Executive Functioning Interventions for Autism

Recruiting at1 trial location

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: San Diego State University

Disqualifiers: Autism, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This project aims to follow up on a prior project examining the impact of training therapists in an executive functioning intervention Unstuck and On Target (UOT) adapted for community mental health settings. Study aims are to test the clinical and implementation effectiveness of training mental health therapists in Unstuck and On Target, an executive functioning intervention, relative to Unified Protocol for Children, a transdiagnostic intervention for emotional disorders. This includes examining the implementation of Unstuck and associated outcomes (e.g., effective delivery, expanded use of Unstuck beyond autism, the feasibility of Unstuck) and impact on changes in child executive functioning and behaviors.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Unified Protocol for Children, Unstuck and On Target for autism?

Research shows that executive function training can help children with autism improve certain skills, like reducing repetitive behaviors, and school-based interventions like AIMS have shown improvements in academic skills for autistic students. These findings suggest that treatments targeting executive functioning may be beneficial for children with autism. ^{1 2 3 4 5}

How does the treatment 'Unified Protocol for Children, Unstuck and On Target' differ from other treatments for autism?

The 'Unified Protocol for Children, Unstuck and On Target' treatment is unique because it focuses on improving executive functioning, which includes skills like flexible thinking and self-control, in children with autism. This approach is different from other treatments that may not specifically target these cognitive skills, and it uses structured interventions to enhance these abilities, potentially leading to better social and behavioral outcomes. ^{2 4 5 6 7}

Research Team

Eligibility Criteria

This trial is for children with Autism Spectrum Disorder or related executive function challenges. It's designed to see if therapists trained in a specific program can help these kids better than a general emotional disorder treatment.

Inclusion Criteria

Therapists: Employed as staff or trainee at a participating program, employed at the program for at least the next 12 months, providing psychotherapy services to children, having an eligible child on current caseload

My child is between 7-12 years old, has autism, and is seeing a participating therapist.

My program is publicly-funded, offers therapy for kids, and has 8 or more mental health staff.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

EBI Implementation

Implementation of the Unstuck and On Target intervention and Unified Protocol for Children, focusing on training therapists and delivering interventions to children

6 months

Regular sessions as per intervention protocol

Follow-up

Participants are monitored for changes in mental health symptoms, executive functioning, and intervention fidelity

12 months

Assessments at 6-month and 12-month intervals post-EBI implementation

Long-term Follow-up

Extended monitoring of intervention reach and psychotherapy quality

18 months

Final assessment at 18 months post-EBI implementation

Treatment Details

Interventions

• Unified Protocol for Children (Behavioral Intervention)
• Unstuck and On Target (Behavioral Intervention)

Trial Overview The study compares two interventions: 'Unstuck and On Target' which helps with planning and flexibility, against the 'Unified Protocol for Children', which treats various emotional disorders. The focus is on how well each method works when used by community therapists.

Participant Groups

Group I: Unstuck and On Target Active Control 1 Intervention

Unstuck and on Target (Unstuck; Cannon et al., 2021) is a cognitive-behavioral, intervention designed to be feasibly delivered by teachers and school staff in the elementary school setting. It was adapted for and pilot-tested in outpatient mental health. Unstuck targets key executive functions, including flexibility, goal-setting, planning, and coping. Sessions include prescribed content and activities to facilitate guided practice and home extension activities to aid generalization beyond the therapeutic session. It includes both child- and caregiver-directed strategies. It has been shown effective for youth with autism and attention-deficit/hyperactivity disorder.

Group II: Unified Protocol for Children Active Control 1 Intervention

Unified Protocol for Children is a transdiagnostic, cognitive-behaviorally based treatment targeting shared core dysfunctions underlying emotional disorders, including distress intolerance and emotional dysregulation. It was developed by integrating cognitive-behavioral and mindfulness strategies and includes prescribed activities, in-vivo experiments, and home-extension components to promote generalization. It includes both child- and caregiver-directed strategies. In addition to its effectiveness for youth with emotional disorders, recent work supports its efficacy for youth with additional non-emotional disorders (e.g., externalizing challenges, irritability).

Who Is Running the Clinical Trial?

San Diego State University

Lead Sponsor

Trials

182

Recruited

119,000+

William Tong

San Diego State University

Chief Executive Officer since 2023

PhD in Chemistry from Iowa State University

Ramin Farzaneh-Far

San Diego State University

Chief Medical Officer since 2024

MD

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Dr. Joshua A. Gordon

National Institute of Mental Health (NIMH)

Chief Executive Officer since 2016

MD, PhD

Dr. Shelli Avenevoli

National Institute of Mental Health (NIMH)

Chief Medical Officer

PhD

University of California, San Diego

Collaborator

Trials

1,215

Recruited

1,593,000+

Dr. Christopher Longhurst

University of California, San Diego

Chief Medical Officer since 2021

MD and MS in Medical Informatics from UC Davis

Patty Maysent

University of California, San Diego

Chief Executive Officer since 2016

MBA from Stanford University

University of Colorado - Anschutz Medical Campus

Collaborator

Trials

9

Recruited

1,700+

University of Colorado, Denver

Collaborator

Trials

1,842

Recruited

3,028,000+

Aviva Abosch

University of Colorado, Denver

Chief Medical Officer since 2019

MD

Uday B. Kompella

University of Colorado, Denver

Chief Executive Officer since 2015

PhD in Pharmaceutical Sciences

Findings from Research

The AIMS intervention, implemented in schools, showed small to moderate improvements in executive functioning (EF) skills among 47 middle-school students with autism spectrum disorder (ASD) without intellectual disability, compared to a waitlist control group.

Students receiving AIMS also demonstrated better academic functioning, indicating that school-based interventions can effectively enhance EF skills in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Achieving Independence and Mastery in School: A School-Based Executive Function Group Intervention for Autistic Middle Schoolers. Tamm, L., Hamik, E., Yeung, TS., et al.[2023]

A study involving 70 children with autism spectrum disorder showed that a computerized executive function training program, guided by a coach, led to changes in brain responses, indicating potential improvements in executive function skills.

While the training did not result in significant behavioral changes in lab tasks or overall executive function use, parents reported a decrease in restricted and repetitive behaviors in children who received the training, suggesting some positive effects on functioning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A preliminary randomized, controlled trial of executive function training for children with autism spectrum disorder. Faja, S., Clarkson, T., Gilbert, R., et al.[2023]

A proof of concept trial for a new intervention targeting academic executive functioning skills in middle school youth with autism spectrum disorders (ASD) showed high feasibility and satisfaction among participants, indicating potential for effectiveness.

Focus groups with parents and youth highlighted the necessity for such an intervention and identified successful strategies, emphasizing the importance of promoting independence in youth with ASD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Academic Needs in Middle School: Perspectives of Parents and Youth with Autism. Tamm, L., Duncan, A., Vaughn, A., et al.[2021]

In a study of 250 children with autism spectrum disorder (ASD) followed for about 10 years, middle-childhood executive functioning (EF) was found to mediate the relationship between early-childhood autism symptoms and various adolescent outcomes, including externalizing behavior and academic performance.

The results suggest that improving executive functioning in middle childhood could potentially enhance adolescent outcomes for children with ASD, highlighting the need for further experimental studies to explore this intervention's effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Middle-childhood executive functioning mediates associations between early-childhood autism symptoms and adolescent mental health, academic and functional outcomes in autistic children. Ameis, SH., Haltigan, JD., Lyon, RE., et al.[2022]

Children with autism spectrum disorder (ASD) showed significant deficits in executive functioning (EF), particularly in vigilance, response inhibition, cognitive flexibility, and working memory, compared to typically developing peers.

The study found that while children with ADHD had specific deficits in vigilance, inhibition, and working memory, they did not consistently show problems across all EF measures, highlighting the distinct cognitive profiles of these neurodevelopmental disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Examining executive functioning in children with autism spectrum disorder, attention deficit hyperactivity disorder and typical development. Corbett, BA., Constantine, LJ., Hendren, R., et al.[2021]

Young individuals with autism showed significant impairments in executive function compared to both non-autistic individuals with moderate learning disabilities and normally developing children, as assessed through two challenging tasks.

The impairments were specifically linked to tasks that required higher levels of executive control, supporting the idea that executive dysfunction is a characteristic feature of autism, which aligns with the 'Supervisory Attentional System' model of frontal function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence for executive dysfunction in autism. Hughes, C., Russell, J., Robbins, TW.[2022]

The study developed a new 52-item Executive Functioning Scale (EFS) that effectively measures both non-affective and affective executive functioning subdomains, showing strong reliability and internal consistency across diverse age, sex, race, and ethnicity groups.

Initial psychometric evaluation with over 2,900 participants, including 243 with autism, indicates that the EFS can be a valuable tool for both research and clinical settings to assess executive functioning in children and adolescents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and validation of the Executive Functioning Scale. Uljarević, M., Cai, RY., Hardan, AY., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Achieving Independence and Mastery in School: A School-Based Executive Function Group Intervention for Autistic Middle Schoolers. [2023]

2. England pubmed.ncbi.nlm.nih.gov

A preliminary randomized, controlled trial of executive function training for children with autism spectrum disorder. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Academic Needs in Middle School: Perspectives of Parents and Youth with Autism. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Middle-childhood executive functioning mediates associations between early-childhood autism symptoms and adolescent mental health, academic and functional outcomes in autistic children. [2022]

5. Ireland pubmed.ncbi.nlm.nih.gov

Examining executive functioning in children with autism spectrum disorder, attention deficit hyperactivity disorder and typical development. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Evidence for executive dysfunction in autism. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Development and validation of the Executive Functioning Scale. [2023]