About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
chronological age between 6-24 months
has at least one older biological sibling diagnosed with autism
Disqualifiers
adverse neurological history
primary sensory deficit (hearing or visual impairment)
pre-term birth (gestation <37 weeks)
pre-existing diagnosis of autism or language delay
Trial design
Parallel
Treatments tested in this trial
tele-ImPACT
BehavioralParticipants will receive 12 weeks of Project ImPACT intervention as delivered via Telehealth
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
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.
Sponsors and contacts
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