A Phase 2 interventional study of Program for the Education and Enrichment of Relational Skills in Autism Spectrum Disorder, sponsored by Istituto Superiore di Sanità. Completed at 1 site in Italy. Open to participants aged 12 Years to 18 Years. Per ClinicalTrials.gov, last updated 2022-07-25.
Sponsored by Istituto Superiore di Sanità · Phase 2, Interventional, and Treatment
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.
1,344 studies on the registry are indexed under Autistic Disorder; 334 are open to participants now.
This study's enrollment of 37 is below the median of 45 across 1,044 interventional studies indexed under Autistic Disorder.
Browse Autistic Disorder studies →Istituto Superiore di Sanità is the lead sponsor of 17 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Teens and parents participate in the training once a week for 14 consecutive weeks in parallel groups.
Behavioral: Program for the Education and Enrichment of Relational Skills
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.
Social training targeting adolescents with ASD and focused on making and keeping friends
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.
Time frame: pre-treatment, after 14 weeks and 3 months after the start of training (within two weeks)
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.
Time frame: pre-treatment, after 14 weeks and 3 months after the start of training (within two weeks)
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.
Time frame: pre-treatment, after 14 weeks and 3 months after the start of training (within two weeks)
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
Time frame: pre-treatment, after 14 weeks and 3 months after the start of training (within two weeks)
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.
Time frame: pre-treatment, after 14 weeks and 3 months after the start of training (within two weeks)
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
Time frame: pre-treatment, after 14 weeks and 3 months after the start of training (within two weeks)
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
Time frame: pre-treatment, after 14 weeks and 3 months after the start of training (within two weeks)
Autism Quotient (AQ) (Baron-Cohen et al., 2001)
It was administered to parents separately to evaluate autism traits.
Time frame: pre-treatment (within two weeks)
Adaptive Behavior Assessment System - Second Edition (ABAS-II) (Harrison & Oakland 2003)
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.
Time frame: pre-treatment (within two weeks)
Social validity
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).
Time frame: post-treatment (within two weeks)
Plan to share: No
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