Autism Spectrum Disorder Clinical Trial
Official title:
Intervention Effects of Intensity and Delivery Style for Toddlers With Autism
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.
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05207956 -
App for Strengthening Services In Specialized Therapeutic Support
|
N/A | |
| Completed |
NCT03286621 -
Development of Eye-tracking Based Markers for Autism in Young Children
|
||
| Completed |
NCT02608333 -
Efficiency of Early Intervention for Autism Spectrum Disorder
|
N/A | |
| Recruiting |
NCT05935722 -
Evaluation of a Home-based Parenting Support Program: Parenting Young Children
|
N/A | |
| Active, not recruiting |
NCT06259539 -
A YouTube Curriculum for Children With Autism and Obesity
|
N/A | |
| Active, not recruiting |
NCT06303791 -
Digital-based Psychosocial Intervention for Parents of Children With Neurodevelopmental Disorders
|
N/A | |
| Enrolling by invitation |
NCT05017779 -
A Hybrid Effectiveness-implementation Trial of a High School-based Executive Function Treatment for Autistic Youth
|
N/A | |
| Completed |
NCT04772898 -
Effectiveness of a 6-week Hippotherapy Program in Children With Autism Spectrum Disorder
|
N/A | |
| Recruiting |
NCT04987541 -
The Therapeutic Effect of TBS Stimulation on Emotion Regulation in Autism Spectrum Disorder
|
N/A | |
| Completed |
NCT04308915 -
Mobile-based Games for Cognitive Training in Children With Neurodevelopmental Disorders
|
N/A | |
| Completed |
NCT06038435 -
The Effect of Cognitive Orientation Approach on Daily Occupational Performance With Autism Spectrum Disorder
|
N/A | |
| Terminated |
NCT04049981 -
Investigation of Mechanisms of Action in Superpower Glass
|
Phase 1/Phase 2 | |
| Completed |
NCT03693313 -
The Effect of CrossFit Kids on Social Skills in Children With Autism Spectrum Disorder (CrossFit KAMP)
|
N/A | |
| Recruiting |
NCT04107064 -
Achieving Steady Work Among Adults With Autism Through Specialized Employment Program
|
N/A | |
| Recruiting |
NCT03812068 -
Parent-mediated Developmental Behavioral Intervention
|
N/A | |
| Completed |
NCT03206996 -
Exposure Therapy for Auditory Sensitivity in Autism
|
N/A | |
| Completed |
NCT02299700 -
Study to Evaluate the Janssen Autism Knowledge Engine in Children and Adults With Autism Spectrum Disorder
|
N/A | |
| Completed |
NCT03422016 -
Electroretinogram in Autistic Spectrum Disorders
|
||
| Active, not recruiting |
NCT03548779 -
North Carolina Genomic Evaluation by Next-generation Exome Sequencing, 2
|
N/A | |
| Recruiting |
NCT05114538 -
Improving the Part C Early Intervention Service Delivery System for Children With ASD
|
N/A |