SOCIAL: Adaptation and Validation of the In-person PEERS® Program for Adolescents With Autism.

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10-14
SponsorIRCCS Fondazione Stella Maris

About this trial

Autism Spectrum Disorder (ASD) falls under the category of high complexity disorders which, in most cases, accompany individuals throughout their entire life with significant impacts and costs for individuals, their families, and society at large. Adolescence is a time of increasing challenge for teenagers with ASD and their families, as it is a time to lay the foundations for the transition to adulthood but at the same time, it is a period of clear mismatch between the abilities and interests of teenagers with ASD and the expectations of their peers. It becomes increasingly difficult to initiate and maintain friendships that require social skills, communicate through social media, or make appropriate use of humor. It is in peer relationships that recognizing and applying implicit social norms is more difficult, and social errors can lead to a bad reputation, exclusion, and being bullied.

This creates the need for concrete responses through evidence-based treatment programs adapted to the Italian context. In this scenario, the Program for the Education and Enrichment of Relational Skills (PEERS®) fits in, a psychosocial intervention that falls under the category of Social Skill Training (SST) conducted in a group context, evidence-based, originating from the United States for adolescents with ASD that involves structured teaching of knowledge and skills related to social relationships.

SOCIAL has three main objectives: clinical, scientific, and social. The clinical objective is articulated in the study of the effectiveness of the in-person PEERS® program on an Italian population of adolescents with ASD (aged between 10 and 14) to respond to the evident need for a psychosocial intervention adapted to the Italian context. The scientific objective aims to identify an electroencephalographic biomarker that acts as a predictor of the efficacy of PEERS® and is specific to a particular individual profile. Finally, the social objective intends to extend the support network of adolescents with ASD through meetings with schools to train Teachers, thus parallelizing the treatment for generalization of the skills acquired during clinical treatment and also to the school context where peers play a key role.

SOCIAL aims to respond to a gap that exists in Italy for a critical age group involving teenagers with ASD, proposing an evidence-based treatment that extends to family and school contexts.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

(a) age between 10 and 14 years;

clinical diagnosis of Autism Spectrum Disorder according to ICD-10 (WHO, 1992);

absence of intellectual disability (IQ over 85);

absence of a concomitant major psychiatric disorder (e.g., schizophrenia, bipolar disorder, psychiatric illness);

Disqualifiers

Full IQ below 85;

concomitant major psychiatric disorders

Trial design

Design model

Sequential

Treatments tested in this trial

  • PEERS

    Behavioral

    The Program for the Education and Enrichment of Relational Skills (PEERS®) is world-renowned for providing evidence-based social skills treatment to adolescents with autism spectrum disorder (ASD), attention-deficit/hyperactivity disorder (ADHD), anxiety, depression, and other socio-emotional problems.

  • Control

    Behavioral

    This group will also consist of children diagnosed with high-functioning ASD. However, these children will not receive PEERS therapy. Instead, they will continue their usual treatments in their local settings without participating in the PEERS therapy sessions. This group\'s outcomes will be compared with the experimental group to assess the effectiveness of PEERS therapy.

Treatment groups

36 Participants
are divided into 2 treatment groups
Group A: PEERSExperimental treatment 1 intervention
Group B: CONTROLSActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Test of Adolescent Social Skills Knowledge-Revised (TASSK-R)

The TASSK-R is a self-report, criterion-referenced measure that assesses teens' knowledge about social skills taught throughout the program. It consists of 26 sentence stems in which adolescents are asked to choose from two possible answers. A higher score indicates more knowledge about social skills related to the treatment.

Time frame
T0 (before treatment) T1 (after 16 weeks from T0) T2 (9 months after T1)
2

Quality of Socialization Questionnaire-Revised (QSQ-R)

The QSQ-R assesses the frequency and quality of encounters of the adolescent with friends, as reported by adolescents (SQA-R) and parents (SQP-R). To verify the reliability of the report, adolescents and parents are asked to provide a list of names of the friends with whom the adolescent met. A 12-item questionnaire assesses the level of conflict during the most recent encounter with a peer, with answers given on a Likert scale.

Time frame
T0 (before treatment) T1 (after 16 weeks from T0) T2 (9 months after T1)
3

Scala di reattività sociale-2 (SRS-2)

The SRS-2 is a quantitative measure consisting of 65 items that assess the symptoms characteristic of autism spectrum disorders. The SRS-2 has been used in previous PEERS® program evaluations and has shown to be sensitive to treatment effects.

Time frame
T0 (before treatment) T1 (after 16 weeks from T0) T2 (9 months after T1)
4

Social Skills Improvement System Rating Scales (SSiS)

The SSiS is a 79-item measure that assesses general social skills general social skills and problem behaviour. It is a parent report on the behaviour of adolescents on a 4-point scale. There are standard scores are available for the general domains of social skills and problem behaviour. The SSiS has a high internal reliability.

Time frame
T0 (before treatment) T1 (after 16 weeks from T0) T2 (9 months after T1)

Secondary outcomes

1

Child Behavior Checklist 6-18 years (CBCL 6/18)

The CBCL 6-18 is widely used to assess developmental psychopathology through scales that assess syndromic, general, and emotional-behavioral dimensions according to certain DSM diagnostic categories.

Time frame
T0 (before treatment) T1 (after 16 weeks from T0) T2 (9 months after T1)
2

Youth Self Report 11-18 years (YSR 11-18)

The YSR was built with the aim of having a self-descriptive tool to obtain information direct information from adolescents, aged 11-18 years of age, about their skills and their behavioral and emotional problems.

Time frame
T0 (before treatment) T1 (after 16 weeks from T0) T2 (9 months after T1)
3

Teacher Report Form 6-18 years (TRF 6-18)

The TRF compiled by the teacher assesses the behavioural problems that an adolescent may manifest at school.

Time frame
T0 (before treatment) T1 (after 16 weeks from T0) T2 (9 months after T1)
4

Vineland Adaptive Behavior Scales, Second Edition (VABS-II)

VABS-II uses four specific domains: Communication, Everyday Life Skills, Socialisation, and Motor Skills. The scores of the sub-scales are summed up to obtain a composite adaptive behavior score

Time frame
T0 (before treatment) T1 (after 16 weeks from T0) T2 (9 months after T1)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: