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| ID | Type | Description | Link |
|---|---|---|---|
| 1K23MH136346-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Waitlist control | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Unstuck and On Target | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At baseline and 1 month post-implementation. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
- Individuals will be excluded only if they do not meet one or more of the inclusion criteria listed above.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jonathan Safer-Lichtenstein, PhD | Contact | 303-724-3300 | jonathan.safer@cuanschutz.edu | |
| Ulises Venegas-Rivera | Contact | ulises.venegas-rivera@cuanschutz.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Anschutz School of Medicine | Recruiting | Aurora | Colorado | 80045 | United States |
Deidentitifed data will be shared with NDA
Will be reported per NDA timeline
Request login access to NDA
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| ID | Term |
|---|---|
| D001321 | Autistic Disorder |
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| 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. | 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). | 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. | At baseline and 1 month post-implementation. |
| D019958 | Attention Deficit and Disruptive Behavior Disorders |