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Autism SiblingSibwatchNCT07069413

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

A study testing tele-ImPACT in people with Autism Sibling, run by University of Texas at Austin at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 6 to 24 months
Conditions the study is for
Autism Sibling
What is being tested?
tele-ImPACT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
2 sitesUnited States
Study dates
1 Apr 2026to 31 Mar 2032
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 24 months
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

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

Who cannot join

  • 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 locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Lauren Hampton, Ph.D. contact

512-471-2090

Sibwatch@utexas.edu

United States2 sites, 2 recruiting
  • Little Longhorn Lab

    Austin, Texas, 78712

    Lauren Hampton, PhD, 512-471-2090, sibwatch@austin.utexas.edu

    Recruiting
  • VUMC

    Nashville, Tennessee, 37232

    Catherine Bush, (615) 936-5470

    Recruiting

Other trials in United States

About this study

Official title: Sibwatch: Optimizing Intervention Options for Infants and Toddlers With a High Likelihood of Social Communication Delays and Language Disorder

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.

Read the detailed description

Autism is a neurodevelopmental condition that is highly prevalent and that comes at a high cost to affected children and their families. The costs of autism can be attributed, at least in part, to the effects of the condition on children's social communication and language development. Younger siblings of autistic children (HL-Sibs) are highly likely to receive a future diagnosis of autism and/or language disorder themselves. Even those HL-Sibs who are not diagnosed have an increased likelihood of displaying differences in social communication and delays in language development. There is increasing support that preemptive interventions may influence caregivers' use of strategies that scaffold development and translate to effects on social communication and language skills in HL-Sibs. However, prior studies of preemptive interventions have been limited by the inclusion of samples that are rather homogenous, likely reflecting those families who can readily access the medical centers and academic institutions conducting this research. Additionally, past investigations suggest that effects of preemptive interventions may (a) yield only indirect effects on child social communication and language, and (b) vary according to child and caregiver factors, but no previously identified mediators or moderators of preemptive intervention effects have been replicated, and many factors that likely explain or influence differential intervention effects have not yet been explored. Further, the extant literature testing the efficacy of preemptive interventions has administered treatments across a broad range of child ages, and researchers do not yet know precisely when preemptive treatment is most likely to yield favorable effects. Finally, some studies have reported high rates of attrition amongst families assigned to treatment, suggesting that caregivers may not find preemptive interventions to be acceptable. The present study will, thus, evaluate the efficacy of ImPACT, an intervention that is established for use with autistic children and that has amassed some past empirical support as delivered in vivo in HL-Sibs, as administered by telehealth (hereafter referred to as tele-ImPACT) relative to a no-treatment control for effects on caregiver strategy use, proximal child skills, and distal child social communication and language in a large, representative sample in the context of a rigorous randomized clinical trial. Advanced analytic approaches will be employed to test numerous putative moderators and mediators of tele-ImPACT effects, and qualitative approaches will be utilized to assess the acceptability of the candidate treatment amongst caregivers. INNOVATION AND IMPACT: This innovative and interdisciplinary study is expected to (a) provide empirical support for a novel preemptive intervention that is theoretically motivated and developmentally informed, as well as accessible for and acceptable to families affected by autism in the United States, and (b) lend new insights into the developmental windows in which, mechanisms by which, and the subgroups for which this intervention works. Such findings would have strong implications for theory, policy, research, and clinical practice in young children at elevated likelihood for autism and developmental language disorder.

Conditions
Autism Sibling
Being tested
tele-ImPACT
Keywords
autism
Medical subject headings
Autistic Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • tele-ImPACTBehavioural

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

Study groups in NCT07069413
Study groupRoleWhat they receive
Business as UsualNo interventionControl arm where participants will receive community treatments, as usual.
tele-ImPACTExperimentalParticipants will receive 12 weeks of intervention
Receives: Behavioral: tele-ImPACT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 9 months

  2. 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.

    Measured: 9 months

  3. 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.

    Measured: 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jul 2025
  2. Study start1 Apr 2026
  3. Primary completion31 Mar 2031 (estimated)
  4. Study completion31 Mar 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
140 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07069413
Sponsor's protocol ID
STUDY00006726
Acronym
Sibwatch
Status last verified
Jun 2026
First submitted
30 Jun 2025
Last updated
12 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing tele-ImPACT in people with Autism Sibling, run by University of Texas at Austin at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lauren Hampton, Ph.D. (512-471-2090, Sibwatch@utexas.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Child Social Communication (time frame: 9 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026; AzTrials last refreshed its copy on 6 Nov 2026.

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