AutismNCT07084324
Spanish-language Executive Function Intervention for Children With Autism and/or ADHD
A study testing Unstuck and On Target in people with Autism and ADHD, run by University of Colorado, Denver at 1 site in United States.
Trial 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.. Read more about this study
- Who is it for?
- Ages 8 to 11 years
- What is being tested?
- Unstuck and On Target
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2025to Mar 2030
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
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- 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.
Who cannot join
- Individuals will be excluded only if they do not meet one or more of the inclusion criteria listed above.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ulises Venegas-Rivera contact
United States1 site, 1 recruiting
- Recruiting
University of Colorado Anschutz School of Medicine
Aurora, Colorado, 80045
Jonathan Safer-Lichtenstein, PhD, 3012215283, jonathan.safer@cuanschutz.edu
jonathan.safer@cuanschutz.edu
About this study
Official title: Evaluating a Spanish-language Executive Functioning Intervention for Children With Autism and/or ADHD and Their Families
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?
Read more
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
- Being tested
- Unstuck and On Target
- Keywords
- executive functioning, autism, ADHD, Hispanic/Latine
- Medical subject headings
- Autistic Disorder, Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unstuck and On TargetBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Unstuck and On Target |
| Waitlist control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline and 1 month post-implementation.
Secondary outcomes (4)
Behavior Rating Inventory of Executive Function Second Edition
The Behavior Rating Inventory of Executive Function- Second Edition is a 63-item rating scale completed by caregivers to assess executive function impairment in children. T scores have a population mean of 50 and standard deviation of 10, with a minimum score of 30 and maximum score of 95. Scales assessed included the Behavioral Regulation Index, Emotion Regulation Index and Cognitive Regulation Index, together forming an overall composite score, the Global Executive Composite. Values below represent the change in T-scores scores from baseline to post-intervention for participating children. T scores at or above 70 are considered clinically significant.
Scores represent the change in T scores from baseline to post. Negative values represent decrease in impairment (better outcome) while positive scores representing an increase in impairment (worse outcome) from baseline to post when looking at the condition groups as a whole.
Measured: At baseline, 1 month and 3 months post-implementation.
Caregiver Strain Questionnaire- Short Form 7
The Caregiver Strain Questionnaire-Short Form 7 is a seven item self-reported questionnaire of objective and subjective internalized caregiver strain that has been translated into Spanish. Caregivers rate how difficult or impactful different situations have been over the past month as a result of their child's behavior on a five-point Likert scale ranging from 1 "not at all" to 5 "very much." Scores are summed for a total range of 7 to 35, with higher scores indicating greater strain.
Measured: At baseline and 1 month post-implementation.
Flexibility Interference Questionnaire
A brief questionnaire developed by researchers for parents to report how often their child's difficulties with flexibility interfere with daily adaptive functioning. It includes seven items addressing different real-world impacts, each scored on a Likert scale from 0 to 3, where 0 indicates no impact of executive function difficulties and 3 indicates severe impact. Total scores range from 0 (least interfering) to 21 (most interfering).
Measured: At baseline and 1 month post-implementation.
Executive Functions Knowledge Questionnaire
A set of 15 true/false or multiple-choice items assesses knowledge of executive function skills and support strategies. Each question is scored as correct or incorrect, and scores are summed to yield a total number of correct responses. Socres range from 0 to 15, with higher scores indicting greater EF knowledge.
Measured: At baseline and 1 month post-implementation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start15 Jul 2025
- Primary completionMar 2029 (estimated)
- Study completionMar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutismStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07084324
- Sponsor's protocol ID
- 24-1821
- Other IDs
- 1K23MH136346-01A1
- Status last verified
- Mar 2026
- First submitted
- 16 Jul 2025
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentitifed data will be shared with NDA