Trial Outcomes & Findings for Intensive Intervention for Toddlers With Autism (EARLY STEPS) (NCT NCT00698997)

Last Updated: 2020-02-17

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

118 participants

Primary outcome timeframe

24 months

Results posted on

2020-02-17

Participant Flow

Children were recruited from pediatricians, developmental disability settings, and university website postings using IRB-approved materials.

Participant milestones

Participant milestones
Measure	1 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 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.	2 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 Study STARTED	55	63
Overall Study COMPLETED	45	36
Overall Study NOT COMPLETED	10	27

Reasons for withdrawal

Reasons for withdrawal
Measure	1 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 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.	2 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 Study Lost to Follow-up	3	0
Overall Study Withdrawal by Subject	7	27

Baseline Characteristics

Intensive Intervention for Toddlers With Autism (EARLY STEPS)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Early Start Denver Model n=55 Participants 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 n=63 Participants Standard community care: Treatment and interventions, chosen by families, meeting current standards of community intervention for toddlers with autism and ASD	Total n=118 Participants Total of all reporting groups
Age, Continuous	20.58 months STANDARD_DEVIATION 3.37 • n=93 Participants	20.70 months STANDARD_DEVIATION 3.21 • n=4 Participants	20.64 months STANDARD_DEVIATION 3.29 • n=27 Participants
Sex: Female, Male Female	14 Participants n=93 Participants	12 Participants n=4 Participants	26 Participants n=27 Participants
Sex: Female, Male Male	41 Participants n=93 Participants	51 Participants n=4 Participants	92 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=93 Participants	10 Participants n=4 Participants	16 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	45 Participants n=93 Participants	49 Participants n=4 Participants	94 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	4 Participants n=93 Participants	4 Participants n=4 Participants	8 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	5 Participants n=93 Participants	2 Participants n=4 Participants	7 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	2 Participants n=93 Participants	5 Participants n=4 Participants	7 Participants n=27 Participants
Race (NIH/OMB) White	37 Participants n=93 Participants	43 Participants n=4 Participants	80 Participants n=27 Participants
Race (NIH/OMB) More than one race	8 Participants n=93 Participants	9 Participants n=4 Participants	17 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=93 Participants	4 Participants n=4 Participants	7 Participants n=27 Participants
Region of Enrollment United States	55 participants n=93 Participants	63 participants n=4 Participants	118 participants n=27 Participants

PRIMARY outcome

Timeframe: 24 months

Outcome measures

Outcome measures
Measure	1 Early Start Denver Model n=55 Participants 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 n=63 Participants Standard community care: Treatment and interventions, chosen by families, meeting current standards of community intervention for toddlers with autism and ASD
Language Age Equivalent	39.59 language age in months Standard Deviation 15.31	36.09 language age in months Standard Deviation 14.52

SECONDARY outcome

Timeframe: 24 months

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.

Outcome measures

Outcome measures
Measure	1 Early Start Denver Model n=55 Participants 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 n=63 Participants Standard community care: Treatment and interventions, chosen by families, meeting current standards of community intervention for toddlers with autism and ASD
Overall Developmental Quotient (DQ)	83.09 developmental quotient Standard Error 26.12	79.14 developmental quotient Standard Error 25.58

SECONDARY outcome

Timeframe: 24 months

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.

Outcome measures

Outcome measures
Measure	1 Early Start Denver Model n=55 Participants 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 n=63 Participants Standard community care: Treatment and interventions, chosen by families, meeting current standards of community intervention for toddlers with autism and ASD
Adaptive Behavior Age Equivalent Scores	39.76 months Standard Deviation 12.07	36.69 months Standard Deviation 14.32

SECONDARY outcome

Timeframe: 24 months

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.

Outcome measures

Outcome measures
Measure	1 Early Start Denver Model n=55 Participants 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 n=63 Participants Standard community care: Treatment and interventions, chosen by families, meeting current standards of community intervention for toddlers with autism and ASD
Autism Severity	6.69 units on a scale Standard Deviation 1.96	6.19 units on a scale Standard Deviation 2.52

Adverse Events

1 Early Start Denver Model

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Care Available in the Community

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Sally Rogers

University California Davis

Phone: 916-703-0264

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place