Launching! to Adulthood (¡Iniciando! la Adultez) program, to test for a preliminary signal of effect between baseline and post-treatment for the Launching! to Adulthood (¡Iniciando! la Adultez) program and to identify preliminary neural mechanisms of action, including biomarkers of brain structure and connectivity, in terms of treatment response for 15 Latino young adults participating in the ¡Iniciando! therapy program.
Detailed description
The Launching! to Adulthood (¡Iniciando! la Adultez) program uses a culturally sensitive therapy program that was translated into Spanish to help Latino young adults with Autism Spectrum Disorder (ASD) who are transitioning to adulthood (18-25 years old) and their parents. The program aims to make the transition to adulthood easier for young adults and their families, and it includes specific cultural values of Latino young adults and their family members. The ¡Iniciando! la adultez program helps autistic young adults manage mental health needs like depression and anxiety and also addresses several areas impacting transition, including mental health barriers, executive functioning, and motivation. The ¡Iniciando! program also helps parents manage their own needs and addresses several areas, including psychoeducation and mental health.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Launching! to Adulthood (¡Iniciando! la Adultez) program | Experimental | Behavioral: Launching! to Adulthood (¡Iniciando! la Adultez) program |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- confirmed case of ASD
- a score of >14 on the Social Communication Questionnaire-Lifetime (SCQ-L110) completed with the mother or father
- meet DSM-5 criteria for ASD based on a Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 ASD symptom checklist
- previous diagnosis of ASD from a licensed mental health or medical professional
- speak English
Key exclusion criteria (6 listed)
- history of a psychotic disorder or current psychotic symptoms
- suicidal ideation with intent or plan
- current alcohol or other substance use disorder rated severe
- concurrent enrollment in another clinical trial for autism spectrum disorder
- expression of unwillingness to complete study procedures
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 |
|---|---|---|
| Launching! to Adulthood (¡Iniciando! la Adultez) programThe program includes cognitive behavioral and acceptance and commitment therapy, with a focus on developing goals during the transition to adulthood through a values framework. After a combined (parents and young adults) 90-minute introductory group meeting in-person, parents and the transition-aged young adults with ASD attend 9 separate, 90-minute weekly group telehealth meetings. Additionally, young adults have weekly personal coaching meetings for 30-minutes to discuss progress toward goals and barriers encountered. Leaders teach transition-aged young adult's skills through various social activities, as well as other skills (e.g., emotion regulation, cognitive diffusion) to help overcome barriers towards their goals. The treatment targets three core factors (i.e., mental health conditions, social skills, and coping with and adapting to stress). Leaders teach parents new parenting skills, knowledge of ASD, and readiness to support their young adult's transition to independent life. | Behavioural | Launching! to Adulthood (¡Iniciando! la Adultez) program |
Primary outcome
Change in adaptive behavior as assessed by the Adaptive Behaviour Assessment System, Third Edition
Time frame: baseline, mid-treatment (5 weeks after baseline) , post-treatment (12 weeks after baseline), 3 month follow up, 6 month follow up
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
Change in Quality of life as assessed by the Autism Spectrum Quality of Life (ASQoL) questionnaire
Time frame: baseline, mid-treatment (5 weeks after baseline) , post-treatment (12 weeks after baseline), 3 month follow up, 6 month follow up
This is a 9 item questionnaire. Questions 1-5 and 9 are each scored from 1(not at all) to 5(totally) a higher number indicating better outcome and questions 6-8 are reverse scored from 5(never) to 1(always) a higher score indicating worse outcome
Change in Anxiety as assessed by the Generalized Anxiety Disorder-7 (GAD7)
Time frame: baseline, mid-treatment(5 weeks after baseline) , post-treatment (12 weeks after baseline), 3 month follow up, 6 month follow up
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
Change in depression as assessed by the Patient Health Questionnaire (PHQ-9)
Time frame: baseline, mid-treatment(5 weeks after baseline) , post-treatment (12 weeks after baseline), 3 month follow up, 6 month follow up
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
4 secondary outcomes
Change in caregiver burden as assessed by the Rapid Screen for Caregiver Burden (CBI)
Time frame: baseline, mid treatment (5 weeks after baseline) , post-treatment (12 weeks after baseline), 3 month follow up, 6 month follow up
Change in efficacy of coping with life's challenges as assessed by the Coping Self-Efficacy Scale (CSES)
Time frame: baseline, mid treatment (5 weeks after baseline) , post-treatment (12 weeks after baseline),3 month follow up, 6 month follow up
Change in stress as assessed by the Riverside Acculturation Stress Inventory (RASI)
Time frame: baseline, mid treatment (5 weeks after baseline) , post-treatment (12 weeks after baseline), 3 month follow up, 6 month follow up
Change in goal attainment Goal Attainment Scaling (GAS)
Time frame: week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, week 9, week 10, week 11, week 12
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 27 Aug 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Antonio Pagan, 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 Launching! to Adulthood (¡Iniciando! la Adultez) program in people with Autism Spectrum Disorder, 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 7 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 27 Aug 2025. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in adaptive behavior as assessed by the Adaptive Behaviour Assessment System, Third Edition (time frame: baseline, mid-treatment (5 weeks after baseline) , post-treatment (12 weeks after baseline), 3 month follow up, 6 month follow up). The study lists 4 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 27 Aug 2025.