Skip to main content
OpenTrials
Completed

NCT Number: NCT05473104

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Istituto Superiore di Sanità

Roma, Rome, 00161, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Program for the Education and Enrichment of Relational Skills

Behavioral

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

Primary outcomes

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

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

    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.

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

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

    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.

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

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

    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.

Secondary outcomes

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

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

    CBCL is widely used to evaluate developmental psychopathology through scales that assess specific dimensions (Anxiety/Depression; Withdrawal/Depression; Somatic Complaints; Social Problems; Thinking Problems; Attention Problems; Rule-Breaking Behaviors; Aggressive Behaviors), general (Internalizing, Externalizing, and Total Problems), emotional-behavioral problems according to some of the DSM diagnostic categories (Affective Problems; Anxiety Problems; Somatic Problems; Attention-Deficit/Hyperactivity Problems; Oppositional-Provocative Problems; Conduct Problems). We used parent, teacher, and adolescent forms

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

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

    It is a 50-item questionnaire completed by adolescents, assessing anxiety in children and adolescents from 8 to 19 years of age comprehensively.

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

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

    It is a comprehensive, multi-perspective assessment of depressive symptoms in children and adolescents aged 7 to 17 years that allows early identification of depressive symptoms and provides an index of their extent and severity. We used the children and adolescent version

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

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

    ICompleted by caregivers, assessing the executive functioning profile of children between the ages of 5 and 18 years oldand adolescents aged 7 to 17 years that allows early identification of depressive symptoms and provides an index of their extent and severity. We used the children and adolescent version

Other outcomes

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

    Time frame: pre-treatment (within two weeks)

    It was administered to parents separately to evaluate autism traits.

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

    Time frame: pre-treatment (within two weeks)

    It is a rating scale that measures daily living skills. It can detect these skills in individuals aged 0-89 years. For the present study, the caregivers' form was used to assess the behavior of people aged 5 to 21.

  3. Social validity

    Time frame: post-treatment (within two weeks)

    The questionnaire was administered to adolescents, and caregivers to evaluate the usefulness of the program sessions (using a 3-point likert scale) and whether they would recommend the training to other families/peers. Finally, they were asked to indicate 3 strengths and 3 weaknesses. The questionnaires were constructed specifically for the current research project from a reworking of a form found in another study that used PEERS® to test the program's effectiveness with participants with Turner Syndrome (Wolstencroft et al., 2018).

Sponsors and collaborators

Lead sponsor

Istituto Superiore di Sanità

Other

Collaborators

  • University of Roma La Sapienza

Registry information

Official study 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).

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jul 25, 2022
Registry last updated
Jul 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.