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Trial record 2 of 7 for:    autism UC Davis

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by University of California, Davis
Sponsor:
Collaborators:
University of Washington
Vanderbilt University
Harvard University
Information provided by (Responsible Party):
University of California, Davis
ClinicalTrials.gov Identifier:
NCT02272192
First received: October 20, 2014
Last updated: NA
Last verified: October 2014
History: No changes posted
  Purpose

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 15-30 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 Intervention
Autism Spectrum Disorder
Behavioral: Play-based
Behavioral: Discrete Trial Teaching

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intervention Effects of Intensity and Delivery Style for Toddlers With Autism

Resource links provided by NLM:


Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • Overall developmental quotients on Mullen Scales [ Time Frame: two years ] [ Designated as safety issue: No ]
    overall developmental age/chronological age on standard early childhood developmental scale


Secondary Outcome Measures:
  • receptive and expressive language scores on Mullen Scales [ Time Frame: two years ] [ Designated as safety issue: No ]
  • adaptive behavior scores on Vineland Adaptive Behavior Scales [ Time Frame: two years ] [ Designated as safety issue: No ]
    measures everyday functioning via [parent report in four domains - communication, socialization, daily living skills, and motor skills

  • symptom severity scores from Autism Diagnostic Observational Schedule [ Time Frame: two years ] [ Designated as safety issue: No ]
  • communication and problem solving scores from Individual Growth Development Indices [ Time Frame: two years ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • parent delivery of interventions [ Time Frame: two years ] [ Designated as safety issue: No ]
    coding of parent teaching interactions videotaped by parents in their homes


Estimated Enrollment: 100
Study Start Date: March 2013
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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, 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.

  Eligibility

Ages Eligible for Study:   15 Months to 30 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 5. meets full autism criteria on the Autism Diagnostic Interview-Revised (ADI-R; Kim & Lord, 2011 algorithms) 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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02272192

Contacts
Contact: Sally J Rogers, Ph.D. (916)703-0264 sally.rogers@ucdmc.ucdavis.edu
Contact: Marie Rocha, Ph.D. (916)703-0356 marie.rocha@ucdmc.ucdavis.edu

Locations
United States, California
UC Davis MIND Institute Recruiting
Sacramento, California, United States, 95817
Contact: Sally J Rogers, Ph.D.    916-703-0264    sally.rogers@ucdmc.ucdavis.edu   
Contact: Marie Rocha, Ph.D.    916 703-0356    marie.rocha@ucdmc.ucdavis.edu   
United States, Tennessee
Vanderbilt University Recruiting
Nashville, Tennessee, United States, 37240
Contact: Paul Yoder, Ph.D.         
United States, Washington
University of Washington Autism Center Recruiting
Seattle, Washington, United States, 98195
Contact: Annette Estes, Ph.D.         
Sponsors and Collaborators
University of California, Davis
University of Washington
Vanderbilt University
Harvard University
Investigators
Principal Investigator: Sally J Rogers, Ph.D. UC Davis MIND Institute
  More Information

No publications provided

Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT02272192     History of Changes
Other Study ID Numbers: UCaliforniaDavis
Study First Received: October 20, 2014
Last Updated: October 20, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Davis:
autism
autism spectrum disorder
intensive intervention
early intervention
Early Start Denver Model

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Mental Disorders
Mental Disorders Diagnosed in Childhood

ClinicalTrials.gov processed this record on November 20, 2014