Promoting Development in Toddlers With Communication Delays

NCT01012076 | Completed

• 1 other identifier: G07-02-055-03
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Autism Spectrum Disorder

Keywords

maternal synchrony; parent-child; parent child play; social communication

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Early Social Communication Scale

  3 months

• Early Social Communication Scale

  6 months

• Early Social Communication Scale

  12 months

Study Arms (2)

Active Control

ACTIVE COMPARATOR

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

Experimental Treatment

EXPERIMENTAL

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

Interventions

Active Control vs Experimental Treatment BEHAVIORAL

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 Control; Experimental Treatment

Eligibility Criteria

• Age: 15 Months - 30 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Autism Speaks: lead

Study Sites (2)

University of California, Los Angeles

Los Angeles, California, United States

Location

Hunter College

New York, New York, United States

Location

Related Publications (4)

• 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.

  PMID: 12058846 BACKGROUND

• 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.

  PMID: 16262930 BACKGROUND

• 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.

  PMID: 18999331 BACKGROUND

• 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.

  PMID: 25260191 DERIVED

MeSH Terms

Conditions

Autism Spectrum Disorder; Communication

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Behavior

Study Officials

• Connie Kasari, Ph.D.

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 10, 2009
• First Posted: November 11, 2009
• Study Start: April 1, 2007
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: June 14, 2012

Record last verified: 2012-06

Locations

US (2)