Promoting Development in Toddlers With Communication Delays

Not Applicable

Completed

• Conditions: Autism Spectrum Disorder
• Interventions: Behavioral: Active Control vs Experimental Treatment

• Registration Number: NCT01012076
• Lead Sponsor: Autism Speaks

Brief Summary

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.

Detailed Description

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).

Study Timeline

• Study Start: 2007-04
• Study First Submitted: 2009-11-10
• Study First Submitted QC: 2009-11-10
• Study First Posted: 2009-11-11
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-13
• Last Update Posted: 2012-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• The child is between 15 and 30 months of age;
• The child scores at least one standard deviation below average on the Social Composite Score of the CSBS DP.

Exclusion Criteria

• The child has been diagnosed with a known medical condition that has been linked to either autism or mental retardation (e.g., Fragile X, Tuberous Sclerosis, Cerebral Palsy, Hydrocephalus).
• The child has a severe visual, hearing, or motor impairment or fragile health condition that would prevent him/her from validly participating in the assessment procedures.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active Control	Active Control vs Experimental Treatment	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.
Experimental Treatment	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.

Primary Outcome Measures

Name	Time	Method
Maternal Synchronization	12 months	Maternal Synchronization will be measured at 12 month follow up of study.

Secondary Outcome Measures

Name	Time	Method
Early Social Communication Scale	12 months	Early Social Communication Scale will be used to measure joint attention at 12 month follow up.

Trial Locations

Locations (2)

Hunter College; 🇺🇸 New York, New York, United States

University of California, Los Angeles; 🇺🇸 Los Angeles, California, United States