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Pivotal Response Treatment for Infants At-Risk for Autism Spectrum Disorder

Pivotal Response Treatment for Infants At-Risk for Autism Spectrum Disorder

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01691066
Enrollment
30
Registered
2012-09-24
Start date
2012-09-30
Completion date
2017-02-27
Last updated
2020-06-26

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

Conditions

Autism Spectrum Disorders

Brief 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.

Interventions

BEHAVIORALInfant Toddler Years PRT

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
Yale University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

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

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)

Design outcomes

Primary

MeasureTime frameDescription
Feasibility of a novel behavioral treatment24 monthsAssessment 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.
Acceptability of a novel behavioral treatment24 monthsAssessment 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

Countries

United States

Outcome results

None listed

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