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OpenTrials
Completed

NCT Number: NCT01012076

Promoting Development in Toddlers With Communication Delays

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.

Completed

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Key information

Age range

15 month–30 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, Los Angeles, Los Angeles, California, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Maternal Synchronization

    Time frame: 3 months

    Maternal Synchronization will be measured at exit of study.

  2. Maternal Synchronization

    Time frame: 6 months

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

  3. Maternal Synchronization

    Time frame: 12 months

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

Secondary outcomes

  1. Early Social Communication Scale

    Time frame: 3 months

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

  2. Early Social Communication Scale

    Time frame: 6 months

    Early Social Communication Scale will be used to measure joint attention at 6 month follow up.

  3. Early Social Communication Scale

    Time frame: 12 months

    Early Social Communication Scale will be used to measure joint attention at 12 month follow up.

Sponsors and collaborators

Lead sponsor

Autism Speaks

Other

Registry information

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Nov 11, 2009
Registry last updated
Jun 14, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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