Comparative Effectiveness of EIBI and Adaptive ABA for Children With Autism
Condition: Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder
Study type: Interventional

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).
    

Detailed description: 
      Background: 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. Research indicates that EIBI
      accelerates development of cognitive and adaptive skills in many children with ASD. However,
      the evidence base has important gaps, notably a dearth of randomized controlled trials
      (RCTs), limited data on whether EIBI reduces ASD symptoms, and few studies on outcomes of
      EIBI in community settings such as private agencies where most children with ASD receive
      services. In addition, EIBI is expensive and requires a substantial commitment of time and
      effort from children and families.

      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).

      Objectives/Hypotheses: Investigators 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. They 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).
      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).

      Specific Aims: The primary aim is to compare EIBI and MABA on key child and parent outcomes
      after 24 weeks of intervention, at a 24 week follow-up (week 48), and at age 5 years and/or
      90 weeks. The investigators also intend to explore whether child functioning and family
      environment moderate the effects of intervention, and examine potential facilitators and
      barriers to future implementation of MABA (e.g., parent and provider buy-in, fidelity of
      intervention, cost).

      Design: 132 children with ASD will be randomized to receive 24 weeks of either 1) EIBI as
      usual for approximately 20 hours per week or 2) MABA in which children start with
      intervention focused on social communication 5 hours per week for 4 weeks and then, depending
      on clinical evaluation of their response, either continue in this intervention or receive
      augmented intervention for 20 weeks, up to 10 hours per week. Both EIBI and MABA use a tiered
      delivery system in which trained paraprofessionals provide most of the direct intervention
      under the supervision of licensed or credentialed professionals. Participants will be
      recruited from 4 sites that have longstanding relationships with nearby military bases:
      Vanderbilt University Medical Center, Cleveland Clinic, Nationwide Children's Hospital, and
      May Institute. Experts on military families will advise the study team on implementation of
      the study. Child outcome measures assess 1) adaptive skills, 2) ASD symptoms, 3) cognition,
      and 4) language. Parent outcome measures assess caregiver stress and sense of competence.
      Linear mixed models (LMMs) will be used to contrast the two interventions in terms of change
      in outcomes on each measure from baseline through the primary endpoint (end of intervention
      at Week 24) and at follow-up evaluations. To explore moderators, investigators will augment
      the LMMs with standard moderated (i.e., covariate-by-treatment) regression analyses. To
      examine implementation, investigators will compare EIBI and MABA on implementation variables
      such as buy-in, fidelity, and cost.
    

Intervention name(s): MABA; EIBI
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Adaptive, modular, behavioral intervention.; Early Intensive Behavioral Intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 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.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Autism Spectrum Disorder; EIBI; ABA