Autism Spectrum DisorderISOLDENCT04078061
Comparative Effectiveness of EIBI and Adaptive ABA for Children With Autism
A study testing MABA and EIBI in people with Autism Spectrum Disorder, run by University of Rochester at 5 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 months to 5 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- MABA and EIBI
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 5 sitesUnited States
- Study dates
- 22 Aug 2019to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 months to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Cleveland Clinic
Cleveland, Ohio, 44145
Nationwide Children's Hospital
Columbus, Ohio, 43081
May Institute
Jacksonville, North Carolina, 28546
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
May Institute
Richmond, Virginia, 23230
About this study
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).
Read the 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.
- Conditions
- Autism Spectrum Disorder
- Being tested
- MABA, EIBI
- Keywords
- Autism Spectrum Disorder, EIBI, ABA
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MABABehavioural
Adaptive, modular, behavioral intervention.
EIBIBehavioural
Early Intensive Behavioral Intervention
| Study group | Role | What they receive |
|---|---|---|
| MABA | Active comparator | Not described Receives: Behavioral: MABA |
| EIBI | Active comparator | Not described Receives: Behavioral: EIBI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
OACIS is an expansion of the Clinical Global Impressions scale that takes about 20 minutes to complete. Rather than giving one overall rating for severity and one overall rating for improvement (as is done with the CGI), providers rate severity and improvement on a 7-point Likert scale in 10 domains: ASD symptoms, social interaction, aberrant behaviors, repetitive behaviors, verbal communication, nonverbal communication, hyperactivity, anxiety, sensory sensitivity, and restricted, narrow interests. This scale will be used in two different ways: (1) it will be administered by the clinician for use in the tailoring aspect of the MABA intervention arm as described above, (2) it will be administered by treatment blind independent evaluators with this separate administration to be used in the analysis of secondary child outcomes.
Measured: Baseline, Week4, Week 12, Week24, Week48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2019
- Study start22 Aug 2019
- Primary completion30 Sep 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- The Cleveland Clinic, May Institute, Nationwide Children's Hospital, Vanderbilt University Medical Center, University of Michigan, University of Virginia
- Responsible party
- Principal investigator, Susan Hyman, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04078061
- Sponsor's protocol ID
- W81XWH-18-1-0790
- Acronym
- ISOLDE
- Status last verified
- Oct 2023
- First submitted
- 20 Aug 2019
- Last updated
- 31 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39989401
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of EIBI and Adaptive ABA for Children With Autism
- ClinicalTrials.gov ID
- NCT04078061
- Acronym / sponsor ID
- ISOLDE / W81XWH-18-1-0790
- Conditions
- Autism Spectrum Disorder
- Keywords
- Autism Spectrum Disorder, EIBI, ABA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- The Cleveland Clinic, May Institute, Nationwide Children's Hospital, Vanderbilt University Medical Center, University of Michigan, University of Virginia
- Study start
- 22 Aug 2019 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 4 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| MABA | Active comparator | Behavioral: MABA |
| EIBI | Active comparator | Behavioral: EIBI |
Who may qualify
- Ages
- 18 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MABAAdaptive, modular, behavioral intervention. | Behavioural | MABA |
| EIBIEarly Intensive Behavioral Intervention | Behavioural | EIBI |
Primary outcome
Change in Vineland Adaptive Behavior Scale (VABS-3)
Time frame: Baseline, Week4, Week 12, Week24, Week48, Week 90, Age 5
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.
1 secondary outcome
Change in ASD symptoms using the Ohio Autism Clinical Impressions Scale (OACIS)
Time frame: Baseline, Week4, Week 12, Week24, Week48
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
- Derived from this study: PubMed 39989401Levato 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MABA and EIBI in people with Autism Spectrum Disorder, run by University of Rochester at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Vineland Adaptive Behavior Scale (VABS-3) (time frame: Baseline, Week4, Week 12, Week24, Week48, Week 90, Age 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04078061, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2023.