SOCIAL: Adaptation and Validation of the In-person PEERS® Program for Adolescents With Autism.

Objectives SOCIAL has 3 objectives, clinical, scientific, and social in nature. At the clinical level, its objective is to test the validity and effectiveness of the in-person PEERS® program adapted to an Italian population. The main rationale is to respond to the need for a Social Skill Training adapted to the Italian context, highly acceptable, and evidence-based.

SOCIAL involves a sample of 36 adolescents with a diagnosis of autism spectrum disorder (ASD) and their parents. The subjects will be randomized into two groups (experimental group and control group). All subjects will undergo a battery of questionnaires prescribed by the PEERS® protocol administered before treatment (T0), at the end (T1), and at the 9-month follow-up from the beginning of treatment (T2). The subjects will also undergo a high-density electroencephalographic evaluation during the viewing of social content stimuli at T0, T1, and T2. The experimental group will participate in the PEERS® protocol, while the control group will undergo the usual treatment provided by the territorial reality. Test scores will be compared within-group over time (T0-T1-T2) and between groups (experimental group vs. control group).

The second scientific objective will use the electroencephalographic signal (mu rhythm desynchronization in sensorimotor regions) as a predictor of the effectiveness of PEERS®. This measure, not strictly associated with severity, becomes an implicit predictor not mediated by cognitive factors that suggest the potential effectiveness of specific treatment for a certain individual profile. As secondary outcomes, scores related to questionnaires investigating the adolescents behavior and adaptive level will also be considered.

The last social objective aims to extend the support network of adolescents with ASD to the school context through meetings that parallel the treatment in order to (1) provide supportive strategies to teachers in continuity with clinical treatment and (2) monitor the transfer of social skills in the classroom context for generalization of the skills acquired during clinical treatment.

The hypothesis is that social skills will improve following treatment for the experimental group and that the impact will also extend to other social conditions while maintaining appropriate behavior.

Methodology Participants Participants will be recruited from the Day Hospital of the IRCCS Stella Maris Foundation and residents within a distance of no more than 20/30 kilometers from the IRCCS site.

Inclusion criteria will be: (a) age between 10 and 14 years old; (b) clinical diagnosis of Autism Spectrum Disorder according to ICD-10 (WHO, 1992); (c) absence of intellectual disability (IQ over 85); (d) absence of major concomitant psychiatric disorders (e.g., schizophrenia, bipolar disorder); (e) absence of oppositional/aggressive behavior (outside of the family context); (f) difficulty in developing and/or maintaining peer relationships; (g) self-motivation to participate in treatment for both the adolescent and the family; (h) availability of a caregiver to attend regular sessions with parents and to support the participant during the program; (i) consent of parents and adolescents to participate in all evaluations and to be recorded during treatment sessions.

In accordance with the PEERS® guidelines for adolescents, the parents of candidates will undergo an initial screening through a face-to-face interview. If the initial criteria are satisfied, the parent and adolescent will be invited to an entrance interview with a psychologist who will assess the participants motivation, the risk of problem behaviors, and mental health status. During the interview, the parents availability and readiness to play the role of social coach will also be evaluated.

Once the above criteria are satisfied, the third phase will involve the administration of the Autism Diagnostic Observation Schedule, Second Edition for better phenotyping of the diagnosis, while cognitive and adaptive functioning will be evaluated using the WISC-IV (Wechsler, 2003) and Vineland-II scales. The tests will be administered by certified clinical personnel.

Instruments

Primary Outcome Measure

1. Test of Adolescent Social Skills Knowledge-Revised. 2. Quality of Socialization 2.Questionnaire-Revised. 3. Social Responsiveness Scale-2. 4. Social Skills Improvement System Rating Scales (SSiS) 5. Social Anxiety Scale (SAS) 6. Friendship Qualities Scale (FQS) 7. Piers-Harris SelfConcept ScaleSecond Edition (PHS-2) 8. Quality of Play Questionnaire (QPQ) 9. ADOS-BOSCC

Secondary Outcome Measures

1. Child Behavior Checklist 6-18 years (CBCL 6/18) 2. Youth Self Report 11-18 years (YSR 11-18) 3. Teacher Report Form 6-18 years (TRF 6-18) 4. Vineland Adaptive Behavior Scales, Second Edition (VABS-II) 5. Parenting Stress Index - IV (PSI-IV)

Electroencephalography (EEG). All subjects included in the study will undergo an approximately ten-minute electroencephalographic evaluation. The subjects will observe social content stimuli (intentional actions involving two people or basic emotional expressions). Signal analysis will focus on mu rhythm desynchronization, known in the literature as an indicator of cortical reactivity during the observation of social motor stimuli. The subjects brain reactivity will be: 1) compared to available databases of typically developing subjects during the observation of the same stimuli; 2) compared between subjects as an index of sample homogeneity at baseline; 3) for the experimental group only, the quantification of desynchronization will be considered as an index of prediction of the efficacy of the PEERS® treatment through linear and multiple regression analyses. It will be evaluated whether subjects who are more responsive to social stimuli have better prerequisites that lead to a more effective treatment. EEG recordings will be made at T0, T1, and T2 by researchers from the CNR Neuroscience Institute of Parma with proven experience in EEG signal recording and analysis. The EEG system ( BRAIN QUICK® EEG System) is a facility already available at the IRCCS Fondazione Stella Maris and will be made available to the SOCIAL project.

Experimental design Eligible study participants will be randomly assigned to either the experimental or control group. The randomization sequence will be generated using MATLAB scripts (R2021a) with a 1:1 allocation using random blocks of 2 or 4, stratified by age group. The procedure will be conducted by an independent researcher who will only know the participants identification number, age group, and sex. The latter variable is used to prevent there being only one female or male in a group. Group assignment will be concealed from participants, their parents, and personnel administering standardized tests until participants have completed baseline measures (T0).

Procedures The treatment will be conducted by PEERS® Certified Providers recognized by the Semel Institute at the University of California, Los Angeles (UCLA). The parent groups will be led by two PEERS® Certified psychologists who participated in the adaptation of the program.

Subjects in the experimental group (n=18) and their parents (n=18) will participate in one 90-minute PEERS® session per week for a total of 16 sessions. As a maximum of 6 participants per group is required, the sample will be further divided into three randomized groups. Group 1-PEERS® (n=6) will start the treatment, which will last 16 weeks, at the end of which (T1) the tests reported in the Table will be administered and the electroencephalographic activity will be recorded. Nine months after the start of the treatment, subjects will be recalled for follow-up. The procedure described above will also be used for Group 2-PEERS® (n=6) and Group 3-PEERS® (n=6). The control group sample (Group 1-CTRL, Group 2-CTRL, Group 3-CTRL) will follow the same approach, with the difference that no treatment will be proposed beyond the normal rehabilitative practices already followed.

PEERS Intervention The Program for the Education and Enrichment of Relational Skills (PEERS®) focuses on the skills necessary to initiate and maintain peer relationships, such as conversation skills, communication via electronic devices, conflict resolution, appropriate use of humor, entering and exiting peer groups, good sportsmanship, organizing get-togethers, managing disputes, changing reputation, and handling different types of bullying. The teaching techniques and materials are adapted to the learning styles of individuals with Autism Spectrum Disorder (ASD), which include visual thinking, good memory, and systematization.

In each of the 16 sessions, a therapist presents relevant skills through direct instruction, Socratic questioning, and role-playing. Participants practice skills in behavioral rehearsal exercises and receive feedback on their performance from the treatment team. Between sessions, weekly homework assignments are given, which involve practicing skills with parents and socializing with peers (e.g., talking on the phone with another group member or arranging a get-together with a friend).

Parents (or other adult family members, referred to as social coaches; in the program) participate in parallel sessions and learn how to facilitate their teens skill acquisition.

All sessions will be video recorded and treatment implementation quality will be monitored by the project supervisor (PEERS® Certified Provider). Participants treatment adherence will be monitored by recording attendance of both adolescents and social coaches, and completion rates of homework assignments.

Teens who receive PEERS® treatment will receive additional support through involvement of their school teachers. In fact, in parallel with the 16 PEERS sessions, teachers will be offered the opportunity to complete 16 sessions of Teachers coaching. Weekly tele-assistance sessions of 60 minutes will be conducted where the PEERS® Certified Provider who conducts treatment sessions with the adolescent will have a conversation with a reference teacher of the adolescent.

Ecological validity

At the end of the treatment, adolescents and parents will complete an evaluation questionnaire specifically designed for the study. The survey will include questions about participants satisfaction with various elements of the program, time burden, overall satisfaction, and willingness to recommend the program to other adolescents on the autism spectrum or their parents. The survey will also include two open-ended questions about the positive aspects of the program and those that could be improved or modified.

Results that the project aims to achieve

The efficacy of the PEERS® program for adolescents has already been confirmed by RCT studies as well as the feasibility of cultural adaptation conducted in various countries. However, the Italian adaptation is not yet available.

The expected results are: 1) to validate the efficacy of PEERS® in the Italian context; 2) to identify an electroencephalographic biomarker that acts as a predictor of treatment efficacy for a specific individual profile; 3) to provide teachers with supportive strategies in continuity with clinical treatment.

• Child Behavior Checklist 6-18 years (CBCL 6/18) [Time frame: T0 (before treatment) T1 (after 16 weeks from T0) T2 (9 months after T1)]
• Youth Self Report 11-18 years (YSR 11-18) [Time frame: T0 (before treatment) T1 (after 16 weeks from T0) T2 (9 months after T1)]
• Teacher Report Form 6-18 years (TRF 6-18) [Time frame: T0 (before treatment) T1 (after 16 weeks from T0) T2 (9 months after T1)]
• Vineland Adaptive Behavior Scales, Second Edition (VABS-II) [Time frame: T0 (before treatment) T1 (after 16 weeks from T0) T2 (9 months after T1)]
• Parenting Stress Index - IV (PSI-IV) [Time frame: T0 (before treatment) T1 (after 16 weeks from T0) T2 (9 months after T1)]
• hd-EEG (Electrical Geodesics, Inc., Eugene, OR, USA) [Time frame: T0 (before treatment) T1 (after 16 weeks from T0) T2 (9 months after T1)]