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Intensive Intervention for Toddlers With Autism (EARLY STEPS)

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ClinicalTrials.gov Identifier: NCT00698997
Recruitment Status : Completed
First Posted : June 17, 2008
Results First Posted : February 17, 2020
Last Update Posted : February 17, 2020
Sponsor:
Collaborators:
University of Washington
University of Michigan
National Institutes of Health (NIH)
University of California, Los Angeles
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of California, Davis

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions Autism
Autism Spectrum Disorder
Interventions Behavioral: Early Start Denver Model
Behavioral: Standard community care
Enrollment 118
Recruitment Details Children were recruited from pediatricians, developmental disability settings, and university website postings using IRB-approved materials.
Pre-assignment Details  
Arm/Group Title 1 Early Start Denver Model 2 Standard Care Available in the Community
Hide Arm/Group Description

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 was assigned to receive 20 hrs. a week of ESDM intervention in their homes, 50 wks. a year, for 2 years by trained interventionists (ITs). Parents delivered ESDM in natural family routines & play activities as they chose. In addition, children received additional public and or private services as their families chose.

Both phases followed published treatment manuals and all treatment was supervised by professionals with ESDM certification.

Standard community care: Treatment and interventions, chosen by families, meeting current standards of community intervention for toddlers with autism and ASD
Period Title: Overall Study
Started 55 [1] 63 [1]
Completed 45 [2] 36 [3]
Not Completed 10 27
Reason Not Completed
Lost to Follow-up             3             0
Withdrawal by Subject             7             27
[1]
1 enrollment
[2]
45 - final participant assessment completed
[3]
36 - final assessment completed
Arm/Group Title Early Start Denver Model Standard Care Available in the Community Total
Hide Arm/Group Description

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 care: Treatment and interventions, chosen by families, meeting current standards of community intervention for toddlers with autism and ASD Total of all reporting groups
Overall Number of Baseline Participants 55 63 118
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 55 participants 63 participants 118 participants
20.58  (3.37) 20.70  (3.21) 20.64  (3.29)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 55 participants 63 participants 118 participants
Female
14
  25.5%
12
  19.0%
26
  22.0%
Male
41
  74.5%
51
  81.0%
92
  78.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 55 participants 63 participants 118 participants
Hispanic or Latino
6
  10.9%
10
  15.9%
16
  13.6%
Not Hispanic or Latino
45
  81.8%
49
  77.8%
94
  79.7%
Unknown or Not Reported
4
   7.3%
4
   6.3%
8
   6.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 55 participants 63 participants 118 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
5
   9.1%
2
   3.2%
7
   5.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
   3.6%
5
   7.9%
7
   5.9%
White
37
  67.3%
43
  68.3%
80
  67.8%
More than one race
8
  14.5%
9
  14.3%
17
  14.4%
Unknown or Not Reported
3
   5.5%
4
   6.3%
7
   5.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 55 participants 63 participants 118 participants
55 63 118
1.Primary Outcome
Title Language Age Equivalent
Hide Description 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.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1 Early Start Denver Model Standard Care Available in the Community
Hide Arm/Group Description:

Early Start Denver Model: 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 care: Treatment and interventions, chosen by families, meeting current standards of community intervention for toddlers with autism and ASD
Overall Number of Participants Analyzed 55 63
Mean (Standard Deviation)
Unit of Measure: language age in months
39.59  (15.31) 36.09  (14.52)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1 Early Start Denver Model, Standard Care Available in the Community
Comments We used a generalized linear mixed model (GLMM). Change-over-Time was modeled as a linear within-subject effect of time across all observed data for each participant. We fit splines to manage the differing lengths of time in parent-training versus direct treatment. In all analyses, site was included as a categorical covariate to account for potential differences. Effect sizes were reported following Cohen's recommendations as f2.
Type of Statistical Test Other
Comments Non- equivalence.
Statistical Test of Hypothesis P-Value .03
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter slope difference
Estimated Value 1.01
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Overall Developmental Quotient (DQ)
Hide Description 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.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1 Early Start Denver Model Standard Care Available in the Community
Hide Arm/Group Description:

Early Start Denver Model: 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 care: Treatment and interventions, chosen by families, meeting current standards of community intervention for toddlers with autism and ASD
Overall Number of Participants Analyzed 55 63
Mean (Standard Error)
Unit of Measure: developmental quotient
83.09  (26.12) 79.14  (25.58)
3.Secondary Outcome
Title Adaptive Behavior Age Equivalent Scores
Hide Description 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.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1 Early Start Denver Model Standard Care Available in the Community
Hide Arm/Group Description:

Early Start Denver Model: 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 care: Treatment and interventions, chosen by families, meeting current standards of community intervention for toddlers with autism and ASD
Overall Number of Participants Analyzed 55 63
Mean (Standard Deviation)
Unit of Measure: months
39.76  (12.07) 36.69  (14.32)
4.Secondary Outcome
Title Autism Severity
Hide Description 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.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1 Early Start Denver Model 2Standard Care Available in the Community
Hide Arm/Group Description:

Early Start Denver Model: 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 Care available in the Community

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

Overall Number of Participants Analyzed 55 63
Mean (Standard Deviation)
Unit of Measure: units on a scale
6.69  (1.96) 6.19  (2.52)
Time Frame 24 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 1 Early Start Denver Model Standard Care Available in the Community
Hide Arm/Group Description

Early Start Denver Model: 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 care: Treatment and interventions, chosen by families, meeting current standards of community intervention for toddlers with autism and ASD
All-Cause Mortality
1 Early Start Denver Model Standard Care Available in the Community
Affected / at Risk (%) Affected / at Risk (%)
Total   0/55 (0.00%)   0/63 (0.00%) 
Hide Serious Adverse Events
1 Early Start Denver Model Standard Care Available in the Community
Affected / at Risk (%) Affected / at Risk (%)
Total   0/55 (0.00%)   0/63 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
1 Early Start Denver Model Standard Care Available in the Community
Affected / at Risk (%) Affected / at Risk (%)
Total   0/55 (0.00%)   0/63 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Sally Rogers
Organization: University California Davis
Phone: 916-703-0264
EMail: sjrogers@ucdavis.edu
Layout table for additonal information
Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT00698997    
Other Study ID Numbers: 200816233
1R01MH081757 ( U.S. NIH Grant/Contract )
First Submitted: June 12, 2008
First Posted: June 17, 2008
Results First Submitted: September 18, 2019
Results First Posted: February 17, 2020
Last Update Posted: February 17, 2020