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Autism Spectrum DisorderPhase 2NCT05473104

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

A Phase 2 study testing Program for the Education and Enrichment of Relational Skills in people with Autism Spectrum Disorder, run by Istituto Superiore di Sanità at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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)… Read more about this study

Who is it for?
Ages 12 to 18 years
Conditions the study is for
Autism Spectrum Disorder
What is being tested?
Program for the Education and Enrichment of Relational Skills
Could I receive a placebo?
No, everyone receives an active treatment
How many people
37 participants
Where
1 siteItaly
Study dates
14 Jan 2021to 14 Nov 2021
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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:

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Italy1 site

  • Istituto Superiore di Sanità

    Roma, Rome, 00161

Other trials in Italy

About this study

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).

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.

Being tested
Program for the Education and Enrichment of Relational Skills
Keywords
Autism Spectrum Disorder, social skills training
Medical subject headings
Autism Spectrum Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Program for the Education and Enrichment of Relational SkillsBehavioural

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

Study groups in NCT05473104
Study groupRoleWhat they receive
experimental groupExperimentalTeens and parents participate in the training once a week for 14 consecutive weeks in parallel groups.
Receives: Behavioral: Program for the Education and Enrichment of Relational Skills
waiting-list groupNo interventionTeens 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

  3. 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.

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

Secondary outcomes (4)

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

    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

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

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

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

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

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

    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

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

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

    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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jul 2022
  2. Study start14 Jan 2021
  3. Primary completion14 Apr 2021
  4. Study completion14 Nov 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Care provider, Outcomes assessor
Enrolment
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05473104
Sponsor's protocol ID
871
Status last verified
Jul 2022
First submitted
4 Jul 2022
Last updated
25 Jul 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 38190054

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Program for the Education and Enrichment of Relational Skills in people with Autism Spectrum Disorder, run by Istituto Superiore di Sanità at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05473104, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2022.

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