NCT07222982

Brief 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. 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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
57mo left

Started Jan 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress6%
Jan 2026Feb 2031

First Submitted

Initial submission to the registry

October 1, 2025

Completed
29 days until next milestone

First Posted

Study publicly available on registry

October 30, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

January 15, 2026

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2030

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2031

Last Updated

October 31, 2025

Status Verified

October 1, 2025

Enrollment Period

4 years

First QC Date

October 1, 2025

Last Update Submit

October 29, 2025

Conditions

Keywords

autisminterventionsocial performance

Outcome Measures

Primary Outcomes (1)

  • Social Responsiveness

    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 Outcomes (10)

  • Friendship

    Day 1 (Baseline) Week 10 (Post-intervention) Week 22 (3-Month Follow-up)

  • Anxiety

    Day 1 (Baseline) Week 10 (Post-intervention) Week 22 (3-Month Follow-up)

  • Depression

    Day 1 (Baseline) Week 10 (Post-intervention) Week 22 (3-Month Follow-up)

  • Capacity for social and interpersonal pleasure

    Day 1 (Baseline) Week 10 (Post-intervention) Week 22 (3-Month Follow-up)

  • Cognitive flexibility

    Day 1 (Baseline) Week 10 (Post-intervention) Week 22 (3-Month Follow-up)

  • +5 more secondary outcomes

Study Arms (2)

SDARI-YA

EXPERIMENTAL

follow SDARI Protocol

Behavioral: SDARI-YA

AYA

ACTIVE COMPARATOR

follow AYA Protocol

Other: AYA

Interventions

SDARI-YABEHAVIORAL

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.

SDARI-YA
AYAOTHER

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.

Also known as: Control
AYA

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Drexel University

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Autism Spectrum DisorderAutistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Matthew Lerner, PhD

    Drexel University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

China Parenteau, B.A.

CONTACT

Kyleigh Hricak, B.A.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
N/A participants, providers and PI will know what condition the individual is placed in.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: SDARIYA vs AYA (control)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 1, 2025

First Posted

October 30, 2025

Study Start

January 15, 2026

Primary Completion (Estimated)

February 1, 2030

Study Completion (Estimated)

February 1, 2031

Last Updated

October 31, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations