PEERS® for Italy, a Study on Social Skills Intervention for Adolescents With Autism Spectrum Disorder (ASD).

NCT05473104 | Completed Phase 2 DMC

• 1 other identifier: 871
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

TThe research aims to verify the Italian adaptation of a parent-mediated group training focused on social skills for adolescents with autism spectrum disorder (ASD). The Program for the Education and Enrichment of Relational Skills PEERS® is an evidence-based program with substantial literature (over 40 studies) applied in several countries. For the present study, about 40 adolescents, both boys, and girls with ASD, are enrolled and randomized into two groups. Groups (experimental group and waiting list) took part in the Italian telehealth adaptation of PEERS® at different times and were evaluated at several time points (baseline, pre-treatment, post-treatment, and follow-up). The objective of the comparison was to explore the primary outcomes, such as the impact of training on social knowledge and performance, and secondary outcomes, like psychiatric comorbidities and neuropsychological profile. The hypothesis is that social skills (knowledge and performance) improve after training in the experimental group and affect the secondary outcomes, and the achievements are maintained at 3-months follow-up.

Conditions

Autism Spectrum Disorder

Keywords

Autism Spectrum Disorder; social skills training

Outcome Measures

Primary Outcomes (3)

• Social Responsiveness Scale (SRS) (Costantino & Gruber, 2005), changes after 14 weeks and 3 months.

  is a quantitative measure completed by caregivers and teachers, consisting of 65 items, assessing symptoms characteristic of autism spectrum disorders, in children and adolescents aged 4 to 18 years. In this study it is used as a primary outcome measure to assess global social skills.

  pre-treatment, after 14 weeks and 3 months after the start of training (within two weeks)

• Quality of Socialization Questionnaire-Revised (QSQ-R) (Laugeson & Frankel, 2010; Laugeson et al., 2012), changes after 14 weeks and 3 months.

  It is a social performance measure filled out both by caregivers and adolescents, assessing, through numbers and quality of get-togethers, the ability to know how to make and maintain friendships in the natural contexts of adolescents.

  pre-treatment, after 14 weeks and 3 months after the start of training (within two weeks)

• Test of Adolescent Social Skills Knowledge (TASSK) (Laugeson & Frankel 2010), changes after 14 weeks and 3 months.

  It is a 30-question questionnaire completed by adolescents to monitor the acquisition of the topics covered within the PEERS®. It is used to evaluate social knowledge.assessing, through numbers and quality of get-togethers, the ability to know how to make and maintain friendships in the natural contexts of adolescents.

  pre-treatment, after 14 weeks and 3 months after the start of training (within two weeks)

Secondary Outcomes (4)

• Child Behavior Checklist (CBCL) (Achenbach & Rescorla, 2001), changes after 14 weeks and 3 months.

  pre-treatment, after 14 weeks and 3 months after the start of training (within two weeks)

• Multidimensional Anxiety Scale for Children-Second Edition (MASC-2) (March, 2013), changes after 14 weeks and 3 months.

  pre-treatment, after 14 weeks and 3 months after the start of training (within two weeks)

• Children's Depression Inventory, Second Edition (CDI-2) (Kovacs, 2010), changes after 14 weeks and 3 months.

  pre-treatment, after 14 weeks and 3 months after the start of training (within two weeks)

• Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2) (Gioia et al., 2015), changes after 14 weeks and 3 months.

  pre-treatment, after 14 weeks and 3 months after the start of training (within two weeks)

Other Outcomes (3)

• Autism Quotient (AQ) (Baron-Cohen et al., 2001)

  pre-treatment (within two weeks)

• Adaptive Behavior Assessment System - Second Edition (ABAS-II) (Harrison & Oakland 2003)

  pre-treatment (within two weeks)

• Social validity

  post-treatment (within two weeks)

Study Arms (2)

experimental group

EXPERIMENTAL

Teens and parents participate in the training once a week for 14 consecutive weeks in parallel groups.

Behavioral: Program for the Education and Enrichment of Relational Skills

waiting-list group

NO INTERVENTION

Teens and parents participate in the training in a second moment, immediately after the experimental group concluded the program, once a week for 14 consecutive weeks in parallel groups.

Interventions

Program for the Education and Enrichment of Relational Skills BEHAVIORAL

Social training targeting adolescents with ASD and focused on making and keeping friends

experimental group

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• a previous and current diagnosis of ASD, by a clinical team, according to DSM-5, clinical observation and structured assessment with standardized tests (Autism Diagnostic Observation Schedule- Second Edition; ADOS-2; Lord et al., 2012)
• Verbal Comprehension Index scores at least 80 on the Italian version of the WISC-IV scale (Orsini et al.,2012).
• Chronological age between 12 and 18 years;
• Social problems as reported both by the parents and adolescents;
• Italian fluency for the adolescent and parent
• Abstention from other social skills training (following a manualized protocol).
• No history of adolescent major mental illness, such as bipolar disorder, schizophrenia, or psychosis;

You may not qualify if:

• No diagnosis of ASD.
• IQ Total score below 70 or Verbal Comprehension Index scores below 80 on the Italian version of the WISC-IV scale (Orsini et al.,2012).
• Lack of motivation (both parents or adolescents).
• Participation in another social skills training (following a manualized protocol).
• Auto-aggressive behaviors

Sponsors & Collaborators

• Istituto Superiore di Sanità: lead
• University of Roma La Sapienza: collaborator

Study Sites (1)

Istituto Superiore di Sanità

Roma, Rome, 00161, Italy

Location

Related Publications (1)

• Fatta LM, Laugeson EA, Bianchi D; Italian Peers(R) team support group; Laghi F, Scattoni ML. Program for the Education and Enrichment of Relational Skills (PEERS(R)) for Italy: A Randomized Controlled Trial of a Social Skills Intervention for Autistic Adolescents. J Autism Dev Disord. 2025 Jan;55(1):202-220. doi: 10.1007/s10803-023-06211-3. Epub 2024 Jan 8.

  PMID: 38190054 DERIVED

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D Psy.D

Study Record Dates

• First Submitted: July 4, 2022
• First Posted: July 25, 2022
• Study Start: January 14, 2021
• Primary Completion: April 14, 2021
• Study Completion: November 14, 2021
• Last Updated: July 25, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)