Clinical trial NCT04302818: SKOLKONTAKT - Social Skills Training in a School Setting
Official title: SKOLKONTAKT - Social Skills Training in a School Setting, a Randomized Controlled Pilot
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Attention Deficit Hyperactivity Disorder
Anxiety
Depression
Keywords: Social skills group training
School-based intervention
Evidenced-based intervention
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Marcus och Amalia Wallenbergs minnesfond
First posted: 2020-03-10
Enrollment: 33
Sex: ALL
Minimum age (years): 15
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study investigates the behavioral effects of an adapted manual-based social skills training program (SKOLKONTAKT) for the mainstream education plan delivered by school personnel, with pupils (15-20 years) with social-communication needs; either formally diagnosed (i.e. autism spectrum disorders or ADHD) or teacher-reported subclinical difficulties. N=40 are recruited from a community school in the Stockholm area (Sweden).

Detailed description: So far, research has failed to consider the effectiveness of social skills training in school settings, and has instead focused on clinical or laboratory settings. This approach presents an interesting paradox given that the primary goal of social skills training is to affect change in the child's behavior in everyday life including school. Research undertaken in authentic everyday environments is not only more likely to result in real world outcomes for children and adolescents with ASD and ADHD, but greater utility in guiding models of service delivery. The objective of the current line of research is to adapt and evaluate methods originally designed to support children and adolescents with ASD and ADHD in clinical settings ("KONTAKT"), to be feasible and effective in school settings, that can be conducted by school personnel, and are are applicable to children with autistic and inattentive, hyperactive-impulsive disorders, as well as other less defined special social needs ("SKOLKONTAKT").

Eligibility criteria: Inclusion Criteria:

* Formally diagnosed autism spectrum disorder
* Formally diagnosed attention deficit hyperactivity disorder
* Teacher-reported subclinical social-communication special needs

Exclusion Criteria:

* Severe psychiatric comorbidity that challenges administration of the group-intervention, including but not limited to severe oppositional defiant disorder
* Severe psychiatric comorbidity that makes the participant to vulnerable to participate in the group-intervention, including but not limited to suicidality, severe depression

Primary outcomes:
measure: Social Skills Group Questionnaire (SSGQ)
timeFrame: Change in score from baseline after 12 weeks of social skills training and at 3 months follow-up. Total time frame 6 months.
Secondary outcomes:
measure: Social Responsiveness Scale-2 (SRS-ll)
timeFrame: Change in score from baseline immediately after the intervention (12-13 weeks after baseline) and at 3 months follow-up (24-25 weeks after baseline). Total time frame 6 months.
measure: KIDSCREEN-27 (short version)
timeFrame: Change in score from baseline immediately after the intervention (12-13 weeks after baseline) and at 3 months follow-up (24-25 weeks after baseline).Total time frame 6 months.
measure: Worlds Health Organisation Disability Assessment Schedule 2.0 (WHODAS 2.0)
timeFrame: Change in score from baseline immediately after the intervention (12-13 weeks after baseline) and at 3 months follow-up (24-25 weeks after baseline). Total time frame 6 months.
measure: Conners 3-F
timeFrame: Change in score from baseline immediately after the intervention (12-13 weeks after baseline) and at 3 months follow-up (24-25 weeks after baseline). Total time frame 6 months.
measure: Negative Effects Questionnaire (NEQ)
timeFrame: Change from baseline immediately after the intervention. Total time frame 3 months.
measure: Goal Attainment Scaling (GAS)
timeFrame: Change in score from baseline immediately after the intervention (12-13 weeks after baseline). Total time frame 3 months.
Other outcomes:
measure: Pre-assessment questionnaire
timeFrame: At baseline.
measure: Evaluation questionnaire
timeFrame: Reported immediately after the intervention.
measure: Evaluation questionnaire (school-staff)
timeFrame: Reported immediately after the intervention.
measure: Evaluation questionnaire (principal)
timeFrame: Reported immediately after the intervention.
measure: School grade
timeFrame: Change in score from baseline immediately after the intervention. Total time frame 3 months.
measure: School attendance
timeFrame: Change in score from baseline immediately after the intervention. Total time frame 3 months.
measure: Attendance in intervention-group
timeFrame: Summary score of attended sessions. Scored immediately following every session of the intervention (3 sessions/week; 12 weeks). Total time frame 3 months.
Locations:
city: Stockholm
country: Sweden
facility: CAP Research Center, Center of Neurodevelopmental disorders at Karolinska Institutet (KIND)
Study officials:
affiliation: CAP Research center, Karolinska Institutet
name: Sven Bölte, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Choque Olsson N, Rautio D, Asztalos J, Stoetzer U, Bolte S. Social skills group training in high-functioning autism: A qualitative responder study. Autism. 2016 Nov;20(8):995-1010. doi: 10.1177/1362361315621885. Epub 2016 Feb 24.
citation: Choque Olsson N, Flygare O, Coco C, Gorling A, Rade A, Chen Q, Lindstedt K, Berggren S, Serlachius E, Jonsson U, Tammimies K, Kjellin L, Bolte S. Social Skills Training for Children and Adolescents With Autism Spectrum Disorder: A Randomized Controlled Trial. J Am Acad Child Adolesc Psychiatry. 2017 Jul;56(7):585-592. doi: 10.1016/j.jaac.2017.05.001. Epub 2017 May 10.
citation: Jonsson U, Olsson NC, Coco C, Gorling A, Flygare O, Rade A, Chen Q, Berggren S, Tammimies K, Bolte S. Long-term social skills group training for children and adolescents with autism spectrum disorder: a randomized controlled trial. Eur Child Adolesc Psychiatry. 2019 Feb;28(2):189-201. doi: 10.1007/s00787-018-1161-9. Epub 2018 May 10.