Pilot of Unstuck and On Target in Ecuador

NCT07571434 | Completed

• 1 other identifier: 23-2400
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Autism Spectrum Disorder; Attention Deficit Disorder With Hyperactivity (ADHD)

Outcome Measures

Primary Outcomes (2)

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

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

• Executive Function Challenge Task (EFCT)

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

Study Arms (2)

Unstuck

EXPERIMENTAL

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

Waitlist

NO INTERVENTION

Interventions

Spanish-Language Unstuck and On Target (SL-Unstuck) BEHAVIORAL

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.

Unstuck

Eligibility Criteria

• Age: 8 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Neurodesarrollo Quito: collaborator

Study Sites (1)

Neurodesarrollo Quito

Quito, 170528, Ecuador

Location

Related Publications (5)

• 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.

  PMID: 30859514 BACKGROUND

• 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/

  PMID: 40554639 BACKGROUND

• 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.

  PMID: 24256459 BACKGROUND

• 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.

  PMID: 41766921 BACKGROUND

• 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

  BACKGROUND

Related Links

• Official website for the Unstuck and On Target curriculum available in English and Spanish

MeSH Terms

Conditions

Autism Spectrum Disorder; Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Attention Deficit and Disruptive Behavior Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized control trial comparing immediate intervention to waitlist control

Study Record Dates

• First Submitted: April 24, 2026
• First Posted: May 6, 2026
• Study Start: September 8, 2025
• Primary Completion: February 19, 2026
• Study Completion: April 18, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

EC (1)