SKOLKONTAKT - Social Skills Training in a School Setting

Depression Clinical Trial

— SKOLKONTAKT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04302818
• Other study ID #: SKOLKONTAKT
• Status: Completed
• Phase: N/A
• Start date: September 2, 2019
• Est. completion date: March 31, 2021

Study information

• Verified date: March 2022
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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").

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: March 31, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 20 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Autism Spectrum Disorder
• Depression
• Disease

Intervention

Behavioral:
• SKOLKONTAKT
N=21 participants are offered manualized and structured group training SKOLKONTAKT. The intervention includes 12 weeks, 3 sessions (50 minutes) per week.
• Social activity group
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.

Locations

Country	Name	City	State
Sweden	CAP Research Center, Center of Neurodevelopmental disorders at Karolinska Institutet (KIND)	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Marcus och Amalia Wallenbergs minnesfond

Country where clinical trial is conducted

Sweden, 

References & Publications (3)

Choque Olsson N, Flygare O, Coco C, Görling A, Råde A, Chen Q, Lindstedt K, Berggren S, Serlachius E, Jonsson U, Tammimies K, Kjellin L, Bölte 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. — View Citation

Choque Olsson N, Rautio D, Asztalos J, Stoetzer U, Bölte S. Social skills group training in high-functioning autism: A qualitative responder study. Autism. 2016 Nov;20(8):995-1010. Epub 2016 Feb 24. — View Citation

Jonsson U, Olsson NC, Coco C, Görling A, Flygare O, Råde A, Chen Q, Berggren S, Tammimies K, Bölte 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pre-assessment questionnaire	Expectations and person characteristics (parent and participant reported together) reported in a qualitative queastionnaire.	At baseline.
Other	Evaluation questionnaire	Qualitative questionnaire for intervention evaluation (parent and participant reported together)	Reported immediately after the intervention.
Other	Evaluation questionnaire (school-staff)	Qualitative questionnaire for intervention evaluation (school-staff reported)	Reported immediately after the intervention.
Other	Evaluation questionnaire (principal)	Qualitative questionnaire for intervention evaluation (school principal-reported)	Reported immediately after the intervention.
Other	School grade	Percent of grades indicating typical progress in subjects (teacher-reported)	Change in score from baseline immediately after the intervention. Total time frame 3 months.
Other	School attendance	Percent of school attendance (teacher-reported)	Change in score from baseline immediately after the intervention. Total time frame 3 months.
Other	Attendance in intervention-group	Number of sessions attended by participant (group-leader reported)	Summary score of attended sessions. Scored immediately following every session of the intervention (3 sessions/week; 12 weeks). Total time frame 3 months.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	Negative Effects Questionnaire (NEQ)	Record of adverse events during intervention (parent-reported).	Change from baseline immediately after the intervention. Total time frame 3 months.
Secondary	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.

External Links

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