Randomized Study of Intensive One-on-one Behavioral Treatment Versus Individualized Parent Training in Preschool Aged Children With Autism
intensive one-on-one behavioral treatment
+ Individualized in home parent training
Autism Spectrum Disorder+9
+ Child Development Disorders, Pervasive
+ Nervous System Diseases
Treatment Study
Summary
Study start date: May 1, 1998
Actual date on which the first participant was enrolled.PROTOCOL OUTLINE: This is a randomized study. Children are randomized to receive either 35 hours of intensive one-on-one behavioral treatment in the home and neighborhood for 2 years or individualized, in home parent training for 6 months. A common group of tests to evaluate autism are administered at intake, 12 and 24 months into treatment, and when patients reach age 6.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.102 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 2 to 3 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
INCLUSION CRITERIA: --Disease Characteristics-- Diagnosis of autism based on the Autism Diagnostic Interview using the ICD-10 research criteria Ratio IQ score greater than 35 determined from the Bayley Scales of Infant Development --Patient Characteristics-- Other: Must reside within 60 km (37.5 miles) of a treatment site EXCLUSION CRITERIA: Severe medically induced limitations defined as: Any condition requiring prosthetic devices (e.g., blindness, deafness, or cerebral palsy) Any illness that has prevented or would prevent a subject from participating in 30 hours a week of treatment for six consecutive weeks or more (e.g., metastasized cancer or end stage renal disease) Any known genetic disorder (e.g., Fragile X, PKU, or Down Syndrome) Any other disorder that rules out autism according to ICD-10 criteria (e.g., Rett's Syndrome)
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives