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AutismNCT00698997

Intensive Intervention for Toddlers With Autism (EARLY STEPS)

A study testing Early Start Denver Model and Standard community care in people with Autism and Autism Spectrum Disorder, run by University of California, Davis at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Goals of the current project: (1) Does the Early Start Denver Model experimental intervention for toddlers with autism reduce disability associated with autism significantly more than standard community interventions?; and (2) What environmental, child, and biological characteristics mediate and moderate intervention… Read more about this study

Who is it for?
Ages 12 to 24 months
Conditions the study is for
Autism, Autism Spectrum Disorder
What is being tested?
Early Start Denver Model and Standard community care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
118 participants
Where
1 siteUnited States
Study dates
Apr 2008to Dec 2013
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 12 to 24 months
  • All sexes
  • No healthy volunteers
  • Child

Inclusion criteria: (1) 12-24 months of age at the time of telephone screening and living within 60 minutes of the university clinic; (2) ambulatory; (3) unimpaired hand use; (4) parent agreement to have a caregiver present during all home sessions; (5) attendance at all intake sessions; (6) permission to videotape evaluations and ESDM treatment; (7) English as one primary language of the parent; (8) unimpaired hearing and vision; (9) developmental quotient of 35 or higher on the Mullen Scales of Early Learning (MSEL); and (10) meets all of these ASD diagnostic criteria: (a) Autism Diagnostic Observation Scale for Toddlers (ADOS-T) cutoff score of 12 if child produces no words or 10 if child produces some words; (b) agreement by two experienced psychologists that ASD is present; and that child meets DSM-IV criteria for Autistic Disorder or Pervasive Developmental Disorder Not Otherwise Specified (PDDNOS). 5,7,8 Exclusion criteria: (1) serious parental substance abuse; (2) parental self-report of bipolar disorder or psychosis; (3) known genetic syndromes; (4) serious medical conditions (e.g., encephalitis, concussion, seizure disorder); (5) significant sensory impairment; (6) birth weight <1600 grams and/or gestational age < 34 weeks; (7) history of intraventricular hemorrhage; (8) known exposure to neurotoxins (including alcohol, drugs); (9) non-English-speaking parents; and for the ESDM-assigned group only, (10) current enrollment in an intensive, 1:1 delivered behavioral intervention of more than 10 hours per week. There was no other restrictions on additional community-based treatment.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • UC Davis Mind Institute

    Sacramento, California, 95817

Other trials in United States

About this study

Official title: Intensive Intervention for Toddlers With Autism

Goals of the current project: (1) Does the Early Start Denver Model experimental intervention for toddlers with autism reduce disability associated with autism significantly more than standard community interventions?; and (2) What environmental, child, and biological characteristics mediate and moderate intervention response and outcomes at age 4?

Read the detailed description

Thanks to the development of better diagnostic tools and a greater level of professional education, autism is being identified in two year olds and in even younger children, with such early diagnosis justified by the rationale that the earlier intervention begins, the better the outcomes may be. However, there are no published outcome data on intervention models or effectiveness for children who begin intervention by or before 24 months. Furthermore, some teaching procedures considered appropriate for older children, (e.g., 40 hours per week of adult-directed intervention, much repetitive practice while sitting at a table (Lovaas, 2002), 1987) are considered developmentally inappropriate for toddlers (Sandall, McLean, \& Smith, 2000).

Dawson and Rogers have implemented a feasibility study of a intervention designed for toddlers with autism using a randomized controlled design. The approach involves a relationship-based frame to accomplish developmentally based objectives using naturalistic application of applied behavior analytic principles. The approach fuses the Denver Model (Rogers, Hall, Osaki, Reaven, \& Herbison, 2000) and Pivotal Response Training (Koegel, Koegel, \& Carter, 1999), and is delivered 1:1 for 25 or more hours per week to 24 toddlers with autism for a two year period. The contrast group receives standard community based intervention. Preliminary results demonstrate large and significant group effects after only 12 months and considerable variability of intervention outcomes in both groups.

All families will be referred to the appropriate community service programs, if they have not been referred previously.

Being tested
Early Start Denver Model, Standard community care
Keywords
autism, autism spectrum disorder, intensive intervention for toddlers with autism, PDD NOS, early steps study, early start denver model, early intervention for infants and toddlers with autism, toddler treatment, Sally Rogers, University of California, Davis, University of Michigan, MIND Institute
Medical subject headings
Autistic Disorder, Autism Spectrum Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Early Start Denver ModelBehavioural

    Also called intensive intervention for infants and toddlers with autism and ASD, autism treatment, PDD NOS, University of California, Davis

    Phase 1 of ESDM intervention: 12 weekly, 1 to 1.5 hr. sessions focused on teaching \& coaching parents to use the ESDM in all natural caretaking routines \& play periods with their child. Parents are taught \& coached on 1 aspect of the ESDM each week in the clinic session, \& then practice it at home daily in natural family routines \& play.

    Phase 2: each child in the ESDM will receive 25 hrs. a week of ESDM intervention in their homes, 50 wks. a year, for 2 years. 20 hrs. weekly will be delivered by trained interventionists (ITs); 5 hrs. weekly will be delivered by parents. (ITs) will provide ten 2 hour teaching episodes involving play activities per week in the home. Parents will continue to deliver the ESDM in natural family routines \& play activities. In addition, each child will receive additional services through public services, or other therapies that the parents may choose, for several more hrs. per week.

  • Standard community careBehavioural

    Also called Current, standard community based intervention for toddlers with autism, intensive intervention for infants and toddlers with autism and ASD, autism treatment, PDD NOS

    Treatment and interventions, chosen by families, meeting current standards of community intervention for toddlers with autism and ASD

Study groups in NCT00698997
Study groupRoleWhat they receive
1 Early Start Denver ModelExperimentalPhase 1 of ESDM intervention: 12 weekly, 1 to 1.5 hr. sessions focused on teaching \& coaching parents to use the ESDM in all natural caretaking routines \& play periods with their child. Parents are taught \& coached on 1 aspect of the ESDM each week in the clinic session, \& then practice it at home daily in natural family routines \& play. Phase 2: each child in the ESDM will receive 25 hrs. a week of ESDM intervention in their homes, 50 wks. a year, for 2 years. 20 hrs. weekly will be delivered by trained interventionists (ITs); 5 hrs. weekly will be delivered by parents. (ITs) will provide ten 2 hour teaching episodes involving play activities per week in the home. Parents will continue to deliver the ESDM in natural family routines \& play activities. In addition, each child will receive additional services through public services, or other therapies that the parents may choose, for several more hrs. per week.
Receives: Behavioral: Early Start Denver Model
2 Standard Care available in the CommunityOtherAny intervention that were available and that families accessed in their communities
Receives: Behavioral: Standard community care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Language Age Equivalent

    Composite language measure consisting of an average of the Expressive Language and the Receptive Language age equivalent scores from the Mullen Scales of Early Learning.The Mullen Scales of Early Learning (MSEL) is a developmental test with five subscales: gross motor, visual reception, fine motor, receptive language, and expressive language. The lower the score on this scale, the more immature the ability; the higher the score, the more mature the ability. Measurements were taken at baseline, 6 months, 12 months, and 24 months and a hierarchical longitudinal growth curve approach used to calculate overall rate of growth during the 24 month period.

    Measured: 24 months

Secondary outcomes (3)

  1. Overall Developmental Quotient (DQ)

    Overall DQ was calculated by averaging the Time 1 (baseline) age equivalence scores of the two language and two nonverbal subtests from the Mullen Scales of Early Learning (MSEL), dividing by child age in months, and multiplying by 100 to create a quotient score, in order to capture the full range of variability of the sample, since many children fell below the basal standard score. The Mullen Scales of Early Learning (MSEL) is a developmental test with five subscales: gross motor, visual reception, fine motor, receptive language, and expressive language. Gross motor score was not used for the calculations. The lower the score on this scale, the more immature the ability; the higher the score, the more mature the ability. Measurements were taken at baseline, 6 months, 12 months, and 24 months and a hierarchical longitudinal growth curve approach used to calculate overall rate of growth during the 24 month period.

    Measured: 24 months

  2. Adaptive Behavior Age Equivalent Scores

    Adaptive behavior age equivalent was characterized by averaging the means of the age equivalents in months of the four domain scores from the Vineland Adaptive Behavior Scales - Second edition (VABS) because the manual does not provide developmental ages corresponding to total scores that could be used to construct quotient scores. Data were provided by parents who were not naïve to group assignment. The Vineland Adaptive Behavior Scales 2 provide a standardized measure of adaptive behavior in four domains: motor, language, social, and activities of daily living. Information is gathered from parents via parent questionnaire. The lower the score on each domain score and the overall score, the more immature the ability; the higher the score, the more mature the ability. Measurements were taken at baseline, 6 months, 12 months, and 24 months and a hierarchical longitudinal growth curve approach used to calculate overall rate of growth during the 24 month period.

    Measured: 24 months

  3. Autism Severity

    Autism severity was calculated using the Calibrated Severity Scores, derived by using tables in publications by Gotham, Pickles, \& Lord( 2012) (Esler, Bal, Guthrie, Weismer, and Lord, 2015). We identified the severity score listed in the CSS table that was associated with a subject's ADOS-2 total score for the ADOS module that was administered to each subject at each of four time points - at entry into the project, and 6 months, 12 months, and 24 months after enrollment. The ADOS Calibrated Severity Score scale range is 1-10, with lower scores representing milder and less numerous symptoms and higher scores representing more severe and more numerous systems. Scores 1-3 represent few to no ASD symptoms, scores of 4-5 represent mild to moderate symptoms and concerns related to ASD, and scores of 6-10 represent moderate to severe symptom severity.

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jun 2008 (estimated)
  2. Study startApr 2008
  3. Primary completionJul 2013
  4. Study completionDec 2013

Resources

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
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
118 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00698997
Sponsor's protocol ID
200816233
Other IDs
1R01MH081757
Status last verified
Feb 2020
First submitted
12 Jun 2008
Last updated
17 Feb 2020
Data monitoring committee
Yes
Individual data sharing
Yes: Individual participant data from primary analyses are available on NDA.

Publications

  • Brown H, Swain D, Kim HW, Rogers S, Estes A, Kasari C, Lord C, Kim SH. Examining variability in Naturalistic Developmental Behavioral Intervention strategy use in caregivers of children with autism spectrum disorders. J Child Psychol Psychiatry. 2025 Jan;66(1):4-15. doi: 10.1111/jcpp.13994. Epub 2024 May 8.

    PubMed 38719439

  • Rogers SJ, Estes A, Lord C, Munson J, Rocha M, Winter J, Greenson J, Colombi C, Dawson G, Vismara LA, Sugar CA, Hellemann G, Whelan F, Talbott M. A Multisite Randomized Controlled Two-Phase Trial of the Early Start Denver Model Compared to Treatment as Usual. J Am Acad Child Adolesc Psychiatry. 2019 Sep;58(9):853-865. doi: 10.1016/j.jaac.2019.01.004. Epub 2019 Jan 24.

    PubMed 30768394

  • Zhou V, Munson JA, Greenson J, Hou Y, Rogers S, Estes AM. An exploratory longitudinal study of social and language outcomes in children with autism in bilingual home environments. Autism. 2019 Feb;23(2):394-404. doi: 10.1177/1362361317743251. Epub 2017 Dec 13.

    PubMed 29237275

Questions about this trial

What is this clinical trial studying?

A study testing Early Start Denver Model and Standard community care in people with Autism and Autism Spectrum Disorder, run by University of California, Davis at 1 site 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?

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 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Yes. Results are posted in the registry (first posted 17 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Language Age Equivalent (time frame: 24 months). 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 NCT00698997, which also lists 3 linked publications.

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 17 Feb 2020.

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