Social Skills Intervention for Autism

Overseen By Aarti Nair, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Loma Linda University

Disqualifiers: Epilepsy, Tumor, Psychiatric history, others

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

Compensation: Varies

Number of Visits: 4

Duration: 16 weeks

90 Participants Needed

Trial Summary

What is the purpose of this trial?

Difficulties in reciprocal social interaction are hallmark features of several neuropsychiatric disorders, most notably autism spectrum disorder (ASD) and schizophrenia spectrum disorder (SSD). While recent studies have demonstrated substantial overlap in genetic etiology between ASD and SSD, little is known about common versus unique neural mechanisms that may underlie these downstream social deficits that cross diagnostic boundaries. Thus, a comprehensive imaging study examining social deficits in youth with ASD and adolescent- onset SSD at the neurochemical, connectivity, as well as functional activation level will be crucial in furthering our understanding of these underlying neural mechanisms. Specifically, the current project aims to examine how targeted social skills interventions may impact the organization of large-scale functional brain networks implicated in social cognition in these disorders, leading to improved outcomes. Thirty adolescents with ASD and 30 adolescents with SSD will undergo the Program for the Education and Enrichment of Relational Skills (PEERS), which is a 16-week parent-assisted social skills intervention that aims to improve friendship quality and social skills in teens with social difficulties. All participants will receive pre- and post-treatment MRI scans including functional MRI and magnetic resonance spectroscopy to quantify neural changes resulting from the intervention. All participants will also receive behavioral and social cognition assessments pre- and post-intervention to quantify real- world gains in social behaviors resulting from the intervention. Additionally, 30 typically developing adolescents will be recruited to serve as control participants and undergo two MRI and behavioral assessment sessions 16-weeks apart with no intervention in between. Specific aims include (1) examining inter-group disruptions in connectivity patterns, activation levels, and neurometabolite concentrations in key social brain regions pre-treatment in ASD and SSD groups, (2) examining inter-group changes in connectivity patterns, activation levels, and neurometabolite concentrations in key social brain regions in response to treatment in ASD and SSD groups, and, (3) dimensionally identifying intra-group differences in brain responses and how they relate to real-world treatment outcomes.

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the PEERS social skills intervention treatment for autism?

Research shows that the PEERS program helps adolescents with autism improve their social skills, reduce social anxiety, and decrease problem behaviors. Studies have found that participants in the program have better social interactions and increased social engagement compared to those who did not participate. ^{1 2 3 4 5}

Is the PEERS social skills intervention safe for humans?

The PEERS social skills intervention has been studied in various groups, including young children and adolescents with autism, and no safety concerns have been reported in these studies. It appears to be a safe program for improving social skills. ^{5 6 7 8 9}

How is the PEERS social skills intervention treatment different from other treatments for autism?

The PEERS social skills intervention is unique because it is a group-based program specifically designed to improve social skills in individuals with autism, and it can be adapted for different cultures and age groups, including young children and adolescents. It also offers a remote, parent-mediated version, making it accessible for families who need flexible options. ^{4 10 11 12 13}

Research Team

Aarti Nair, PhD

Principal Investigator

Loma Linda University

Eligibility Criteria

This trial is for adolescents aged 12-18 with Autism Spectrum Disorder (ASD) or Schizophrenia Spectrum Disorder (SSD), who have verbal and full-scale IQs over 70. They should not have significant medical conditions that affect brain imaging, no psychiatric history if they're typically developing controls, and must be able to safely undergo MRI scans.

Inclusion Criteria

I am an adolescent with ASD or SSD enrolled in the PEERS program.

Thirty demographically comparable typically developing (TD) controls will be recruited through community samples, and in compliance with the LLU Institutional Review Board (IRB) standards

ASD adolescents will be recruited through the Loma Linda University Behavioral Health Institute (LLU BHI), LLU Behavior Medicine Center (BMC), and LLU Department of Psychology Child and Family Center (CFC)

Exclusion Criteria

Any psychiatric history for TD controls

I don't have conditions like epilepsy that would affect brain scans.

Participants with any MRI contraindications (e.g., history of metal fragment injury or metal implants, current orthodontic braces or nonremovable retainers)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo the 16-week PEERS social skills intervention, including pre- and post-treatment MRI scans and behavioral assessments

16 weeks

2 visits (in-person) for MRI and assessments

Control

Typically developing control participants undergo cognitive assessments and MRI imaging 16 weeks apart with no intervention

16 weeks

2 visits (in-person) for MRI and assessments

Follow-up

Participants are monitored for long-term maintenance of social skills and neural changes post-intervention

4 weeks

Treatment Details

Interventions

• PEERS social skills intervention

Trial Overview The study tests the PEERS social skills intervention's effect on brain function in teens with ASD or SSD. It involves pre- and post-treatment MRI scans to observe neural changes after a 16-week program designed to enhance friendship quality and social skills.

Participant Groups

Group I: Patient arm Experimental Treatment 1 Intervention

Both ASD and SSD participants will undergo cognitive assessments and MRI imaging pre- and post- the 16-week PEERS social skills intervention.

Group II: Control arm Active Control 1 Intervention

Typically developing control participants will undergo cognitive assessments and MRI imaging 16 weeks apart with no intervention in between.

Who Is Running the Clinical Trial?

Loma Linda University

Lead Sponsor

Trials

322

Recruited

267,000+

Findings from Research

The PEERS program significantly improved friendship skills and social knowledge among 58 adolescents with higher-functioning ASD, as evidenced by increased social interactions and decreased social anxiety after the intervention.

Participants in the PEERS program also showed reductions in core autistic symptoms and problem behaviors, highlighting the program's effectiveness in enhancing social functioning in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A replication and extension of the PEERS intervention: examining effects on social skills and social anxiety in adolescents with autism spectrum disorders. Schohl, KA., Van Hecke, AV., Carson, AM., et al.[2021]

Adolescents with Autism Spectrum Disorder (ASD) who participated in the PEERS social skills intervention showed significant improvements in vocal expressiveness and rapport quality after treatment, compared to those in a waitlist group.

The effectiveness of the PEERS program was linked to the knowledge gained during the intervention, indicating that the skills learned directly contributed to better social interactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief Report: Assessment of Intervention Effects on In Vivo Peer Interactions in Adolescents with Autism Spectrum Disorder (ASD). Dolan, BK., Van Hecke, AV., Carson, AM., et al.[2018]

The PEERS program, a social skills intervention for adolescents with autism spectrum disorder, demonstrated significant improvements in social engagement, cognition, communication, and motivation in a small pilot study involving five participants.

Participants also experienced notable reductions in internalizing and autistic symptoms after completing the PEERS intervention, suggesting its effectiveness in community settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Pilot Study Examining the Effectiveness of the PEERS Program on Social Skills and Anxiety in Adolescents with Autism Spectrum Disorder. Hill, TL., Gray, SAO., Baker, CN., et al.[2020]

The PEERS® intervention significantly improved social skills and reduced social deficits in 82 Taiwanese young adults with autism spectrum disorder (ASD), showing effectiveness similar to previous studies in North America.

Improvements in social functioning were maintained at 3 and 6 months post-treatment, and were positively correlated with baseline severity of autism and IQ, suggesting that these factors may influence the effectiveness of the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness, durability, and clinical correlates of the PEERS social skills intervention in young adults with autism spectrum disorder: the first evidence outside North America. Chien, YL., Tsai, WC., Chen, WH., et al.[2023]

The PEERS® for Preschoolers (P4P) program, a caregiver-assisted social skills intervention, was found to be feasible for implementation with 15 children with autism spectrum disorder (ASD), showing promise in recruitment and retention.

The P4P program demonstrated effectiveness in improving social skills in young children with ASD, with these improvements maintained even after the intervention ended.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Examining Feasibility and Outcomes of the PEERS® for Preschoolers Program. Factor, RS., Rea, HM., Laugeson, EA., et al.[2023]

The PEERS Program significantly improved social skills in high-functioning adolescents with ASD, enhancing areas such as social communication and peer interactions, based on assessments from both participants and teachers.

Improvements in social skills were not only significant but also durable, with many gains maintained and even enhanced at a 14-week follow-up, indicating the long-term effectiveness of the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence-based social skills training for adolescents with autism spectrum disorders: the UCLA PEERS program. Laugeson, EA., Frankel, F., Gantman, A., et al.[2022]

The PEERS social skills intervention was effective in improving social functioning for adolescents with autism spectrum disorder (ASD), as reported by both the adolescents and their parents.

This pilot study included a diverse sample of 13 adolescents with ASD and utilized an objective measure of conversational skills, showing that improvements were maintained four months after the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perceived and Observed Treatment Gains Following PEERS: A Preliminary Study with Latinx Adolescents with ASD. Veytsman, E., Baker, E., Martin, AM., et al.[2023]

In a study involving 22 caregiver-child dyads, the PEERS® for Preschoolers (P4P) program showed that 60% of participants improved their social skills after treatment, with 53.85% maintaining these improvements at follow-up (4-16 weeks later).

The program also indicated that fewer social communication difficulties were linked to better social skills and reduced behavioral issues, suggesting that addressing specific autistic traits can enhance the effectiveness of social skills interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PEERS® for Preschoolers preliminary outcomes and predictors of treatment response. Antezana, L., Albright, J., Scarpa, A., et al.[2023]

The Multimodal Anxiety and Social Skills Intervention (MASSI) program was found to be feasible and well-accepted by families in a pilot study involving 30 adolescents with autism spectrum disorders (ASD) and moderate anxiety symptoms.

Participants showed a significant 16% improvement in social impairment related to ASD, indicating that MASSI may effectively enhance social skills, although the reduction in anxiety symptoms (26%) was not statistically significant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled trial: Multimodal Anxiety and Social Skill Intervention for adolescents with autism spectrum disorder. White, SW., Ollendick, T., Albano, AM., et al.[2022]

The ACCEPT study is a randomized controlled trial involving 150 adolescents with autism spectrum disorder, comparing the effectiveness of the PEERS® social skills intervention against an active control group focused on puberty psychoeducation.

The primary outcome measure is the Contextual Assessment of Social Skills (CASS), which evaluates social skills in real interactions, allowing for a comprehensive assessment of the intervention's impact on social conversational abilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The ACCEPT-study: design of an RCT with an active treatment control condition to study the effectiveness of the Dutch version of PEERS® for adolescents with autism spectrum disorder. van Pelt, BJ., Idris, S., Jagersma, G., et al.[2020]

The Mandarin version of the PEERS® program is feasible and culturally acceptable for autistic adolescents in China, showing promise in improving their social skills and emotional well-being after 14 sessions.

Participants with better school support and parents with lower initial well-being benefited more from the program, suggesting that these factors may enhance the effectiveness of social skills training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adaptation and Feasibility of the Mandarin Version of PEERS&#174; for Autistic Adolescents. Lao, U., Li, Y., Bai, W., et al.[2023]

The parent-mediated telehealth version of the PEERS® for Preschoolers (P4P) program was found to be feasible and satisfactory for families, providing a new way to support social skills development in young children with autism spectrum disorder (ASD).

After participating in the program, parents reported increased confidence in their ability to coach their children in social skills, which suggests that the intervention may effectively empower families to support their children's social development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remote PEERS&#174; for preschoolers: A pilot parent-mediated social skills intervention for young children with social challenges over telehealth. Factor, RS., Glass, L., Baertschi, D., et al.[2022]

After a two-day training on the PEERS program, 15 community clinicians reported increased confidence in delivering social skills interventions for adolescents with Autism Spectrum Disorder (ASD).

The implementation of five PEERS groups in community mental health settings demonstrated the feasibility of expanding social skills interventions, although no significant changes were observed in family quality of life, social skills, or parenting stress among the 14 participating families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increasing Access to Empirically-Validated Interventions for Autism Spectrum Disorder:: Dissemination of PEERS into Community Health Settings. Dewey, L., Rose, C., Mueller, J., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

A replication and extension of the PEERS intervention: examining effects on social skills and social anxiety in adolescents with autism spectrum disorders. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Brief Report: Assessment of Intervention Effects on In Vivo Peer Interactions in Adolescents with Autism Spectrum Disorder (ASD). [2018]

3. United States pubmed.ncbi.nlm.nih.gov

A Pilot Study Examining the Effectiveness of the PEERS Program on Social Skills and Anxiety in Adolescents with Autism Spectrum Disorder. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Effectiveness, durability, and clinical correlates of the PEERS social skills intervention in young adults with autism spectrum disorder: the first evidence outside North America. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Examining Feasibility and Outcomes of the PEERS® for Preschoolers Program. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Evidence-based social skills training for adolescents with autism spectrum disorders: the UCLA PEERS program. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Perceived and Observed Treatment Gains Following PEERS: A Preliminary Study with Latinx Adolescents with ASD. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

PEERS® for Preschoolers preliminary outcomes and predictors of treatment response. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Randomized controlled trial: Multimodal Anxiety and Social Skill Intervention for adolescents with autism spectrum disorder. [2022]

10. England pubmed.ncbi.nlm.nih.gov

The ACCEPT-study: design of an RCT with an active treatment control condition to study the effectiveness of the Dutch version of PEERS® for adolescents with autism spectrum disorder. [2020]

11. United States pubmed.ncbi.nlm.nih.gov

Adaptation and Feasibility of the Mandarin Version of PEERS&#174; for Autistic Adolescents. [2023]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Remote PEERS&#174; for preschoolers: A pilot parent-mediated social skills intervention for young children with social challenges over telehealth. [2022]

13. United States pubmed.ncbi.nlm.nih.gov

Increasing Access to Empirically-Validated Interventions for Autism Spectrum Disorder:: Dissemination of PEERS into Community Health Settings. [2022]