Intervention Effects of Intensity and Delivery Style for Toddlers With Autism

Completed · Not applicable

Conditions studied: Autism Spectrum Disorder

In brief

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.

Key facts

Study ID

NCT02272192

Run by

University of California, Davis

People needed

87

Starts

2013-03-01

Expected to finish

2019-07-01

Last updated by the study team

2020-01-06

Who can join

Age: 1 and older, up to 3. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

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).

Where it is running

• UC Davis MIND Institute — Sacramento, California, United States
• Vanderbilt University — Nashville, Tennessee, United States
• University of Washington Autism Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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