Pilot of Unstuck and On Target in Ecuador

May 4, 2026 updated by: University of Colorado, Denver

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.

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ecuador
      • Quito, Ecuador, 170528
        • Neurodesarrollo Quito

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Waitlist
Experimental: Unstuck
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2)
Time Frame: At baseline and again at post-intervention appointment about 10 weeks later
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
At baseline and again at post-intervention appointment about 10 weeks later

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Collaborators

Neurodesarrollo Quito

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 8, 2025

Primary Completion (Actual)

February 19, 2026

Study Completion (Actual)

April 18, 2026

Study Registration Dates

First Submitted

April 24, 2026

First Submitted That Met QC Criteria

May 4, 2026

First Posted (Actual)

May 6, 2026

Study Record Updates

Last Update Posted (Actual)

May 6, 2026

Last Update Submitted That Met QC Criteria

May 4, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-2400

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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