Promoting Development in Toddlers With Communication Delays

NCT ID: NCT01012076

Last Updated: 2012-06-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-04-30
• Study Completion Date: 2011-10-31

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).

Conditions

Autism Spectrum Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Active Control vs Experimental Treatment

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Active Control vs Experimental Treatment

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 15 Months
• Maximum Eligible Age: 30 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Autism Speaks

OTHER

Sponsor Role: lead

Responsible Party

Autism Speaks

Principal Investigators

Connie Kasari, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

University of California, Los Angeles

Los Angeles, California, United States

Hunter College

New York, New York, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 12058846 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16262930 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18999331 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 25260191 (View on PubMed)

Other Identifiers

G07-02-055-03

Identifier Type: -

Identifier Source: org_study_id