Executive Function Group Therapy for Autism Spectrum Disorder

Recruiting at 1 trial location

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

64 Participants Needed

Trial Summary

What is the purpose of this trial?

This project explores the association between learning and cognitive flexibility by testing whether a cognitive behavioral intervention designed to improve flexibility in ASD changes learning and associated neural activation using model-based functional magnetic resonance imaging (m-fMRI). The study proposes that variability in learning mechanisms is associated with behavioral flexibility and explains differences in adaptive and treatment outcomes. The study employs a longitudinal case-controlled design in 60 14-18 year old youth with ASD at 3 time-points 8 months apart, each including m-fMRI during learning and behavioral measurement of executive and adaptive function. Aim 1 tests the hypothesis that individual variation in learning biases and their neural correlates predicts behavioral flexibility and is stable over time. Aim 2 tests plasticity of learning mechanisms induced by a cognitive-behavioral intervention for flexibility. Aim 3 tests hypothesis about intervention-induced plasticity of neural functional connectivity.

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 data supports the effectiveness of the treatment Executive function group therapy for Autism Spectrum Disorder?

Research shows that executive function training can improve daily skills in adults with autism, and rating scales have been useful in assessing intervention outcomes for executive dysfunction in autism. Additionally, cognitive remediation therapy targeting executive function has shown improvements in both cognitive and social functioning for individuals with autism. ^{1 2 3 4 5}

Is Executive Function Group Therapy for Autism Spectrum Disorder safe?

Group therapies, including occupational and psychotherapy, can have side effects, with some patients reporting negative experiences. It's important to consider these potential side effects when planning and participating in group therapy sessions. ^{6 7 8 9 10}

How is executive function group therapy different from other treatments for autism spectrum disorder?

Executive function group therapy is unique because it specifically targets executive function deficits, which are cognitive processes like working memory and cognitive flexibility, to improve everyday functioning in individuals with autism spectrum disorder. Unlike other treatments that may focus on social skills or general cognitive support, this therapy aims to enhance specific neurocognitive processes that are often impaired in autism. ^{1 5 11 12 13}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

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

Treatment of Executive Function Deficits in autism spectrum disorder with repetitive transcranial magnetic stimulation: A double-blind, sham-controlled, pilot trial. [2021]

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

Characteristic Executive Dysfunction for High-Functioning Autism Sustained to Adulthood. [2021]

3. Korea (South) pubmed.ncbi.nlm.nih.gov

An Intervention Program Targeting Daily Adaptive Skills Through Executive Function Training for Adults with Autism Spectrum Disorder: A Pilot Study. [2021]

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

Contribution of rating scales to intervention for executive dysfunction. [2016]

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

The effects of cognitive remediation therapy using the frontal/executive program for autism spectrum disorder. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

[Side Effects of Occupational Group Therapy]. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Review: Adverse event monitoring and reporting in studies of pediatric psychosocial interventions: a systematic review. [2023]

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

Adverse events of group psychotherapy in the in-patient setting - results of a naturalistic trial. [2019]

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

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

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

Applying Trauma-Focused Cognitive-Behavioral Therapy in Group Format. [2022]

11. Egypt pubmed.ncbi.nlm.nih.gov

Social Skills Intervention Participation and Associated Improvements in Executive Function Performance. [2020]

12. England pubmed.ncbi.nlm.nih.gov

Evidence for executive dysfunction in autism. [2022]

13. Netherlands pubmed.ncbi.nlm.nih.gov

Comparing response inhibition and flexibility for two components of executive functioning in children with autism spectrum disorder and normal children. [2021]