Autism SiblingSibWatchNCT05307094
Optimizing Intervention Options for Toddlers With Early Social Communication Delays
A study testing Improving Parents as Communication Teachers in people with Autism Sibling, run by University of Texas at Austin at 1 site in United States.
Trial summary
Improving social communication outcomes for toddler siblings of children with autism, who are at high risk for multiple language and communication deficits beyond autism, has important public health implications. Read more about this study
- Who is it for?
- Ages 11 to 18 monthsHealthy volunteers can take part
- Conditions the study is for
- Autism Sibling
- What is being tested?
- Improving Parents as Communication Teachers
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2022to 31 Dec 2025
- 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 11 to 18 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Has a biological sibling diagnosed on the autism spectrum
- Caregiver is willing to participate in study procedures
- No known hearing or vision loss
- Caregiver speaks enough English to participate in the intervention/assessments which are delivered in English.
- Caregiver uses English for at least half of the day with the toddler.
Who cannot join
- Currently receiving early intervention services
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas at Austin
Austin, Texas, 78712
About this study
Improving social communication outcomes for toddler siblings of children with autism, who are at high risk for multiple language and communication deficits beyond autism, has important public health implications. The proposed study is a pilot sequential multiple random assignment trial of 44 high-risk siblings that examines the feasibility, acceptability, and preliminary effects of an adaptive intervention for social communication. Evaluating effective parent-mediated communication support strategies for toddlers at high-risk supports NIDCD's mission of behavioral research focused on disordered language development and the prevention of health impairments such as communication disorders.
Read the detailed description
High-risk siblings, the infant/toddler siblings of children with autism, are at increased risk for a multitude of language, communication, and academic delays (Ozonoff, Young, Landa, 2015). Although 20% of high-risk siblings will develop autism, those who do not exhibit elevated scores on autism diagnostic assessment, delayed social communication, delayed language, and impairments in social skills even at an early age (Stone, McMahon, Yoder, \& Walden, 2007). For high-risk siblings, little is known about when to intervene, how to adapt as concerns develop, and for whom intervention is most beneficial. Thus, the goal of this pilot study is to examine the feasibility, acceptability, and initial effectiveness of an adaptive parent-mediated intervention focused on social communication for high-risk toddlers. We propose an adaptive intervention model that provides intervention options to respond to the ever-changing concern about high-risk toddlers' development. The objective of the proposed study is to examine the acceptability and feasibility of ongoing monitoring and adaptive intervention decisions for this high-risk sibling population. The specific aims include (1) to examine the effects of the adaptive intervention on parent and family outcomes (2) to evaluate and refine the intervention components and study procedures, and (3) to explore the effects of the adaptive intervention on child outcomes. Taken together, these aims provide a foundation to better understand the best adaptive treatment model for high-risk toddlers in response to evolving concern. The proposed pilot study will enroll 44 high-risk sibling toddlers who will be randomly assigned to one of two initial conditions: monthly monitoring or parent-mediated social communication intervention. Following the initial phase of intervention, toddlers will be assessed for social communication development. Those who are rated in the area of concern for social communication development will be re-randomized to receive one of two additional conditions: parent-mediated or parent-plus-clinician social communication intervention. Those who score as low-concern will receive increased monitoring for the remainder of the intervention period. Assessments will occur prior to intervention, following intervention, and 4-months following the end of intervention. The proposed research is significant because it will be the first examination of the impact of an adaptive intervention on parent and child outcomes for high-risk siblings. Understanding the effects of adaptive intervention decisions on parent implementation of social communication strategies and child social communication outcomes is a key step in optimizing interventions for this high-risk sibling group. This initial pilot study will demonstrate the feasibility, acceptability, and initial effects necessary to support a full-scale clinical trial in a future R01 application.
- Conditions
- Autism Sibling
- Being tested
- Improving Parents as Communication Teachers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Improving Parents as Communication TeachersBehavioural
Also called ImPACT
A parent-mediated naturalistic developmental behavioral intervention delivered 2-times per week with a primary caregiver and the child.
| Study group | Role | What they receive |
|---|---|---|
| Intervention first | Experimental | Participants will first be randomly assigned to a parent-mediated social communication intervention. At month 3 participants' social communication will be evaluated. Participants who present with delayed social communication skills will be randomly assigned to 2 additional treatment options: continue, or add video feedback. Participants who do not present with social communication delays will reduce intervention to a weekly phone call. Receives: Behavioral: Improving Parents as Communication Teachers |
| Developmental monitoring first | Active comparator | Participants will first be assigned to receive monthly monitoring of social communication development. At month 3 participants' social communication will be evaluated. Participants who present with delayed social communication skills will be randomly assigned to 2 additional treatment options: continue, or add video feedback. Participants who do not present with social communication delays will continue to receive developmental monitoring. Receives: Behavioral: Improving Parents as Communication Teachers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parent implementation
Parent use of naturalistic strategies with their child using a fidelity of implementation checklist.
Measured: immediately following the intervention period
Child social communication
Child social communication rate, coded and averaged across a semi-structured parent-child social interactions (including play and snack activties). One score will be derived from the total observation
Measured: immediately following the intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2022
- Study start15 Jan 2022
- Primary completion31 May 2025
- Study completion31 Dec 2025 (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
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Sequential Multiple Assignment Randomized Trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05307094
- Sponsor's protocol ID
- 1R21DC018908-01A1
- Acronym
- SibWatch
- Status last verified
- Nov 2025
- First submitted
- 24 Feb 2022
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Intervention Options for Toddlers With Early Social Communication Delays
- ClinicalTrials.gov ID
- NCT05307094
- Acronym / sponsor ID
- SibWatch / 1R21DC018908-01A1
- Conditions
- Autism Sibling
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Study start
- 15 Jan 2022 (actual)
- Primary completion
- 31 May 2025 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 1 Apr 2022 (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.
Improving social communication outcomes for toddler siblings of children with autism, who are at high risk for multiple language and communication deficits beyond autism, has important public health implications. The proposed study is a pilot sequential multiple random assignment trial of 44 high-risk siblings that examines the feasibility, acceptability, and preliminary effects of an adaptive intervention for social communication. Evaluating effective parent-mediated communication support strategies for toddlers at high-risk supports NIDCD's mission of behavioral research focused on disordered language development and the prevention of health impairments such as communication disorders.
Detailed description
High-risk siblings, the infant/toddler siblings of children with autism, are at increased risk for a multitude of language, communication, and academic delays (Ozonoff, Young, Landa, 2015). Although 20% of high-risk siblings will develop autism, those who do not exhibit elevated scores on autism diagnostic assessment, delayed social communication, delayed language, and impairments in social skills even at an early age (Stone, McMahon, Yoder, \& Walden, 2007). For high-risk siblings, little is known about when to intervene, how to adapt as concerns develop, and for whom intervention is most beneficial. Thus, the goal of this pilot study is to examine the feasibility, acceptability, and initial effectiveness of an adaptive parent-mediated intervention focused on social communication for high-risk toddlers. We propose an adaptive intervention model that provides intervention options to respond to the ever-changing concern about high-risk toddlers' development. The objective of the proposed study is to examine the acceptability and feasibility of ongoing monitoring and adaptive intervention decisions for this high-risk sibling population. The specific aims include (1) to examine the effects of the adaptive intervention on parent and family outcomes (2) to evaluate and refine the intervention components and study procedures, and (3) to explore the effects of the adaptive intervention on child outcomes. Taken together, these aims provide a foundation to better understand the best adaptive treatment model for high-risk toddlers in response to evolving concern. The proposed pilot study will enroll 44 high-risk sibling toddlers who will be randomly assigned to one of two initial conditions: monthly monitoring or parent-mediated social communication intervention. Following the initial phase of intervention, toddlers will be assessed for social communication development. Those who are rated in the area of concern for social communication development will be re-randomized to receive one of two additional conditions: parent-mediated or parent-plus-clinician social communication intervention. Those who score as low-concern will receive increased monitoring for the remainder of the intervention period. Assessments will occur prior to intervention, following intervention, and 4-months following the end of intervention. The proposed research is significant because it will be the first examination of the impact of an adaptive intervention on parent and child outcomes for high-risk siblings. Understanding the effects of adaptive intervention decisions on parent implementation of social communication strategies and child social communication outcomes is a key step in optimizing interventions for this high-risk sibling group. This initial pilot study will demonstrate the feasibility, acceptability, and initial effects necessary to support a full-scale clinical trial in a future R01 application.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Sequential Multiple Assignment Randomized Trial
| Arm | Type | Receives |
|---|---|---|
| Intervention first | Experimental | Behavioral: Improving Parents as Communication TeachersParticipants will first be randomly assigned to a parent-mediated social communication intervention. At month 3 participants' social communication will be evaluated. Participants who present with delayed social communication skills will be randomly assigned to 2 additional treatment options: continue, or add video feedback. Participants who do not present with social communication delays will reduce intervention to a weekly phone call. |
| Developmental monitoring first | Active comparator | Behavioral: Improving Parents as Communication TeachersParticipants will first be assigned to receive monthly monitoring of social communication development. At month 3 participants' social communication will be evaluated. Participants who present with delayed social communication skills will be randomly assigned to 2 additional treatment options: continue, or add video feedback. Participants who do not present with social communication delays will continue to receive developmental monitoring. |
Who may qualify
- Ages
- 11 to 18 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Has a biological sibling diagnosed on the autism spectrum
- Caregiver is willing to participate in study procedures
- No known hearing or vision loss
- Caregiver speaks enough English to participate in the intervention/assessments which are delivered in English.
- Caregiver uses English for at least half of the day with the toddler.
Key exclusion criteria (1 listed)
- Currently receiving early intervention services
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 |
|---|---|---|
| Improving Parents as Communication TeachersAlso: ImPACTA parent-mediated naturalistic developmental behavioral intervention delivered 2-times per week with a primary caregiver and the child. | Behavioural | Developmental monitoring first, Intervention first |
Primary outcome
Parent implementation
Time frame: immediately following the intervention period
Parent use of naturalistic strategies with their child using a fidelity of implementation checklist.
Child social communication
Time frame: immediately following the intervention period
Child social communication rate, coded and averaged across a semi-structured parent-child social interactions (including play and snack activties). One score will be derived from the total observation
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 2 Dec 2025.
- Individual participant dataSharing planned: No
Related trials for Autism Sibling
Recruiting
Sibwatch: Optimizing Intervention Options for Infants and Toddler Siblings of Autistic Children
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Promoting Early Intervention Timing and Attention to Language
MONITOR, COACH
Not yet recruiting
Milieu Teaching-AV: Adaptation of Milieu Teaching That Encourages Looking to the Mouth
Autism, Autism Spectrum Disorder
RecruitingObservational study
Screening for Neurodevelopmental Disorders in Siblings of Children With Autism Diagnosed in Tertiary Centers
Autism Spectrum Disorder, Siblings
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Improving Parents as Communication Teachers in people with Autism Sibling, run by University of Texas at Austin at 1 site 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 5 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parent implementation (time frame: immediately following the intervention period). The study lists 2 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 2 Dec 2025.