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Promoting Development in Toddlers With Communication Delays

Primary Purpose

Autism Spectrum Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Active Control vs Experimental Treatment
Sponsored by
Autism Speaks
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring maternal synchrony, parent-child, parent child play, social communication

Eligibility Criteria

15 Months - 30 Months (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of California, Los Angeles
  • Hunter College

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Active Control

Experimental Treatment

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Maternal Synchronization
Maternal Synchronization will be measured at exit of study.
Maternal Synchronization
Maternal Synchronization will be measured at 6 month follow up of study.
Maternal Synchronization
Maternal Synchronization will be measured at 12 month follow up of study.

Secondary Outcome Measures

Early Social Communication Scale
Early Social Communication Scale will be used to measure joint attention behaviors at exit of study.
Early Social Communication Scale
Early Social Communication Scale will be used to measure joint attention at 6 month follow up.
Early Social Communication Scale
Early Social Communication Scale will be used to measure joint attention at 12 month follow up.

Full Information

First Posted
November 10, 2009
Last Updated
June 13, 2012
Sponsor
Autism Speaks
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1. Study Identification

Unique Protocol Identification Number
NCT01012076
Brief Title
Promoting Development in Toddlers With Communication Delays
Official Title
Promoting Development in Toddlers With Communication Delays
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Autism Speaks

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
Keywords
maternal synchrony, parent-child, parent child play, social communication

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active Control
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Experimental Treatment
Arm Type
Experimental
Arm Description
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 Type
Behavioral
Intervention Name(s)
Active Control vs Experimental Treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Maternal Synchronization
Description
Maternal Synchronization will be measured at exit of study.
Time Frame
3 months
Title
Maternal Synchronization
Description
Maternal Synchronization will be measured at 6 month follow up of study.
Time Frame
6 months
Title
Maternal Synchronization
Description
Maternal Synchronization will be measured at 12 month follow up of study.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Early Social Communication Scale
Description
Early Social Communication Scale will be used to measure joint attention behaviors at exit of study.
Time Frame
3 months
Title
Early Social Communication Scale
Description
Early Social Communication Scale will be used to measure joint attention at 6 month follow up.
Time Frame
6 months
Title
Early Social Communication Scale
Description
Early Social Communication Scale will be used to measure joint attention at 12 month follow up.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Months
Maximum Age & Unit of Time
30 Months
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Connie Kasari, Ph.D.
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Los Angeles
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Hunter College
City
New York
State/Province
New York
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
12058846
Citation
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.
Results Reference
background
PubMed Identifier
16262930
Citation
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.
Results Reference
background
PubMed Identifier
18999331
Citation
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.
Results Reference
background
PubMed Identifier
25260191
Citation
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.
Results Reference
derived

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Promoting Development in Toddlers With Communication Delays

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