Autism Spectrum Disorder (ASD)NCT06868537
A Trial of the Launching! to Adulthood Program
A study testing Launching! to adulthood group therapy in people with Autism Spectrum Disorder (ASD), 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 effectiveness of the Launching intervention (Pagan et al., 2024) in improving adaptive functioning, transition readiness, and social cognition in young adults with Autism Spectrum Disorder (ASD), compared to a delayed treatment control group, to examine whether the… Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Autism Spectrum Disorder (ASD)
- What is being tested?
- Launching! to adulthood group therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2025to 1 Sep 2027
- 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 from a licensed mental health or medical professional
- score of >14 on the Social Communication Questionnaire-Lifetime (SCQ-L) 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
- willing and motivated to participate in the treatment
- a parent willing to participate
- verbal intelligence quotient (IQ) score >70 as assessed by the Kaufman Brief Intelligence Test 2nd edition revised (KBIT-2-R)
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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Antonio Pagan, PhD, (713) 486-2700, Antonio.Pagan@uth.tmc.edu
Katherine Loveland, PhD, (713) 486-2587, Katherine.A.Loveland@uth.tmc.edu
About this study
Official title: A Randomized Controlled Trial of the Launching! to Adulthood Program
The purpose of this study is to evaluate the effectiveness of the Launching intervention (Pagan et al., 2024) in improving adaptive functioning, transition readiness, and social cognition in young adults with Autism Spectrum Disorder (ASD), compared to a delayed treatment control group, to examine whether the Launching intervention leads to improvements in executive functioning, co-occurring mental health symptoms, and quality of life, as measured by caregiver and self-report assessments, to assess the maintenance of treatment gains 12 weeks post-treatment and to replicate the findings of the Launching pilot study in an independent sample of young adults with ASD.
- Conditions
- Autism Spectrum Disorder (ASD)
- Being tested
- Launching! to adulthood group therapy, standard of care
- Keywords
- Launching intervention
- 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 group therapyBehavioural
Participants will be in a 12-week therapy program that includes weekly group sessions and individual coaching.
standard of careBehavioural
Participants will receive a list of resources
| Study group | Role | What they receive |
|---|---|---|
| Launching! to adulthood group therapy | Experimental | Not described Receives: Behavioral: Launching! to adulthood group therapy |
| No intervention then Launching! to adulthood group therapy | Active comparator | Not described Receives: Behavioral: Launching! to adulthood group therapy; Behavioral: standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, week 12, week 24
Change in social response as assessed by the Social Responsiveness Scale, Second Edition (SRS-2)
This is a 65 item questionnaire and each is scored on a 4-point Likert scale from 1(Not True) to 4(Almost Always True) for a maximum raw score of 120, higher score indicating worse outcome.
Measured: Baseline, week 12, week 24
Change in transition readiness as assessed by the Transition Readiness Scale (TRS)-child version
This is a 30 item questionnaire and each is scored from 1(not true for me ) to 4(true for me) for a maximum score of 120, higher score indicating better outcome.
Measured: Baseline, week 12, week 24
Change in transition readiness as assessed by the Transition Readiness Scale (TRS)-parent version
This is a 30 item questionnaire and each is scored from 1(not true for them) to 4(true for them) for a maximum score of 120, higher score indicating better outcome.
Measured: Baseline, week 12, week 24
Secondary outcomes (6)
Change in executive functioning as assessed by the Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2)
This is a 75 item questionnaire and each is scored from 1(never) to 3(often) for a maximum score of 225, higher number indicating worse outcome
Measured: Baseline, week 12, week 24
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
Measured: Baseline, week 12, week 24
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
Measured: Baseline, week 12, week 24
Change in quality of life as assessed by the 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
Measured: Baseline, week 12, week 24
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
Measured: Baseline, week 12, week 24
Change in parental stress as assessed by the Parental Stress Scale (PSS)
This is a 14 item questionnaire and each item is scored from 1 (strongly disagree) to 5 (strongly agree) for a score range of 18-90, higher score indicating more stress
Measured: Baseline, week 12, week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start15 Jul 2025
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum Disorder (ASD)Studies 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- 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
- NCT06868537
- Sponsor's protocol ID
- HSC-MS-25-0098
- Status last verified
- Aug 2025
- First submitted
- 5 Mar 2025
- Last updated
- 5 Sep 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 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of the Launching! to Adulthood Program
- ClinicalTrials.gov ID
- NCT06868537
- Acronym / sponsor ID
- HSC-MS-25-0098
- Conditions
- Autism Spectrum Disorder (ASD)
- Keywords
- Launching intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 15 Jul 2025 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 11 Mar 2025 (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 effectiveness of the Launching intervention (Pagan et al., 2024) in improving adaptive functioning, transition readiness, and social cognition in young adults with Autism Spectrum Disorder (ASD), compared to a delayed treatment control group, to examine whether the Launching intervention leads to improvements in executive functioning, co-occurring mental health symptoms, and quality of life, as measured by caregiver and self-report assessments, to assess the maintenance of treatment gains 12 weeks post-treatment and to replicate the findings of the Launching pilot study in an independent sample of young adults with ASD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Launching! to adulthood group therapy | Experimental | Behavioral: Launching! to adulthood group therapy |
| No intervention then Launching! to adulthood group therapy | Active comparator | Behavioral: Launching! to adulthood group therapy, Behavioral: standard of care |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- confirmed case of ASD from a licensed mental health or medical professional
- score of >14 on the Social Communication Questionnaire-Lifetime (SCQ-L) 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
- willing and motivated to participate in the treatment
- a parent willing to participate
Key exclusion criteria (5 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 group therapyParticipants will be in a 12-week therapy program that includes weekly group sessions and individual coaching. | Behavioural | Launching! to adulthood group therapy, No intervention then Launching! to adulthood group therapy |
| standard of careParticipants will receive a list of resources | Behavioural | No intervention then Launching! to adulthood group therapy |
Primary outcome
Change in adaptive functioning as assessed by the Adaptive Behavior Assessment System, Third Edition (ABAS-3)
Time frame: Baseline, week 12, week 24
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 social response as assessed by the Social Responsiveness Scale, Second Edition (SRS-2)
Time frame: Baseline, week 12, week 24
This is a 65 item questionnaire and each is scored on a 4-point Likert scale from 1(Not True) to 4(Almost Always True) for a maximum raw score of 120, higher score indicating worse outcome.
Change in transition readiness as assessed by the Transition Readiness Scale (TRS)-child version
Time frame: Baseline, week 12, week 24
This is a 30 item questionnaire and each is scored from 1(not true for me ) to 4(true for me) for a maximum score of 120, higher score indicating better outcome.
Change in transition readiness as assessed by the Transition Readiness Scale (TRS)-parent version
Time frame: Baseline, week 12, week 24
This is a 30 item questionnaire and each is scored from 1(not true for them) to 4(true for them) for a maximum score of 120, higher score indicating better outcome.
6 secondary outcomes
Change in executive functioning as assessed by the Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2)
Time frame: Baseline, week 12, week 24
Change in depression as assessed by the Patient Health Questionnaire-9 (PHQ-9) for depressive symptoms
Time frame: Baseline, week 12, week 24
Change in anxiety as assessed by the Generalized Anxiety Disorder-7 (GAD-7) for anxiety symptoms
Time frame: Baseline, week 12, week 24
Change in quality of life as assessed by the World Health Organization Quality of Life Brief Version (WHOQOL-BREF)
Time frame: Baseline, week 12, week 24
Change in quality of life as assessed by the Autism Spectrum Quality of Life (ASQoL) questionnaire
Time frame: Baseline, week 12, week 24
Change in parental stress as assessed by the Parental Stress Scale (PSS)
Time frame: Baseline, week 12, week 24
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 5 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Autism Spectrum Disorder (ASD)
Not yet recruiting
"Family Resilience And Mind-body Enhancement" (FRAME): A Randomised Controlled Trial
Autism
Recruiting
Trial of Center-Based vs. In-Home Pivotal Response Treatment (PRT) in Autism
Autism, Autism Spectrum Disorder
Recruiting
Neuroimaging Predictors of Improvement to Pivotal Response Treatment (PRT) in Young Children With Autism
Autism Spectrum Disorder, Autism
RecruitingPhase 2
A Study of Esomeprazole in Children With Autism
Autism, Autism Spectrum Disorder
Recruiting
Transcranial Magnetic Stimulation for Restricted and Repetitive Behavior in ASD
Autism Spectrum Disorder, Autism
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.
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 group therapy in people with Autism Spectrum Disorder (ASD), 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 6 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 5 Sep 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?
Contact Antonio Pagan, PhD ((713) 486-2700, Antonio.Pagan@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in adaptive functioning as assessed by the Adaptive Behavior Assessment System, Third Edition (ABAS-3) (time frame: Baseline, week 12, week 24). 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 5 Sep 2025.