NCT03274622: IMPACT

Efficacy of IMPACT in Infant Siblings of Children With ASD

Completed NA Last updated 2 October 2019

What this trial tests

NA trial testing Impact Parent Training in Autism Spectrum Disorder in 97 participants. Completed in 30 August 2019.

Timeline

16 February 2016

Primary endpoint
30 August 2019

30 August 2019

Quick facts

Lead sponsor	Vanderbilt University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	97
Start date	16 February 2016
Primary completion	30 August 2019
Estimated completion	30 August 2019
Sites	2 locations across United States

Drugs / interventions tested

• Impact Parent Training
• No Impact

Conditions studied

• Autism Spectrum Disorder — all drugs for Autism Spectrum Disorder →

Sponsor

Vanderbilt University

Who can join

Adults 12 Months to 18 Months, any sex, with Autism Spectrum Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Over a 5 year period infant and baby siblings of children with autism spectrum disorders (ASD) will be recruited to this study and will be randomized into 2 groups. Parents of the intervention group will receive 12 weeks of coaching in how to implement this intervention. Parents randomized to the control group will not receive intervention coaching. Both groups will attend a series of clinic appointments for data collection that occur at 3 month intervals over a 9 month period.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Project ImPACT Reduces Social Hyporesponsiveness and Translates to More Optimal Expressive Language Outcomes in Some Infants at Increased Likelihood of Autism.
   Markfeld JE, Feldman JI, Bush CT, Yoder PJ, et al · · 2025 · PMID 40549283 · DOI 10.1007/s10803-025-06928-3