Clinical trial NCT01012076: Promoting Development in Toddlers With Communication Delays
Official title: Promoting Development in Toddlers With Communication Delays
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: maternal synchrony
parent-child
parent child play
social communication
Lead sponsor: Autism Speaks
Sponsor class: OTHER
First posted: 2009-11-11
Enrollment: 60
Sex: ALL
Minimum age (years): 15
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Maternal Synchronization
timeFrame: 3 months
measure: Maternal Synchronization
timeFrame: 6 months
measure: Maternal Synchronization
timeFrame: 12 months
Secondary outcomes:
measure: Early Social Communication Scale
timeFrame: 3 months
measure: Early Social Communication Scale
timeFrame: 6 months
measure: Early Social Communication Scale
timeFrame: 12 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
city: New York
country: United States
facility: Hunter College
state: New York
Study officials:
affiliation: University of California, Los Angeles
name: Connie Kasari, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.