Clinical trial NCT05473104: PEERS® for Italy, a Study on Social Skills Intervention for Adolescents With Autism Spectrum Disorder (ASD).
Official title: Program for the Education and Enrichment of Relational Skills (PEERS®) for Italy. A RCT's Study on Social Skills Intervention for Adolescents With Autism Spectrum Disorder (ASD).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Autism Spectrum Disorder
Keywords: Autism Spectrum Disorder
social skills training
Lead sponsor: Istituto Superiore di Sanità
Sponsor class: OTHER
Collaborators: name: University of Roma La Sapienza
First posted: 2022-07-25
Enrollment: 37
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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;
* No history of hearing, visual, or physical impairmentsExclusion Criteria:

Exclusion Criteria:

* 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

Primary outcomes:
measure: Social Responsiveness Scale (SRS) (Costantino & Gruber, 2005), changes after 14 weeks and 3 months.
timeFrame: pre-treatment, after 14 weeks and 3 months after the start of training (within two weeks)
measure: Quality of Socialization Questionnaire-Revised (QSQ-R) (Laugeson & Frankel, 2010; Laugeson et al., 2012), changes after 14 weeks and 3 months.
timeFrame: pre-treatment, after 14 weeks and 3 months after the start of training (within two weeks)
measure: Test of Adolescent Social Skills Knowledge (TASSK) (Laugeson & Frankel 2010), changes after 14 weeks and 3 months.
timeFrame: pre-treatment, after 14 weeks and 3 months after the start of training (within two weeks)
Secondary outcomes:
measure: Child Behavior Checklist (CBCL) (Achenbach & Rescorla, 2001), changes after 14 weeks and 3 months.
timeFrame: pre-treatment, after 14 weeks and 3 months after the start of training (within two weeks)
measure: Multidimensional Anxiety Scale for Children-Second Edition (MASC-2) (March, 2013), changes after 14 weeks and 3 months.
timeFrame: pre-treatment, after 14 weeks and 3 months after the start of training (within two weeks)
measure: Children's Depression Inventory, Second Edition (CDI-2) (Kovacs, 2010), changes after 14 weeks and 3 months.
timeFrame: pre-treatment, after 14 weeks and 3 months after the start of training (within two weeks)
measure: Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2) (Gioia et al., 2015), changes after 14 weeks and 3 months.
timeFrame: pre-treatment, after 14 weeks and 3 months after the start of training (within two weeks)
Other outcomes:
measure: Autism Quotient (AQ) (Baron-Cohen et al., 2001)
timeFrame: pre-treatment (within two weeks)
measure: Adaptive Behavior Assessment System - Second Edition (ABAS-II) (Harrison & Oakland 2003)
timeFrame: pre-treatment (within two weeks)
measure: Social validity
timeFrame: post-treatment (within two weeks)
Locations:
city: Roma
country: Italy
facility: Istituto Superiore di Sanità
state: Rome
Study officials:
References: