Effects of a Brief Early Start Denver Model (ESDM)–Based Parent
Intervention on Toddlers at Risk for Autism Spectrum Disorders:
A Randomized Controlled Trial
Dr. Sally J. Rogers, Ph.D.,
University of California–Davis (UC Davis) Medical Investigation of Neurodevelopmental Disorders
(MIND) Institute
Dr. Annette Estes, Ph.D.,
University of Washington
Dr. Catherine Lord, Ph.D.,
Weill Cornell Medical College
Dr. Laurie Vismara, Ph.D.,
University of California–Davis (UC Davis) Medical Investigation of Neurodevelopmental Disorders
(MIND) Institute
Dr. Jamie Winter, Ph.D.,
University of Washington
Dr. Annette Fitzpatrick, Ph.D.,
University of Washington
Dr. Mengye Guo, Ph.D., and
University of Washington
Dr. Geraldine Dawson, Ph.D.
Autism Speaks and the University of North Carolina
Abstract
Objective—This study was carried out to examine the efficacy of a 12-week, low intensity (one-
hour-per-week of therapist contact), parent-delivered intervention for toddlers at risk for autism
spectrum disorders (ASD) ages 14–24 months and their families.
Method—A randomized controlled trial involving 98 children and families was carried out in
three different sites investigating the efficacy of a parent delivery of the Early Start Denver Model
(P-ESDM) (which fosters parental use of a child-centered responsive interaction style that embeds
many teaching opportunities into play) compared to community treatment as usual. Assessments
© 2012 American Academy of Child & Adolescent Psychiatry. Published by Elsevier Inc. All rights reserved.
Correspondence to Sally J. Rogers, Ph.D., UC Davis MIND Institute, Psychiatry and Behavioral Sciences, 2825 50th Street,
Sacramento, CA 95817; sally.rogers@ucdmc.ucdavis.edu.
Disclosure: Drs. Rogers, Vismara, and Dawson have received royalties from the sale of books and other printed Early Start Denver
Model (ESDM) materials. Drs. Estes, Lord, Winter, Fitzpatrick, and Guo report no biomedical financial interests or potential conflicts
of interest.
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Author Manuscript
J Am Acad Child Adolesc Psychiatry
. Author manuscript; available in PMC 2013 October 01.
Published in final edited form as:
J Am Acad Child Adolesc Psychiatry
. 2012 October ; 51(10): 1052–1065. doi:10.1016/j.jaac.
2012.08.003.
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were completed at baseline and 12 weeks later, immediately after the end of parent coaching
sessions.
Results—There was no effect of group assignment on parent-child interaction characteristics or
on any child outcomes. Both groups of parents improved interaction skills and both groups of
children demonstrated progress. Parents receiving P-ESDM demonstrated significantly stronger
working alliances with their therapists than did the community group. Children in the community
group received significantly more intervention hours than those in the P-ESDM group. For the
group as a whole, both younger child age at the start of intervention, and a greater number of
intervention hours, were positively related to degree of improvement in children’s behavior for
most variables.
Conclusions—Parent-implemented intervention studies for early ASD have thus far not
demonstrated the large effects seen in intensive treatment studies. Evidence that both younger age
and more intervention hours positively affect developmental rates has implications for clinical
practice, service delivery, and public policy.
Keywords
Early Start Denver Model (ESDM); early intervention; toddler; parent–child interaction; autism
Introduction
Efficacy of very early intervention for improving short-term outcomes in autism spectrum
disorders (ASD) has led scientists to develop diagnostic measures for children under the age
of 2 in order to begin treatments as early as possible.
1
Practice, theory (attachment), and
research have all emphasized the importance and efficacy of parent-delivered interventions
for children with developmental difficulties early in life.
2
Studies of parent-child
interactions in ASD have found that, on average, parents of children with autism are as
responsive to their children as parents of children with other or no diagnoses.
3–4
Additionally, parental sensitivity and responsivity to children’s cues have been found to
predict language outcomes in ASD, as they do in typical development.
5–7
Thus, the effects
of parent-delivered toddler interventions are likely mediated by the quality and quantity of
parent–child interactions.
The inclusion of parents (as well as other family members) has been identified as an
essential component of effective early intervention programs,
8
and many autism studies
using single subject designs have demonstrated the positive effects of parent-delivered
interventions for reducing problem behaviors, improving children’s nonverbal and verbal
communication skills, and increasing appropriate play and imitation skills.
9–18
Parent-
implemented intervention leads to better generalization and maintenance of skills than
therapist-implemented intervention.
19
However, few studies have examined the impact of parent-delivered intervention on
outcomes for children with ASD younger than three years of age. One empirically supported
intervention approach built for children with ASD younger than 3 is the Early Start Denver
Model (ESDM), a developmental, relationship-based intervention that fuses approaches
validated by the science of child development and the science of applied behavior
analysis.
20–21
A randomized controlled trial of the ESDM of children ages 18–30 months,
delivered by trained interventionists in child homes for 15–20 hours-per-week for two years,
demonstrated significant group effects on IQ, language, and adaptive behavior.
20
The extent
to which parents can deliver ESDM was tested by Vismara et al. using a single subject
design with eight children with ASD under the age of 3.
22
The study documented positive
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gains in parent learning of the techniques, and marked gains in child social attention,
imitation, and spontaneous language.
Recently, several randomized controlled studies of parent-delivered interventions for young
children with ASD have been reported. Several of these report parent behavior change but
lack of overall group effects on children’s developmental scores and autism symptoms 23–,
25. Kasari
23
reported some behavioral gains but no data regarding changes on standardized
measures of development or primary autism symptoms.
Purpose of the Present Study
The present study was designed to examine the effect of P-ESDM with a rigorous design,
using the same curriculum, procedures, and manual as in the earlier P-ESDM study, with a
much larger and younger multisite sample, a randomized controlled group design, and a
more elaborate measurement system.
22
The primary goal of the study was to determine
whether P-ESDM was more effective for improving outcomes of children with ASD than
community treatment as usual.
Hypotheses
1.
Children receiving 12 weeks of the P-ESDM will demonstrate greater gains in
social communication and developmental quotients than will those in the
community intervention group.
2.
Parents receiving 12 weeks of P-ESDM parent training will show more skilled use
of interactive techniques measured by the P-ESDM Fidelity measure than will
parents in the community intervention group.
3.
Two child pre-intervention variables that will moderate the effects of P-ESDM on
child social and developmental outcomes are social orienting and imitation, key
behaviors that support social learning in typically developing pre-verbal toddlers
and two of the earliest distinguishing features of ASD in toddlers
24–25
4.
Parents receiving P-ESDM will demonstrate more positive working relations with
their primary therapist than will parents in the community intervention group.
Method
Participants
Recruitment—We recruited toddlers at risk for ASD, ages 12–24 months, and their
families living within 30 minutes of the three sites (Sacramento, Seattle, and Ann Arbor),
primarily from pediatricians, regional centers for developmental disabilities, and university
autism clinics and research programs. Inclusion criteria included: met risk criteria for ASD
on two screeners and met criteria for ASD in a clinical assessment, was ambulatory
(crawling or walking), had developmental quotients (DQ) of 35 or higher, and had English
as one language spoken daily in the home. Exclusion criteria included parental self-reported
significant mental illness or substance abuse, child significant medical conditions including
cerebral palsy, gestational age of less than 35 weeks, genetic disorders related to
developmental disabilities, DQ below 35, and current or previous enrollment in intensive 1:1
autism intervention of more than 10 hours per week.
Enrollment—The enrollment process began with a telephone screen using two autism
screening measures administered by phone to parents of 228 referrals who met initial
inclusion/exclusion criteria. Of these 228, 57 were discontinued because they did not meet
screening criteria or by choice. One child was excluded because of DQ below 35 during
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initial screening. One hundred sixty six children met autism risk criteria on both screeners
and were evaluated diagnostically. Of these, 118 children met inclusion criteria for
developmental quotient and for ASD symptoms (the cutoff score on the Autism Diagnostic
Observation Scale for Toddlers [ADOS-T] and the clinical judgment of ASD of two
independent clinicians based on observation and scores). Furthermore, level of ASD
symptoms was quite stable over the 3 month period, with all but one child continuing to
meet ADOS-T cutoff scores and clinical judgment for ASD at the 12 week follow-up.
Twenty families declined to enroll, and 98 families enrolled in the study and were
randomized to P-ESDM treatment or community treatment groups. Following the
enrollment visit (Time 1, or T1), children and parents returned for a second evaluation
session to gather the remaining measures. Parents were informed of the randomization
assignment at this visit, and received diagnostic feedback, a clinical diagnostic report, and
detailed referral information about community-based services. Twelve weeks then passed
during which families received intervention, followed by a re-assessment (Time 2, or T2),
again involving two assessment visits, feedback, reports and recommendations to the
families.
Family incomes, ethnicity, and educational levels of the families are included in Table 1.
Twenty four of the 98 children had a sibling with ASD, 9 in the ESDM group and 15 in the
community group. In addition, 26 children had siblings with another developmental
disorder, 10 in the ESDM group and 13 in the community group: including speech or other
developmental delays, learning disabilities, seizure disorders, cerebral palsy, Down
syndrome, or intellectual disability.
Randomization—Immediately after families consented to enroll, staff members contacted
the project’s Data Coordinating Center (DCC) at University of Washington for an ID
number and group assignment. Children were randomized using a computer algorithm based
on pre-specified blocks based on age (12–20 months or greater than 20 months), gender, and
DQ (less than 60, 60 or greater). Blocks were monitored and a difference of 3 between
intervention/control resulted in a compensatory assignment in order to maximize equal
sample in both groups.
Measures
Screeners—Early Screening of Autistic Traits Questionnaire (ESAT) is an autism risk
parent interview that has been tested in several studies, including a population-based study
of 31,000 14–15 month old children in the Netherlands. This tool was used for children 12–
15 months.
26
Infant Toddler Checklist (ITC) is a broadband parent questionnaire developed to
determine risk for communication disorders including ASD. The ITC is a standardized tool
that has both screening cutoffs and standard scores at monthly intervals from 6 to 24 months
based on a normative sample of over 2,188 children.
27
This screener was used with all
children in the study.
The Modified Checklist for Autism in Toddlers (M-CHAT) is a 23-item parent
questionnaire developed to screen for autism symptoms in children ages 16–30 months.
28
The M–CHAT has been validated in two large validation studies.
29–30
This tool was used
for children 16–24 months.
ASD Diagnosis—Autism Diagnostic Observation Scale for Toddlers (ADOS-T) was
used at both assessment points for all children with permission.
31
The tool uses a semi-
structured observational assessment that provides a number of opportunities for interaction
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(e.g., play, turn-taking games, looking at books, etc.) and measures social and
communicative behaviors, as well as repetitive behaviors diagnostic of autism on a scale of
0–3. The full range of scores was used, including 3’s, to maximize the range of each item.
Subtotals were computed separately for the two domains, Social Affect and Restricted,
Repetitive Behaviors.
32
Lab personnel were trained to 85% reliability on the full range of
scores. Inter-observer reliability at individual sites was assessed on at least 20% of
interviews, and any deviation from standard led to retraining.
Developmental Measures—Mullen Scales of Early Learning (MSEL) is a
standardized, normed developmental assessment for children aged birth through 68
months.
33
It provides an overall index of ability, the Early Learning Composite and subscale
scores of Receptive Language, Expressive Language, Visual Reception, and Fine Motor
skill. The MSEL was administered at enrollment and 12 weeks later, at the end of
intervention, as a dependent measure of treatment efficacy. The MSEL was administered
strictly according to standard procedures across the three sites, and administration practices
were monitored throughout. Reinforcers for child attention and cooperation were used as
needed to support children’s motivation and cooperation. Twenty percent of the assessments
were scored by two raters for reliability checks. Because the standard t scores on the MSEL
have a floor of 20, and many subjects had scores at the floor on individual subscales, we
created three developmental quotient scores (DQ; DA/CAx100) from the subscale
developmental age (DA) equivalents to use as measures of intervention efficacy: a verbal
developmental quotient (Verbal DQ) comprised of the two language scales; a nonverbal
developmental quotient comprised of the Visual Reception and Fine Motor scales
(Nonverbal DQ); and an overall developmental quotient created from these four subscales.
MacArthur-Bates Communicative Development Inventory: Words and gestures
(MCDI) is a 396-word parent report vocabulary checklist used to capture the expressive
words, gestures, and receptive vocabulary a child has demonstrated in the past week.
34
This
is a psychometrically strong instrument, and raw scores in young children with ASD are
concurrently associated with communicative word use in language samples (
r
= .67 to .
72).
35
This was gathered at both time points and raw scores were used as a dependent
measure of treatment efficacy.
Vineland Adaptive Behavior Scales, Second Edition (VABS II) examines four domains
of adaptive behavior: communication, self-care, social and motor skills.
36
The VABS-II has
excellent psychometric properties. It was administered to the primary caretaker by telephone
at both assessment points. The dependent measures of treatment efficacy were the age
equivalent scores and the developmental quotients for the four domains.
Child Moderating Variables
Imitation: Twelve imitation tasks were administered in a playful 10 minute or less probe
that examined familiar and novel object imitations and manual and oral-facial gestural
imitations.
37
This scale has been used in several previous autism studies. These were live
coded using one of three scores: full pass (2), partial pass (1), and failure (0), resulting in a
total imitation score.
Orienting to social, nonsocial and joint attention stimuli: A brief task developed by
Dawson (2004) assessed child social engagement.
25
The task involved child orienting to
three types of probes: four “social” noises (e.g., human-produced; voice, finger snap, clap,
and hum) and (b) four nonsocial noises (timer ticking, phone beep, sandpaper scratch, light
switch click), and (c) four joint attention bids. All sounds were delivered at the same decibel
level by a lab assistant. The observing experimenter recorded each child’s head turns or gaze
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