Comparative Effectiveness of EIBI and Adaptive ABA for Children With Autism

NCT04078061 | Completed DMC

• 1 other identifier: W81XWH-18-1-0790
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 5

Brief Summary

Approximately 15,000 children with autism spectrum disorder (ASD) in military families currently receive applied behavior analysis (ABA) interventions through TRICARE insurance. This includes early intensive behavioral intervention (EIBI), which involves 20 or more hours per week of individualized instruction based on ABA and is often considered the standard of care for toddlers and preschoolers with ASD. More recently, research has found that less intensive, time limited ABA interventions can effectively target specific core and associated features of ASD. With these latest data, the investigators assert that an individualized approach to adapting and combining targeted interventions could be at least as effective as EIBI, yet substantially reduce expenditures of time and resources. The investigators call this approach adaptive, modular ABA (MABA), and propose to compare EIBI as usual, provided for approximately 20 hours per week, and MABA, provided for up to 10 hours per week, in a 24-week RCT of 132 children with ASD, under age 5 years, in military families. The investigators hypothesize that, at the end of intervention, MABA will be no less effective than EIBI as usual, or only slightly so, on the primary outcome measure (a standardized measure of adaptive skills). The primary investigators also hypothesize that, at follow-ups conducted 24 weeks after intervention and 90 weeks and/or when children are 5 years old, MABA will be superior to EIBI on primary and secondary child outcomes (tests of cognitive and language function, parent- and provider-rated ASD symptoms and adaptive skills) and on parent outcomes (parent stress and sense of competence).

Conditions

Autism Spectrum Disorder

Keywords

Autism Spectrum Disorder; EIBI; ABA

Outcome Measures

Primary Outcomes (1)

• Change in Vineland Adaptive Behavior Scale (VABS-3)

  The investigators hypothesize that MABA will be no less effective than EIBI when children are assessed using the (VABS-3). The VABS-3 assesses adaptive skills in three domains: Communication, Daily Living Skills, and Socialization. It was selected as the primary outcome because (1) it measures coping with everyday settings, which can be considered the best indicator of intervention success, (2) it was recently normed with a nationally representative sample of 2560 parents with excellent reliability and validity, (3) it is an outcome measure that is suitable for the developmental level of the participants, (4) it is deemed by the TRICARE Operations Manual to be reliable and valid, (5) investigators have empirically identified the minimal clinically important difference in VABS-3 standard scores for children with ASD. Thus, the VABS-3 is uniquely suited for testing our primary hypothesis that MABA will be no less effective than EIBI.

  Baseline, Week4, Week 12, Week24, Week48, Week 90, Age 5

Secondary Outcomes (1)

• Change in ASD symptoms using the Ohio Autism Clinical Impressions Scale (OACIS)

  Baseline, Week4, Week 12, Week24, Week48

Study Arms (2)

MABA

ACTIVE COMPARATOR

Behavioral: MABA

EIBI

ACTIVE COMPARATOR

Behavioral: EIBI

Interventions

MABA BEHAVIORAL

Adaptive, modular, behavioral intervention.

MABA

EIBI BEHAVIORAL

Early Intensive Behavioral Intervention

EIBI

Eligibility Criteria

• Age: 18 Months - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Diagnosis of ASD based on expert evaluation, including both: (1) Confirmation by a research-reliable administration of the Autism Diagnostic Observation Schedule-2 (ADOS-2), OR confirmation by a routine clinical assessment and observation when a research-reliable ADOS-2 is not able to be collected due to COVID-19 restrictions, and (2) A symptom checklist based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition
• In process of being approved or already approved through TRICARE for ABA services
• Not yet receiving ABA services
• With no plans to move location for the 6 month intervention period
• Medications have been stable for the 6 weeks prior to enrollment in the study
• Family demonstrates proficiency in written and spoken English

You may not qualify if:

• Diagnosis of genetic disorders known to be associated with ASD such as Fragile X, Down syndrome, or tuberous sclerosis
• Severe motor disabilities such as cerebral palsy that prevents walking or any diagnosis which might prevent standard implementation of the intervention
• Profound uncorrected vision or hearing loss

Sponsors & Collaborators

• University of Rochester: lead
• The Cleveland Clinic: collaborator
• May Institute: collaborator
• Nationwide Children's Hospital: collaborator
• Vanderbilt University Medical Center: collaborator
• University of Michigan: collaborator
• University of Virginia: collaborator

Study Sites (5)

May Institute

Jacksonville, North Carolina, 28546, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44145, United States

Location

Nationwide Children's Hospital

Columbus, Ohio, 43081, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

May Institute

Richmond, Virginia, 23230, United States

Location

Related Publications (1)

• Levato L, Hochheimer S, Wang H, Wallace L, Hyman S, Anderson C, Warren Z, Butter E, Martin R, Lee E, Smith T, Johnson C. Parent Outcomes from a Randomized Controlled Trial Investigating a Modular Behavioral Intervention for Young Autistic Children. Autism Res. 2025 Mar;18(3):675-683. doi: 10.1002/aur.70013. Epub 2025 Feb 24.

  PMID: 39989401 DERIVED

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Participating children will be randomized to EIBI or MABA with equal probability. All randomizations will occur within site and will be further stratified on 1) baseline Vineland Adaptive Behavior Scale-3 (VABS-3) Composite SS (\>65 vs ≤65) and 2) age (\<3yrs vs. \>3yrs). This procedure will ensure that treatment groups are balanced for these two baseline variables, which are known to correlate highly with outcome during- and post-treatment. The project statistician will use blocked randomization with randomly selected blocks of size 4, 6 and 8 to generate each allocation sequence. All block-randomized allocation sequences will be concealed from all other study personnel.

Study Record Dates

• First Submitted: August 20, 2019
• First Posted: September 4, 2019
• Study Start: August 22, 2019
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: October 31, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)