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
  Purpose

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.


Condition Intervention
Autism Spectrum Disorder
Behavioral: Active Control vs Experimental Treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Promoting Development in Toddlers With Communication Delays

Resource links provided by NLM:


Further study details as provided by Autism Speaks:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 60
Study Start Date: April 2007
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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).

  Eligibility

Ages Eligible for Study:   15 Months to 30 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01012076

Locations
United States, California
University of California, Los Angeles
Los Angeles, California, United States
United States, New York
Hunter College
New York, New York, United States
Sponsors and Collaborators
Autism Speaks
Investigators
Principal Investigator: Connie Kasari, Ph.D. University of California, Los Angeles
  More Information

Publications:
Responsible Party: Autism Speaks
ClinicalTrials.gov Identifier: NCT01012076     History of Changes
Other Study ID Numbers: G07-02-055-03
Study First Received: November 10, 2009
Last Updated: June 13, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Autism Speaks:
maternal synchrony
parent-child
parent child play
social communication

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on August 25, 2014