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Recruiting NCT07084324

Spanish-language Executive Function Intervention for Children With Autism and/or ADHD

No phase Interventional Autism ADHD

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Unstuck and On Target.
Who it may be relevant to
Registry conditions: Autism, ADHD. Basic parameters: 8 years — 11 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Evaluating a Spanish-language Executive Functioning Intervention for Children With Autism and/or ADHD and Their Families

Overview

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

Interventions

  • Behavioral 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 pr

Primary outcome measures

  • Executive Function Challenge Task [Time frame: At baseline and 1 month post-implementation.]
Secondary outcome measures (4)
  • Behavior Rating Inventory of Executive Function Second Edition [Time frame: At baseline, 1 month and 3 months post-implementation.]
  • Caregiver Strain Questionnaire- Short Form 7 [Time frame: At baseline and 1 month post-implementation.]
  • Flexibility Interference Questionnaire [Time frame: At baseline and 1 month post-implementation.]
  • Executive Functions Knowledge Questionnaire [Time frame: At baseline and 1 month post-implementation.]

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.

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Colorado Anschutz School of Medicine — Aurora

Identifiers

NCT: NCT07084324 · 24-1821 · 1K23MH136346-01A1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗