Intervention Effects of Intensity and Delivery Style for Toddlers With Autism
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 87
- Locations
- 3
- Primary Endpoint
- Expressive Communication Composite Score
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 15 Months to 30 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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).
Arms & Interventions
EIBI 25 hr/week
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"
Intervention: Early Intensive Behavioral Intervention (EIBI) (Behavioral)
ESDM15 hr/week
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
Intervention: Early Start Denver Model (ESDM) (Behavioral)
ESDM 25 hr/week
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
Intervention: Early Start Denver Model (ESDM) (Behavioral)
EIBI 15 hr/week
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"
Intervention: Early Intensive Behavioral Intervention (EIBI) (Behavioral)
Outcomes
Primary Outcomes
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
- Autism Severity Composite Score(two years)
- Nonverbal Development Composite Score(two years)
- Receptive Language Composite Score(two years)