- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04302818
SKOLKONTAKT - Social Skills Training in a School Setting (SKOLKONTAKT)
March 28, 2022 updated by: Sven Bölte, Karolinska Institutet
SKOLKONTAKT - Social Skills Training in a School Setting, a Randomized Controlled Pilot
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).
Study Overview
Status
Completed
Intervention / Treatment
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").
Study Type
Interventional
Enrollment (Actual)
33
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Stockholm, Sweden, 113 30
- CAP Research Center, Center of Neurodevelopmental disorders at Karolinska Institutet (KIND)
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
13 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Social skills group training SKOLKONTAKT
Manualised social skills group training.
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N=21 participants are offered manualized and structured group training SKOLKONTAKT.
The intervention includes 12 weeks, 3 sessions (50 minutes) per week.
Other Names:
|
Active Comparator: Active control comparison group
Social activities in a group setting.
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Social Skills Group Questionnaire (SSGQ)
Time Frame: Change in score from baseline after 12 weeks of social skills training and at 3 months follow-up. Total time frame 6 months.
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Social skills (parent-, self- and (blinded) teacher-reported), higher score indicating improvement in skills
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Change in score from baseline after 12 weeks of social skills training and at 3 months follow-up. Total time frame 6 months.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Social Responsiveness Scale-2 (SRS-ll)
Time Frame: 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.
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Autistic symptoms (parent-reported), decrease in scores indicating less clinical symptoms.
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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.
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KIDSCREEN-27 (short version)
Time Frame: 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.
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Health-related Quality of Life (self-reported).
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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.
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Worlds Health Organisation Disability Assessment Schedule 2.0 (WHODAS 2.0)
Time Frame: 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.
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Daily functioning as affected by functional disability (parent-reported).
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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.
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Conners 3-F
Time Frame: 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.
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ADHD-related symptoms (parent-reported), decrease in scores indicating less clinical symptoms.
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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.
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Negative Effects Questionnaire (NEQ)
Time Frame: Change from baseline immediately after the intervention. Total time frame 3 months.
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Record of adverse events during intervention (parent-reported).
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Change from baseline immediately after the intervention. Total time frame 3 months.
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Goal Attainment Scaling (GAS)
Time Frame: Change in score from baseline immediately after the intervention (12-13 weeks after baseline). Total time frame 3 months.
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Personalised goal-setting (self-reported).
Goal attaingment reported on a five-point scale, where higher score indicates better outcome.
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Change in score from baseline immediately after the intervention (12-13 weeks after baseline). Total time frame 3 months.
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pre-assessment questionnaire
Time Frame: At baseline.
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Expectations and person characteristics (parent and participant reported together) reported in a qualitative queastionnaire.
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At baseline.
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Evaluation questionnaire
Time Frame: Reported immediately after the intervention.
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Qualitative questionnaire for intervention evaluation (parent and participant reported together)
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Reported immediately after the intervention.
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Evaluation questionnaire (school-staff)
Time Frame: Reported immediately after the intervention.
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Qualitative questionnaire for intervention evaluation (school-staff reported)
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Reported immediately after the intervention.
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Evaluation questionnaire (principal)
Time Frame: Reported immediately after the intervention.
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Qualitative questionnaire for intervention evaluation (school principal-reported)
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Reported immediately after the intervention.
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School grade
Time Frame: Change in score from baseline immediately after the intervention. Total time frame 3 months.
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Percent of grades indicating typical progress in subjects (teacher-reported)
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Change in score from baseline immediately after the intervention. Total time frame 3 months.
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School attendance
Time Frame: Change in score from baseline immediately after the intervention. Total time frame 3 months.
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Percent of school attendance (teacher-reported)
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Change in score from baseline immediately after the intervention. Total time frame 3 months.
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Attendance in intervention-group
Time Frame: Summary score of attended sessions. Scored immediately following every session of the intervention (3 sessions/week; 12 weeks). Total time frame 3 months.
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Number of sessions attended by participant (group-leader reported)
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Summary score of attended sessions. Scored immediately following every session of the intervention (3 sessions/week; 12 weeks). Total time frame 3 months.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Sven Bölte, Professor, CAP Research center, Karolinska Institutet
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 2, 2019
Primary Completion (Actual)
March 31, 2021
Study Completion (Actual)
March 31, 2021
Study Registration Dates
First Submitted
February 12, 2020
First Submitted That Met QC Criteria
March 6, 2020
First Posted (Actual)
March 10, 2020
Study Record Updates
Last Update Posted (Actual)
March 29, 2022
Last Update Submitted That Met QC Criteria
March 28, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SKOLKONTAKT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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