SDARI Program for Autism

(SDARIYA Trial)

Overseen By Kyleigh Hricak, B.A.

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Drexel University

Disqualifiers: Severe medical, psychiatric condition, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 14

Duration: 10 weeks

54 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a group program called SDARI can help autistic young adults feel more connected and improve their social relationships. Participants will join one of two groups: one will engage in the SDARI program, while the other will participate in activities not focused on social connection. Researchers will compare the groups to assess SDARI's effectiveness. The trial is ideal for autistic young adults, aged 18 to 30, who have finished high school and can attend weekly sessions in Philadelphia. As an unphased trial, it offers a unique opportunity to contribute to understanding and enhancing social connections for autistic young adults.

Do I need to stop taking my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that the SDARI program is safe for autistic young adults?

Research has shown that the SDARI (Socio-dramatic Affective Relational Intervention) program is a non-invasive treatment. It does not involve medication or physical procedures but instead focuses on social activities and group interactions. Because SDARI relies on structured social activities, it is generally considered safe and well-tolerated. As it is not a drug or medical procedure, similar social programs have reported no physical side effects.

While specific detailed data on SDARI's safety is lacking, the program's nature suggests it is low risk. Participants engage in activities designed to build connections and improve social skills, which typically present minimal safety concerns. Those who join will participate in group sessions and activities, so any potential risks relate more to personal comfort in social settings rather than medical issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The SDARI-YA protocol for autism is generating excitement because it represents a new approach to therapy by focusing on structured developmental interventions tailored for young adults. Unlike traditional treatments, which often rely on behavioral therapies or medication, SDARI-YA emphasizes a personalized, protocol-driven strategy that adapts to the individual's developmental needs. This method aims to enhance social and communication skills more effectively by addressing the unique challenges faced by young adults with autism. Researchers are hopeful that this innovative approach could lead to more significant improvements in quality of life for individuals on the autism spectrum, offering a fresh perspective beyond conventional therapies.

What evidence suggests that the SDARI program is effective for improving social connections in autistic young adults?

Research has shown that social programs like SDARI can help people with autism. In this trial, participants will join either the SDARI-YA program or the AYA program. A review of friendship programs for children and teens with autism found that structured activities improved their social connections. Although SDARI hasn't been extensively studied in adults, similar programs for younger individuals have demonstrated significant improvements in social skills. These programs often enhance participants' sense of connection and support. Early participation in such programs has been linked to positive outcomes, suggesting that SDARI might help young adults with autism improve their social relationships. ^{6 7 8 9 10}

Who Is on the Research Team?

Matthew Lerner, PhD

Principal Investigator

Drexel University

Are You a Good Fit for This Trial?

This trial is for autistic young adults aged 18-30 who want to improve their social connections. Participants must have traits of autism and an IQ that allows them to participate in group activities. They should be willing to attend weekly sessions, engage in games and surveys, and may invite someone close to complete related surveys.

Inclusion Criteria

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

Exclusion Criteria

Are unable to complete study measures and/or procedures in English

Score ≤ 65 on the RAADS

Score ≤ 70 on the KBIT-2R

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants attend weekly in-person group sessions for 10 weeks, engaging in SDARI or control activities

10 weeks

10 visits (in-person)

Follow-up

Participants are monitored for changes in social connections and mental health through assessments

12 weeks

3 visits (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• SDARI-YA

Trial Overview The SDARI program's effectiveness on enhancing social relationships among autistic adults is being tested against a control group doing non-social focused activities. The study involves attending weekly sessions for 10 weeks with assessments before, during, and after the intervention.

How Is the Trial Designed?

Group I: SDARI-YA Experimental Treatment 1 Intervention

follow SDARI Protocol

Group II: AYA Active Control 1 Intervention

follow AYA Protocol

Who Is Running the Clinical Trial?

Drexel University

Lead Sponsor

Trials

160

Recruited

48,600+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07222982

Social Groups for Autistic Young Adults (SDARIYA) Researchers will compare the two groups to see if SDARI leads to better outcomes. Participants will: Complete screening to confirm eligibility ( ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1750946722000344

Friendship interventions and measurements in children ... This systematic review examined friendship interventions for children and adolescents with autism spectrum disorder (ASD). It also explored measures of ...

3. researchgate.net researchgate.net/publication/247784781_Inclusive_Programming_for_Toddlers_with_Autism_Spectrum_Disorders_Outcomes_From_the_Children's_Toddler_School

Inclusive Programming for Toddlers with Autism Spectrum ... The toddler program demonstrated effectiveness over its first 10 years in the community, including findings of significant gains in ...

4. go.drugbank.com go.drugbank.com/conditions/DBCOND0006160

Autism Spectrum Disorder (DBCOND0006160) Confirmatory Efficacy Trial of Cognitive Enhancement Therapy for Adult Autism Spectrum Disorder, No drug interventions, treatment, Not Available, completed.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4064565/

Predictors of Outcomes in Autism Early Intervention Response to early intervention programs in autism is variable. However, the factors associated with positive versus poor treatment outcomes remain unknown.

6. nationalautismassociation.org nationalautismassociation.org/resources/autism-safety-facts/

Autism & Safety Facts AUTISM AND SAFETY DATA · 65% of parents reported that their children with Asperger's syndrome had been victimized by peers in some way within the past year · 47% ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2831678/

Lancet retracts 12-year-old article linking autism to MMR ... Twelve years after publishing a landmark study that turned tens of thousands of parents around the world against the measles, mumps and rubella (MMR) vaccine

8. hrsa.gov hrsa.gov/grants/find-funding/HRSA-23-069

Autism Secondary Data Analysis Research (Autism SDAR) The purpose of the SDAR program is to support research that analyzes existing national data sets and/or administrative records to answer questions.

9. cdc.gov cdc.gov/autism/index.html

Autism Spectrum Disorder (ASD) ASD is a developmental disability that can cause significant social, communication, and behavioral challenges.

10. sciencedirect.com sciencedirect.com/science/article/pii/S0147651325008644

Relationship between PFAS and attention-deficit ... Both prenatal and postnatal PFAS exposure have been associated with adverse neurodevelopmental outcomes in children, including attention-deficit ...