Recruiting

SL-Unstuck

Sponsor:

University of Colorado, Denver

Code:

NCT07084324

Conditions

Autism

ADHD

Eligibility Criteria

Sex: All

Age: 8 - 11

Healthy Volunteers: Not accepted

Interventions

Unstuck and On Target

Study Details

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

Study ID

NCT07084324

Start date

Jul 15, 2025

Status verified date

Mar, 2026

Completion date

Mar, 2030

Anticipated

Primary completion date

Mar, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8 - 11

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

\- Individuals will be excluded only if they do not meet one or more of the inclusion criteria listed above.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Spanish Langauge Unstuck and On Target (SL-Unstuck)

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.

no intervention: Waitlist control

Interventions

Unstuck and On Target

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.

Primary outcome measure

  • Executive Function Challenge Task [ Time Frame: At baseline and 1 month post-implementation. ]

Central Contacts and Locations

Central contacts

Jonathan Safer-Lichtenstein, PhD

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

Ulises Venegas-Rivera

ulises.venegas-rivera@cuanschutz.edu

Locations

University of Colorado Anschutz School of Medicine

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Jonathan Safer-Lichtenstein, PhD

3012215283jonathan.safer@cuanschutz.edu

jonathan.safer@cuanschutz.edu

Principal Investigator:

Jonathan Safer-Lichtenstein, PhD

More Information

Sponsor

University of Colorado, Denver

Last update posted

Apr 3, 2026

Last verified

Mar, 2026

Keywords

  • executive functioning
  • autism
  • ADHD
  • Hispanic/Latine

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2026-04-03.