Sibwatch: Optimizing Intervention Options for Infants and Toddler Siblings of Autistic Children

NCT07069413 | Recruiting

• 1 other identifier: STUDY00006726
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 2

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

Keywords

autism

Outcome Measures

Primary Outcomes (3)

• Child Social Communication

  A single z-score average of two scales: VABS socialization standard score (0-100) and ADOS-2 reflected social affect calibrated severity score (inverse coded 1-10). High scores indicate great social communication skills.

  9 months

• Child Receptive Language

  A single z-score average of two scales: MSEL receptive scaled score (20-80) and VABS expressive scaled score (1-24). With higher scores indicating greater receptive language ability.

  9 months

• Child Expressive Language

  A single z-score average of two scales:MSEL expressive scaled score (20-80), VABS expressive scaled score (1-24). With higher scores indicating greater expressive language skills.

  9 months

Study Arms (2)

Business as Usual

NO INTERVENTION

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

tele-ImPACT

EXPERIMENTAL

Participants will receive 12 weeks of intervention

Behavioral: tele-ImPACT

Interventions

tele-ImPACT BEHAVIORAL

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

tele-ImPACT

Eligibility Criteria

• Age: 6 Months - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Texas at Austin: lead

Study Sites (2)

VUMC

Nashville, Tennessee, 37232, United States

RECRUITING

Little Longhorn Lab

Austin, Texas, 78712, United States

RECRUITING

MeSH Terms

Conditions

Autistic Disorder

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Central Study Contacts

Lauren Hampton, Ph.D.

CONTACT

512-471-2090; Sibwatch@utexas.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All outcomes assessment ratings will be conducted by an assessor naive to treatment condition. All assessments will be administered by an assessor also naive to treatment condition.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 30, 2025
• First Posted: July 16, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): March 31, 2031
• Study Completion (Estimated): March 31, 2032
• Last Updated: June 12, 2026

Record last verified: 2026-06

Locations

US (2)