AutismPhase 2NCT05926687
Optimizing Outcomes for Young Autistic Children
A Phase 2 study testing Social Communication, Disruptive Behavior and Social Communication + Reduce Frequency in people with Autism and Autism Spectrum Disorder, run by Northwestern University at 1 site in United States.
Trial summary
The overarching goal of the proposed study is to: (a) determine how best to sequence two parent-mediated interventions: a social communication intervention (Project ImPACT, Improving Parents as Communication Teachers) and a disruptive behavior intervention (Parent Training for Disruptive Behavior) and (b) examine… Read more about this study
- Who is it for?
- Ages 18 to 48 monthsHealthy volunteers can take part
- Conditions the study is for
- Autism, Autism Spectrum Disorder
- What is being tested?
- Social Communication, Disruptive Behavior and Social Communication + Reduce Frequency
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jul 2023to 28 Feb 2027
- Phase
- Phase 2
- 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 18 to 48 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Child is between 18 and 48 months old
- Child scores above the research cutoff for ASD on the TELE-ASD-PEDS
- Child has no other known diagnosis or disability at study entry
- Child has normal vision
- Child is exposed to English at least 50% of the time
- Child has a caregiver willing to learn the intervention strategies
- Caregiver wants help supporting their child's social communication and behavior regulation
- Caregiver understands conversational English well enough to participate in caregiver instruction
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimizing Outcomes Through Sequencing Parent-Mediated Interventions for Young Children With Autism
The overarching goal of the proposed study is to: (a) determine how best to sequence two parent-mediated interventions: a social communication intervention (Project ImPACT, Improving Parents as Communication Teachers) and a disruptive behavior intervention (Parent Training for Disruptive Behavior) and (b) examine moderators and mediators of intervention outcomes.
Read the detailed description
Despite advances in early identification of and intervention for children with autism spectrum disorders (ASD), the long-term outcomes for children with ASD remain variable. As many as 40% of children with ASD are minimally verbal at 9 years of age, and 75% of adults with ASD have persistent social communication (SC) difficulties. Furthermore, as many as 70% of children with ASD have a co-occurring diagnosis of disruptive behavior (DB) disorder. Parents play an important role in SC development and in the prevention of and intervention for DB. As such, the overarching goal of the proposed study is to: (a) determine how best to sequence two parent-mediated interventions: an SC intervention (Project ImPACT, Improving Parents as Communication Teachers) and a DB intervention (Parent Training for Disruptive Behavior) and (b) examine moderators and mediators of intervention outcomes. While evidence of efficacy and feasibility exist for both of these interventions individually, an adaptive intervention approach that considers and optimizes both interventions has not been evaluated. This type of adaptive intervention approach may be particularly needed in parent-mediated interventions due to the cost, burden, and complexity of teaching parents to use multiple intervention strategies. To determine the optimal intervention sequence that considers parent moderators and parent use of intervention strategies, the investigators propose a sequential, multiple assignment, randomized trial (SMART) design in which the investigators will initially randomly assign 184 children with ASD, between 18 and 48 months of age, to receive either the SC or DB intervention. Following each respective manualized, 12-week intervention (first-stage intervention; SC or DB), the interventionist will measure the parents' use of intervention strategies. At this point, all parents will be re-randomized before starting the second-stage intervention. Second-stage intervention decisions are designed to be responsive to parents' implementation of the first-stage intervention strategies. That is, parents who are implementing the first-stage intervention strategies with high fidelity (high implementers) will be re-randomized to receive the same intervention at a lower frequency (Reduce) or to receive the other intervention (Switch). Parents who are implementing the first-stage intervention strategies with low fidelity (low implementers) will be re-randomized to receive the same intervention with an additional parent instructional method, such as video feedback (Augment) or to receive the other intervention (Switch). After 24 weeks of intervention (12 weeks for first stage, 12 weeks for second stage), the investigators will assess child SC skills, child DB, and family life participation in everyday activities. The investigators will also measure parent-child joint engagement continually during intervention to examine the extent to which joint engagement mediates intervention outcomes. The proposed research is significant because if an intervention for one domain (SC or DB) has an impact on the other, an intervention sequence that systematically includes both interventions may have an even greater impact on both domains.
- Conditions
- Autism, Autism Spectrum Disorder
- Being tested
- Social Communication, Disruptive Behavior, Social Communication + Reduce Frequency, Social Communication + Add Tools, Disruptive Behavior + Reduce Frequency
- Keywords
- intervention, early intervention, toddlers, autistic, autism, virtual, tele-health
- Medical subject headings
- Autistic Disorder, Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social CommunicationBehavioural
Also called SC, Project Impact
Intervention: Social Communication Who: Parent \& Child \& Therapist Frequency: 1-hour twice/week
Disruptive BehaviorBehavioural
Also called RUBI, DB
Intervention: Disruptive Behavior Who: Parent \& Therapist only Frequency: 1-hour once/week
Social Communication + Reduce FrequencyBehavioural
Intervention: Social Communication Who: Parent \& Child \& Therapist Frequency: 1-hour once/week
Social Communication + Add ToolsBehavioural
Intervention: Social Communication Who: Parent \& Child \& Therapist Frequency: 1-hour twice/week
Disruptive Behavior + Reduce FrequencyBehavioural
Intervention: Disruptive Behavior Who: Parent \& Therapist only Frequency: 1-hour every other week
Disruptive Behavior + Add ToolsBehavioural
Intervention: Disruptive Behavior Who: Parent \& Therapist only Frequency: 1-hour once/week
| Study group | Role | What they receive |
|---|---|---|
| Social Communication + Reduce Frequency | Active comparator | Starting Intervention: Social Communication Who: Parent \& Child \& Therapist Frequency: 1-hour twice/week
Secondary Intervention: "Reduce Frequency" of Social Communication Intervention Intervention: Social Communication Who: Parent \& Child \& Therapist Reduce Frequency: 1-hour once/week Receives: Behavioral: Social Communication; Behavioral: Social Communication + Reduce Frequency |
| Social Communication + Add Tools | Active comparator | Starting Intervention: Social Communication Who: Parent \& Child \& Therapist Frequency: 1-hour twice/week
Secondary Intervention: "Add Tools" to Social Communication Intervention Intervention: Social Communication Who: Parent \& Child \& Therapist Frequency: 1-hour twice/week Add: Video feedback Receives: Behavioral: Social Communication; Behavioral: Social Communication + Add Tools |
| Social Communication + Switch Intervention to Disruptive Behavior | Active comparator | Starting Intervention: Social Communication Who: Parent \& Child \& Therapist Frequency: 1-hour twice/week
Secondary Intervention: Switch to Disruptive Behavior Intervention Who: Parent \& Therapist only Frequency: 1-hour once/week Receives: Behavioral: Social Communication; Behavioral: Disruptive Behavior |
| Disruptive Behavior + Reduce Frequency | Active comparator | Starting Intervention: Disruptive Behavior Who: Parent \& Therapist only Frequency: 1-hour once/week
Secondary Intervention: "Reduce Frequency" of Disruptive Behavior Intervention Intervention: Disruptive Behavior Who: Parent \& Therapist only Reduce Frequency: 1-hour every other week Receives: Behavioral: Disruptive Behavior; Behavioral: Disruptive Behavior + Reduce Frequency |
| Disruptive Behavior + Add Tools | Active comparator | Starting Intervention: Disruptive Behavior Who: Parent \& Therapist only Frequency: 1-hour once/week
Secondary Intervention: "Add Tools" to Disruptive Behavior Intervention Intervention: Disruptive Behavior Who: Parent \& Therapist \& Child Frequency: 1-hour once/week Add: Video feedback Receives: Behavioral: Disruptive Behavior; Behavioral: Disruptive Behavior + Add Tools |
| Disruptive Behavior + Switch Intervention to Social Communication | Active comparator | Starting Intervention: Disruptive Behavior Who: Parent \& Therapist only Frequency: 1-hour once/week
Secondary Intervention: "Switch" to Social Communication Intervention Who: Parent \& Child \& Therapist Frequency: 1-hour twice/week Receives: Behavioral: Social Communication; Behavioral: Disruptive Behavior |
What is being measured
The primary outcome is the main question the study is designed to answer.
Observed Child Social Communication
The child's observed social communication is measured from a caregiver-child interaction in which the dyad interacts across a variety of daily activities using materials in their home. This interaction will be recorded and coded for the child's social communication using the codebook from the Early Communication Indicator assessment.
Measured: Between 25-30 weeks
Observed Child Disruptive Behavior
The child's disruptive behavior is measured from a caregiver-child interaction in which the dyad interacts across a variety of daily activities using materials in their home. This interaction will be recorded and coded for the child's disruptive behavior using the Disruptive Behavior Diagnostic Observation (DB-DOS) codebook.
Measured: Between 25-30 weeks
Caregiver Report of Child Social Communication
The caregiver's assessment of the child's social communication is measured from the Developmental Profile 4 (DP-4) Social-Emotional and Communication Scales. This assessment will yield a total raw score ranging from 0 (minimum) to 70 (maximum), with higher scores indicating better outcomes.
Measured: Between 25-30 weeks
Caregiver Report of Child Disruptive Behavior
The caregiver's assessment of the child's disruptive behavior is measured from the Eyberg Child Behavior Inventory.
Measured: Between 25-30 weeks
Family Life Impairment Scale
Family life participation outcomes are measured using the Family Life Impairment Scale. The measure's values range from 0 (minimum) to 38 (maximum) with higher scores indicating worse outcomes.
Measured: Between 25-30 weeks
Secondary outcomes (2)
Caregiver Satisfaction
The caregiver's satisfaction with the intervention(s) are measured from a researcher developed satisfaction questionnaire. Sample items include asking about the caregiver's confidence in supporting their child's development, the difficulty in finding time to support their child's development, the added stress of participating in the study, the reasonableness of the study time requirement, the satisfaction with their study therapist's presentation of the material, and whether they would recommend the intervention to another family.
Measured: Between 25-30 weeks
Caregiver Perceived Stress
The caregiver's stress levels are measured using the Perceived Stress Scale. The measure's values range from 0 (minimum) to 40 (maximum) with higher scores indicating worse outcomes.
Measured: Between 25-30 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start11 Jul 2023
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutismStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- The investigators propose a sequential, multiple assignment, randomized trial (SMART) design in which the investigators will initially randomly assign 184 children with ASD, between 18 and 48 months of age, to receive either the SC or DB intervention. Following each respective manualized, 12-week intervention (first-stage intervention; SC or DB), the interventionist will measure the parents' use of intervention strategies. At this point, all parents will be re-randomized before starting the second-stage intervention. Participants will be re-randomized to receive the same intervention at a lower frequency (Reduce) or to receive the other intervention (Switch). Parents who need additional parent instructional method, such as video feedback will be randomized to receive additional tools (Augment).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 184 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Texas at Austin
- Responsible party
- Principal investigator, Megan Roberts, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05926687
- Sponsor's protocol ID
- STU00216950
- Status last verified
- Oct 2026
- First submitted
- 7 Jun 2023
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will share the final dataset in two ways: the National Database for Autism Research (NDAR) and the Inter-University Consortium for Political and Social Research (ICPSR).
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Outcomes Through Sequencing Parent-Mediated Interventions for Young Children With Autism
- ClinicalTrials.gov ID
- NCT05926687
- Acronym / sponsor ID
- STU00216950
- Conditions
- Autism, Autism Spectrum Disorder
- Keywords
- intervention, early intervention, toddlers, autistic, autism, virtual, tele-health
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 184 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- University of Texas at Austin
- Study start
- 11 Jul 2023 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 3 Jul 2023 (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.
The overarching goal of the proposed study is to: (a) determine how best to sequence two parent-mediated interventions: a social communication intervention (Project ImPACT, Improving Parents as Communication Teachers) and a disruptive behavior intervention (Parent Training for Disruptive Behavior) and (b) examine moderators and mediators of intervention outcomes.
Detailed description
Despite advances in early identification of and intervention for children with autism spectrum disorders (ASD), the long-term outcomes for children with ASD remain variable. As many as 40% of children with ASD are minimally verbal at 9 years of age, and 75% of adults with ASD have persistent social communication (SC) difficulties. Furthermore, as many as 70% of children with ASD have a co-occurring diagnosis of disruptive behavior (DB) disorder. Parents play an important role in SC development and in the prevention of and intervention for DB. As such, the overarching goal of the proposed study is to: (a) determine how best to sequence two parent-mediated interventions: an SC intervention (Project ImPACT, Improving Parents as Communication Teachers) and a DB intervention (Parent Training for Disruptive Behavior) and (b) examine moderators and mediators of intervention outcomes. While evidence of efficacy and feasibility exist for both of these interventions individually, an adaptive intervention approach that considers and optimizes both interventions has not been evaluated. This type of adaptive intervention approach may be particularly needed in parent-mediated interventions due to the cost, burden, and complexity of teaching parents to use multiple intervention strategies. To determine the optimal intervention sequence that considers parent moderators and parent use of intervention strategies, the investigators propose a sequential, multiple assignment, randomized trial (SMART) design in which the investigators will initially randomly assign 184 children with ASD, between 18 and 48 months of age, to receive either the SC or DB intervention. Following each respective manualized, 12-week intervention (first-stage intervention; SC or DB), the interventionist will measure the parents' use of intervention strategies. At this point, all parents will be re-randomized before starting the second-stage intervention. Second-stage intervention decisions are designed to be responsive to parents' implementation of the first-stage intervention strategies. That is, parents who are implementing the first-stage intervention strategies with high fidelity (high implementers) will be re-randomized to receive the same intervention at a lower frequency (Reduce) or to receive the other intervention (Switch). Parents who are implementing the first-stage intervention strategies with low fidelity (low implementers) will be re-randomized to receive the same intervention with an additional parent instructional method, such as video feedback (Augment) or to receive the other intervention (Switch). After 24 weeks of intervention (12 weeks for first stage, 12 weeks for second stage), the investigators will assess child SC skills, child DB, and family life participation in everyday activities. The investigators will also measure parent-child joint engagement continually during intervention to examine the extent to which joint engagement mediates intervention outcomes. The proposed research is significant because if an intervention for one domain (SC or DB) has an impact on the other, an intervention sequence that systematically includes both interventions may have an even greater impact on both domains.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 6
- Model description
- The investigators propose a sequential, multiple assignment, randomized trial (SMART) design in which the investigators will initially randomly assign 184 children with ASD, between 18 and 48 months of age, to receive either the SC or DB intervention. Following each respective manualized, 12-week intervention (first-stage intervention; SC or DB), the interventionist will measure the parents' use of intervention strategies. At this point, all parents will be re-randomized before starting the second-stage intervention. Participants will be re-randomized to receive the same intervention at a lower frequency (Reduce) or to receive the other intervention (Switch). Parents who need additional parent instructional method, such as video feedback will be randomized to receive additional tools (Augment).
| Arm | Type | Receives |
|---|---|---|
| Social Communication + Reduce Frequency | Active comparator | Behavioral: Social Communication, Behavioral: Social Communication + Reduce FrequencyStarting Intervention: Social Communication Who: Parent \& Child \& Therapist Frequency: 1-hour twice/week Secondary Intervention: "Reduce Frequency" of Social Communication Intervention Intervention: Social Communication Who: Parent \& Child \& Therapist Reduce Frequency: 1-hour once/week |
| Social Communication + Add Tools | Active comparator | Behavioral: Social Communication, Behavioral: Social Communication + Add ToolsStarting Intervention: Social Communication Who: Parent \& Child \& Therapist Frequency: 1-hour twice/week Secondary Intervention: "Add Tools" to Social Communication Intervention Intervention: Social Communication Who: Parent \& Child \& Therapist Frequency: 1-hour twice/week Add: Video feedback |
| Social Communication + Switch Intervention to Disruptive Behavior | Active comparator | Behavioral: Social Communication, Behavioral: Disruptive BehaviorStarting Intervention: Social Communication Who: Parent \& Child \& Therapist Frequency: 1-hour twice/week Secondary Intervention: Switch to Disruptive Behavior Intervention Who: Parent \& Therapist only Frequency: 1-hour once/week |
| Disruptive Behavior + Reduce Frequency | Active comparator | Behavioral: Disruptive Behavior, Behavioral: Disruptive Behavior + Reduce FrequencyStarting Intervention: Disruptive Behavior Who: Parent \& Therapist only Frequency: 1-hour once/week Secondary Intervention: "Reduce Frequency" of Disruptive Behavior Intervention Intervention: Disruptive Behavior Who: Parent \& Therapist only Reduce Frequency: 1-hour every other week |
| Disruptive Behavior + Add Tools | Active comparator | Behavioral: Disruptive Behavior, Behavioral: Disruptive Behavior + Add ToolsStarting Intervention: Disruptive Behavior Who: Parent \& Therapist only Frequency: 1-hour once/week Secondary Intervention: "Add Tools" to Disruptive Behavior Intervention Intervention: Disruptive Behavior Who: Parent \& Therapist \& Child Frequency: 1-hour once/week Add: Video feedback |
| Disruptive Behavior + Switch Intervention to Social Communication | Active comparator | Behavioral: Social Communication, Behavioral: Disruptive BehaviorStarting Intervention: Disruptive Behavior Who: Parent \& Therapist only Frequency: 1-hour once/week Secondary Intervention: "Switch" to Social Communication Intervention Who: Parent \& Child \& Therapist Frequency: 1-hour twice/week |
Who may qualify
- Ages
- 18 to 48 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Child is between 18 and 48 months old
- Child scores above the research cutoff for ASD on the TELE-ASD-PEDS
- Child has no other known diagnosis or disability at study entry
- Child has normal vision
- Child is exposed to English at least 50% of the time
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Social CommunicationAlso: SC, Project ImpactIntervention: Social Communication Who: Parent \& Child \& Therapist Frequency: 1-hour twice/week | Behavioural | Disruptive Behavior + Switch Intervention to Social Communication, Social Communication + Add Tools, Social Communication + Reduce Frequency, Social Communication + Switch Intervention to Disruptive Behavior |
| Disruptive BehaviorAlso: RUBI, DBIntervention: Disruptive Behavior Who: Parent \& Therapist only Frequency: 1-hour once/week | Behavioural | Disruptive Behavior + Add Tools, Disruptive Behavior + Reduce Frequency, Disruptive Behavior + Switch Intervention to Social Communication, Social Communication + Switch Intervention to Disruptive Behavior |
| Social Communication + Reduce FrequencyIntervention: Social Communication Who: Parent \& Child \& Therapist Frequency: 1-hour once/week | Behavioural | Social Communication + Reduce Frequency |
| Social Communication + Add ToolsIntervention: Social Communication Who: Parent \& Child \& Therapist Frequency: 1-hour twice/week | Behavioural | Social Communication + Add Tools |
| Disruptive Behavior + Reduce FrequencyIntervention: Disruptive Behavior Who: Parent \& Therapist only Frequency: 1-hour every other week | Behavioural | Disruptive Behavior + Reduce Frequency |
| Disruptive Behavior + Add ToolsIntervention: Disruptive Behavior Who: Parent \& Therapist only Frequency: 1-hour once/week | Behavioural | Disruptive Behavior + Add Tools |
Primary outcome
Observed Child Social Communication
Time frame: Between 25-30 weeks
The child's observed social communication is measured from a caregiver-child interaction in which the dyad interacts across a variety of daily activities using materials in their home. This interaction will be recorded and coded for the child's social communication using the codebook from the Early Communication Indicator assessment.
Observed Child Disruptive Behavior
Time frame: Between 25-30 weeks
The child's disruptive behavior is measured from a caregiver-child interaction in which the dyad interacts across a variety of daily activities using materials in their home. This interaction will be recorded and coded for the child's disruptive behavior using the Disruptive Behavior Diagnostic Observation (DB-DOS) codebook.
Caregiver Report of Child Social Communication
Time frame: Between 25-30 weeks
The caregiver's assessment of the child's social communication is measured from the Developmental Profile 4 (DP-4) Social-Emotional and Communication Scales. This assessment will yield a total raw score ranging from 0 (minimum) to 70 (maximum), with higher scores indicating better outcomes.
Caregiver Report of Child Disruptive Behavior
Time frame: Between 25-30 weeks
The caregiver's assessment of the child's disruptive behavior is measured from the Eyberg Child Behavior Inventory.
Family Life Impairment Scale
Time frame: Between 25-30 weeks
Family life participation outcomes are measured using the Family Life Impairment Scale. The measure's values range from 0 (minimum) to 38 (maximum) with higher scores indicating worse outcomes.
2 secondary outcomes
Caregiver Satisfaction
Time frame: Between 25-30 weeks
Caregiver Perceived Stress
Time frame: Between 25-30 weeks
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 19 Oct 2026.
- Individual participant dataSharing planned: Yes. We will share the final dataset in two ways: the National Database for Autism Research (NDAR) and the Inter-University Consortium for Political and Social Research (ICPSR).
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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. 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 Phase 2 study testing Social Communication, Disruptive Behavior and Social Communication + Reduce Frequency in people with Autism and Autism Spectrum Disorder, run by Northwestern University 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 8 inclusion and 0 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 19 Oct 2026. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Observed Child Social Communication (time frame: Between 25-30 weeks). The study lists 5 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 19 Oct 2026.