Randomized Controlled Trial of a Spanish-language Executive Function Intervention for Neurodivergent Children

NCT07084324 | Not Yet Recruiting DMC

• 2 other identifiers: 24-18211K23MH136346-01A1
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to learn whether the Spanish-language version of Unstuck and On Target (SL-Unstuck), an executive functioning (EF) intervention, is feasible, acceptable, and effective for Spanish-speaking caregivers and their neurodivergent children (ages 8-11) in the U.S.. The main questions it aims to answer are:

• Is SL-Unstuck acceptable to Spanish-speaking caregivers and children?
• Does SL-Unstuck improve child EF, caregiver EF knowledge, and caregiver strain? Researchers will compare families randomly assigned to immediate SL-Unstuck versus waitlist control to see if participating in the intervention improves EF and family outcomes. Participants will:
• Attend 8 weekly SL-Unstuck sessions at a clinic (parallel child and caregiver groups)
• Complete pre- and post-intervention assessments on child EF, caregiver strain, and satisfaction
• Participate in a focus group to share feedback on the intervention

Conditions

Autism; ADHD

Keywords

executive functioning; autism; ADHD; Hispanic/Latine

Outcome Measures

Primary Outcomes (1)

• Executive Function Challenge Task

  The Executive Functioning Challenge Task deliberately tests a child's ability to utilize key executive functions like planning and flexibility by presenting scenarios that reveal potential areas of difficulty in their EF skills. The test yields Flexibility and Planning raw scores with a minimum of 0 and maximum of 8. Higher scores indicate greater impairment in executive functioning. A total executive functioning raw score is also calculated as the sum of planning and flexibility scores. Values below represent the change in average raw scores from baseline to post-intervention for participating children. Negative scores represent an overall decrease in executive functioning impairment (better outcome) while positive scores representing an increase in executive functioning impairment (worse outcome) from baseline to post when looking at the condition groups as a whole.

  At baseline and 1 month post-implementation.

Secondary Outcomes (4)

• Behavior Rating Inventory of Executive Function Second Edition

  At baseline, 1 month and 3 months post-implementation.

• Caregiver Strain Questionnaire- Short Form 7

  At baseline and 1 month post-implementation.

• Flexibility Interference Questionnaire

  At baseline and 1 month post-implementation.

• Executive Functions Knowledge Questionnaire

  At baseline and 1 month post-implementation.

Study Arms (2)

Spanish Langauge Unstuck and On Target (SL-Unstuck)

EXPERIMENTAL

Participants in this arm will receive SL-Unstuck immediately. The intervention includes 8 weekly 90-minute clinic-based group sessions with parallel groups for children and caregivers.

Behavioral: Unstuck and On Target

Waitlist control

NO INTERVENTION

Interventions

Unstuck and On Target BEHAVIORAL

Children will receive the Unstuck and On Target (Unstuck) curriculum, a manualized cognitive-behavioral intervention that teaches executive functioning (EF) skills such as flexibility, emotional regulation, and goal-setting. Caregivers will attend concurrent Spanish-language sessions focused on understanding EF challenges and learning strategies to support their child's skills at home. Weekly home practice sheets in Spanish summarize each session and provide practical tips and activities. The program is designed to be neurodiversity-affirming and accessible to Spanish-speaking families.

Spanish Langauge Unstuck and On Target (SL-Unstuck)

Eligibility Criteria

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

You may qualify if:

• Child is 8-11 years old.
• Child meets DSM-5 criteria for Autism Spectrum Disorder and/or ADHD
• Child has verbal skills at a 7-year-old level or greater (as measured by WASI Vocabulary and Similarities subtests)
• Caregiver endorses at least one of the following executive functioning problems:
• Difficulty accepting feedback or criticism.
• Difficulty handling frustration.
• Difficulty starting non-preferred activities.
• Frequent meltdowns.
• Not stopping a behavior after being told to stop.
• Shutting down in the face of a challenge.
• Caregiver is at least 18 years old.
• Caregiver identifies Spanish as their preferred or primary language.

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Institute of Mental Health (NIMH): collaborator

MeSH Terms

Conditions

Autistic Disorder; Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Jonathan Safer-Lichtenstein, PhD

CONTACT

303-724-3300; jonathan.safer@cuanschutz.edu

Ulises Venegas-Rivera

CONTACT

ulises.venegas-rivera@cuanschutz.edu

Study Design

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

Study Record Dates

• First Submitted: July 16, 2025
• First Posted: July 24, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Will be reported per NDA timeline
• Access Criteria: Request login access to NDA