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

Istituto Superiore di Sanità

Status and phase: Completed; Phase 2

Conditions: Autism Spectrum Disorder

Treatments: Behavioral: Program for the Education and Enrichment of Relational Skills

Study type: Interventional

Funder types: Other

Identifiers

NCT05473104

871

Details and patient eligibility

About

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.

Enrollment: 37 patients

Sex: All

Ages: 12 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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37 participants in 2 patient groups

experimental group

Experimental group

Description:

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

Treatment:

Behavioral: Program for the Education and Enrichment of Relational Skills

waiting-list group

No Intervention group

Description:

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.