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SKOLKONTAKT - Social Skills Training in a School Setting (SKOLKONTAKT)

Primary Purpose

Autism Spectrum Disorder, Attention Deficit Hyperactivity Disorder, Anxiety

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
SKOLKONTAKT
Social activity group
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring Social skills group training, School-based intervention, Evidenced-based intervention

Eligibility Criteria

15 Years - 20 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • CAP Research Center, Center of Neurodevelopmental disorders at Karolinska Institutet (KIND)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Social skills group training SKOLKONTAKT

Active control comparison group

Arm Description

Manualised social skills group training.

Social activities in a group setting.

Outcomes

Primary Outcome Measures

Social Skills Group Questionnaire (SSGQ)
Social skills (parent-, self- and (blinded) teacher-reported), higher score indicating improvement in skills

Secondary Outcome Measures

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

Full Information

First Posted
February 12, 2020
Last Updated
March 28, 2022
Sponsor
Karolinska Institutet
Collaborators
Marcus och Amalia Wallenbergs minnesfond
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1. Study Identification

Unique Protocol Identification Number
NCT04302818
Brief Title
SKOLKONTAKT - Social Skills Training in a School Setting
Acronym
SKOLKONTAKT
Official Title
SKOLKONTAKT - Social Skills Training in a School Setting, a Randomized Controlled Pilot
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
September 2, 2019 (Actual)
Primary Completion Date
March 31, 2021 (Actual)
Study Completion Date
March 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
Collaborators
Marcus och Amalia Wallenbergs minnesfond

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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").

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder, Attention Deficit Hyperactivity Disorder, Anxiety, Depression
Keywords
Social skills group training, School-based intervention, Evidenced-based intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Teacher-assessors are blinded pre-, post, and follow-up.
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Social skills group training SKOLKONTAKT
Arm Type
Experimental
Arm Description
Manualised social skills group training.
Arm Title
Active control comparison group
Arm Type
Active Comparator
Arm Description
Social activities in a group setting.
Intervention Type
Behavioral
Intervention Name(s)
SKOLKONTAKT
Other Intervention Name(s)
SKOLKONTAKT Social skills training, SKOLKONTAKT Social skills group training, SKOLKONTAKT School-based social skills training
Intervention Description
N=21 participants are offered manualized and structured group training SKOLKONTAKT. The intervention includes 12 weeks, 3 sessions (50 minutes) per week.
Intervention Type
Behavioral
Intervention Name(s)
Social activity group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Social Skills Group Questionnaire (SSGQ)
Description
Social skills (parent-, self- and (blinded) teacher-reported), higher score indicating improvement in skills
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.
Secondary Outcome Measure Information:
Title
Social Responsiveness Scale-2 (SRS-ll)
Description
Autistic symptoms (parent-reported), decrease in scores indicating less clinical symptoms.
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.
Title
KIDSCREEN-27 (short version)
Description
Health-related Quality of Life (self-reported).
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.
Title
Worlds Health Organisation Disability Assessment Schedule 2.0 (WHODAS 2.0)
Description
Daily functioning as affected by functional disability (parent-reported).
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.
Title
Conners 3-F
Description
ADHD-related symptoms (parent-reported), decrease in scores indicating less clinical symptoms.
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.
Title
Negative Effects Questionnaire (NEQ)
Description
Record of adverse events during intervention (parent-reported).
Time Frame
Change from baseline immediately after the intervention. Total time frame 3 months.
Title
Goal Attainment Scaling (GAS)
Description
Personalised goal-setting (self-reported). Goal attaingment reported on a five-point scale, where higher score indicates better outcome.
Time Frame
Change in score from baseline immediately after the intervention (12-13 weeks after baseline). Total time frame 3 months.
Other Pre-specified Outcome Measures:
Title
Pre-assessment questionnaire
Description
Expectations and person characteristics (parent and participant reported together) reported in a qualitative queastionnaire.
Time Frame
At baseline.
Title
Evaluation questionnaire
Description
Qualitative questionnaire for intervention evaluation (parent and participant reported together)
Time Frame
Reported immediately after the intervention.
Title
Evaluation questionnaire (school-staff)
Description
Qualitative questionnaire for intervention evaluation (school-staff reported)
Time Frame
Reported immediately after the intervention.
Title
Evaluation questionnaire (principal)
Description
Qualitative questionnaire for intervention evaluation (school principal-reported)
Time Frame
Reported immediately after the intervention.
Title
School grade
Description
Percent of grades indicating typical progress in subjects (teacher-reported)
Time Frame
Change in score from baseline immediately after the intervention. Total time frame 3 months.
Title
School attendance
Description
Percent of school attendance (teacher-reported)
Time Frame
Change in score from baseline immediately after the intervention. Total time frame 3 months.
Title
Attendance in intervention-group
Description
Number of sessions attended by participant (group-leader reported)
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sven Bölte, Professor
Organizational Affiliation
CAP Research center, Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
CAP Research Center, Center of Neurodevelopmental disorders at Karolinska Institutet (KIND)
City
Stockholm
ZIP/Postal Code
113 30
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26912485
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.
Results Reference
background
PubMed Identifier
28647010
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.
Results Reference
background
PubMed Identifier
29748736
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.
Results Reference
background
Links:
URL
http://ki.se/kind/center-of-neurodevelopmental-disorders-at-karolinska-institutet-kind
Description
Homepage KIND.

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SKOLKONTAKT - Social Skills Training in a School Setting

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