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

NCT ID: NCT07084324

Last Updated: 2025-07-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-31
• Study Completion Date: 2027-04-30

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Unstuck and On Target

Intervention Type: 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.

Waitlist control

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Jonathan Safer-Lichtenstein, PhD

Role: CONTACT

jonathan.safer@cuanschutz.edu

303-724-3300

Ulises Venegas-Rivera

Role: CONTACT

ulises.venegas-rivera@cuanschutz.edu

Other Identifiers

1K23MH136346-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

24-1821

Identifier Type: -

Identifier Source: org_study_id