Back to resultsPEERS® for Italy, a Study on Social Skills Intervention for Adolescents With Autism Spectrum Disorder (ASD).
Primary Purpose
Autism Spectrum Disorder
Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Program for the Education and Enrichment of Relational Skills
Sponsored by
About this trial
This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring Autism Spectrum Disorder, social skills training
Eligibility Criteria
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
Sites / Locations
- Istituto Superiore di Sanità
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
experimental group
waiting-list group
Arm Description
Teens and parents participate in the training once a week for 14 consecutive weeks in parallel groups.
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.
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
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
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.
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
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
Full Information
NCT ID
NCT05473104
First Posted
July 4, 2022
Last Updated
July 21, 2022
Sponsor
Istituto Superiore di Sanità
Collaborators
University of Roma La Sapienza
1. Study Identification
Unique Protocol Identification Number
NCT05473104
Brief Title
PEERS® for Italy, a Study on Social Skills Intervention for Adolescents With Autism Spectrum Disorder (ASD).
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).
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
January 14, 2021 (Actual)
Primary Completion Date
April 14, 2021 (Actual)
Study Completion Date
November 14, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istituto Superiore di Sanità
Collaborators
University of Roma La Sapienza
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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) 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
Keywords
Autism Spectrum Disorder, social skills training
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
experimental group
Arm Type
Experimental
Arm Description
Teens and parents participate in the training once a week for 14 consecutive weeks in parallel groups.
Arm Title
waiting-list group
Arm Type
No Intervention
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Program for the Education and Enrichment of Relational Skills
Intervention Description
Social training targeting adolescents with ASD and focused on making and keeping friends
Primary Outcome Measure Information:
Title
Social Responsiveness Scale (SRS) (Costantino & Gruber, 2005), changes after 14 weeks and 3 months.
Description
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)
Title
Quality of Socialization Questionnaire-Revised (QSQ-R) (Laugeson & Frankel, 2010; Laugeson et al., 2012), changes after 14 weeks and 3 months.
Description
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)
Title
Test of Adolescent Social Skills Knowledge (TASSK) (Laugeson & Frankel 2010), changes after 14 weeks and 3 months.
Description
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)
Secondary Outcome Measure Information:
Title
Child Behavior Checklist (CBCL) (Achenbach & Rescorla, 2001), changes after 14 weeks and 3 months.
Description
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)
Title
Multidimensional Anxiety Scale for Children-Second Edition (MASC-2) (March, 2013), changes after 14 weeks and 3 months.
Description
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)
Title
Children's Depression Inventory, Second Edition (CDI-2) (Kovacs, 2010), changes after 14 weeks and 3 months.
Description
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)
Title
Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2) (Gioia et al., 2015), changes after 14 weeks and 3 months.
Description
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)
Other Pre-specified Outcome Measures:
Title
Autism Quotient (AQ) (Baron-Cohen et al., 2001)
Description
It was administered to parents separately to evaluate autism traits.
Time Frame
pre-treatment (within two weeks)
Title
Adaptive Behavior Assessment System - Second Edition (ABAS-II) (Harrison & Oakland 2003)
Description
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)
Title
Social validity
Description
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Istituto Superiore di Sanità
City
Roma
State/Province
Rome
ZIP/Postal Code
00161
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
PEERS® for Italy, a Study on Social Skills Intervention for Adolescents With Autism Spectrum Disorder (ASD).
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