Promoting Development in Toddlers With Communication Delays

This study has been completed.
Sponsor:
Information provided by:
Autism Speaks
ClinicalTrials.gov Identifier:
NCT01012076
First received: November 10, 2009
Last updated: June 13, 2012
Last verified: June 2012

November 10, 2009
June 13, 2012
April 2007
October 2011   (final data collection date for primary outcome measure)
  • Maternal Synchronization [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Maternal Synchronization will be measured at exit of study.
  • Maternal Synchronization [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Maternal Synchronization will be measured at 6 month follow up of study.
  • Maternal Synchronization [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Maternal Synchronization will be measured at 12 month follow up of study.
Maternal Synchronization [ Time Frame: Before treatment, during treatments, 6 month follow-up, 12 month follow-up ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01012076 on ClinicalTrials.gov Archive Site
  • Early Social Communication Scale [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Early Social Communication Scale will be used to measure joint attention behaviors at exit of study.
  • Early Social Communication Scale [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Early Social Communication Scale will be used to measure joint attention at 6 month follow up.
  • Early Social Communication Scale [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Early Social Communication Scale will be used to measure joint attention at 12 month follow up.
Early Social Communication Scale [ Time Frame: Before treatment, after treatment, 6-month follow-up, 12-month follow up ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Promoting Development in Toddlers With Communication Delays
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.

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).

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Autism Spectrum Disorder
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.
  • 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.
    Intervention: Behavioral: Active Control vs Experimental Treatment
  • 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.
    Intervention: Behavioral: Active Control vs Experimental Treatment

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
October 2011
October 2011   (final data collection date for primary outcome measure)

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.
Both
15 Months to 30 Months
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01012076
G07-02-055-03
No
Autism Speaks
Autism Speaks
Not Provided
Principal Investigator: Connie Kasari, Ph.D. University of California, Los Angeles
Autism Speaks
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP