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

University of Colorado Denver (CU Denver)

Status: Not yet enrolling

Conditions: ADHD; Autism

Treatments: Behavioral: Unstuck and On Target

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07084324

1K23MH136346-01A1 (U.S. NIH Grant/Contract)

24-1821

Details and patient eligibility

About

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

Enrollment: 40 estimated patients

Sex: All

Ages: 8 to 11 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Spanish Langauge Unstuck and On Target (SL-Unstuck)

Experimental group

Description:

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.

Treatment:

Behavioral: Unstuck and On Target

Waitlist control

No Intervention group