Evaluation of the Effect of a Social Skills Program for Children and Adolescents With ASD

NCT05713162 | Completed

• 1 other identifier: PIC-04-17
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

Research evaluating effectiveness of social skills intervention programs for children and adolescents with Autism Spectrum Disorder is still limited. The main objective of this study was to develop an adaptation of the Social Adjustment Enhancement Intervention program form the University of California for a group of children and adolescents with autism. Our secondary goal was to evaluate the effect of our program through specific indicators. We hypothesized a decrease in comorbid symptomatology, as measured by questionnaires. We also expected an increase in social behaviors, measured through observational methodology.

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (1)

• Change from baseline number of social behaviors as measured by an observational instrument at 10 weeks later (after intervention)

  In order to quantitatively code social behaviors, we applied an observational instrument. First of all, we reorganized and developed an observational instrument inspired by a previous observational instrument and by the approach of social difficulties of the authors of Autism Diagnosis Observational Schedule-2. This instrument allows the observer to quantify the number of occurrences of target behaviors according to pre-established categories. The scale includes six defined dimensions and category systems that meet the requirements of exhaustively and mutual exclusivity.

  Change from Baseline number of social conducts at 10 weeks later (after intervention)

Secondary Outcomes (2)

• Change from baseline results in Child Behavior Checklist (CBCL/6-18): (Achenbach, T. 1992)

  Change from Baseline comorbid symptoms to 10 weeks later (immediately after the intervention)

• Change from baseline results in The Spence Children's Anxiety Scale (SCAS): (Spence, 1997):

  Change from Baseline anxiety symptoms to 10 weeks later (immediately after the intervention)

Study Arms (4)

Children experimental group

EXPERIMENTAL

Children who receive 10 sessions of the social skills training program

Behavioral: Adaptation of the Social Adjustment Enhancement Intervention of the UC Davis MIND Institute (Solomon, 2004).

Adolescent experimental group

EXPERIMENTAL

Adolescents who receive 10 sessions of the social skills training program

Behavioral: Adaptation of the Social Adjustment Enhancement Intervention of the UC Davis MIND Institute (Solomon, 2004).

Children control group

NO INTERVENTION

Children in waiting list (do not receive 10 sessions of the social skills training program)

Adolescent control group

NO INTERVENTION

Adolescents in waiting list (do not receive 10 sessions of the social skills training program)

Interventions

Adaptation of the Social Adjustment Enhancement Intervention of the UC Davis MIND Institute (Solomon, 2004). BEHAVIORAL

The social skills intervention program was based on a consented adaptation of the Social Adjustment Enhancement Intervention of the UC Davis MIND Institute (Solomon, 2004). In order to be feasible in a hospital-based service, we adapted the program to 10 sessions. Session structure included initial greeting, free play time, didactic, joke telling, and closing activities. Topics of didactic sessions were related to social competence, such as empathy, talking about feelings, and solving social problems. We also adapted the content of the sessions, including activities proposed by Solomon (2004) but also from other experts in social cognition, such as García-Winner (2000). Each group was comprised by 7-10 participants. Children groups were conducted by a clinical psychologist, a mental health nurse and the support of two master degree students. Adolescent groups were conducted by a psychologist, a psychiatrist and the support of two master degree students.

Adolescent experimental group; Children experimental group

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• age range between 8 and 17 years old
• confirmed diagnosis of autism spectrum disorder according to Diagnostic and Statistical Manual, fifth version (APA, 2013)
• meeting cut-off at the Autism Diagnostic Observation Schedule-2 (ADOS-2, Lord et al., 2000)
• normal range of Verbal Comprehension.

You may not qualify if:

• severe behavioral problems
• several mental psychopathologies such as schizophrenia
• intellectual functioning below 80.

Sponsors & Collaborators

• Fundació Sant Joan de Déu: lead

Study Sites (1)

Sant Joan de Déu Barcelona Children's Hospital, Sant Joan de Déu Research Foundation (Research Institute)

Barcelona, Spain

Location

Related Publications (2)

• Alcover C, Mairena MA, Mezzatesta M, Elias N, Diez-Juan M, Balana G, Gonzalez-Rodriguez M, Rodriguez-Medina J, Anguera MT, Arias-Pujol E. Mixed Methods Approach to Describe Social Interaction During a Group Intervention for Adolescents With Autism Spectrum Disorders. Front Psychol. 2019 Jun 4;10:1158. doi: 10.3389/fpsyg.2019.01158. eCollection 2019.

  PMID: 31231268 BACKGROUND

• Alcover C, Mairena MA, Rodriguez-Medina J, Mezzatesta M, Balana G, Elias N, Elias M, Arias-Pujol E. Measuring Changes in Social Skills Throughout an Intervention Program for Children with ASD, Contributions from Polar Coordinate Analysis. J Autism Dev Disord. 2023 Jun;53(6):2246-2260. doi: 10.1007/s10803-022-05496-0. Epub 2022 Mar 12.

  PMID: 35279764 BACKGROUND

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Maria A Mairena, PhD

  Sant Joan de Déu Barcelona Children's Hospital, Sant Joan de Déu Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2022
• First Posted: February 6, 2023
• Study Start: January 30, 2017
• Primary Completion: April 30, 2019
• Study Completion: April 30, 2019
• Last Updated: February 6, 2023

Record last verified: 2022-03

Locations

ES (1)