Intervention Effects of Intensity and Delivery Style for Toddlers With Autism
TADPOLE
1 other identifier
interventional
87
1 country
3
Brief Summary
A multi-site randomized study of intensive treatment for toddlers with autism involving 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 progress of very young children with ASD ages 12-30 months old and their families, and the effect of children's developmental rates and autism severity on their response to intervention.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2013
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2013
CompletedFirst Submitted
Initial submission to the registry
October 20, 2014
CompletedFirst Posted
Study publicly available on registry
October 22, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2019
CompletedJanuary 6, 2020
January 1, 2020
6.3 years
October 20, 2014
January 2, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Expressive Communication Composite Score
We used Time 4 means and standard deviations (SDs)s from several measures to compute a z score. The mean of a Z score is always 0 and z scores range from -3 to +3. For this composite a higher score reveals more mature developmental skills. Data from the following measures were used in this composite score: a weighted frequency of intentional communication measured within a 15 minute communication sample; number of different root words measured within the communication sample; the expressive language age equivalent score from he Mullen Scales of Early learning (MSEL); the expressive communication age equivalent scores from the Vineland 2 Adaptive Behavior Scale 2(VABS2); the expressive raw score from the MacArthur Bates Communicative Developmental Inventories; the expressive social communication abilities composite score from the PDD Behavior Inventory; and the expressive language raw score from the PDD Behavior Inventory
two years
Secondary Outcomes (3)
Autism Severity Composite Score
two years
Receptive Language Composite Score
two years
Nonverbal Development Composite Score
two years
Study Arms (4)
ESDM15 hr/week
EXPERIMENTALChildren receive 15 hours a week of 1:1 intervention at home plus parent coaching using the Early Start Denver Model and following its manual
ESDM 25 hr/week
EXPERIMENTALChildren receive 25 hours a week of 1:1 intervention at home plus parent coaching using the Early Start Denver Model and following its manual
EIBI 15 hr/week
EXPERIMENTALChildren receive 15 hours per week of 1:1 intervention at home plus parent training using Early Intensive Behavioral Intervention (EIBI) and following the Manual "A Work in Progress"
EIBI 25 hr/week
EXPERIMENTALChildren receive 25 hours per week of 1:1 intervention at home plus parent training using EIBI and following the Manual "A Work in Progress"
Interventions
The Early Start Denver Model (ESDM) is a comprehensive developmental and 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 based in applied behavioral analysis to deliver this content. The teaching format focuses on trained therapists delivering the intervention 1:1 by engaging reciprocally with children in typical toddler activities involving play or daily routines, adding additional structure for children who need it to progress well. Progress data is collected throughout each session and used to make decisions about teaching approaches.
EIBI is a one-to-one instructional approach based in applied behavior analysis 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. Trial by trial 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.
Eligibility Criteria
You may qualify if:
- months of age at time of assessment;
- ambulatory and without impairments affecting hand use;
- meets criteria for Autistic Spectrum Disorder on the APA Diagnostic and Statistical Manual, 5th revision criteria and on the Autism Diagnostic Observation Schedule for Toddlers:
- clinical consensus of ASD diagnosis by 2 independent staff (including a licensed psychologist) based on observation as well as record review;
- developmental quotient of \>35 on Mullen Scales of Early Learning;
- normal hearing and vision screen;
- caregiver agreement to comply with all project requirements, including regular videotaping at home with provided equipment.
You may not qualify if:
- English not a primary language spoken at home;
- absence at 2 or more appointments without prior notice during the intake assessment;
- more than 10 hours per week of 1:1 ABA based treatment;
- other health or genetic conditions (i.e. fragile X syndrome, seizures, prematurity).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of California, Davislead
- University of Washingtoncollaborator
- Vanderbilt Universitycollaborator
- University of California, Los Angelescollaborator
Study Sites (3)
UC Davis MIND Institute
Sacramento, California, 95817, United States
Vanderbilt University
Nashville, Tennessee, 37240, United States
University of Washington Autism Center
Seattle, Washington, 98195, United States
Related Publications (1)
Rogers SJ, Yoder P, Estes A, Warren Z, McEachin J, Munson J, Rocha M, Greenson J, Wallace L, Gardner E, Dawson G, Sugar CA, Hellemann G, Whelan F. A Multisite Randomized Controlled Trial Comparing the Effects of Intervention Intensity and Intervention Style on Outcomes for Young Children With Autism. J Am Acad Child Adolesc Psychiatry. 2021 Jun;60(6):710-722. doi: 10.1016/j.jaac.2020.06.013. Epub 2020 Aug 24.
PMID: 32853704DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sally J Rogers, Ph.D.
UC Davis MIND Institute
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 20, 2014
First Posted
October 22, 2014
Study Start
March 1, 2013
Primary Completion
July 1, 2019
Study Completion
July 1, 2019
Last Updated
January 6, 2020
Record last verified: 2020-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- All de-identified data will be uploaded into NDAR as soon as primary papers are published. All demographic data are uploaded into NDAR as they are collected.
- Access Criteria
- as per NDAR procedures
All de-identified data will be uploaded into NDAR as soon as primary papers are published. All demographic data are uploaded into NDAR as they are collected.