SKOLKONTAKT - Social Skills Training in a School Setting

Study Overview
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Brief Summary
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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
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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).

Official Title
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SKOLKONTAKT - Social Skills Training in a School Setting, a Randomized Controlled Pilot

Conditions
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Autism Spectrum Disorder, Attention Deficit Hyperactivity Disorder, Anxiety, Depression

Intervention / Treatment
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* Behavioral: SKOLKONTAKT
* Behavioral: Social activity group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Social skills group training SKOLKONTAKT<br>Manualised social skills group training. | Behavioral: SKOLKONTAKT<br>* N=21 participants are offered manualized and structured group training SKOLKONTAKT. The intervention includes 12 weeks, 3 sessions (50 minutes) per week.<br>* Other names: SKOLKONTAKT School-based social skills training;|
| Active Comparator: Active control comparison group<br>Social activities in a group setting. | Behavioral: Social activity group<br>* N=21 participants. The active comparison group includes 12 weeks, 3 sessions (50 minutes) per week. Sessions will include socially oriented activities such as board games, sports or baking as well as a recommended, general agenda.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Social Skills Group Questionnaire (SSGQ) | Social skills (parent-, self- and (blinded) teacher-reported), higher score indicating improvement in skills | Change in score from baseline after 12 weeks of social skills training and at 3 months follow-up. Total time frame 6 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Social Responsiveness Scale-2 (SRS-ll) | Autistic symptoms (parent-reported), decrease in scores indicating less clinical symptoms. | 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. | 
| KIDSCREEN-27 (short version) | Health-related Quality of Life (self-reported). | 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. | 
| Worlds Health Organisation Disability Assessment Schedule 2.0 (WHODAS 2.0) | Daily functioning as affected by functional disability (parent-reported). | 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. | 
| Conners 3-F | ADHD-related symptoms (parent-reported), decrease in scores indicating less clinical symptoms. | 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. | 
| Negative Effects Questionnaire (NEQ) | Record of adverse events during intervention (parent-reported). | Change from baseline immediately after the intervention. Total time frame 3 months. | 
| Goal Attainment Scaling (GAS) | Personalised goal-setting (self-reported). Goal attaingment reported on a five-point scale, where higher score indicates better outcome. | Change in score from baseline immediately after the intervention (12-13 weeks after baseline). Total time frame 3 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Social skills group training, School-based intervention, Evidenced-based intervention