Autism Spectrum DisorderNCT04729127

A Trial of Project ImPACT in Early Intervention

A study testing Project ImPACT in people with Autism Spectrum Disorder, run by University of Pennsylvania at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Our pilot study will address a number of pressing questions, including: Can community clinicians successfully coach parents of children with ASD in evidence-based practice to achieve positive outcomes for their children and themselves? What dose is necessary to achieve change? And what is the cost effectiveness of… Read more about this study

Who is it for?: Ages Up to 30 months
Conditions the study is for: Autism Spectrum Disorder
What is being tested?: Project ImPACT
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 79 participants
Where: 1 siteUnited States
Study dates: 11 Jun 2020to 31 Aug 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 Up to 30 months
All sexes
No healthy volunteers
Child

Who may be able to join

child is <30 months of age (to receive 6 months of intervention)
a classification of autism or high autism risk as determined by the EI system;
receive early intervention services through the infant and toddler program; and
parent is willing to complete the parent measures that are part of this study.

Who cannot join

1) be over 30 months of age

Trial locations and contacts

1 site in 1 country.

United States1 site

Center for Mental Health
Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: A Randomized Trial of Project ImPACT, an Evidence-based Intervention for Infants and Toddlers With Autism Spectrum Disorder

Read the detailed description

The investigators will partner with 6 of Philadelphias 13 agencies serving young children with ASD. The investigators will enroll 3 clinicians per agency (18 total) and 3 families per clinician (54 total). Agencies will be randomized to the 3 arms. The investigators will measure clinician fidelity and parent fidelity through direct observation and selfreport. The investigators will measure child and parent outcomes at baseline and 6 months using measures common to similar trials. Resource use for the economic evaluation will occur quarterly and will take a societal approach. The investigators will partner with a community advisory board to apply the findings from this pilot trial to the development of a larger, system-wide subsequent trial that is feasible and ecologically valid for Philadelphias EI system. The results will provide rigorous information about whether evidence-based autism interventions for young children can be implemented successfully with the resources available in cities like Philadelphia, the role of hours of treatment in improving child outcomes, and the cost-benefit implications for families and community agencies. This project has the potential to dramatically improve the services families of young children with ASD in Philadelphia receive, and significantly improve their long-term outcomes. This preliminary trial would provide the EI system with the information needed to bring this type of intervention to scale across the entire system. It also would serve as the foundation for an application for federal funds to conduct a system-wide study of Project ImPACT as implemented in all Philadelphia agencies serving children with ASD.

Conditions: Autism Spectrum Disorder
Being tested: Project ImPACT
Medical subject headings: Autism Spectrum Disorder

What participants receive

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

Project ImPACTBehavioural
Project ImPACT (Improving Parents As Communication Teachers) is an evidence-based parent-mediated intervention program based on best practices in early intervention. The program is designed for young children up to age six with social communication delays, including autism spectrum disorder. Project ImPACT focuses on social engagement, language, social imitation, and play. Project ImPACT is a naturalistic developmental behavioral intervention (NDBI).

Study groups in NCT04729127
Study group	Role	What they receive
Treatment as usual	No intervention	The families keep receiving their treatment as usual
ImPACT at a dose of 1 hour/week	Active comparator	ImPACT at a dose of 1 hour/week over 6 months Receives: Behavioral: Project ImPACT
ImPACT at 4 hours/week	Active comparator	ImPACT at 4 hours/week over 6 months. Receives: Behavioral: Project ImPACT

What is being measured

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

Vineland Adaptive Behavior Scales 3rd Edition-Communication Domain
The Vineland-3 is a standardized measure of adaptive behavior--the things that people do to function in their everyday lives.
Because it is a norm-based instrument, the examinee's adaptive functioning is compared to that of others his or her age. The ABC score is based on scores for three specific adaptive behavior domains: Communication, Daily Living Skills, and Socialization.
The domain scores are also expressed as standard scores with a mean of 100 and standard deviation of 15. The standard score range for the Communication domain is 20-140. Higher scores indicate better outcomes.
Measured: Time 1 (Baseline) and Time 3 (6 Month Follow Up) for a total of 6 months.
Brief Observation of Social Communication Change (BOSCC)
The BOSCC is a measure of treatment-response for social-communication behaviors.
The BOSCC contains 12 items in total. The score range of individual items is 0-5. Items are then summed to a total score. The range for a total score is 0-60. Higher scores are an indication of more symptom severity.
Measured: Baseline and 6 Month Follow Up (Exit) (6 months)
Early Intervention Parenting Self-Efficacy Scale (EIPSES)
The EIPSES is a measure of parent self-efficacy. It is a 16-item self-report measure that examines parents beliefs about their ability to produce positive changes and promote optimal development in their child with a disability. Once items are summed, the total score ranges from 16-112, with higher scores indicating better self-efficacy and empowerment.
Measured: Baseline and 6 Month Follow Up (6 months)
Parenting Interactions With Children: Checklist of Observations Linked to Outcomes (PICCOLO)
Parent Responsiveness is measured using the Parenting Interactions with Children: Checklist of Observations Linked to Outcomes (PICCOLO™). PICCOLO is a checklist of 29 observable developmentally supportive parenting behaviors, with children ages 10-47 months, in four domains (affection, responsiveness, encouragement, and teaching).
Each item is scored as 0, 1 or 2.
0 = Behavior absent, not observed
1. = Behavior barely there, sometimes
2. = Behavior seen often
Assessors add scores for each item to calculate a domain score and an overall domain score. Total scores can range from 0-58, with higher scores indicating more parent responsiveness to child behavior and actions.
Measured: Collected at Baseline and 6 Month Follow Up (time frame: 6 months)
Project ImPACT Intervention Fidelity Checklist
Parent Treatment Adherence will be assessed through a videotaped parent-child interaction at home. Parent behavior will be scored for use of the intervention strategies using the Project ImPACT Intervention Fidelity Checklist. The scores range from 1 to 5, the higher the score representing the most adherence to the Project ImPACT intervention. The overall score is an average of scores from each item.
Measured: 6 months
Project ImPACT Coaching Fidelity Checklist
Clinician fidelity is measured using the Project ImPACT Coaching Fidelity Checklist. The checklist measures the providers' use of the core components to Project ImPACT. The form uses a 3-point score (scored from 0-2): 0, Not observed; 1, partially observed; and 2, observed. The final score is a summary percentage rating of overall fidelity with a range of 0-100%.
Measured: 3 Month Follow-Up (3 month time frame)
Vineland Adaptive Behavior Scales 3rd Edition-Socialization Domain
The Vineland-3 is a standardized measure of adaptive behavior--the things that people do to function in their everyday lives.
Because it is a norm-based instrument, the examinee's adaptive functioning is compared to that of others his or her age. The ABC score is based on scores for three specific adaptive behavior domains: Communication, Daily Living Skills, and Socialization.
The domain scores are also expressed as standard scores with a mean of 100 and standard deviation of 15. The standard score range for the Socialization domain is 20-140. Higher scores indicate better outcomes.
Measured: 6 months

Secondary outcomes (1)

Parent Empowerment and Coaching in Early Intervention (PEACE) Caregiver Coaching Fidelity Tool
The PEACE Fidelity Tool measures a provider's caregiver coaching quality by evaluating the quality and use of evidence based caregiver coaching strategies during recorded EI session across 5 domains (collaboration, daily routines, demonstration, practice and feedback, and reflection).
The tool consists of 25 items scored on a 5 point scale from 1-5. Domains and total scores are calculated by averaging items. Scores can range from 1-5, with higher scores indicating better coaching competency and quality.
Measured: 3 Month Follow Up (3 Months)

Timeline

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

11 Jun 202031 Aug 2022

First posted28 Jan 2021
Study start11 Jun 2020
Primary completion15 Aug 2022
Study completion31 Aug 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
More trials run by University of PennsylvaniaThe 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: Parallel groups
Masking: None (open label)
Enrolment: 79 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04729127
Sponsor's protocol ID: 842506
Status last verified: Mar 2025
First submitted: 22 Jan 2021
Last updated: 3 Apr 2025
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Trial of Project ImPACT, an Evidence-based Intervention for Infants and Toddlers With Autism Spectrum Disorder
ClinicalTrials.gov ID: NCT04729127
Acronym / sponsor ID: 842506
Conditions: Autism Spectrum Disorder
Study type: Interventional
Recruitment status: Completed
Enrolment: 79 participants (actual)
Lead sponsor: University of PennsylvaniaUniversity, hospital or other
Collaborators: Michigan State University
Study start: 11 Jun 2020 (actual)
Primary completion: 15 Aug 2022 (actual)
Study completion: 31 Aug 2022 (actual)
First posted: 28 Jan 2021 (actual)
Results: Posted 3 Apr 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Treatment as usual	No intervention	–The families keep receiving their treatment as usual
ImPACT at a dose of 1 hour/week	Active comparator	Behavioral: Project ImPACTImPACT at a dose of 1 hour/week over 6 months
ImPACT at 4 hours/week	Active comparator	Behavioral: Project ImPACTImPACT at 4 hours/week over 6 months.

Who may qualify

Ages: Up to 30 months
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (4 listed)

child is <30 months of age (to receive 6 months of intervention)
a classification of autism or high autism risk as determined by the EI system;
receive early intervention services through the infant and toddler program; and
parent is willing to complete the parent measures that are part of this study.

Key exclusion criteria (1 listed)

1) be over 30 months of age

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
Project ImPACTProject ImPACT (Improving Parents As Communication Teachers) is an evidence-based parent-mediated intervention program based on best practices in early intervention. The program is designed for young children up to age six with social communication delays, including autism spectrum disorder. Project ImPACT focuses on social engagement, language, social imitation, and play. Project ImPACT is a naturalistic developmental behavioral intervention (NDBI).	Behavioural	ImPACT at 4 hours/week, ImPACT at a dose of 1 hour/week

Primary outcome

Vineland Adaptive Behavior Scales 3rd Edition-Communication Domain
Time frame: Time 1 (Baseline) and Time 3 (6 Month Follow Up) for a total of 6 months.
The Vineland-3 is a standardized measure of adaptive behavior--the things that people do to function in their everyday lives. Because it is a norm-based instrument, the examinee's adaptive functioning is compared to that of others his or her age. The ABC score is based on scores for three specific adaptive behavior domains: Communication, Daily Living Skills, and Socialization. The domain scores are also expressed as standard scores with a mean of 100 and standard deviation of 15. The standard score range for the Communication domain is 20-140. Higher scores indicate better outcomes.
Brief Observation of Social Communication Change (BOSCC)
Time frame: Baseline and 6 Month Follow Up (Exit) (6 months)
The BOSCC is a measure of treatment-response for social-communication behaviors. The BOSCC contains 12 items in total. The score range of individual items is 0-5. Items are then summed to a total score. The range for a total score is 0-60. Higher scores are an indication of more symptom severity.
Early Intervention Parenting Self-Efficacy Scale (EIPSES)
Time frame: Baseline and 6 Month Follow Up (6 months)
The EIPSES is a measure of parent self-efficacy. It is a 16-item self-report measure that examines parents beliefs about their ability to produce positive changes and promote optimal development in their child with a disability. Once items are summed, the total score ranges from 16-112, with higher scores indicating better self-efficacy and empowerment.
Parenting Interactions With Children: Checklist of Observations Linked to Outcomes (PICCOLO)
Time frame: Collected at Baseline and 6 Month Follow Up (time frame: 6 months)
Parent Responsiveness is measured using the Parenting Interactions with Children: Checklist of Observations Linked to Outcomes (PICCOLO™). PICCOLO is a checklist of 29 observable developmentally supportive parenting behaviors, with children ages 10-47 months, in four domains (affection, responsiveness, encouragement, and teaching). Each item is scored as 0, 1 or 2. 0 = Behavior absent, not observed 1. = Behavior barely there, sometimes 2. = Behavior seen often Assessors add scores for each item to calculate a domain score and an overall domain score. Total scores can range from 0-58, with higher scores indicating more parent responsiveness to child behavior and actions.
Project ImPACT Intervention Fidelity Checklist
Time frame: 6 months
Parent Treatment Adherence will be assessed through a videotaped parent-child interaction at home. Parent behavior will be scored for use of the intervention strategies using the Project ImPACT Intervention Fidelity Checklist. The scores range from 1 to 5, the higher the score representing the most adherence to the Project ImPACT intervention. The overall score is an average of scores from each item.
Project ImPACT Coaching Fidelity Checklist
Time frame: 3 Month Follow-Up (3 month time frame)
Clinician fidelity is measured using the Project ImPACT Coaching Fidelity Checklist. The checklist measures the providers' use of the core components to Project ImPACT. The form uses a 3-point score (scored from 0-2): 0, Not observed; 1, partially observed; and 2, observed. The final score is a summary percentage rating of overall fidelity with a range of 0-100%.
Vineland Adaptive Behavior Scales 3rd Edition-Socialization Domain
Time frame: 6 months
The Vineland-3 is a standardized measure of adaptive behavior--the things that people do to function in their everyday lives. Because it is a norm-based instrument, the examinee's adaptive functioning is compared to that of others his or her age. The ABC score is based on scores for three specific adaptive behavior domains: Communication, Daily Living Skills, and Socialization. The domain scores are also expressed as standard scores with a mean of 100 and standard deviation of 15. The standard score range for the Socialization domain is 20-140. Higher scores indicate better outcomes.

1 secondary outcome

Parent Empowerment and Coaching in Early Intervention (PEACE) Caregiver Coaching Fidelity Tool
Time frame: 3 Month Follow Up (3 Months)

Results and safety

Results posted to the registry on 3 Apr 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment as Usual: Children	18	12
Treatment as Usual: Early Interventionists	6	6
Treatment as Usual: Caregivers	18	12
ImPACT at a Dose of 1 Hour/Week: Children	23	16
ImPACT at a Dose of 1 Hour/Week: Early Interventionists	6	6
ImPACT at a Dose of 1 Hour/Week: Caregivers	23	16
ImPACT at 4 Hours/Week: Children	20	17
ImPACT at 4 Hours/Week: Early Interventionists	6	6
ImPACT at a Dose of 4 Hours/Week: Caregivers	20	17

Primary outcome: Vineland Adaptive Behavior Scales 3rd Edition-Communication Domain

Time frame: Time 1 (Baseline) and Time 3 (6 Month Follow Up) for a total of 6 months.. Mean (Standard Deviation). Unit: units on a scale

Measure	Treatment as Usual n = 12	ImPACT at a Dose of 1 Hour/Week n = 17	ImPACT at 4 Hours/Week n = 17
Baseline	69.4 (15.2)	65.2 (14.0)	63.4 (18.0)
Follow-Up	69.4 (15.7)	61.4 (21.6)	54.9 (18.4)

Treatment as Usual vs ImPACT at a Dose of 1 Hour/Week: p = .79, Regression, Linear
Treatment as Usual vs ImPACT at 4 Hours/Week: p = .27, Regression, Linear

Population analysed: Participants in the arms/groups "Treatment as Usual: Early Interventionists", "ImPACT at a Dose of 1 Hour/Week: Early Interventionists", "ImPACT at 4 Hours/Week: Early Interventionists", "Treatment as Usual: Caregivers", "ImPACT at a Dose of 1 Hour/Week: Caregivers", and ImPACT at 4 Hours/Week: Caregivers" are not included in the analysis as the measure's intent is to assess child outcomes.

Primary outcome: Brief Observation of Social Communication Change (BOSCC)

Time frame: Baseline and 6 Month Follow Up (Exit) (6 months). Mean (Standard Deviation). Unit: score on a scale

Measure	Treatment as Usual: Children n = 12	ImPACT at a Dose of 1 Hour/Week: Children n = 17	ImPACT at 4 Hours/Week: Children n = 17
Baseline	35.6 (29.2)	36.6 (8.5)	37.0 (8.8)
Follow-Up	29.2 (10.3)	34.8 (10.3)	36.2 (5.6)

Treatment as Usual: Children vs ImPACT at a Dose of 1 Hour/Week: Children: p = .04, Regression, Linear
Treatment as Usual: Children vs ImPACT at 4 Hours/Week: Children: p = .02, Regression, Linear

Population analysed: Participants in the arms/groups "Treatment as Usual: Early Interventionists", "ImPACT at a Dose of 1 Hour/Week: Early Interventionists", "ImPACT at 4 Hours/Week: Early Interventionists", "Treatment as Usual: Caregivers", "ImPACT at a Dose of 1 Hour/Week: Caregivers", "ImPACT at 4 Hours/Week: Caregivers" are not included in the analysis as the measure's intent is to assess child outcomes.

Primary outcome: Early Intervention Parenting Self-Efficacy Scale (EIPSES)

Time frame: Baseline and 6 Month Follow Up (6 months). Mean (Standard Deviation). Unit: score on a scale

Measure	Treatment as Usual: Caregivers n = 12	ImPACT at a Dose of 1 Hour/Week: Caregivers n = 17	ImPACT at 4 Hours/Week: Caregivers n = 17
Baseline	87.3 (9.7)	84.8 (9.4)	87.74 (6.14)
Follow-Up	87.5 (9.1)	89.4 (12.2)	89.95 (9.98)

Treatment as Usual: Caregivers vs ImPACT at a Dose of 1 Hour/Week: Caregivers: p = .78, Regression, Linear
Treatment as Usual: Caregivers vs ImPACT at 4 Hours/Week: Caregivers: p = .89, Regression, Linear

Population analysed: Participants in the arms/groups "Treatment as Usual: Early Interventionists", "ImPACT at a Dose of 1 Hour/Week: Early Interventionists", "ImPACT at 4 Hours/Week: Early Interventionists", "Treatment as Usual: Children", "ImPACT at a Dose of 1 Hour/Week: Children", "ImPACT at 4 Hours/Week: Children" are not included in the analysis as the measure's intent is to assess parent outcomes.

Primary outcome: Parenting Interactions With Children: Checklist of Observations Linked to Outcomes (PICCOLO)

Time frame: Collected at Baseline and 6 Month Follow Up (time frame: 6 months). Mean (Standard Deviation). Unit: total score on a scale

Measure	Treatment as Usual: Caregivers n = 12	ImPACT at a Dose of 1 Hour/Week: Caregivers n = 17	ImPACT at 4 Hours/Week: Caregivers n = 17
Baseline	35.5 (2.27)	40.2 (2.10)	38.0 (2.67)
Follow-Up	41.3 (2.24)	36.8 (3.18)	40.8 (2.57)

Treatment as Usual: Caregivers vs ImPACT at a Dose of 1 Hour/Week: Caregivers: p = .07, Regression, Linear
Treatment as Usual: Caregivers vs ImPACT at 4 Hours/Week: Caregivers: p = .88, Regression, Linear

Population analysed: Participants in the arms/groups "Treatment as Usual: Early Interventionists", "ImPACT at a Dose of 1 Hour/Week: Early Interventionists", "ImPACT at 4 Hours/Week: Early Interventionists", "Treatment as Usual: Children", "ImPACT at a Dose of 1 Hour/Week: Children", "ImPACT at 4 Hours/Week: Children" are not included in the analysis as the measure's intent is to assess parent outcomes.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse event data was collected for the course of 2 years for the study. Each participant's adverse event data was assessed during their study duration. For child/parent dyads, this was starting at Baseline and ending once they completed the 6 Month Followup assessment (6-7 month time period). For early interventionists, the adverse event period was starting at enrollment until all their enrolled child/parent dyads were finished with study procedures and their enrollment was complete (2 years). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment as Usual: Children	0 of 18 (0%)	0 of 18 (0%)	0 of 18
Treatment as Usual: Early Interventionists	0 of 6 (0%)	0 of 6 (0%)	0 of 6
ImPACT at a Dose of 1 Hour/Week: Children	0 of 23 (0%)	0 of 23 (0%)	0 of 23
ImPACT at a Dose of 1 Hour/Week: Early Interventionists	0 of 6 (0%)	0 of 6 (0%)	0 of 6
ImPACT at 4 Hours/Week: Children	0 of 20 (0%)	0 of 20 (0%)	0 of 20
ImPACT at 4 Hours/Week: Early Interventionists	0 of 6 (0%)	0 of 6 (0%)	0 of 6
Treatment as Usual: Caregivers	0 of 18 (0%)	0 of 18 (0%)	0 of 18
ImPACT at a Dose of 1 Hour/Week: Caregivers	0 of 23 (0%)	0 of 23 (0%)	0 of 23
ImPACT at 4 Hours/Week: Caregivers	0 of 20 (0%)	0 of 20 (0%)	0 of 20

Limitations and caveats (from the sponsor): The study occurred during the height of the COVID-19 pandemic leading to additional stressors and burdens for participating providers and families. High attrition in family participants occurred largely due to families dropping their services with their provider. BOSCC video recordings were recorded in families' homes over Zoom, which introduced a high variability in quality.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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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 study testing Project ImPACT in people with Autism Spectrum Disorder, run by University of Pennsylvania 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 4 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: finished, as of the sponsor's last update on 3 Apr 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?

Yes. Results are posted in the registry (first posted 3 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Vineland Adaptive Behavior Scales 3rd Edition-Communication Domain (time frame: Time 1 (Baseline) and Time 3 (6 Month Follow Up) for a total of 6 months.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04729127.

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 3 Apr 2025.