Autism Spectrum DisorderNCT07571434
Pilot of Unstuck and On Target in Ecuador
A study testing Spanish-Language Unstuck and On Target (SL-Unstuck) in people with Autism Spectrum Disorder and Attention Deficit Disorder With Hyperactivity (ADHD), run by University of Colorado, Denver at 1 site in Ecuador.
Trial summary
The goal of this clinical trial is to learn about the effects of the Spanish-language intervention, Unstuck and On Target (SL-Unstuck), in Spanish-speaking families in Ecuador of children 8-11 years old with attention deficit hyperactivity disorder (ADHD) or autism. Read more about this study
- Who is it for?
- Ages 8 to 11 years
- Conditions the study is for
- Autism Spectrum Disorder, Attention Deficit Disorder With Hyperactivity (ADHD)
- What is being tested?
- Spanish-Language Unstuck and On Target (SL-Unstuck)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEcuador
- Study dates
- 8 Sep 2025to 18 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 8 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 8-11-years old
- Meet DSM-5 criteria for Autism Spectrum Disorder and/or Attention deficit hyperactivity disorder (ADHD)
- Verbal skills of 7-years-old or greater as measured on the WISC-V Vocabulary subtest
- Caregiver endorsement of at least one specified executive functioning problem
- Caregiver must be at least 18 years old
- Caregiver must identify their preferred/primary language as Spanish
Who cannot join
- Child does not meet criteria for age, diagnosis, verbal language skills, or parent endorsement of EF difficulties
- Caregiver does not meet criteria or age or preferred language
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Piloting Clinic-based Unstuck and On Target in Ecuador
The goal of this clinical trial is to learn about the effects of the Spanish-language intervention, Unstuck and On Target (SL-Unstuck), in Spanish-speaking families in Ecuador of children 8-11 years old with attention deficit hyperactivity disorder (ADHD) or autism. The main objectives of this study are:
- To assess the feasibility and acceptability of SL-Unstuck in Ecuador.
- Compare SL-Unstuck child and caregiver outcomes to waitlist controls in Ecuador.
Read more
Researchers will compare families who are randomized to receive the intervention for 8 weeks to a waitlist control for 8 weeks prior to receiving the intervention.
Participants will:
- Complete pre- and post- intervention measures
- Receive the Spanish-language Unstuck and On Target intervention for 8 weeks
- Participate in focus group to gather qualitative feedback
- Being tested
- Spanish-Language Unstuck and On Target (SL-Unstuck)
- Medical subject headings
- Autism Spectrum Disorder, Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spanish-Language Unstuck and On Target (SL-Unstuck)Behavioural
Unstuck and On Target teaches children the necessary skills to think flexibly and develop plans to reach their goals, while also providing the adults in their lives a framework to help support development of these skills. For this study, participants will receive weekly 90-minute sessions, over the course of 8 weeks. The child portion of the intervention will take place in parallel to 60-minute caregiver sessions.
| Study group | Role | What they receive |
|---|---|---|
| Unstuck | Experimental | Not described Receives: Behavioral: Spanish-Language Unstuck and On Target (SL-Unstuck) |
| Waitlist | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2)
Measured: At baseline and again at post-intervention appointment about 10 weeks later
Executive Function Challenge Task (EFCT)
Measured: At baseline and again at post-intervention appointment about 10 weeks later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start8 Sep 2025
- Primary completion19 Feb 2026
- Study completion18 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Parallel groups
- Model description
- randomized control trial comparing immediate intervention to waitlist control
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Neurodesarrollo Quito
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07571434
- Sponsor's protocol ID
- 23-2400
- Status last verified
- May 2026
- First submitted
- 24 Apr 2026
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Stahmer AC, Vejnoska S, Iadarola S, Straiton D, Segovia FR, Luelmo P, Morgan EH, Lee HS, Javed A, Bronstein B, Hochheimer S, Cho E, Aranbarri A, Mandell D, Hassrick EM, Smith T, Kasari C. Caregiver Voices: Cross-Cultural Input on Improving Access to Autism Services. J Racial Ethn Health Disparities. 2019 Aug;6(4):752-773. doi: 10.1007/s40615-019-00575-y. Epub 2019 Mar 11.
PubMed 30859514Anthony L, Anthony B, Kenworthy L. Improving Classroom Behaviors among Students with Symptoms of Autism Spectrum Disorder or Attention Deficit Hyperactivity Disorder [Internet]. Washington (DC): Patient-Centered Outcomes Research Institute (PCORI); 2020 Jun. Available from http://www.ncbi.nlm.nih.gov/books/NBK615639/
PubMed 40554639Kenworthy L, Anthony LG, Naiman DQ, Cannon L, Wills MC, Luong-Tran C, Werner MA, Alexander KC, Strang J, Bal E, Sokoloff JL, Wallace GL. Randomized controlled effectiveness trial of executive function intervention for children on the autism spectrum. J Child Psychol Psychiatry. 2014 Apr;55(4):374-83. doi: 10.1111/jcpp.12161. Epub 2013 Nov 21.
PubMed 24256459Safer-Lichtenstein J, Campos L, Smith JV, Dahlman T, Mikulich-Gilbertson S, Holmes J, Verbalis A, Ratto A, Hardy K, Armour AC, Anthony BJ, Kenworthy L, Anthony L. "In our language": Acceptability and impact of executive function videos for Spanish-speaking families. Res Autism. 2025 Oct;128:202719. doi: 10.1016/j.reia.2025.202719. Epub 2025 Oct 3.
PubMed 41766921West, E., Travers, J., Kemper, T., Liberty, L., Cote, D., McCollow, M., & Stansberry Brusnahan, L. (2016). Racial and ethnic diversity of participants in research supporting evidence-based practices for learners with autism spectrum disorder. The Journal of Special Education, 50(3), 151-163. DOI: 10.1177/0022466916632495
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Piloting Clinic-based Unstuck and On Target in Ecuador
- ClinicalTrials.gov ID
- NCT07571434
- Acronym / sponsor ID
- 23-2400
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Neurodesarrollo Quito
- Study start
- 8 Sep 2025 (actual)
- Primary completion
- 19 Feb 2026 (actual)
- Study completion
- 18 Apr 2026 (actual)
- First posted
- 6 May 2026 (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 goal of this clinical trial is to learn about the effects of the Spanish-language intervention, Unstuck and On Target (SL-Unstuck), in Spanish-speaking families in Ecuador of children 8-11 years old with attention deficit hyperactivity disorder (ADHD) or autism. The main objectives of this study are:
- To assess the feasibility and acceptability of SL-Unstuck in Ecuador.
- Compare SL-Unstuck child and caregiver outcomes to waitlist controls in Ecuador.
Researchers will compare families who are randomized to receive the intervention for 8 weeks to a waitlist control for 8 weeks prior to receiving the intervention.
Participants will:
- Complete pre- and post- intervention measures
- Receive the Spanish-language Unstuck and On Target intervention for 8 weeks
- Participate in focus group to gather qualitative feedback
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized control trial comparing immediate intervention to waitlist control
| Arm | Type | Receives |
|---|---|---|
| Unstuck | Experimental | Behavioral: Spanish-Language Unstuck and On Target (SL-Unstuck) |
| Waitlist | No intervention | – |
Who may qualify
- Ages
- 8 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 8-11-years old
- Meet DSM-5 criteria for Autism Spectrum Disorder and/or Attention deficit hyperactivity disorder (ADHD)
- Verbal skills of 7-years-old or greater as measured on the WISC-V Vocabulary subtest
- Caregiver endorsement of at least one specified executive functioning problem
- Caregiver must be at least 18 years old
Key exclusion criteria (2 listed)
- Child does not meet criteria for age, diagnosis, verbal language skills, or parent endorsement of EF difficulties
- Caregiver does not meet criteria or age or preferred language
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 |
|---|---|---|
| Spanish-Language Unstuck and On Target (SL-Unstuck)Unstuck and On Target teaches children the necessary skills to think flexibly and develop plans to reach their goals, while also providing the adults in their lives a framework to help support development of these skills. For this study, participants will receive weekly 90-minute sessions, over the course of 8 weeks. The child portion of the intervention will take place in parallel to 60-minute caregiver sessions. | Behavioural | Unstuck |
Primary outcome
Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2)
Time frame: At baseline and again at post-intervention appointment about 10 weeks later
Executive Function Challenge Task (EFCT)
Time frame: At baseline and again at post-intervention appointment about 10 weeks later
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Background: PubMed 30859514Stahmer AC, Vejnoska S, Iadarola S, Straiton D, Segovia FR, Luelmo P, Morgan EH, Lee HS, Javed A, Bronstein B, Hochheimer S, Cho E, Aranbarri A, Mandell D, Hassrick EM, Smith T, Kasari C. Caregiver Voices: Cross-Cultural Input on Improving Access to Autism Services. J Racial Ethn Health Disparities. 2019 Aug;6(4):752-773. doi: 10.1007/s40615-019-00575-y. Epub 2019 Mar 11.
- Background: PubMed 40554639Anthony L, Anthony B, Kenworthy L. Improving Classroom Behaviors among Students with Symptoms of Autism Spectrum Disorder or Attention Deficit Hyperactivity Disorder [Internet]. Washington (DC): Patient-Centered Outcomes Research Institute (PCORI); 2020 Jun. Available from http://www.ncbi.nlm.nih.gov/books/NBK615639/
- Background: PubMed 24256459Kenworthy L, Anthony LG, Naiman DQ, Cannon L, Wills MC, Luong-Tran C, Werner MA, Alexander KC, Strang J, Bal E, Sokoloff JL, Wallace GL. Randomized controlled effectiveness trial of executive function intervention for children on the autism spectrum. J Child Psychol Psychiatry. 2014 Apr;55(4):374-83. doi: 10.1111/jcpp.12161. Epub 2013 Nov 21.
- Background: PubMed 41766921Safer-Lichtenstein J, Campos L, Smith JV, Dahlman T, Mikulich-Gilbertson S, Holmes J, Verbalis A, Ratto A, Hardy K, Armour AC, Anthony BJ, Kenworthy L, Anthony L. "In our language": Acceptability and impact of executive function videos for Spanish-speaking families. Res Autism. 2025 Oct;128:202719. doi: 10.1016/j.reia.2025.202719. Epub 2025 Oct 3.
- BackgroundWest, E., Travers, J., Kemper, T., Liberty, L., Cote, D., McCollow, M., & Stansberry Brusnahan, L. (2016). Racial and ethnic diversity of participants in research supporting evidence-based practices for learners with autism spectrum disorder. The Journal of Special Education, 50(3), 151-163. DOI: 10.1177/0022466916632495
- Official website for the Unstuck and On Target curriculum available in English and SpanishLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spanish-Language Unstuck and On Target (SL-Unstuck) in people with Autism Spectrum Disorder and Attention Deficit Disorder With Hyperactivity (ADHD), run by University of Colorado, Denver at 1 site in Ecuador.
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 2 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: finished, as of the sponsor's last update on 6 May 2026. 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 Ecuador. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2) (time frame: At baseline and again at post-intervention appointment about 10 weeks later). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07571434, which also lists 5 linked publications.
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 6 May 2026.