An interventional study of Active Control vs Experimental Treatment in Autism Spectrum Disorder, sponsored by Autism Speaks. Completed at 2 sites in United States. Open to participants aged 15 Months to 30 Months. Per ClinicalTrials.gov, last updated 2012-06-14.
Sponsored by Autism Speaks · Not applicable, Interventional, and Treatment
Eighty parent-child dyads will be recruited and randomly assigned to either the experimental intervention or an active control condition. Subjects assigned to the experimental group will participate in 12 home-based intervention sessions.
The experimental intervention is manualized, follows an illustrated workbook for parents, and uses individualized video-feedback, modeling, and coaching strategies to help parents establish play interactions that promote communication. All participants take part in comprehensive baseline and post-intervention/post-active control assessments, as well as 6- and 12-month follow up assessments. Families in the active control group will also be invited to participate in an oral feedback session to discuss the results from these assessments. Children's involvement in other forms of intervention will be monitored using a validated intervention log so that the moderating effects of these treatments can be examined.
By targeting parent-child interactions, the current intervention ensures that new child behaviors generalize beyond the immediate context of the intervention and are maintained over time (Schreibman, 2000). In addition, by involving parents in the treatment of their children (e.g., by establishing a daily playtime routine), the current intervention ensures that the intervention strategies are implemented with sufficient intensity for causing developmental change (National Research Council, 2001).
1,727 studies on the registry are indexed under Autism Spectrum Disorder; 504 are open to participants now.
This study's enrollment of 60 is above the median of 52 across 1,371 interventional studies indexed under Autism Spectrum Disorder.
Browse Autism Spectrum Disorder studies →This is the only study on the registry with Autism Speaks as lead sponsor.
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Exclusion Criteria:
The active control involves three 90 minute in-home training sessions. These training sessions will be administered by trained graduate students or a postdoctoral student in a developmental psychology or related field. The active control will follow a standardized treatment manual (Kasari, 2008). This treatment manual was based upon the teacher training workshops created by the Center on the Social and Emotional Foundations for Early Learning. Over the course of the intervention, parent and interventionist cover a hierarchy of intervention topics, aiming to improve the parent's ability to successfully promote the child's social and emotional competency.
Behavioral: Active Control vs Experimental Treatment
The parent education program involves 12 in-home training sessions (90 minutes each), is administered by trained graduate and postdoctoral students in developmental psychology or a related field, and follows a standardized treatment manual (Siller, 2005). Over the course of the intervention, parent and interventionist cover a hierarchy of intervention topics, aiming to promote the ability of the parent-child dyad to successfully manage shared toy play.
Behavioral: Active Control vs Experimental Treatment
The parent education program involves 12 in-home training sessions (90 minutes each), is administered by trained graduate and postdoctoral students in developmental psychology or a related field, and follows a standardized treatment manual (Siller, 2005). The active control involves three 90 minute in-home training sessions. These training sessions will be administered by trained graduate students or a postdoctoral student in a developmental psychology or related field. The active control will follow a standardized treatment manual (Kasari, 2008). This treatment manual was based upon the teacher training workshops created by the Center on the Social and Emotional Foundations for Early Learning.
Maternal Synchronization
Maternal Synchronization will be measured at exit of study.
Time frame: 3 months
Maternal Synchronization
Maternal Synchronization will be measured at 6 month follow up of study.
Time frame: 6 months
Maternal Synchronization
Maternal Synchronization will be measured at 12 month follow up of study.
Time frame: 12 months
Early Social Communication Scale
Early Social Communication Scale will be used to measure joint attention behaviors at exit of study.
Time frame: 3 months
Early Social Communication Scale
Early Social Communication Scale will be used to measure joint attention at 6 month follow up.
Time frame: 6 months
Early Social Communication Scale
Early Social Communication Scale will be used to measure joint attention at 12 month follow up.
Time frame: 12 months
This study is completed, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.
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