Autism Spectrum DisorderSDARIYANCT07222982
Social Groups for Autistic Young Adults (SDARIYA)
A study testing SDARI-YA and AYA in people with Autism Spectrum Disorder, run by Drexel University at 1 site in United States.
Trial summary
This is a clinical trial that will test whether a group program called SDARI (Socio-dramatic Affective Relational Intervention) can help autistic young adults between the ages of 18 and 30 feel more connected to others and improve their social relationships. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- SDARI-YA and AYA
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2026to Feb 2031
- 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 18 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Have graduated from high school (or an equivalent program) and are between the ages of 18-30 years old
- Demonstrate the ability to complete consent and all study measures and procedures in English
- Score ≥ 65 on the RAADS
- Score ≥ 70 on the KBIT-2R
- Score ≥ 6 on the ADOS-2 Module 4
- Are physically able to complete study activities (e.g., no significant physical impairment or mental condition restricting participation in study activities).
- Are physically able to travel to the AJ Drexel Autism Institute at Drexel University in Philadelphia, PA to attend all weekly study sessions
Who cannot join
- Are still enrolled in high school (or an equivalent program) or are not between the ages of 18-30 years old
- Are unable to complete study measures and/or procedures in English
- Are unable to complete consent procedures
- Score ≤ 65 on the RAADS
- Score ≤ 70 on the KBIT-2R
- Score ≤ 6 on the ADOS-2
Show all 9Show fewer
- Cannot physically complete study activities
- Cannot physically travel to the AJ Drexel Autism Institute at Drexel University in Philadelphia, PA to attend study sessions
- Have a severe medical or psychiatric condition preventing them from safely completing study activities
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kyleigh Hricak, B.A. contact
United States1 site, 1 recruiting
- Recruiting
Drexel University
Philadelphia, Pennsylvania, 19104
Matthew Lerner, PhD
About this study
Official title: Social Groups for Autistic Young Adults (SDARI)
This is a clinical trial that will test whether a group program called SDARI (Socio-dramatic Affective Relational Intervention) can help autistic young adults between the ages of 18 and 30 feel more connected to others and improve their social relationships.
The study will try to answer:
Read more
Can SDARI be used successfully with autistic adults? Does SDARI help people feel more connected, supported, and mentally well?
There are two groups in the study. One group will participate in the SDARI program, and the other group will do different structured activities that don't focus on social connection. Researchers will compare the two groups to see if SDARI leads to better outcomes.
Participants will:
Complete screening to confirm eligibility (including autism traits and IQ) Attend weekly in-person group sessions for 10 weeks Take part in games and activities designed to support connection and collaboration Complete surveys and interviews before, during, and after the program Have the option to choose someone close to them (like a friend or family member) to fill out surveys about their experiences
Read the detailed description
The proposed study will evaluate the Socio-dramatic Affective Relational Intervention (SDARI) in autistic young adults aged 18-30 years. SDARI is a group-based, performance-oriented intervention designed to support interpersonal engagement through structured, drama-based activities. The intervention emphasizes experiential learning and minimizes didactic instruction, focusing instead on affectively motivating games, collaborative interactions, and age-appropriate recreational activities.
Participants will be recruited through community organizations, university outreach channels, and autism service agencies. Eligibility will be determined through a multi-step screening process, including the RAADS, ADOS-2 Module 4, and KBIT-2R assessments. Eligible participants will be randomized into either the SDARI intervention group or a time-matched attention control group. Each group will meet weekly for 90-minute sessions over a 10-week period at the AJ Drexel Autism Institute.
The SDARI curriculum integrates three core components:
Use of improvisational and drama-based games tailored to the developmental stage and interests of autistic young adults.
Facilitation of peer-to-peer and participant-staff relationships to foster positive reinforcement and group cohesion.
Incorporation of motivating activities such as noncompetitive physical games and shared-interest tasks to enhance engagement.
The attention control condition will follow the same schedule and structure but will involve recreational activities that do not explicitly promote interpersonal interaction.
Participants will complete assessments at three timepoints: baseline (pre-intervention), post-intervention, and three-month follow-up. Measures will include self-report and informant-report questionnaires assessing interpersonal experiences, social networks, group cohesion, and mental health. Social Network Analysis (SNA) will be used to evaluate changes in participants' social connections and network structures over time.
All sessions will be video-recorded for fidelity monitoring. Staff will receive condition-specific training and weekly supervision to ensure consistency and adherence to the intervention protocol.
The study aims to assess the feasibility, acceptability, and preliminary efficacy of SDARI in autistic adult populations. Outcomes will inform future adaptations and dissemination of SDARI for broader use in clinical and community settings.
- Conditions
- Autism Spectrum Disorder
- Being tested
- SDARI-YA, AYA
- Keywords
- autism, intervention, social performance
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SDARI-YABehavioural
SDARI is a group-based, performance-based intervention designed to provide participants with opportunities to engage in and experience targeted interpersonal interactions, with minimal didactic instruction or instrumental reinforcement. The intervention consists of three core components:
SDARI utilizes affectively motivating acting games that are adapted for the developmental stage and characteristics of the target population.
Clinicians promote strong relationships among participants and between participants and clinicians by fostering a supportive and enjoyable environment, facilitating both structured and unstructured interactions, encouraging collaborative problem-solving, and reinforcing positive peer engagement.
SDARI incorporates motivating activities-such as noncompetitive physical games, shared interests, and goal-oriented tasks-to enhance interpersonal motivation and engagement.
AYAOther
Also called Control
This group provides concrete presentation of thematic content and connects those themes to specific semi-structured, naturalistic games and activities. Themes are addressed and targeted according to the developmental needs of individual group members.
Core Program Principles include:
Use of recreational, motivational activities adapted for the target age range and population Positive reinforcement of interpersonal engagement through structured activities Integration of strong, age-appropriate motivators
The AYA program uniquely combines these elements to facilitate both development and enjoyment. Group members engage in increasingly complex interpersonal interactions within the group setting and gain motivation to generalize these experiences across other environments, including home and educational contexts.
| Study group | Role | What they receive |
|---|---|---|
| SDARI-YA | Experimental | follow SDARI Protocol Receives: Behavioral: SDARI-YA |
| AYA | Active comparator | follow AYA Protocol Receives: Other: AYA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Social Responsiveness
measured by the Social Responsiveness Scale-2 (min= 0 and max=195), higher score= worse outcomes
Measured: Day 1 (Baseline) Week 10 (Post-intervention) Week 22 (3-Month Follow-up)
Secondary outcomes (10)
Friendship
measured by the Quality of Socialization Questionnaire for Young Adults (QSQ-YA):
For the conflict subscale (min 0, max= 24), a higher score indicates worse outcomes.
For the frequency items (min 0, max n/a (i.e. questionnaire asks how many get togethers did you have in a week), a higher count of get-togethers or dates indicates better outcomes
Measured: Day 1 (Baseline) Week 10 (Post-intervention) Week 22 (3-Month Follow-up)
Anxiety
measured by Anxiety Scale for Autism (Adults) (ASA-A) (min=0, max=60, a higher score=worse outcomes)
Measured: Day 1 (Baseline) Week 10 (Post-intervention) Week 22 (3-Month Follow-up)
Depression
measured by The Patient Health Questionnaire (PHQ-9) (min=0, max=27, higher scores=worse outcomes)
Measured: Day 1 (Baseline) Week 10 (Post-intervention) Week 22 (3-Month Follow-up)
Capacity for social and interpersonal pleasure
measured by the Anticipatory and Consummatory Interpersonal Pleasure Scale (ACIPS) (min=17, max=102, higher scores indicate worse outcomes)
Measured: Day 1 (Baseline) Week 10 (Post-intervention) Week 22 (3-Month Follow-up)
Cognitive flexibility
measured by the Cognitive Flexibility Inventory (CFI) (min=20, max= 140, higher scores indicate better outcomes)
Measured: Day 1 (Baseline) Week 10 (Post-intervention) Week 22 (3-Month Follow-up)
Loneliness
measured by the UCLA Loneliness Scale - Revised (min=20, max=80, higher score indicates worse outcomes.
Measured: Day 1 (Baseline) Week 10 (Post-intervention) Week 22 (3-Month Follow-up)
Social processes/dimensions
Other informant report measured by the Stanford Social Dimensions Scale (SSDS) (Social Motivation (14 items): Scores range from 14 to 70.
Social Affiliation (8 items): Scores range from 8 to 40. Expressive Social Communication (7 items): Scores range from 7 to 35. Social Recognition (7 items): Scores range from 7 to 35. Unusual Approach (4 items): Scores range from 4 to 20; higher scores indicate better outcomes)
Measured: Day 1 (Baseline) Week 10 (Post-intervention) Week 22 (3-Month Follow-up)
Empathy
other informant report measured by the Toronto Empathy Questionnaire - Informant Version (TEQ-IV) (min=0, max=64, higher scores indicate better outcomes)
Measured: Day 1 (Baseline) Week 10 (Post-intervention) Week 22 (3-Month Follow-up)
Group cohesion
measured by the Group Cohesiveness Scale (GCS). (min=7 and max=35, higher scores indicate better outcomes)
Measured: Week 1, Week 3, Week 5, Week 7, Week 8, Week 10
Social networks
as measured by Social Networks Survey (SNS) (min/max scores= N/A)
Measured: Day -14 to Day 0; Week 1 to Week 2; Week 11 to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2025
- Study start15 Jan 2026 (estimated)
- Primary completionFeb 2030 (estimated)
- Study completionFeb 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies 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
- Model description
- SDARIYA vs AYA (control)
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Drexel University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew Lerner, Drexel University
- Investigators
- Matthew Lerner, PhD, Principal investigator, Drexel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07222982
- Sponsor's protocol ID
- 2409010784
- Acronym
- SDARIYA
- Status last verified
- Oct 2025
- First submitted
- 1 Oct 2025
- Last updated
- 31 Oct 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 31 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social Groups for Autistic Young Adults (SDARI)
- ClinicalTrials.gov ID
- NCT07222982
- Acronym / sponsor ID
- SDARIYA / 2409010784
- Conditions
- Autism Spectrum Disorder
- Keywords
- autism, intervention, social performance
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Drexel UniversityUniversity, hospital or other
- Study start
- 15 Jan 2026 (estimated)
- Primary completion
- Feb 2030 (estimated)
- Study completion
- Feb 2031 (estimated)
- First posted
- 30 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a clinical trial that will test whether a group program called SDARI (Socio-dramatic Affective Relational Intervention) can help autistic young adults between the ages of 18 and 30 feel more connected to others and improve their social relationships.
The study will try to answer:
Can SDARI be used successfully with autistic adults? Does SDARI help people feel more connected, supported, and mentally well?
There are two groups in the study. One group will participate in the SDARI program, and the other group will do different structured activities that don't focus on social connection. Researchers will compare the two groups to see if SDARI leads to better outcomes.
Participants will:
Complete screening to confirm eligibility (including autism traits and IQ) Attend weekly in-person group sessions for 10 weeks Take part in games and activities designed to support connection and collaboration Complete surveys and interviews before, during, and after the program Have the option to choose someone close to them (like a friend or family member) to fill out surveys about their experiences
Detailed description
The proposed study will evaluate the Socio-dramatic Affective Relational Intervention (SDARI) in autistic young adults aged 18-30 years. SDARI is a group-based, performance-oriented intervention designed to support interpersonal engagement through structured, drama-based activities. The intervention emphasizes experiential learning and minimizes didactic instruction, focusing instead on affectively motivating games, collaborative interactions, and age-appropriate recreational activities.
Participants will be recruited through community organizations, university outreach channels, and autism service agencies. Eligibility will be determined through a multi-step screening process, including the RAADS, ADOS-2 Module 4, and KBIT-2R assessments. Eligible participants will be randomized into either the SDARI intervention group or a time-matched attention control group. Each group will meet weekly for 90-minute sessions over a 10-week period at the AJ Drexel Autism Institute.
The SDARI curriculum integrates three core components:
Use of improvisational and drama-based games tailored to the developmental stage and interests of autistic young adults.
Facilitation of peer-to-peer and participant-staff relationships to foster positive reinforcement and group cohesion.
Incorporation of motivating activities such as noncompetitive physical games and shared-interest tasks to enhance engagement.
The attention control condition will follow the same schedule and structure but will involve recreational activities that do not explicitly promote interpersonal interaction.
Participants will complete assessments at three timepoints: baseline (pre-intervention), post-intervention, and three-month follow-up. Measures will include self-report and informant-report questionnaires assessing interpersonal experiences, social networks, group cohesion, and mental health. Social Network Analysis (SNA) will be used to evaluate changes in participants' social connections and network structures over time.
All sessions will be video-recorded for fidelity monitoring. Staff will receive condition-specific training and weekly supervision to ensure consistency and adherence to the intervention protocol.
The study aims to assess the feasibility, acceptability, and preliminary efficacy of SDARI in autistic adult populations. Outcomes will inform future adaptations and dissemination of SDARI for broader use in clinical and community settings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- SDARIYA vs AYA (control)
| Arm | Type | Receives |
|---|---|---|
| SDARI-YA | Experimental | Behavioral: SDARI-YAfollow SDARI Protocol |
| AYA | Active comparator | Other: AYAfollow AYA Protocol |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Have graduated from high school (or an equivalent program) and are between the ages of 18-30 years old
- Demonstrate the ability to complete consent and all study measures and procedures in English
- Score ≥ 65 on the RAADS
- Score ≥ 70 on the KBIT-2R
- Score ≥ 6 on the ADOS-2 Module 4
Key exclusion criteria (9 listed)
- Are still enrolled in high school (or an equivalent program) or are not between the ages of 18-30 years old
- Are unable to complete study measures and/or procedures in English
- Are unable to complete consent procedures
- Score ≤ 65 on the RAADS
- Score ≤ 70 on the KBIT-2R
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 |
|---|---|---|
| SDARI-YASDARI is a group-based, performance-based intervention designed to provide participants with opportunities to engage in and experience targeted interpersonal interactions, with minimal didactic instruction or instrumental reinforcement. The intervention consists of three core components: SDARI utilizes affectively motivating acting games that are adapted for the developmental stage and characteristics of the target population. Clinicians promote strong relationships among participants and between participants and clinicians by fostering a supportive and enjoyable environment, facilitating both structured and unstructured interactions, encouraging collaborative problem-solving, and reinforcing positive peer engagement. SDARI incorporates motivating activities-such as noncompetitive physical games, shared interests, and goal-oriented tasks-to enhance interpersonal motivation and engagement. | Behavioural | SDARI-YA |
| AYAAlso: ControlThis group provides concrete presentation of thematic content and connects those themes to specific semi-structured, naturalistic games and activities. Themes are addressed and targeted according to the developmental needs of individual group members. Core Program Principles include: Use of recreational, motivational activities adapted for the target age range and population Positive reinforcement of interpersonal engagement through structured activities Integration of strong, age-appropriate motivators The AYA program uniquely combines these elements to facilitate both development and enjoyment. Group members engage in increasingly complex interpersonal interactions within the group setting and gain motivation to generalize these experiences across other environments, including home and educational contexts. | Other | AYA |
Primary outcome
Social Responsiveness
Time frame: Day 1 (Baseline) Week 10 (Post-intervention) Week 22 (3-Month Follow-up)
measured by the Social Responsiveness Scale-2 (min= 0 and max=195), higher score= worse outcomes
10 secondary outcomes
Friendship
Time frame: Day 1 (Baseline) Week 10 (Post-intervention) Week 22 (3-Month Follow-up)
Anxiety
Time frame: Day 1 (Baseline) Week 10 (Post-intervention) Week 22 (3-Month Follow-up)
Depression
Time frame: Day 1 (Baseline) Week 10 (Post-intervention) Week 22 (3-Month Follow-up)
Capacity for social and interpersonal pleasure
Time frame: Day 1 (Baseline) Week 10 (Post-intervention) Week 22 (3-Month Follow-up)
Cognitive flexibility
Time frame: Day 1 (Baseline) Week 10 (Post-intervention) Week 22 (3-Month Follow-up)
Loneliness
Time frame: Day 1 (Baseline) Week 10 (Post-intervention) Week 22 (3-Month Follow-up)
Social processes/dimensions
Time frame: Day 1 (Baseline) Week 10 (Post-intervention) Week 22 (3-Month Follow-up)
Empathy
Time frame: Day 1 (Baseline) Week 10 (Post-intervention) Week 22 (3-Month Follow-up)
Group cohesion
Time frame: Week 1, Week 3, Week 5, Week 7, Week 8, Week 10
Social networks
Time frame: Day -14 to Day 0; Week 1 to Week 2; Week 11 to Week 12
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 31 Oct 2025.
- Individual participant dataSharing planned: No
Related trials for Autism Spectrum Disorder
RecruitingPhase 3
Multicenter Study of Lumateperone for the Treatment of Irritability Associated With Autism Spectrum Disorder (ASD) in Pediatric Patients
Irritability Associated With Autism Spectrum Disorder
Recruiting
SIT and Deep Pressure Therapy Effects on Motor Coordination in Children With ASD
Autism Spectrum Disorder
Not yet recruiting
Transcranial Magnetic Stimulation (TMS) for Autism Spectrum Disorder
Autism Spectrum Disorder, TMS
RecruitingPhase 3
Safety and Tolerability Trial of Lumateperone in Pediatric Patients With Schizophrenia, Bipolar Disorder or Autism Spectrum Disorder
Schizophrenia, Bipolar Disorder
RecruitingPhase 3
Multicenter Study of Lumateperone for the Treatment of Irritability Associated With Autism Spectrum Disorder in Pediatric Patients
Irritability Associated With Autism Spectrum Disorder
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.
Kyleigh Hricak, B.A. contact
Matthew Lerner, PhD principal investigator
Drexel University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SDARI-YA and AYA in people with Autism Spectrum Disorder, run by Drexel 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 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Oct 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?
Contact China Parenteau, B.A. (5105085858, china.parenteau@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Social Responsiveness (time frame: Day 1 (Baseline) Week 10 (Post-intervention) Week 22 (3-Month Follow-up)). 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 31 Oct 2025.