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Completed

NCT Number: NCT02272192

Intervention Effects of Intensity and Delivery Style for Toddlers With Autism

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.

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Key information

Conditions

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

Age range

15 month–30 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UC Davis MIND Institute, Sacramento, California, United States

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About this study

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 conducted an RCTs to answer the following question: what are the effects of intensity and delivery style on developmental progress of toddlers with ASD?

87 young children with ASD, mean age 23.4 months who live within a specified radius near the university at each site were enrolled in one of three national sites 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 naturalistic developmental-behavioral intervention. Other aspects of intervention held constant were: use of the principles of applied behavior analysis, 1:1 adult:child ratios, parent coaching in the assigned treatment, and treatment location. Developmental progress was measured frequently 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 12-30 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.

Exclusion criteria

  • 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).

Treatment and study plan

Early Start Denver Model (ESDM)

Behavioral

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.

Other names: Naturalistic developmental-behavioral intervention (NDBI)

Early Intensive Behavioral Intervention (EIBI)

Behavioral

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.

Other names: ABA, DTT, Lovaas method

Primary outcomes

  1. Expressive Communication Composite Score

    Time frame: two years

    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

Secondary outcomes

  1. Autism Severity Composite Score

    Time frame: two years

    To build the composite scores for all the outcome measures, we first examined whether the proposed component variables were correlated (for 2 component variables) or factor loaded (for 3 or more component variables) at or above .3. We used Time 4 means and SD 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 severe symptoms of ASD. . from the following measures were used in this composite score: the calibrated severity score from the Autism Diagnostic Observation Schedule 2 and the expressive receptive social communication composite from the PDD Behavior Inventory

  2. Receptive Language Composite Score

    Time frame: two years

    To build the composite scores for all the outcome measures, we first examined whether the proposed component variables were correlated (for 2 component variables) or factor loaded (for 3 or more component variables) at or above .3. We used Time 4 means and SD 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. from the following measures were used in this composite score: receptive language age equivalent score from the MSEL; receptive language age equivalent score from the VABS 2

  3. Nonverbal Development Composite Score

    Time frame: two years

    To build the composite scores for all the outcome measures, we first examined whether the proposed component variables were correlated (for 2 component variables) or factor loaded (for 3 or more component variables) at or above .3. We used Time 4 means and SD 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. from the following measures were used in this composite score: 2 scores - the fine motor and the visual reception age equivalency scores - from the MSEL and 3 age equivalency scores from the VABS2 - daily living, motor skills, and socialization

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Collaborators

  • University of California, Los Angeles
  • University of Washington
  • Vanderbilt University

Registry information

Acronym: TADPOLE

Important dates

Study start
2013
Primary completion
2019
Study completion
2019
First posted
Oct 22, 2014
Registry last updated
Jan 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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