Clinical trial NCT02272192: Intervention Effects of Intensity and Delivery Style for Toddlers With Autism
Official title: Intervention Effects of Intensity and Delivery Style for Toddlers With Autism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: autism
autism spectrum disorder
intensive intervention
early intervention
Early Start Denver Model
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: University of Washington
name: Vanderbilt University
name: University of California, Los Angeles
First posted: 2014-10-22
Enrollment: 87
Sex: ALL
Minimum age (years): 15
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Expressive Communication Composite Score
timeFrame: two years
Secondary outcomes:
measure: Autism Severity Composite Score
timeFrame: two years
measure: Receptive Language Composite Score
timeFrame: two years
measure: Nonverbal Development Composite Score
timeFrame: two years
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis MIND Institute
state: California
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
city: Seattle
country: United States
facility: University of Washington Autism Center
state: Washington
Study officials:
affiliation: UC Davis MIND Institute
name: Sally J Rogers, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.