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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01691066
Other study ID # 1110009256
Secondary ID R03MH092617
Status Completed
Phase N/A
First received
Last updated
Start date September 2012
Est. completion date February 27, 2017

Study information

Verified date June 2020
Source Yale University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study aims to investigate the utility of Pivotal Response Treatment (PRT), a behaviorally derived intervention, to improve the quality and frequency of communication and social engagement of toddlers with siblings who have an autism spectrum disorder (SIBS - ASD) and who demonstrate developmental delays and impairments in social interaction between 12 and 15 months of age.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date February 27, 2017
Est. primary completion date February 27, 2017
Accepts healthy volunteers No
Gender All
Age group 12 Months to 15 Months
Eligibility Inclusion Criteria:

- toddlers, age 12 - 15 months, who have an older sibling with ASD

- delays of at least 1.5 standard deviations in communication (receptive/expressive language) based on developmental testing

- scores that exceed the ASD cutoff on standardized measures of social-communicative behavior

Exclusion Criteria:

- physical or neurological disorder (e.g., seizures, cerebral palsy)

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Infant Toddler Years PRT


Locations

Country Name City State
United States Yale Child Study Center New Haven Connecticut

Sponsors (2)

Lead Sponsor Collaborator
Yale University National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Feasibility of a novel behavioral treatment Assessment of Outcome:
Attendance. Attendance to parent education sessions will be recorded by the therapist.
Parent utilization. To assess the acceptability of the PRT approach, parents will be asked to keep a weekly log of procedure use, including overall estimated duration and choice of activities.
24 months
Primary Acceptability of a novel behavioral treatment Assessment of Outcome:
Parent satisfaction. At post-treatment, parents will be asked to complete a Likert-scale and short response questionnaire rating their satisfaction with various aspects of the program
24 months
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