Promoting Development in Toddlers With Communication Delays
| Tracking Information | |||||
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| First Received Date ICMJE | November 10, 2009 | ||||
| Last Updated Date | June 13, 2012 | ||||
| Start Date ICMJE | April 2007 | ||||
| Primary Completion Date | October 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
Maternal Synchronization [ Time Frame: Before treatment, during treatments, 6 month follow-up, 12 month follow-up ] [ Designated as safety issue: No ] | ||||
| Change History | Complete list of historical versions of study NCT01012076 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
Early Social Communication Scale [ Time Frame: Before treatment, after treatment, 6-month follow-up, 12-month follow up ] [ Designated as safety issue: No ] | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Promoting Development in Toddlers With Communication Delays | ||||
| Official Title ICMJE | Promoting Development in Toddlers With Communication Delays | ||||
| 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. |
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| 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). |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Autism Spectrum Disorder | ||||
| Intervention ICMJE | Behavioral: 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. |
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| Study Arm (s) |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 60 | ||||
| Completion Date | October 2011 | ||||
| Primary Completion Date | October 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 15 Months to 30 Months | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01012076 | ||||
| Other Study ID Numbers ICMJE | G07-02-055-03 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Autism Speaks | ||||
| Study Sponsor ICMJE | Autism Speaks | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Autism Speaks | ||||
| Verification Date | June 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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