ClinicalTrials.gg
CompletedNCT07571434Updated May 6, 2026

Pilot of Unstuck and On Target in Ecuador

An interventional study of Spanish-Language Unstuck and On Target (SL-Unstuck) in Autism Spectrum Disorder and Attention Deficit Disorder With Hyperactivity (ADHD), sponsored by University of Colorado, Denver. Completed at 1 site in Ecuador. Open to participants aged 8 Years to 11 Years. Per ClinicalTrials.gov, last updated 2026-05-06.

Sponsored by University of Colorado, Denver · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled Sep 2025, registered Apr 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
8 Years to 11 Years
Sex
All
01

Study 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. 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
02

Conditions studied

  • Autism Spectrum Disorder
  • Attention Deficit Disorder With Hyperactivity (ADHD)
03

In context

Autism Spectrum Disorder

1,724 studies on the registry are indexed under Autism Spectrum Disorder; 500 are open to participants now.

This study's enrollment of 20 is below the median of 52 across 1,368 interventional studies indexed under Autism Spectrum Disorder.

Browse Autism Spectrum Disorder studies →

Lead sponsor

University of Colorado, Denver is the lead sponsor of 1,543 studies on the registry; 317 are open to participants now.

Of its 147 completed or terminated interventional studies of FDA-regulated products, 92 (63%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
8 Years to 11 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 8-11-years old
  • Meet 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

Exclusion criteria

Exclusion Criteria:

  • 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Unstuck

    Behavioral: Spanish-Language Unstuck and On Target (SL-Unstuck)

  • No intervention
    Waitlist

Interventions

  • BehavioralSpanish-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.

06

What researchers measure

Primary outcomes

  1. Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2)

    Time frame: At baseline and again at post-intervention appointment about 10 weeks later

  2. Executive Function Challenge Task (EFCT)

    Time frame: At baseline and again at post-intervention appointment about 10 weeks later

07

Study locations

1 site
  • Neurodesarrollo Quito
    Quito, 170528, Ecuador
08

References and documents

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 30859514 ↗
  • Anthony 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 40554639 ↗
  • Kenworthy 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 24256459 ↗
  • Safer-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 41766921 ↗
  • West, 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

Individual participant data

Plan to share: Yes

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07571434
Collaborators
Neurodesarrollo Quito
Responsible party
Sponsor
First posted
May 6, 2026
Start date
Sep 8, 2025
Primary completion
Feb 19, 2026
Completion
Apr 18, 2026
Last update
May 6, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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