Recruiting

Tele-ImPACT

Sponsor:

University of Texas at Austin

Code:

NCT07069413

Conditions

Autism Sibling

Eligibility Criteria

Sex: All

Age: 0 - 2

Healthy Volunteers: Not accepted

Interventions

tele-ImPACT

Study Details

Brief summary:

This rigorous randomized controlled trial will evaluate the efficacy and acceptability of a preemptive, telehealth intervention (tele-ImPACT) in a large, representative sample of infant siblings of autistic children, who are known to be at high likelihood of receiving a future diagnosis of autism and/or developmental language disorder (HL-Sibs). If our hypotheses are supported, this innovative and interdisciplinary study will provide empirical support for a novel approach to treatment that is theoretically motivated and developmentally informed, as well as accessible for and acceptable to families, and will lend new insights into the developmental windows in which, mechanisms by which, and subgroups for which the treatment works. Such findings would have strong implications for research, policy, theory, and practice in young children at risk for autism and/or language disorder.

Conditions

Autism Sibling

Study ID

NCT07069413

Start date

Apr 1, 2026

Status verified date

Jun, 2026

Completion date

Mar 31, 2032

Anticipated

Primary completion date

Mar 31, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 2

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • chronological age between 6-24 months
  • has at least one older biological sibling diagnosed with autism

Exclusion Criteria:

  • adverse neurological history
  • primary sensory deficit (hearing or visual impairment)
  • pre-term birth (gestation <37 weeks)
  • pre-existing diagnosis of autism or language delay

Study Design

Enrollment

140 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

no intervention: Business as Usual

Control arm where participants will receive community treatments, as usual.

experimental: tele-ImPACT

Participants will receive 12 weeks of intervention

Interventions

tele-ImPACT

Participants will receive 12 weeks of Project ImPACT intervention as delivered via Telehealth

Primary outcome measure

  • Child Social Communication [ Time Frame: 9 months ]
  • Child Receptive Language [ Time Frame: 9 months ]
  • Child Expressive Language [ Time Frame: 9 months ]

Central Contacts and Locations

Central contacts

Locations

VUMC

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Catherine Bush

(615) 936-5470

Little Longhorn Lab

Recruiting

Austin, Texas, United States, 78712

Contacts

More Information

Sponsor

University of Texas at Austin

Last update posted

Jun 12, 2026

Last verified

Jun, 2026

Keywords

  • autism

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Texas at Austin on 2026-06-12.