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

NCT ID: NCT05473104

Last Updated: 2022-07-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-14

Study Completion Date

2021-11-14

Brief Summary

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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.

Detailed Description

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Conditions

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Autism Spectrum Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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experimental group

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

Group Type EXPERIMENTAL

Program for the Education and Enrichment of Relational Skills

Intervention Type BEHAVIORAL

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

waiting-list group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Program for the Education and Enrichment of Relational Skills

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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;

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
Minimum Eligible Age

12 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Roma La Sapienza

OTHER

Sponsor Role collaborator

Istituto Superiore di Sanità

OTHER

Sponsor Role lead

Responsible Party

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Laura Maria Fatta

Ph.D Psy.D

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Istituto Superiore di Sanità

Roma, Rome, Italy

Site Status

Countries

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Italy

References

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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.

Reference Type DERIVED
PMID: 38190054 (View on PubMed)

Other Identifiers

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871

Identifier Type: -

Identifier Source: org_study_id

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