Early Intervention Program for Autism Spectrum Disorder

Overseen By Antonio Hardan, MD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Severe psychiatric disorder, others

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

Compensation: Varies

Number of Visits: 12

Duration: 12 weeks

75 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a 12-week early intervention program designed to improve social communication skills in children with developmental disorders, such as Autism Spectrum Disorder. The Center Based Early Intervention Program provides an intensive learning environment, either in a center-based preschool setting or at home. It suits children aged 2 to just under 6 years who have been diagnosed with developmental disorders and can participate in standard testing. The trial explores whether this structured support can positively impact their daily interactions. As an unphased trial, it offers families a unique opportunity to contribute to groundbreaking research that could enhance early intervention strategies.

Do I need to stop my current medications to join the trial?

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

What prior data suggests that this early intervention program is safe for children with developmental disorders?

Research shows that early intervention programs for autism spectrum disorder (ASD) are generally safe and well-received by young children. Studies have found that these programs can lead to positive results without major negative effects.

For instance, early intervention for autism has been associated with long-term improvements in communication and social skills. No strong evidence indicates serious side effects from these programs. Children who participated generally responded well.

The goal is to help children enhance their social communication skills, either in a center or at home. This personalized approach has proven both beneficial and safe for children with developmental disorders, like autism or intellectual disabilities. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Early Intervention Program for Autism Spectrum Disorder because it offers flexible treatment options that adapt to different family needs. Unlike traditional therapies that may require frequent visits to a clinical setting, this program can be delivered either at a center or at home, making it more accessible and convenient for families. This flexibility could lead to more consistent therapy for children, potentially improving outcomes by integrating treatment into daily life. Additionally, early intervention is crucial for children with autism, and this program emphasizes starting treatment as soon as possible to maximize developmental gains.

What evidence suggests that this early intervention program is effective for social communication deficits in children with developmental disorders?

Research shows that early intervention programs can help young children with developmental disorders, such as Autism Spectrum Disorder (ASD), enhance their social communication skills. For example, studies have found that these programs can boost thinking abilities, language skills, and everyday behaviors in preschool-aged children. This trial will evaluate the effectiveness of a Center-Based or In-Home Early Intervention Program. Programs held in centers, where children learn in groups, have been linked to positive results. Research comparing home-based and center-based programs found that both can help children learn new skills. Some evidence even suggests that combining center-based programs with parent-focused activities can be a cost-effective way to achieve benefits. These findings support the idea that early intervention programs effectively help children with developmental disorders improve their social communication. ^{3 5 6 7 8}

Who Is on the Research Team?

Antonio Hardan, MD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for preschool-aged children (2 to almost 5 years old) diagnosed with developmental disorders like Autism Spectrum Disorder, neurogenetic disorders, or intellectual disability. They must be able to complete certain tests and have no severe psychiatric conditions like bipolar disorder.

Inclusion Criteria

I have been diagnosed with a developmental disorder like autism.

I am between 2 and 4 years old.

I have been diagnosed with a developmental disorder like autism.

Exclusion Criteria

Lack of availability during program hours

Current or lifetime diagnosis of severe psychiatric disorder (e.g., bipolar disorder, etc.)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 12-week early intervention program in an intensive center-based preschool environment or in the home

12 weeks

12 weekly sessions

Follow-up

Participants are monitored for changes in social communication deficits after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Center Based Early Intervention Program
• Center Based or In Home Early Intervention Program

Trial Overview The study is testing a 12-week early intervention program aimed at improving social communication in young children with developmental disorders. It compares two settings: an intensive center-based preschool environment and in-home treatment.

How Is the Trial Designed?

Group I: Center Based or In-Home Early Intervention Program Experimental Treatment 1 Intervention

Center Based Early Intervention Program is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Early Intervention Program for:

• Autism Spectrum Disorder
• Neurogenetic disorders
• Intellectual disability

Approved in European Union as Early Intervention Services for:

• Developmental disorders
• Autism Spectrum Disorder
• Intellectual disability

Approved in Canada as Early Childhood Intervention for:

• Developmental delays
• Autism Spectrum Disorder
• Neurogenetic disorders

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

John & Marcia Goldman Foundation

Collaborator

Trials

2

Recruited

120+

Published Research Related to This Trial

The Early Start Denver Model (ESDM) was effectively implemented in an Italian community setting, showing good feasibility through high retention rates and satisfaction among parents and therapists.

Children receiving ESDM for 2 hours per week over one year demonstrated greater improvements in communication, social skills, and maladaptive behaviors compared to a control group receiving standard treatment, indicating its efficacy in enhancing developmental outcomes for young children with autism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and Outcomes of the Early Start Denver Model Delivered within the Public Health System of the Friuli Venezia Giulia Italian Region. Devescovi, R., Colonna, V., Dissegna, A., et al.[2021]

Early Intensive Behavioral Intervention (EIBI) shows low-quality evidence of improving adaptive behavior and IQ in young children with autism spectrum disorders (ASD), based on a systematic review of five studies involving 219 children.

No adverse effects were reported, but the overall quality of evidence is low, indicating a need for more rigorous studies to better understand the effectiveness of EIBI in treating ASD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early intensive behavioral intervention (EIBI) for young children with autism spectrum disorders (ASD). Reichow, B., Hume, K., Barton, EE., et al.[2022]

The Frankfurt Early Intervention Program (FFIP) showed promising improvements in socialization skills and mental age in preschool-aged children with autism spectrum disorders after one year of therapy, with a treatment frequency of 2 hours per week.

While the results indicate medium effect sizes, they suggest that lower intensity interventions like FFIP may yield less cognitive gain compared to higher intensity programs, highlighting the need for further research through randomized-controlled studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Frankfurt early intervention program FFIP for preschool aged children with autism spectrum disorder: a pilot study. Freitag, CM., Feineis-Matthews, S., Valerian, J., et al.[2021]

Parents of children with autism who underwent 2 years of early intensive behavioral intervention (EIBI) reported generally positive experiences, highlighting benefits for their child and the family as a whole.

Despite the positive outcomes, parents also faced challenges in managing home-based EIBI, indicating a need for more supportive interventions to assist families during this process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parents' experiences of home-based applied behavior analysis programs for young children with autism. Grindle, CF., Kovshoff, H., Hastings, RP., et al.[2021]

Community-based early intervention (EI) programs for children with autism spectrum disorder (ASD) showed small but statistically significant improvements in cognitive, communication, social, and adaptive functioning, based on a review of 33 studies involving 1,713 participants.

Programs affiliated with universities and hospitals were more effective in improving cognitive and adaptive behaviors compared to other community EI programs, highlighting the importance of program quality in achieving better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of community-based early intervention for children with autism spectrum disorder: a meta-analysis. Nahmias, AS., Pellecchia, M., Stahmer, AC., et al.[2020]

Early intensive behavioral intervention is the most effective treatment for young children with autism spectrum disorders (ASDs), establishing a strong evidence base for its efficacy.

Less intensive behavioral interventions can also effectively address specific concerns in older children and adolescents, highlighting the adaptability of behavioral treatments across different age groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral interventions for children with autism spectrum disorders. LeBlanc, LA., Gillis, JM.[2019]

A community-based model of Early Intensive Behavioral Intervention (EIBI) for children with autism, where parents act as primary therapists, showed significant improvements in children's developmental scores after one year of intervention, indicating its potential effectiveness.

The study involved 13 children aged 2 to 5 years and demonstrated that while children's autism symptoms decreased, parental stress levels remained stable, suggesting that this model may be manageable for families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Behavioral intervention for preschool children with autism – outcome of parent-based Intervention]. Molnár, C., Eldevik, S.[2019]

The outcome survey of early intensive behavioral intervention (EIBI) for young children with autism showed no instances of 'recovery,' indicating that while EIBI may not lead to complete recovery, it still results in high parental satisfaction with the treatment.

Despite parental satisfaction, children continued to rely on extensive educational and developmental services after EIBI, suggesting that the anticipated reduction in service needs post-treatment did not occur.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcome survey of early intensive behavioral intervention for young children with autism in a community setting. Boyd, RD., Corley, MJ.[2019]

A follow-up study involving 41 children with autism, who previously participated in a 2-year early intensive behavioral intervention (EIBI), found that the initial benefits of the intervention diminished over a 2-year period after it ended.

Children who received parent-commissioned interventions showed better outcomes compared to those who had university-supervised interventions, highlighting the importance of tailoring support to individual needs and the potential necessity for ongoing maintenance programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Two-year outcomes for children with autism after the cessation of early intensive behavioral intervention. Kovshoff, H., Hastings, RP., Remington, B.[2019]

Children with autism spectrum disorders showed significant improvements in intellectual functioning and reduced autism symptom severity after participating in a low-to-moderate intensity early intensive behavioral intervention (EIBI) program for 10 to 20 hours per week.

While the gains in intellectual functioning were maintained one year after treatment, the reduction in autism symptom severity reverted to near pretreatment levels, highlighting the need for ongoing support to sustain behavioral improvements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Follow-Up of Children With Autism Spectrum Disorder 1 Year After Early Behavioral Intervention. Rivard, M., Morin, M., Mello, C., et al.[2020]

The development of an intensive early intervention (EI) program using applied behavior analysis has shown sustained growth and improved developmental outcomes for toddlers with autism spectrum disorder (ASD).

High parent satisfaction ratings indicate the program's effectiveness, while the article also highlights the need for continued advocacy and education to address barriers to accessing EI services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Expanding Access to Clinical Services for Toddlers with Autism Spectrum Disorders. Mathews, TL., Lugo, AM., King, ML., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9457367/

The Efficacy of Early Interventions for Children with Autism ... This study was aimed to investigate the efficacy of early interventions in improving the cognitive ability, language, and adaptive behavior of pre-school ...

2. bmcpediatr.biomedcentral.com bmcpediatr.biomedcentral.com/articles/10.1186/1471-2431-13-3

Clinical outcomes of an early intervention program for ... This study evaluated the effectiveness of the ESDM for preschool-aged children with ASD using a predominantly group-based intervention in a community child ...

3. bmj.com bmj.com/content/383/bmj-2023-076733

Autism intervention meta-analysis of early childhood ... Conclusion The available evidence on interventions to support young autistic children has approximately doubled in four years. Some evidence ...

4. dovepress.com dovepress.com/predicting-communication-skills-outcomes-for-preschool-children-with-a-peer-reviewed-fulltext-article-NDT

Autism Spectrum Disorder following early intervention | NDT Clinical outcomes of an early intervention program for preschool children with Autism spectrum disorder in a group setting. BMC Paediatr ...

5. jamanetwork.com jamanetwork.com/journals/jamapediatrics/fullarticle/2819784

Determining Associations Between Intervention Amount ... This meta-analysis investigates if the amount of intervention provided to young autistic children is associated with improved child ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9923898/

Early Intervention for Children With Autism Spectrum Disorder ... This article reviews current evidence for autism spectrum disorder (ASD) interventions for children aged <3 years, based on peer-reviewed articles published ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/23294523/

Clinical outcomes of an early intervention program for ... This study evaluated the effectiveness of the ESDM for preschool-aged children with ASD using a predominantly group-based intervention in a community child ...

8. ies.ed.gov ies.ed.gov/use-work/awards/leap-usa-follow-project

LEAP–USA Follow-up Project | IES LEAP-USA was developed as a comprehensive intervention model for preschool children with autism. Based on inclusion with typically developing peers.