Social Groups for Autistic Young Adults (SDARIYA)

Официальное название

Social Groups for Autistic Young Adults (SDARI)

Обзор

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

Подробное описание

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.

Вмешательства

• Поведенческое SDARI-YA
  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 betw
• Другое AYA
  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

Первичные конечные точки

• Social Responsiveness [Срок оценки: Day 1 (Baseline) Week 10 (Post-intervention) Week 22 (3-Month Follow-up)]

Вторичные конечные точки (10)

• Friendship [Срок оценки: Day 1 (Baseline) Week 10 (Post-intervention) Week 22 (3-Month Follow-up)]
• Anxiety [Срок оценки: Day 1 (Baseline) Week 10 (Post-intervention) Week 22 (3-Month Follow-up)]
• Depression [Срок оценки: Day 1 (Baseline) Week 10 (Post-intervention) Week 22 (3-Month Follow-up)]
• Capacity for social and interpersonal pleasure [Срок оценки: Day 1 (Baseline) Week 10 (Post-intervention) Week 22 (3-Month Follow-up)]
• Cognitive flexibility [Срок оценки: Day 1 (Baseline) Week 10 (Post-intervention) Week 22 (3-Month Follow-up)]
• Loneliness [Срок оценки: Day 1 (Baseline) Week 10 (Post-intervention) Week 22 (3-Month Follow-up)]
• Social processes/dimensions [Срок оценки: Day 1 (Baseline) Week 10 (Post-intervention) Week 22 (3-Month Follow-up)]
• Empathy [Срок оценки: Day 1 (Baseline) Week 10 (Post-intervention) Week 22 (3-Month Follow-up)]
• Group cohesion [Срок оценки: Week 1, Week 3, Week 5, Week 7, Week 8, Week 10]
• Social networks [Срок оценки: Day -14 to Day 0; Week 1 to Week 2; Week 11 to Week 12]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Drexel University — Philadelphia

Идентификаторы

NCT: NCT07222982 · 2409010784

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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