Executive Functioning Interventions for Autism

Recruiting at 1 trial location

Overseen By Hannah E Reynolds, MPH

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: San Diego State University

Disqualifiers: Autism, others

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

Compensation: Varies

Number of Visits: 24

672 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of two treatment programs for children with autism and emotional challenges. The first program, Unstuck and On Target, aims to improve skills such as flexibility and planning. The second, Unified Protocol for Children, addresses emotional issues like stress and irritability. Children aged 6-12, whether diagnosed or suspected to have autism, or with no history of autism, and already receiving therapy, may be suitable participants. The trial seeks to determine which program is more effective and easier to implement in real-world settings. As an unphased study, it offers a unique opportunity to enhance understanding and treatment options for children with autism and emotional challenges.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that "Unstuck and On Target" helps children with autism and ADHD improve flexibility, planning, and coping skills. Testing has occurred in settings such as outpatient mental health clinics. So far, children have handled it well, with no reports of serious side effects.

The "Unified Protocol for Children" is another program designed to assist kids with emotional challenges like anxiety and depression. Studies have found it effective, and importantly, no serious side effects have been reported.

Both programs have been tested in various settings and have shown promising results without major safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these interventions for autism because they offer new ways to support executive functioning, a key challenge for many individuals on the spectrum. "Unstuck and On Target" is unique in its school-friendly design, making it easier for teachers and staff to implement cognitive-behavioral strategies that enhance flexibility, goal-setting, and coping skills. Meanwhile, the "Unified Protocol for Children" stands out by integrating cognitive-behavioral and mindfulness techniques to address emotional and non-emotional disorders, promoting broader emotional regulation. Unlike traditional methods that may focus narrowly on symptoms, these interventions provide holistic, practical strategies that involve both children and their caregivers, potentially leading to more sustainable improvements.

What evidence suggests that this trial's treatments could be effective for autism?

This trial will compare two interventions for children with autism: "Unstuck and On Target" (UOT) and the "Unified Protocol for Children" (UP-C). Research has shown that UOT improves classroom behavior, flexibility, and problem-solving skills in children with autism spectrum disorder (ASD). These improvements appeared not only in controlled settings but also persisted for at least a year after the program ended. Meanwhile, UP-C effectively treats emotional issues in children, such as anxiety and internalizing symptoms, using cognitive-behavioral and mindfulness techniques. Recent studies suggest it also helps with other challenges, like irritability. Both treatments show promise in supporting children with various autism-related and emotional regulation issues. ^{1 3 4 5 6}

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Unified Protocol for Children
• Unstuck and On Target

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.

How Is the Trial Designed?

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+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

University of California, San Diego

Collaborator

Trials

1,215

Recruited

1,593,000+

University of Colorado - Anschutz Medical Campus

Collaborator

Trials

9

Recruited

1,700+

University of Colorado, Denver

Collaborator

Trials

1,842

Recruited

3,028,000+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10852158/

Unified Protocol for Children w/ Anxiety Disorders: RCT

This study aimed to investigate UP-C's efficacy in treating children's anxiety disorders compared to cognitive behavior therapy (CBT).

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S2666915325001003

The efficacy of the unified protocol for emotional disorders ...

Overall, our findings suggest that the UP-C/A is effective in treating internalizing symptoms in children and adolescents that can be offered in different ...

3.

pcori.org

pcori.org/research-results/2023/comparing-two-ways-help-autistic-individuals-manage-emotions

Comparing Two Ways To Help Autistic Individuals Manage ...

This study compares the clinical effectiveness of two approaches, the Unified Protocol (UP) and the Emotion Awareness and Skills Enhancement ...

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06158581

Comparing Two Different Emotion Therapies for Autistic ...

This study will compare the effectiveness of two transdiagnostic interventions for autistic adolescents and young adults - an intervention in widespread use ...

5.

frontiersin.org

frontiersin.org/journals/psychology/articles/10.3389/fpsyg.2021.731819/full

Unified Protocol for Emotional Disorders in Japanese Children

However, although child-reported DSRS-C scores significantly improved at the 3-month follow-up compared with pre-treatment (MD = −3.98, 95% CI = −7.71 to −0.25, ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11815469/

Efficacy of unified protocol for transdiagnostic treatment ...

This study is a two-armed, randomised controlled trial on the efficacy of 12 week UP-A on adolescents with emotional disorders along with their parents.