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

NCT07207213 | Not Yet Recruiting

• 1 other identifier: PEERS_ITA
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Autism Spectrum Disorder (ASD) falls under the category of high complexity disorders which, in most cases, accompany individuals throughout their entire life with significant impacts and costs for individuals, their families, and society at large. Adolescence is a time of increasing challenge for teenagers with ASD and their families, as it is a time to lay the foundations for the transition to adulthood but at the same time, it is a period of clear mismatch between the abilities and interests of teenagers with ASD and the expectations of their peers. It becomes increasingly difficult to initiate and maintain friendships that require social skills, communicate through social media, or make appropriate use of humor. It is in peer relationships that recognizing and applying implicit social norms is more difficult, and social errors can lead to a bad reputation, exclusion, and being bullied. This creates the need for concrete responses through evidence-based treatment programs adapted to the Italian context. In this scenario, the Program for the Education and Enrichment of Relational Skills (PEERS®) fits in, a psychosocial intervention that falls under the category of Social Skill Training (SST) conducted in a group context, evidence-based, originating from the United States for adolescents with ASD that involves structured teaching of knowledge and skills related to social relationships. SOCIAL has three main objectives: clinical, scientific, and social. The clinical objective is articulated in the study of the effectiveness of the in-person PEERS® program on an Italian population of adolescents with ASD (aged between 10 and 14) to respond to the evident need for a psychosocial intervention adapted to the Italian context. The scientific objective aims to identify an electroencephalographic biomarker that acts as a predictor of the efficacy of PEERS® and is specific to a particular individual profile. Finally, the social objective intends to extend the support network of adolescents with ASD through meetings with schools to train Teachers, thus parallelizing the treatment for generalization of the skills acquired during clinical treatment and also to the school context where peers play a key role. SOCIAL aims to respond to a gap that exists in Italy for a critical age group involving teenagers with ASD, proposing an evidence-based treatment that extends to family and school contexts.

Conditions

Autism Spectrum Disorder

Keywords

Autism; Adolescents; UCLA-PEERS; Social Skills; Intervention

Outcome Measures

Primary Outcomes (9)

• Test of Adolescent Social Skills Knowledge-Revised (TASSK-R)

  The TASSK-R is a self-report, criterion-referenced measure that assesses teens' knowledge about social skills taught throughout the program. It consists of 26 sentence stems in which adolescents are asked to choose from two possible answers. A higher score indicates more knowledge about social skills related to the treatment.

  T0 (before treatment) T1 (after 16 weeks from T0) T2 (9 months after T1)

• Quality of Socialization Questionnaire-Revised (QSQ-R)

  The QSQ-R assesses the frequency and quality of encounters of the adolescent with friends, as reported by adolescents (SQA-R) and parents (SQP-R). To verify the reliability of the report, adolescents and parents are asked to provide a list of names of the friends with whom the adolescent met. A 12-item questionnaire assesses the level of conflict during the most recent encounter with a peer, with answers given on a Likert scale.

  T0 (before treatment) T1 (after 16 weeks from T0) T2 (9 months after T1)

• Scala di reattività sociale-2 (SRS-2)

  The SRS-2 is a quantitative measure consisting of 65 items that assess the symptoms characteristic of autism spectrum disorders. The SRS-2 has been used in previous PEERS® program evaluations and has shown to be sensitive to treatment effects.

  T0 (before treatment) T1 (after 16 weeks from T0) T2 (9 months after T1)

• Social Skills Improvement System Rating Scales (SSiS)

  The SSiS is a 79-item measure that assesses general social skills general social skills and problem behaviour. It is a parent report on the behaviour of adolescents on a 4-point scale. There are standard scores are available for the general domains of social skills and problem behaviour. The SSiS has a high internal reliability.

  T0 (before treatment) T1 (after 16 weeks from T0) T2 (9 months after T1)

• Social Anxiety Scale (SAS)

  The SAS consists of 22 items and was developed to assess the social anxiety experienced by adolescents in the context of relationships with peers. The items are rated on 5-point Likert scale points.

  T0 (before treatment) T1 (after 16 weeks from T0) T2 (9 months after T1)

• Friendship Qualities Scale (FQS)

  The FQS is a self-reported measure for adolescents on the quality of best friendships. It consists of 23 items rated on a 5-point Likert scale.

  T0 (before treatment) T1 (after 16 weeks from T0) T2 (9 months after T1)

• Piers-Harris SelfConcept ScaleSecond Edition (PHS-2)

  The PHS-2 assesses self-esteem and self-concept. In the clinical field, it is used to determine the specific areas of conflict, coping, defense mechanisms defense mechanisms, and appropriate intervention techniques.

  T0 (before treatment) T1 (after 16 weeks from T0) T2 (9 months after T1)

• Quality of Play Questionnaire (QPQ)

  The QPQ consists of 12 items assessing the frequency of peer meetings during the previous month previous month and the level of conflict. This scale has been used as an outcome measure in previous studies previous studies that tested the effectiveness of social skills training.

  T0 (before treatment) T1 (after 16 weeks from T0) T2 (9 months after T1)

• ADOS-BOSCC

  The BOSCC (Brief Observation of Social Communication Change) is a play-based, observation tool used to measure subtle changes in social communication behaviors of individuals with autism spectrum disorder (ASD), particularly in response to early intervention. While the original BOSCC coding scheme was developed by modifying and expanding upon the Autism Diagnostic Observation Schedule (ADOS), it is a distinct outcome measure used to track changes in ASD symptoms over time. The BOSCC is considered a reliable and sensitive measure for detecting changes, even in minimally verbal individuals, and can be used across various studies and conteXT

  T0 (before treatment) T1 (after 16 weeks from T0) T2 (9 months after T1)

Secondary Outcomes (6)

• Child Behavior Checklist 6-18 years (CBCL 6/18)

  T0 (before treatment) T1 (after 16 weeks from T0) T2 (9 months after T1)

• Youth Self Report 11-18 years (YSR 11-18)

  T0 (before treatment) T1 (after 16 weeks from T0) T2 (9 months after T1)

• Teacher Report Form 6-18 years (TRF 6-18)

  T0 (before treatment) T1 (after 16 weeks from T0) T2 (9 months after T1)

• Vineland Adaptive Behavior Scales, Second Edition (VABS-II)

  T0 (before treatment) T1 (after 16 weeks from T0) T2 (9 months after T1)

• Parenting Stress Index - IV (PSI-IV)

  T0 (before treatment) T1 (after 16 weeks from T0) T2 (9 months after T1)

Study Arms (2)

PEERS

EXPERIMENTAL

Twenty subjects will be carry out PEERS intervention

Behavioral: PEERS

CONTROLS

ACTIVE COMPARATOR

Twenty subjects will be carry out Treatment As Usual

Behavioral: Control

Interventions

PEERS BEHAVIORAL

The Program for the Education and Enrichment of Relational Skills (PEERS®) is world-renowned for providing evidence-based social skills treatment to adolescents with autism spectrum disorder (ASD), attention-deficit/hyperactivity disorder (ADHD), anxiety, depression, and other socio-emotional problems.

Also known as: TAU (TREATMENT AS USUAL)

PEERS

Control BEHAVIORAL

This group will also consist of children diagnosed with high-functioning ASD. However, these children will not receive PEERS therapy. Instead, they will continue their usual treatments in their local settings without participating in the PEERS therapy sessions. This group\'s outcomes will be compared with the experimental group to assess the effectiveness of PEERS therapy.

CONTROLS

Eligibility Criteria

• Age: 10 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Full IQ below 85;
• concomitant major psychiatric disorders

Sponsors & Collaborators

• IRCCS Fondazione Stella Maris: lead

Study Sites (1)

IRCCS Stella Maris

Calambrone, Pisa, 56018, Italy

Location

Related Publications (23)

• Laugeson EA, Frankel F, Gantman A, Dillon AR, Mogil C. Evidence-based social skills training for adolescents with autism spectrum disorders: the UCLA PEERS program. J Autism Dev Disord. 2012 Jun;42(6):1025-36. doi: 10.1007/s10803-011-1339-1.

  PMID: 21858588 BACKGROUND

• Bramer GR. International statistical classification of diseases and related health problems. Tenth revision. World Health Stat Q. 1988;41(1):32-6.

  PMID: 3376487 BACKGROUND

• Laugeson EA, Frankel F, Mogil C, Dillon AR. Parent-assisted social skills training to improve friendships in teens with autism spectrum disorders. J Autism Dev Disord. 2009 Apr;39(4):596-606. doi: 10.1007/s10803-008-0664-5. Epub 2008 Nov 18.

  PMID: 19015968 BACKGROUND

• Lord C, Rutter M, DiLavore P, Risi S, Gotham K, & Bishop S (2012). Autism diagnostic observation schedule-2nd edition (ADOS-2). Los Angeles, CA: Western Psychological Services

  BACKGROUND

• Wechsler D. Wechsler Intelligence Scale for Children. 4th ed. PsychCorp; San Antonio, TX, USA: 2003.

  BACKGROUND

• Balboni, G., Belacchi, C., Bonichini, S., & Coscarelli, A. (2016). Vineland adaptive behavior scales. Survey interview form. Standardizzazione italiana (2nd ed.) [Vineland adaptive behavior scales. Survey interview form. Italian Standardization (2nd ed.)]. Giunti OS Organizzazioni Speciali.

  BACKGROUND

• Laugeson, E. A. (2018). Quality of Socialization Questionnaire - Adolescent (QSQA- Revised). Supplement materials provided on the PEERS Certified Training Seminar, Los Angeles

  BACKGROUND

• J. N. Constantino and C. P. Gruber (2012). Social Responsiveness Scale-Second Edition (SRS-2). Torrance, CA: Western Psychological Services.

  BACKGROUND

• Gresham, F. M., & Elliott, S. N. (2008). Social skills improvement system: Rating scales. Bloomington, MN: Pearson Assessments

  BACKGROUND

• La Greca AM, Lopez N. Social anxiety among adolescents: linkages with peer relations and friendships. J Abnorm Child Psychol. 1998 Apr;26(2):83-94. doi: 10.1023/a:1022684520514.

  PMID: 9634131 BACKGROUND

• Bukowski, W. M., Hoza, B., & Boivin, M. (1994). Measuring Friendship Quality During Pre- and Early Adolescence: The Development and Psychometric Properties of the Friendship Qualities Scale. Journal of Social and Personal Relationships, 11(3), 471-484. https://doi.org/10.1177/0265407594113011

  BACKGROUND

• Piers, E. V.

  BACKGROUND

• Frankel F, Mintz J. Measuring the quality of play dates. 2011

  BACKGROUND

• Achenbach, T. M., & Rescorla, L. A. (2001). Manual for the ASEBA School-Age Forms and Profiles. Burlington, VT: University of Vermont Research Center for Children, Youth, & Families.

  BACKGROUND

• Abidin R.R. (2012). Parenting Stress Index, Fourth Edition (PSI-4). Lutz, FL: Psychological Assessment Resources

  BACKGROUND

• Zheng S, Kim H, Salzman E, Ankenman K, Bent S. Improving Social Knowledge and Skills among Adolescents with Autism: Systematic Review and Meta-Analysis of UCLA PEERS(R) for Adolescents. J Autism Dev Disord. 2021 Dec;51(12):4488-4503. doi: 10.1007/s10803-021-04885-1. Epub 2021 Jan 29.

  PMID: 33512626 BACKGROUND

• Shum KK, Cho WK, Lam LMO, Laugeson EA, Wong WS, Law LSK. Learning How to Make Friends for Chinese Adolescents with Autism Spectrum Disorder: A Randomized Controlled Trial of the Hong Kong Chinese Version of the PEERS(R) Intervention. J Autism Dev Disord. 2019 Feb;49(2):527-541. doi: 10.1007/s10803-018-3728-1.

  PMID: 30143950 BACKGROUND

• Yoo HJ, Bahn G, Cho IH, Kim EK, Kim JH, Min JW, Lee WH, Seo JS, Jun SS, Bong G, Cho S, Shin MS, Kim BN, Kim JW, Park S, Laugeson EA. A randomized controlled trial of the Korean version of the PEERS((R)) parent-assisted social skills training program for teens with ASD. Autism Res. 2014 Feb;7(1):145-61. doi: 10.1002/aur.1354. Epub 2014 Jan 9.

  PMID: 24408892 BACKGROUND

• Rabin SJ, Israel-Yaacov S, Laugeson EA, Mor-Snir I, Golan O. A randomized controlled trial evaluating the Hebrew adaptation of the PEERS(R) intervention: Behavioral and questionnaire-based outcomes. Autism Res. 2018 Aug;11(8):1187-1200. doi: 10.1002/aur.1974. Epub 2018 Aug 10.

  PMID: 30095232 BACKGROUND

• Platos M, Wojaczek K, Laugeson EA. Effects of Social Skills Training for Adolescents on the Autism Spectrum: a Randomized Controlled Trial of the Polish Adaptation of the PEERS(R) Intervention via Hybrid and In-Person Delivery. J Autism Dev Disord. 2023 Nov;53(11):4132-4146. doi: 10.1007/s10803-022-05714-9. Epub 2022 Aug 24.

  PMID: 36001196 BACKGROUND

• Idris S, van Pelt BJ, Jagersma G, Duvekot J, Maras A, van der Ende J, van Haren N, Greaves-Lord K. A randomized controlled trial to examine the effectiveness of the Dutch version of the Program for the Education and Enrichment of Relational Skills (PEERS(R)). BMC Psychiatry. 2022 Apr 22;22(1):293. doi: 10.1186/s12888-022-03913-3.

  PMID: 35459118 BACKGROUND

• Rizzolatti G, Fabbri-Destro M, Cattaneo L. Mirror neurons and their clinical relevance. Nat Clin Pract Neurol. 2009 Jan;5(1):24-34. doi: 10.1038/ncpneuro0990.

  PMID: 19129788 BACKGROUND

• Fabbri-Destro M, Avanzini P, De Stefani E, Innocenti A, Campi C, Gentilucci M. Interaction Between Words and Symbolic Gestures as Revealed By N400. Brain Topogr. 2015 Jul;28(4):591-605. doi: 10.1007/s10548-014-0392-4. Epub 2014 Aug 15.

  PMID: 25124860 BACKGROUND

MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder; Social Skills

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Social Behavior; Behavior

Study Officials

• Antonio Narzisi, PhD

  IRCCS Stella Maris Foundation, Pisa (Calambrone), Italy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Antonio Narzisi, PhD

CONTACT

00393205690832; antonio.narzisi@fsm.unipi.it

Annarita Milone, MD

CONTACT

00393389339732; annarita.milone@fsm.unipi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 9, 2024
• First Posted: October 3, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: October 3, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)