AutismNCT06596226
Evaluating Pathways Mutual Gaze Protocol on Social Skills in Young Children Suspected of Autism
A study testing Pathways Parent Mediated Intervention and Pathways Parent Mediated Intervention without Mutual Gaze in people with Autism, run by The University of Texas at Dallas at 1 site in United States.
Trial summary
Purpose of the Study: The goal of this clinical trial is to find out if a technique called the "mutual gaze procedure," used in Pathways Early Intervention (Pathways), is the key to helping improve social communication, language, and everyday skills in young children (16-30 months old) who are at high risk for autism… Read more about this study
- Who is it for?
- Ages 16 to 30 months
- Conditions the study is for
- Autism
- What is being tested?
- Pathways Parent Mediated Intervention and Pathways Parent Mediated Intervention without Mutual Gaze
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Sep 2024to 15 Dec 2026
- 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 16 to 30 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children must be between 16-30 months old at the start of the study;
- Children must receive social disability index of 7 or lower if child is 16-20 months old, or 8.1 or lower if child is 21-30 months old on the EarliPointTM assessment with a researcher (i.e., human) confirming social challenges are present;
- Parents must report no other known neurological or genetic concerns or disorders
- Parents must be fluent in English or Spanish
- Parents must live within a 30-mile radius of the Callier Center Dallas or Callier Center Richardson.
Who cannot join
- Children younger than 16 months or older than 30 months at the start of the study
- Children who are not at high risk for autism based on an EarliPointTM assessment (with researcher confirmation of social challenges)
- Children whose parents report they have any other known neurological or genetic concerns or disorders;
- Children whose parents are not fluent in English or Spanish
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas at Dallas
Richardson, Texas, 75080
About this study
Official title: Evaluating The Efficacy of Pathways Parent-Mediated Intervention's Mutual Gaze Protocol on Social Skills in Young Children Suspected of Having Autism: A Randomized Control Trial
Purpose of the Study: The goal of this clinical trial is to find out if a technique called the "mutual gaze procedure," used in Pathways Early Intervention (Pathways), is the key to helping improve social communication, language, and everyday skills in young children (16-30 months old) who are at high risk for autism, particularly those from diverse cultural and language backgrounds.
What Will Happen: Researchers will compare two versions of the Pathways Intervention:
Read more
- Version 1: Includes mutual gaze strategies.
- Version 2: Does not include mutual gaze strategies.
What to Expect: Participants will:
- Attend 12 sessions of Pathways Intervention, each lasting 1.5 hours (or 15 weeks if there are cancellations).
- Come to the clinic for a developmental check-up three times: before starting Pathways, right after completing Pathways, and three months after finishing Pathways.
Read the detailed description
Purpose of the Study: The primary goal of this clinical trial is to evaluate whether a parent-mediated treatment can improve social communication, language, and adaptive functioning in 16-30-month-old children from diverse cultural and language backgrounds who are at high risk for autism (referred to as children with social challenges).
Study Design:
- Study Phase: N/A
- Intervention Model: Participants are assigned to one of two groups in parallel.
Study Description:
- Participants: 80 children aged 16-30 months who show social communication challenges and are at high risk for autism will be randomly assigned to one of two groups:
- Group 1: Pathways Intervention with mutual gaze strategies.
- Group 2: Pathways Intervention without mutual gaze strategies.
- Intervention Sessions: Participants will attend 12 sessions, each lasting 1.5 hours, over approximately 15 weeks (allowing for possible cancellations) of parent-mediated intervention in their homes or another convenient location.
Assessments: To track progress and evaluate long-term effects, participants will undergo several culturally and linguistically appropriate assessments at three time points:
- Baseline: Within two weeks before starting the intervention.
- Post-Intervention: Within two weeks after completing the intervention.
- Three-Month Follow-Up: 12-15 weeks after completing the intervention.
Each evaluation will take around two hours and will include:
- Child Assessments:
- Mullen Scale of Early Learning (MSEL): Assesses general developmental age (administered only at baseline).
- Communication and Symbolic Behavior Scales-Developmental Profile (CSBS-DP): Evaluates social communication.
- EarliPointTM: Measures social, verbal, and nonverbal cognition.
- Caregiver Questionnaires:
- Vineland Adaptive Behavior Scales, Third Edition (VABS-III): Assesses adaptive functioning.
- PhenX Toolkit Core Measures: Collects family and child demographic information, including parents' and grandparents' place of birth (administered only at baseline).
The CSBS-DP and VABS-III have been validated as appropriate measures for determining meaningful changes in children with or at high risk for autism, based on previous research
- Conditions
- Autism
- Being tested
- Pathways Parent Mediated Intervention, Pathways Parent Mediated Intervention without Mutual Gaze
- Keywords
- Autism Intervention, Social development, Social communication
- Medical subject headings
- Autistic Disorder, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pathways Parent Mediated InterventionBehavioural
Pathways-trained research clinicians will conduct 90-minute weekly coaching sessions with caregivers in the family's home or other convenient location. Caregivers will receive a written version of the program manual. Sessions will review information about social communication, infusing mutual gaze in social sensory routines, and using naturalistic developmental behavioral strategies. Interventionists will demonstrate intervention strategies and provide caregivers with practice feedback and self-reflection.
Pathways Parent Mediated Intervention without Mutual GazeBehavioural
Pathways-trained research clinicians will conduct 90-minute weekly coaching sessions with caregivers in the family's home or other convenient location. Caregivers will receive a written version of the program manual. Sessions will review information about social communication, social sensory routines, and naturalistic developmental behavioral strategies described in the program manual. Interventionists will demonstrate intervention strategies and provide caregivers with practice feedback and self-reflection.
| Study group | Role | What they receive |
|---|---|---|
| Pathways with a Mutal Gaze Protocol | Experimental | 12 90-minute sessions (or 15 weeks, whichever comes first) of Pathways manualized Naturalistic Developmental Behavioral Intervention (NDBI) parent-mediated intervention (research version). Pathways uses a coaching model. Receives: Behavioral: Pathways Parent Mediated Intervention |
| Pathways without Mutual Gaze Protocol | Active comparator | 12 90-minute sessions (or 15 weeks, whichever comes first) of Pathways manualized Naturalistic Developmental Behavioral Intervention (NDBI) parent-mediated intervention (research version) without the Mutual Gaze protocol. Pathways uses a coaching model. Receives: Behavioral: Pathways Parent Mediated Intervention without Mutual Gaze |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improved Social skills
Assessors blind to group assignment will evaluate each child for social skills using the EarliPointTM The EarliPointTM is an FDA-authorized eye-tracking tool that uses artificial intelligence (AI) eye-tracking technology to assess social disability in children between 16 and 30 months by measuring the number of social interactions a child observes on the portable eye-tracking screen. EarliTech will be used to measure improved social skills. There are 2 different EarliTech Scores: social disability and Verbal and nonverbal. Social disability scores range from -15 to +25, higher scores indicate better ability. Verbal and nonverbal scores range from 0-90, high scores indicate better ability.
Measured: At baseline (i.e., within two weeks prior to the start of intervention); Post-intervention (i.e., within two weeks after completing the intervention); At three-month follow-up
Improved Social Communication Skills
Change in the raw scores obtained on the social, speech and symbolic composite of The Communication and Symbolic Behavior Scales- Developmental Profile (CSBS-DP) will be measured. Raw scores for the social, speech and symbolic composite range from 0-64, 0-54 and 0-53 respectively, 0 being the worst score. The CSBS-DP is a direct assessment of early social communication.
Measured: At baseline (i.e., within two weeks prior to the start of intervention); Post-intervention (i.e., within two weeks after completing the intervention); At three-month follow-up
Change in Adaptive Functioning
The Vineland II is a standardized parent interview to assess adaptive functioning. Change in raw scores obtained on Vineland Adaptive Behavior Scales, Second Edition (Vineland II) will be measured. The Vineland II has 4 domains - Communication, Daily Living, Social Skills and Relationships, Physical Activity. The raw scores for these domains range from 0-252, 0-286, 0-224, 0-154 respectively (lower scores being worse outcomes).
Measured: At baseline (i.e., within two weeks prior to the start of intervention); Post-intervention (i.e., within two weeks after completing the intervention); At three-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start10 Sep 2024
- Primary completion15 Oct 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for AutismStudies of the same condition, open and under way.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Texas at Dallas
- Sponsor type
- University, hospital or other
- Collaborators
- Texas Higher Education Coordinating Board
- Responsible party
- Principal investigator, Pamela Rollins, The University of Texas at Dallas
- Investigators
- Pamela Rollins, EdD, Principal investigator, The University of Texas at Dallas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06596226
- Sponsor's protocol ID
- UTD IRB 24-804
- Status last verified
- May 2026
- First submitted
- 21 Aug 2024
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Considering reporting the collected data to the National Institute of Mental Health Data Archive (NDA). NDA provides a robust system for defining data dictionaries and metadata for all datasets, and the uploaded data itself will be in delimited plain text format. The shared data will include demographic data and measures administered to participants, as well as analyzed data.
Publications
Anagnostou E, Jones N, Huerta M, Halladay AK, Wang P, Scahill L, Horrigan JP, Kasari C, Lord C, Choi D, Sullivan K, Dawson G. Measuring social communication behaviors as a treatment endpoint in individuals with autism spectrum disorder. Autism. 2015 Jul;19(5):622-36. doi: 10.1177/1362361314542955. Epub 2014 Aug 5.
PubMed 25096930(Anagnostou et al., 2015; Chatham et al., 2018; McCracken et al., 2021).
Chatham CH, Taylor KI, Charman T, Liogier D'ardhuy X, Eule E, Fedele A, Hardan AY, Loth E, Murtagh L, Del Valle Rubido M, San Jose Caceres A, Sevigny J, Sikich L, Snyder L, Tillmann JE, Ventola PE, Walton-Bowen KL, Wang PP, Willgoss T, Bolognani F. Adaptive behavior in autism: Minimal clinically important differences on the Vineland-II. Autism Res. 2018 Feb;11(2):270-283. doi: 10.1002/aur.1874. Epub 2017 Sep 21.
PubMed 28941213McCracken JT, Anagnostou E, Arango C, Dawson G, Farchione T, Mantua V, McPartland J, Murphy D, Pandina G, Veenstra-VanderWeele J; ISCTM/ECNP ASD Working Group. Drug development for Autism Spectrum Disorder (ASD): Progress, challenges, and future directions. Eur Neuropsychopharmacol. 2021 Jul;48:3-31. doi: 10.1016/j.euroneuro.2021.05.010. Epub 2021 Jun 19.
PubMed 34158222Mullen, E. M. (1995). Mullen Scales of Early Learning. American Guidance Service, Guilford Press.
Wetherby, A., & Prizant, B. (2002). Communication and Symbolic Behavior Scales- Developmental Profile (1st normed ed.). Paul H. Brookes.
Sparrow, S. S., Cicchetti, D. V., & Saulnier, C. A. (2016). Vineland Adaptive Behavior Scales, Third Edition (Vineland-3). Pearson.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating The Efficacy of Pathways Parent-Mediated Intervention's Mutual Gaze Protocol on Social Skills in Young Children Suspected of Having Autism: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06596226
- Acronym / sponsor ID
- UTD IRB 24-804
- Conditions
- Autism
- Keywords
- Autism Intervention, Social development, Social communication
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- The University of Texas at DallasUniversity, hospital or other
- Collaborators
- Texas Higher Education Coordinating Board
- Study start
- 10 Sep 2024 (actual)
- Primary completion
- 15 Oct 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 19 Sep 2024 (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.
Purpose of the Study: The goal of this clinical trial is to find out if a technique called the "mutual gaze procedure," used in Pathways Early Intervention (Pathways), is the key to helping improve social communication, language, and everyday skills in young children (16-30 months old) who are at high risk for autism, particularly those from diverse cultural and language backgrounds.
What Will Happen: Researchers will compare two versions of the Pathways Intervention:
- Version 1: Includes mutual gaze strategies.
- Version 2: Does not include mutual gaze strategies.
What to Expect: Participants will:
- Attend 12 sessions of Pathways Intervention, each lasting 1.5 hours (or 15 weeks if there are cancellations).
- Come to the clinic for a developmental check-up three times: before starting Pathways, right after completing Pathways, and three months after finishing Pathways.
Detailed description
Purpose of the Study: The primary goal of this clinical trial is to evaluate whether a parent-mediated treatment can improve social communication, language, and adaptive functioning in 16-30-month-old children from diverse cultural and language backgrounds who are at high risk for autism (referred to as children with social challenges).
Study Design:
- Study Phase: N/A
- Intervention Model: Participants are assigned to one of two groups in parallel.
Study Description:
- Participants: 80 children aged 16-30 months who show social communication challenges and are at high risk for autism will be randomly assigned to one of two groups:
- Group 1: Pathways Intervention with mutual gaze strategies.
- Group 2: Pathways Intervention without mutual gaze strategies.
- Intervention Sessions: Participants will attend 12 sessions, each lasting 1.5 hours, over approximately 15 weeks (allowing for possible cancellations) of parent-mediated intervention in their homes or another convenient location.
Assessments: To track progress and evaluate long-term effects, participants will undergo several culturally and linguistically appropriate assessments at three time points:
- Baseline: Within two weeks before starting the intervention.
- Post-Intervention: Within two weeks after completing the intervention.
- Three-Month Follow-Up: 12-15 weeks after completing the intervention.
Each evaluation will take around two hours and will include:
- Child Assessments:
- Mullen Scale of Early Learning (MSEL): Assesses general developmental age (administered only at baseline).
- Communication and Symbolic Behavior Scales-Developmental Profile (CSBS-DP): Evaluates social communication.
- EarliPointTM: Measures social, verbal, and nonverbal cognition.
- Caregiver Questionnaires:
- Vineland Adaptive Behavior Scales, Third Edition (VABS-III): Assesses adaptive functioning.
- PhenX Toolkit Core Measures: Collects family and child demographic information, including parents' and grandparents' place of birth (administered only at baseline).
The CSBS-DP and VABS-III have been validated as appropriate measures for determining meaningful changes in children with or at high risk for autism, based on previous research
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pathways with a Mutal Gaze Protocol | Experimental | Behavioral: Pathways Parent Mediated Intervention12 90-minute sessions (or 15 weeks, whichever comes first) of Pathways manualized Naturalistic Developmental Behavioral Intervention (NDBI) parent-mediated intervention (research version). Pathways uses a coaching model. |
| Pathways without Mutual Gaze Protocol | Active comparator | Behavioral: Pathways Parent Mediated Intervention without Mutual Gaze12 90-minute sessions (or 15 weeks, whichever comes first) of Pathways manualized Naturalistic Developmental Behavioral Intervention (NDBI) parent-mediated intervention (research version) without the Mutual Gaze protocol. Pathways uses a coaching model. |
Who may qualify
- Ages
- 16 to 30 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children must be between 16-30 months old at the start of the study;
- Children must receive social disability index of 7 or lower if child is 16-20 months old, or 8.1 or lower if child is 21-30 months old on the EarliPointTM assessment with a researcher (i.e., human) confirming social challenges are present;
- Parents must report no other known neurological or genetic concerns or disorders
- Parents must be fluent in English or Spanish
- Parents must live within a 30-mile radius of the Callier Center Dallas or Callier Center Richardson.
Key exclusion criteria (4 listed)
- Children younger than 16 months or older than 30 months at the start of the study
- Children who are not at high risk for autism based on an EarliPointTM assessment (with researcher confirmation of social challenges)
- Children whose parents report they have any other known neurological or genetic concerns or disorders;
- Children whose parents are not fluent in English or Spanish
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 |
|---|---|---|
| Pathways Parent Mediated InterventionPathways-trained research clinicians will conduct 90-minute weekly coaching sessions with caregivers in the family's home or other convenient location. Caregivers will receive a written version of the program manual. Sessions will review information about social communication, infusing mutual gaze in social sensory routines, and using naturalistic developmental behavioral strategies. Interventionists will demonstrate intervention strategies and provide caregivers with practice feedback and self-reflection. | Behavioural | Pathways with a Mutal Gaze Protocol |
| Pathways Parent Mediated Intervention without Mutual GazePathways-trained research clinicians will conduct 90-minute weekly coaching sessions with caregivers in the family's home or other convenient location. Caregivers will receive a written version of the program manual. Sessions will review information about social communication, social sensory routines, and naturalistic developmental behavioral strategies described in the program manual. Interventionists will demonstrate intervention strategies and provide caregivers with practice feedback and self-reflection. | Behavioural | Pathways without Mutual Gaze Protocol |
Primary outcome
Improved Social skills
Time frame: At baseline (i.e., within two weeks prior to the start of intervention); Post-intervention (i.e., within two weeks after completing the intervention); At three-month follow-up
Assessors blind to group assignment will evaluate each child for social skills using the EarliPointTM The EarliPointTM is an FDA-authorized eye-tracking tool that uses artificial intelligence (AI) eye-tracking technology to assess social disability in children between 16 and 30 months by measuring the number of social interactions a child observes on the portable eye-tracking screen. EarliTech will be used to measure improved social skills. There are 2 different EarliTech Scores: social disability and Verbal and nonverbal. Social disability scores range from -15 to +25, higher scores indicate better ability. Verbal and nonverbal scores range from 0-90, high scores indicate better ability.
Improved Social Communication Skills
Time frame: At baseline (i.e., within two weeks prior to the start of intervention); Post-intervention (i.e., within two weeks after completing the intervention); At three-month follow-up
Change in the raw scores obtained on the social, speech and symbolic composite of The Communication and Symbolic Behavior Scales- Developmental Profile (CSBS-DP) will be measured. Raw scores for the social, speech and symbolic composite range from 0-64, 0-54 and 0-53 respectively, 0 being the worst score. The CSBS-DP is a direct assessment of early social communication.
Change in Adaptive Functioning
Time frame: At baseline (i.e., within two weeks prior to the start of intervention); Post-intervention (i.e., within two weeks after completing the intervention); At three-month follow-up
The Vineland II is a standardized parent interview to assess adaptive functioning. Change in raw scores obtained on Vineland Adaptive Behavior Scales, Second Edition (Vineland II) will be measured. The Vineland II has 4 domains - Communication, Daily Living, Social Skills and Relationships, Physical Activity. The raw scores for these domains range from 0-252, 0-286, 0-224, 0-154 respectively (lower scores being worse outcomes).
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 26 Jun 2026.
- Background: PubMed 25096930Anagnostou E, Jones N, Huerta M, Halladay AK, Wang P, Scahill L, Horrigan JP, Kasari C, Lord C, Choi D, Sullivan K, Dawson G. Measuring social communication behaviors as a treatment endpoint in individuals with autism spectrum disorder. Autism. 2015 Jul;19(5):622-36. doi: 10.1177/1362361314542955. Epub 2014 Aug 5.
- Background(Anagnostou et al., 2015; Chatham et al., 2018; McCracken et al., 2021).
- Background: PubMed 28941213Chatham CH, Taylor KI, Charman T, Liogier D'ardhuy X, Eule E, Fedele A, Hardan AY, Loth E, Murtagh L, Del Valle Rubido M, San Jose Caceres A, Sevigny J, Sikich L, Snyder L, Tillmann JE, Ventola PE, Walton-Bowen KL, Wang PP, Willgoss T, Bolognani F. Adaptive behavior in autism: Minimal clinically important differences on the Vineland-II. Autism Res. 2018 Feb;11(2):270-283. doi: 10.1002/aur.1874. Epub 2017 Sep 21.
- Background: PubMed 34158222McCracken JT, Anagnostou E, Arango C, Dawson G, Farchione T, Mantua V, McPartland J, Murphy D, Pandina G, Veenstra-VanderWeele J; ISCTM/ECNP ASD Working Group. Drug development for Autism Spectrum Disorder (ASD): Progress, challenges, and future directions. Eur Neuropsychopharmacol. 2021 Jul;48:3-31. doi: 10.1016/j.euroneuro.2021.05.010. Epub 2021 Jun 19.
- BackgroundMullen, E. M. (1995). Mullen Scales of Early Learning. American Guidance Service, Guilford Press.
- BackgroundWetherby, A., & Prizant, B. (2002). Communication and Symbolic Behavior Scales- Developmental Profile (1st normed ed.). Paul H. Brookes.
- BackgroundSparrow, S. S., Cicchetti, D. V., & Saulnier, C. A. (2016). Vineland Adaptive Behavior Scales, Third Edition (Vineland-3). Pearson.
- Individual participant dataSharing planned: No. Considering reporting the collected data to the National Institute of Mental Health Data Archive (NDA). NDA provides a robust system for defining data dictionaries and metadata for all datasets, and the uploaded data itself will be in delimited plain text format. The shared data will include demographic data and measures administered to participants, as well as analyzed data.
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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.
Pamela Rollins, EdD principal investigator
The University of Texas at Dallas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pathways Parent Mediated Intervention and Pathways Parent Mediated Intervention without Mutual Gaze in people with Autism, run by The University of Texas at Dallas 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 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: under way, not looking for participants, as of the sponsor's last update on 26 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 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?
Improved Social skills (time frame: At baseline (i.e., within two weeks prior to the start of intervention); Post-intervention (i.e., within two weeks after completing the intervention); At three-month follow-up). 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?
On the ClinicalTrials.gov record for NCT06596226, which also lists 7 linked publications.
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 26 Jun 2026.