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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
United States2 sites, 2 recruiting
- 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
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 group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: tele-ImPACT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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
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.
- First posted16 Jul 2025
- Study start1 Apr 2026
- Primary completion31 Mar 2031 (estimated)
- Study completion31 Mar 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism SiblingStudies of the same condition, open and under way.
- More trials run by University of Texas at AustinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lauren Hampton, University of Texas at Austin
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
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sibwatch: Optimizing Intervention Options for Infants and Toddlers With a High Likelihood of Social Communication Delays and Language Disorder
- ClinicalTrials.gov ID
- NCT07069413
- Acronym / sponsor ID
- Sibwatch / STUDY00006726
- Conditions
- Autism Sibling
- Keywords
- autism
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 31 Mar 2031 (estimated)
- Study completion
- 31 Mar 2032 (estimated)
- First posted
- 16 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Business as Usual | No intervention | –Control arm where participants will receive community treatments, as usual. |
| tele-ImPACT | Experimental | Behavioral: tele-ImPACTParticipants will receive 12 weeks of intervention |
Who may qualify
- Ages
- 6 to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- chronological age between 6-24 months
- has at least one older biological sibling diagnosed with autism
Key exclusion criteria (4 listed)
- adverse neurological history
- primary sensory deficit (hearing or visual impairment)
- pre-term birth (gestation <37 weeks)
- pre-existing diagnosis of autism or language delay
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tele-ImPACTParticipants will receive 12 weeks of Project ImPACT intervention as delivered via Telehealth | Behavioural | tele-ImPACT |
Primary outcome
Child Social Communication
Time frame: 9 months
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
Time frame: 9 months
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
Time frame: 9 months
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Autism Sibling
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Milieu Teaching-AV: Adaptation of Milieu Teaching That Encourages Looking to the Mouth
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Active, not recruiting
Optimizing Intervention Options for Toddlers With Early Social Communication Delays
Autism Sibling
RecruitingObservational study
Screening for Neurodevelopmental Disorders in Siblings of Children With Autism Diagnosed in Tertiary Centers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
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.