Pilot of 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.

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

Completed

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Key information

Conditions

Autism Spectrum Disorder Attention Deficit Disorder With Hyperactivity (ADHD) Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

8 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Neurodesarrollo Quito

Quito, 170528, Ecuador

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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

Treatment and study plan

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.

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

Neurodesarrollo Quito

Registry information

Official study title

Piloting Clinic-based Unstuck and On Target in Ecuador

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: May 6, 2026
Registry last updated: May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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