Executive Function Group Therapy for Autism Spectrum Disorder

Not currently recruiting at 3 trial locations

Overseen By Lauren Kenworthy

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Children's National Research Institute

Disqualifiers: Neurological disorder, Metal implants, Pregnancy, others

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

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a group therapy designed to help teens with autism improve their thinking and learning flexibility. The researchers aim to determine if this executive function group therapy changes how these teens learn and how their brains function during learning tasks. The study uses brain scans to observe these changes over time. Teens with autism, diagnosed by a doctor and without interfering medical conditions, might be suitable for this study. As an unphased trial, it offers participants a unique opportunity to contribute to groundbreaking research that could enhance educational strategies for teens with autism.

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's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this cognitive-behavioral intervention is safe for youth with ASD?

Research shows that group therapy focused on improving thinking skills is generally safe for children with autism. Studies have found that this therapy can enhance skills like planning and attention while reducing autism symptoms. Although detailed information about side effects is limited, a review of similar therapies found that only about a third of studies examined them. This suggests that serious side effects are not often reported, but more detailed safety information would be helpful. Overall, research supports the therapy's safety and potential benefits for young people with autism. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard therapies for autism spectrum disorder that often focus on behavioral interventions or medications, executive function group therapy targets the core cognitive skills like planning, organization, and impulse control. This therapy is unique because it emphasizes improving executive functions, which are crucial for daily decision-making and problem-solving. Researchers are excited about this approach because enhancing these cognitive skills could lead to better social interactions and overall life management for individuals with autism, potentially offering broader benefits than traditional methods.

What evidence suggests that executive function group therapy is effective for autism spectrum disorder?

Research has shown that group therapy focused on improving thinking skills can help people with Autism Spectrum Disorder (ASD) become more adaptable and better at solving problems. In one study, children with ASD who participated in this therapy behaved better in the classroom. Another study found that participants learned all the skills they were taught, indicating the therapy's effectiveness. Additionally, programs that train thinking skills have boosted these abilities in children and teens with ASD, supporting the benefits of this group therapy. These findings suggest that the therapy being tested in the current trial could help people with autism improve their everyday skills. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adolescents aged 14-18 with Autism Spectrum Disorder who have an IQ over 80 and can communicate effectively in English. They must meet specific criteria on autism diagnostic tools and have normal or corrected hearing and vision. Those with metal implants, braces, pregnancy, significant neurological issues, or conditions affecting study participation are excluded.

Inclusion Criteria

Broad ASD diagnosis according to Diagnostic Statistical Manual, fifth edition (DSM-5) criteria established by parent report of prior clinical diagnosis and confirmed by meeting cutoff criteria on the Social Communication Questionnaire (i.e., raw score > 11) or the Autism Diagnostic Observation Schedule-2 (ADOS-2), Module 4 (total score ≥7).

My hearing and vision are normal or corrected to normal.

Full scale IQ > 80 on a standardized IQ test, either confirmed through educational testing within the last two years or confirmed by the Wechsler Abbreviated Scale of Intelligence (WASI-2) administered by research personnel. If current IQ testing (FSIQ) is not interpretable based on discrepancies between verbal and perceptual skills, we will use the best available verbal IQ estimate.

Exclusion Criteria

Presence of a known medical condition in the participant that would interfere with his/her ability to participate in the study.

I do not have a history of major brain conditions like epilepsy, severe injury, infections, or stroke.

Contraindications for MRI such as metal implants, dental braces, pregnancy (determined by parent or self-report).

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Initial assessment of learning and cognitive flexibility using m-fMRI and behavioral measurements

8-12 months before intervention

Intervention

Cognitive-behavioral intervention designed to improve flexibility in ASD, with m-fMRI and behavioral measurements

8 months

3 time-points 8 months apart

Follow-up

Participants are monitored for changes in executive function and neural activation post-intervention

8-12 months after intervention

What Are the Treatments Tested in This Trial?

Interventions

• Executive function group therapy

Trial Overview The trial tests if executive function group therapy can improve learning flexibility in teens with ASD using brain scans (m-fMRI) to observe changes. It's a long-term study where participants are assessed three times over eight months to see how the therapy affects their brain activity and behavior.

How Is the Trial Designed?

Group I: Executive function group therapy Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Children's National Research Institute

Lead Sponsor

Trials

227

Recruited

258,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Georgetown University

Collaborator

Trials

355

Recruited

142,000+

Published Research Related to This Trial

In a study of 180 in-patients undergoing group psychotherapy, 60-65% reported experiencing adverse events such as mood deterioration or unwanted treatment reactions, indicating that these therapies can have significant negative effects for many individuals.

The study found that while reports of unwanted treatment reactions decreased over time, they were negatively associated with symptom improvement, and 34% of patients prematurely terminated their therapy, highlighting the need to consider patient characteristics and group conditions as predictors of adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events of group psychotherapy in the in-patient setting - results of a naturalistic trial. Schneibel, R., Wilbertz, G., Scholz, C., et al.[2019]

In a systematic review of 117 studies on psychosocial interventions for childhood mental disorders, only 31% monitored adverse events, highlighting a significant gap in safety reporting.

Among the studies that did monitor adverse events, there was a lack of consistency in how these events were defined and assessed, with only 11% evaluating the causes of the events, which is crucial for understanding the risks associated with these treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review: Adverse event monitoring and reporting in studies of pediatric psychosocial interventions: a systematic review. Lodewyk, K., Bagnell, A., Courtney, DB., et al.[2023]

Group therapy has become more popular due to its effectiveness and cost benefits, but it's crucial to evaluate the psychological risks associated with these interventions.

The author suggests that instead of focusing on single risk factors for negative outcomes in group therapy, an interactional model should be used to better understand and mitigate these risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse outcomes in group psychotherapy: risk factors, prevention, and research directions. Roback, HB.[2022]

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]

Citations

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

Randomized Controlled Effectiveness Trial of Executive ... UOT improved classroom behavior, flexibility and problem-solving in children with ASD. Individuals with variable background/training in ASD successfully ...

2. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/abs/10.1002/bin.2023

The effectiveness of an executive function program for ... The executive function program resulted in acquisition of all six targeted executive functioning skills for all the participants. While ...

3. nature.com nature.com/articles/s41598-024-83953-9

The effectiveness of social training in individuals with ... Effects of cognitive training programs on executive function in children and adolescents with Autism Spectrum Disorder: A systematic review.

4. withpower.com withpower.com/trial/phase-autism-spectrum-disorder-9-2021-987ae

Executive Function Group Therapy for Autism Spectrum ... Research shows that executive function training can improve daily skills in adults with autism, and rating scales have been useful in assessing intervention ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0891422224000246

Relationship between executive function and autism ... In the present study, EF predicted 57 % of the variability of autism symptoms. •. EF could be included in the early intervention plan for preschool children ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10805505/

Integrated Life Skills Training and Executive Function ... EF strategies are considered effective in improving the therapeutic outcomes of children with ASD.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8534174/

Effects of Cognitive Training Programs on Executive Function ... Most of the interventions identified were effective in enhancing EFs and reducing symptoms in children and young people with ASD.

8. autism.org autism.org/exeuctive-function-autism/

Executive Function and Autism Learn about emerging research on the role of the underlying neuroanatomy related to executive function and autism.