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Promoting Development in Toddlers With Communication Delays

Promoting Development in Toddlers With Communication Delays

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01012076
Enrollment
60
Registered
2009-11-11
Start date
2007-04-30
Completion date
2011-10-31
Last updated
2012-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism Spectrum Disorder

Keywords

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

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).

Interventions

BEHAVIORALActive 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.

Sponsors

Autism Speaks
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
15 Months to 30 Months
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Maternal Synchronization3 monthsMaternal Synchronization will be measured at exit of study.

Secondary

MeasureTime frameDescription
Early Social Communication Scale3 monthsEarly Social Communication Scale will be used to measure joint attention behaviors at exit of study.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026