Promoting Development in Toddlers With Communication Delays

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.

Study Overview

• Status: Completed
• Conditions: Autism Spectrum Disorder
• Intervention / Treatment: Behavioral: Active Control vs Experimental Treatment

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States
      • University of California, Los Angeles
  • New York
    • New York, New York, United States
      • Hunter College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 2 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active Control; 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). 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.
Experimental: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal Synchronization	Maternal Synchronization will be measured at exit of study.	3 months
Maternal Synchronization	Maternal Synchronization will be measured at 6 month follow up of study.	6 months
Maternal Synchronization	Maternal Synchronization will be measured at 12 month follow up of study.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Early Social Communication Scale	Early Social Communication Scale will be used to measure joint attention behaviors at exit of study.	3 months
Early Social Communication Scale	Early Social Communication Scale will be used to measure joint attention at 6 month follow up.	6 months
Early Social Communication Scale	Early Social Communication Scale will be used to measure joint attention at 12 month follow up.	12 months

Collaborators and Investigators

• Sponsor: Autism Speaks
• Investigators: Principal Investigator: Connie Kasari, Ph.D., University of California, Los Angeles

Publications and helpful links

General Publications

• Siller M, Sigman M. The behaviors of parents of children with autism predict the subsequent development of their children's communication. J Autism Dev Disord. 2002 Apr;32(2):77-89. doi: 10.1023/a:1014884404276.
• Tomasello M, Carpenter M, Call J, Behne T, Moll H. Understanding and sharing intentions: the origins of cultural cognition. Behav Brain Sci. 2005 Oct;28(5):675-91; discussion 691-735. doi: 10.1017/S0140525X05000129.
• Siller M, Sigman M. Modeling longitudinal change in the language abilities of children with autism: parent behaviors and child characteristics as predictors of change. Dev Psychol. 2008 Nov;44(6):1691-704. doi: 10.1037/a0013771.
• Kasari C, Siller M, Huynh LN, Shih W, Swanson M, Hellemann GS, Sugar CA. Randomized controlled trial of parental responsiveness intervention for toddlers at high risk for autism. Infant Behav Dev. 2014 Nov;37(4):711-21. doi: 10.1016/j.infbeh.2014.08.007. Epub 2014 Sep 26.

Study record dates

Study Major Dates

• Study Start: April 1, 2007
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: November 10, 2009
• First Submitted That Met QC Criteria: November 10, 2009
• First Posted (Estimate): November 11, 2009

Study Record Updates

• Last Update Posted (Estimate): June 14, 2012
• Last Update Submitted That Met QC Criteria: June 13, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: social communication; maternal synchrony; parent-child; parent child play
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder
• Other Study ID Numbers: G07-02-055-03