Executive Function Treatment for Autism Spectrum Disorder

Overseen By Cara E Pugliese, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Children's National Research Institute

Disqualifiers: Non-English proficiency, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 25

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to test a school-based program called Unstuck & On Target: High School (UOT:HS) to help youth with autism spectrum disorder (ASD) improve skills such as flexibility and planning. School staff deliver 25 one-hour lessons, and the program includes parent support to reinforce skills at home. Participants are divided into two groups: one receiving usual care and the other participating in the UOT:HS intervention. This trial suits high school students with autism who currently receive school-based autism services or have a previous clinical diagnosis and can engage with the program's material. As an unphased trial, the study offers students a unique opportunity to benefit from a specialized program designed to enhance their daily skills and support their educational journey.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on a school-based program for improving skills in students with autism.

What prior data suggests that this intervention is safe for youth with autism spectrum disorder?

Research has shown that Unstuck & On Target has been successfully used with children who have autism spectrum disorder (ASD). In past studies, this program helped kids improve their flexibility, organization, and planning skills. These studies did not find any major safety issues, indicating that the program is generally safe for participants.

Unstuck & On Target is a structured program with lessons that teach important skills in everyday situations. It is designed to be practical and easy to integrate into daily life, making it a safe choice for participants. While the program is now being adapted for high school students, it has been safely used with other age groups before, which is reassuring. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the "Unstuck & On Target: High School" program because it's a unique approach to improving executive function skills in students with Autism Spectrum Disorder. Unlike typical Individualized Education Plans (IEPs) that focus on accommodating students' needs, this curriculum actively teaches skills like flexibility, goal-setting, and planning through interactive lessons during the school day. The program also extends learning beyond the classroom by involving parents with home-based activities and optional training sessions, promoting skill generalization in everyday life. This comprehensive approach aims to equip students with practical skills for real-world challenges, setting it apart from traditional educational supports.

What evidence suggests that the Unstuck & On Target: High School intervention is effective for autism spectrum disorder?

Research shows that the Unstuck & On Target program can improve important thinking skills in students with autism spectrum disorder (ASD). Past studies have demonstrated that this program boosts flexibility, planning, and goal-setting, which are vital for success in adult life. One study found that children in the program were less likely to adhere to routines, a common challenge for those with ASD. Another study compared Unstuck & On Target to other programs and found it effective in improving classroom behavior among students with autism traits. In this trial, participants will either receive the Unstuck & On Target: High School intervention or continue with usual care. These findings suggest that the program helps students better handle changes and manage tasks, crucial skills for their future. ^{2 6 7 8 9}

Who Is on the Research Team?

Lauren Kenworthy, PhD

Principal Investigator

Children's Research Institute, Children's National Hospital

Are You a Good Fit for This Trial?

This trial is for high school students with autism spectrum disorder who have an IQ of 80 or higher and are in mainstream classes at least 20% of the time. They must also show signs of social communication challenges. Students and caregivers must be proficient in English to participate.

Inclusion Criteria

The student spends at least 20% of their time in mainstream educational services, as identified in their IEP or through teacher report.

Your parents or teachers have reported that you have difficulty with social communication, scoring 11 or higher on a questionnaire.

You have been diagnosed with autism by a healthcare professional or have an educational classification for autism.

Exclusion Criteria

Students and caregivers without a level of proficiency in English to complete questionnaires and study procedures in English.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

School staff deliver the Unstuck & On Target: High School (UOT:HS) curriculum to students, with ongoing check-ins and parent home extensions

9 months

25 lessons (in-person)

Follow-up

Participants are monitored for changes in adaptive behavior and executive function skills post-intervention

4-6 months

What Are the Treatments Tested in This Trial?

Interventions

• Unstuck & On Target: High School

Trial Overview The study tests 'Unstuck & On Target: High School' (UOT:HS), a program designed to improve flexibility and planning skills among autistic youth. It involves school staff delivering lessons, check-ins by study staff, and parent trainings to extend learning at home.

How Is the Trial Designed?

Group I: Usual Care Experimental Treatment 1 Intervention

Participants in schools assigned to the TAU condition will continue to receive the standard school-based Individualized Education Plan (IEP) accommodations and school supports that would typically be provided.

Group II: Intervention (Unstuck & On Target: High School) Experimental Treatment 1 Intervention

School staff will receive training on the Unstuck and On Target: High School (UOT:HS) curriculum, and deliver lessons to students during the school day. Interventionists will have the option to participate in ongoing check-ins with study staff. Parents are provided home extensions for each lesson and have the option to participate in trainings delivered by study staff to support generalization of skills to the home environment.

Who Is Running the Clinical Trial?

Children's National Research Institute

Lead Sponsor

Trials

227

Recruited

258,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4532389/

Randomized Controlled Effectiveness Trial of Executive ... This study investigates whether Unstuck and On Target (UOT; Cannon, Kenworthy, Alexander, Werner, & Anthony, 2011) reduces insistence on sameness, improves ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06651086

Hybrid Effectiveness-Implementation Trial of an Executive ... We propose a Hybrid Type 2 randomized trial examining the effectiveness and implementation of an autism EF EBI (Unstuck and On Target) in community mental ...

3. pcori.org pcori.org/research-results/2013/improving-classroom-behaviors-among-students-characteristics-autism-or-attention-deficithyperactivity-disorder

Improving Classroom Behaviors Among Students with ... In this study, the research team compared two programs for students with characteristics of ADHD or autism: Unstuck and On Target, or Unstuck.

4. researchgate.net researchgate.net/publication/268145075_Unstuck_and_On_Target_An_Executive_Functioning_Intervention_for_Children_with_High-Functioning_Autism_Spectrum_Disorders

(PDF) Unstuck and On Target: An Executive Functioning ... We have developed a school-based intervention to improve flexibility, goal-setting and planning in students with ASD, the Unstuck and On Target intervention.

5. advancedautism.com advancedautism.com/post/how-school-based-support-helps-children-with-autism-improve-executive-functioning

How School-Based Support Helps Children with Autism ... This article explores how school-based programs and interventions bolster executive functions in children with autism.

6. schoolmentalhealth.org schoolmentalhealth.org/media/som/microsites/ncsmh/documents/archives/IT-7.pdf

Unstuck and On Target How can we treat EF problems in autism? ➢ Phenotype specific accommodations & teaching self regulatory scripts in everyday settings. ✓. ️. ✓.

7. tandfonline.com tandfonline.com/doi/full/10.1080/18387357.2025.2500374?af=R

Development of unstuck and on target for early childhood (2020). Improving classroom behaviors among students with symptoms of autism spectrum disorder or attention deficit hyperactivity disorder.

8. unstuckandontarget.com unstuckandontarget.com/

Unstuck and On Target: Homepage Unstuck is a suite of tools for educators, families, and clinicians to build executive function skills. Resources include: Curricula for both elementary and ...

9. brookespublishing.com brookespublishing.com/wp-content/uploads/2021/01/cannon-2e_excerpt.pdf?srsltid=AfmBOorz1hCiBQR1qn7kqvV_g68ZC_K4aIYfdS5tR44EqSwnhEIi4yoh

Unstuck and On Target! Unstuck and On Target! is designed for 8- to 11-year-old students who have difficulties with flexibility, organization, and planning.