- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07222982
Social Groups for Autistic Young Adults (SDARIYA) (SDARIYA)
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:
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: China Parenteau, B.A.
- Phone Number: 5105085858
- Email: china.parenteau@gmail.com
Study Contact Backup
- Name: Kyleigh Hricak, B.A.
- Email: kh3434@drexel.edu
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- Recruiting
- Drexel University
-
Contact:
- Matthew Lerner, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: SDARI-YA
follow SDARI Protocol
|
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. |
|
Active Comparator: AYA
follow AYA Protocol
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Day 1 (Baseline) Week 10 (Post-intervention) Week 22 (3-Month Follow-up)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Friendship
Time Frame: Day 1 (Baseline) Week 10 (Post-intervention) Week 22 (3-Month Follow-up)
|
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 |
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)
|
measured by Anxiety Scale for Autism (Adults) (ASA-A) (min=0, max=60, a higher score=worse outcomes)
|
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)
|
measured by The Patient Health Questionnaire (PHQ-9) (min=0, max=27, higher scores=worse outcomes)
|
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)
|
measured by the Anticipatory and Consummatory Interpersonal Pleasure Scale (ACIPS) (min=17, max=102, higher scores indicate worse outcomes)
|
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)
|
measured by the Cognitive Flexibility Inventory (CFI) (min=20, max= 140, higher scores indicate better outcomes)
|
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)
|
measured by the UCLA Loneliness Scale - Revised (min=20, max=80, higher score indicates worse outcomes.
|
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)
|
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) |
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)
|
other informant report measured by the Toronto Empathy Questionnaire - Informant Version (TEQ-IV) (min=0, max=64, higher scores indicate better outcomes)
|
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
|
measured by the Group Cohesiveness Scale (GCS).
(min=7 and max=35, higher scores indicate better outcomes)
|
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
|
as measured by Social Networks Survey (SNS) (min/max scores= N/A)
|
Day -14 to Day 0; Week 1 to Week 2; Week 11 to Week 12
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Matthew Lerner, PhD, Drexel University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2409010784
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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