Intervention Effects of Intensity and Delivery Style for Toddlers With Autism (TADPOLE)

• Sponsor: University of California, Davis
• Collaborators: University of Washington; Vanderbilt University; University of California, Los Angeles
• Information provided by (Responsible Party): University of California, Davis

Study Description

Brief Summary:

A multi-site randomized study of intensive treatment for toddlers with autism. This project proposes a three-site collaborative network plus a data coordinating center to evaluate the effects of intervention intensity and intervention style delivered for 12 months, on the developmental quotients (primary outcome) of very young children with ASD ages 12-30 months old and their families, and the effect of children's initial vocal skills, developmental rates and autism severity on their response to intervention. A second study will examine whether the effects of the Early Start Denver Model intervention are sustained over a three year period for 6-7 year old children who previously were enrolled in a two year study that compared ESDM treatment to usual community interventions.

Condition or disease	Intervention/treatment	Phase
Autism Spectrum Disorder	Behavioral: Play-based; Behavioral: Discrete Trial Teaching	Not Applicable

Detailed Description:

High quality, intensive early intervention is a powerful treatment for ASD, improving IQ and language markedly in randomized controlled clinical trials (RCTs), though little long term follow-up data exists. Few core characteristics that affect child change have been tested. Two potential core characteristics that invoke considerable debate among parents, professionals, and administrators are the delivery style of intervention: play-based versus discrete trial teaching, and the intensity (dosage) of intervention. This ACE treatment network will conduct two RCTs to answer two main questions: study 1: what are the effects of intensity and delivery style on developmental progress of toddlers with ASD, and study 2: do toddlers from a previous RCT of a specific intervention approach, the Early Start Denver Model (ESDM), versus community treatment maintain and generalize treatment effects over 3 years?

A sample of 108 young children with ASD, ages 15-30 months who live within a specified radius near the university at each site will be enrolled in one of three national sites (Univ Cal Davis, Vanderbilt, Univ. Washington) and randomized into one of four cells varying on two dimensions: dosage - 15 or 25 hours per week of 1:1 treatment; and discrete trial teaching or play and routines- based teaching. Other aspects of intervention will be held constant: use of the principles of applied behavior analysis, intensity, parent coaching in the assigned treatment, and location. Developmental progress will be measured monthly allowing for growth curve analysis to examine fine-grained differences in groups as well as interactions among major child and family initial variables and these two experimental variables.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	100 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Intervention Effects of Intensity and Delivery Style for Toddlers With Autism
Study Start Date :	March 2013
Estimated Primary Completion Date :	April 30, 2019
Estimated Study Completion Date :	April 30, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: Play-based 15 hr/week; Children receive 15 hours a week of 1:1 intervention at home plus parent coaching using a play and routines based intervention based on techniques from the Early Start Denver Model	Behavioral: Play-based; The Early Start Denver Model (ESDM) is a comprehensive behavioral early intervention approach for children with autism, ages 12 to 48 months. The program encompasses a developmental curriculum that defines the skills to be taught at any given time and a set of teaching procedures used to deliver this content. The teaching format focuses on natural activities involving play or daily routines, though structure is added for children who need more structure to progress well. Progress data is collected throughout each session and used to make decisions about teaching approaches. Discrete Trial Teaching is not used in this group.; Other Names: Early intervention for toddlers with autism; Early Start Denver Model
Experimental: Play-based 25 hr/week; Children receive 25 hours a week of 1:1 intervention at home plus parent coaching using a play and routines based intervention based on techniques from the Early Start Denver Model	Behavioral: Play-based; The Early Start Denver Model (ESDM) is a comprehensive behavioral early intervention approach for children with autism, ages 12 to 48 months. The program encompasses a developmental curriculum that defines the skills to be taught at any given time and a set of teaching procedures used to deliver this content. The teaching format focuses on natural activities involving play or daily routines, though structure is added for children who need more structure to progress well. Progress data is collected throughout each session and used to make decisions about teaching approaches. Discrete Trial Teaching is not used in this group.; Other Names: Early intervention for toddlers with autism; Early Start Denver Model
Experimental: Discrete Trial Teaching 15 hr/week; Children receive 15 hours per week of 1:1 intervention at home plus parent training using discrete trial teaching and following the Manual "A Work in Progress"	Behavioral: Discrete Trial Teaching; Discrete trial training (DTT) is a one-to-one instructional approach used to teach skills in a planned, controlled, and systematic manner. Each trial or teaching opportunity has a definite beginning and end, thus the descriptor discrete trial. Within DTT, the use of antecedents and consequences is carefully planned and implemented. Positive praise and/or tangible rewards are used to reinforce desired skills or behaviors. Data collection is an important part of DTT and supports decision making by providing teachers/practitioners with information about beginning skill level, progress and challenges, skill acquisition and maintenance, and generalization of learned skills or behaviors.; Other Name: ABA, DTT, Lovaas method
Experimental: Discrete Trial Teaching 25 hr/week; Children receive 25 hours per week of 1:1 intervention at home plus parent training using discrete trial teaching and following the Manual "A Work in Progress"	Behavioral: Discrete Trial Teaching; Discrete trial training (DTT) is a one-to-one instructional approach used to teach skills in a planned, controlled, and systematic manner. Each trial or teaching opportunity has a definite beginning and end, thus the descriptor discrete trial. Within DTT, the use of antecedents and consequences is carefully planned and implemented. Positive praise and/or tangible rewards are used to reinforce desired skills or behaviors. Data collection is an important part of DTT and supports decision making by providing teachers/practitioners with information about beginning skill level, progress and challenges, skill acquisition and maintenance, and generalization of learned skills or behaviors.; Other Name: ABA, DTT, Lovaas method

Outcome Measures

Primary Outcome Measures :

1. Overall developmental quotients on Mullen Scales [ Time Frame: two years ]
   overall developmental age/chronological age on standard early childhood developmental scale

Secondary Outcome Measures :

1. receptive and expressive language scores on Mullen Scales [ Time Frame: two years ]
2. adaptive behavior scores on Vineland Adaptive Behavior Scales [ Time Frame: two years ]
   measures everyday functioning via [parent report in four domains - communication, socialization, daily living skills, and motor skills
3. symptom severity scores from Autism Diagnostic Observational Schedule [ Time Frame: two years ]
4. communication and problem solving scores from Individual Growth Development Indices [ Time Frame: two years ]

Other Outcome Measures:

1. parent delivery of interventions [ Time Frame: two years ]
   coding of parent teaching interactions videotaped by parents in their homes

Eligibility Criteria

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Ages Eligible for Study:	15 Months to 30 Months (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

1.15-30 months of age 2. Ambulatory and without primary motor impairments affecting hand use 3. meets criteria for Autistic Spectrum Disorder using DSM-5 criteria 4. clinical consensus of diagnosis by 2 independent staff, one of whom is a licensed psychologist based on observation as well as record review 6. meets autism cutoff on the Autism Diagnostic Observation Schedule for Toddlers (ADOS - T; Luyster et al, 2009) 7. confidence rating assigned by assessor as relatively confident or very confident in diagnosis.

8. Overall developmental quotient of 35 or higher on Mullen Scales of Early Learning (Mullen, 1995) 9. Parental agreement to complete project materials, to participate in parent coaching twice per month at home, to have therapy assistants in the home 15-25 hours per week, to attend a clinic meeting twice each month and to videotape regularly at home with project provided equipment 10. English as a primary language spoken to the child (60% or more at home as reported by parents), 11. Attendance at all initial evaluation sessions, and no more than 1 failure to keep appointments without calling to cancel during the intake period 12. Hearing and vision screen within the normal range. 13. Lives within a specified radius close to the university (the specific mileage varies somewhat for each site.)

Exclusion Criteria:

1. Children who have been receiving 10 hours per week of intensive, curriculum-based therapy for more than 1 month
2. Families who miss 2 or more consecutive appointments without previous notification

Contacts and Locations

Locations

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United States, California
UC Davis MIND Institute
Sacramento, California, United States, 95817
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37240
United States, Washington
University of Washington Autism Center
Seattle, Washington, United States, 98195

Sponsors and Collaborators

University of California, Davis

University of Washington

Vanderbilt University

University of California, Los Angeles

Investigators

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Principal Investigator:	Sally J Rogers, Ph.D.	UC Davis MIND Institute

More Information

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Responsible Party:	University of California, Davis
ClinicalTrials.gov Identifier:	NCT02272192 History of Changes
Other Study ID Numbers:	406188
First Posted:	October 22, 2014
Last Update Posted:	October 8, 2018
Last Verified:	October 2018

Keywords provided by University of California, Davis:

autism; autism spectrum disorder; intensive intervention; early intervention; Early Start Denver Model

Additional relevant MeSH terms:

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Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders