Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04078061 |
| Other study ID # |
W81XWH-18-1-0790 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 22, 2019 |
| Est. completion date |
September 30, 2023 |
Study information
| Verified date |
October 2023 |
| Source |
University of Rochester |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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).
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.
