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

University of California (UC) Davis

Status: Completed

Conditions: Autism Spectrum Disorder

Treatments: Behavioral: Early Intensive Behavioral Intervention (EIBI); Behavioral: Early Start Denver Model (ESDM)

Study type: Interventional

Funder types: Other

Identifiers

NCT02272192

406188

Details and patient eligibility

About

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.

Full 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.

Enrollment: 87 patients

Sex: All

Ages: 15 to 30 months old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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87 participants in 4 patient groups

ESDM15 hr/week

Experimental group

Description:

Children receive 15 hours a week of 1:1 intervention at home plus parent coaching using the Early Start Denver Model and following its manual

Treatment:

Behavioral: Early Start Denver Model (ESDM)

ESDM 25 hr/week

Experimental group

Description:

Children receive 25 hours a week of 1:1 intervention at home plus parent coaching using the Early Start Denver Model and following its manual

Treatment:

Behavioral: Early Start Denver Model (ESDM)

EIBI 15 hr/week

Experimental group

Description:

Children 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"

Treatment:

Behavioral: Early Intensive Behavioral Intervention (EIBI)

EIBI 25 hr/week

Experimental group

Description:

Children receive 25 hours per week of 1:1 intervention at home plus parent training using EIBI and following the Manual "A Work in Progress"

Treatment:

Behavioral: Early Intensive Behavioral Intervention (EIBI)