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

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

      • Stockholm, Sweden, 113 30
        • CAP Research Center, Center of Neurodevelopmental disorders at Karolinska Institutet (KIND)

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.
N=21 participants are offered manualized and structured group training SKOLKONTAKT. The intervention includes 12 weeks, 3 sessions (50 minutes) per week.
Other Names:
  • SKOLKONTAKT Social skills training
  • SKOLKONTAKT Social skills group training
  • SKOLKONTAKT School-based social skills training
Active Comparator: Active control comparison group
Social activities in a group setting.
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.
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)
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.
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)
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.
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)
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.
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
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.
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)
Time Frame: Change from baseline immediately after the intervention. Total time frame 3 months.
Record of adverse events during intervention (parent-reported).
Change from baseline immediately after the intervention. Total time frame 3 months.
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.
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.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pre-assessment questionnaire
Time Frame: At baseline.
Expectations and person characteristics (parent and participant reported together) reported in a qualitative queastionnaire.
At baseline.
Evaluation questionnaire
Time Frame: Reported immediately after the intervention.
Qualitative questionnaire for intervention evaluation (parent and participant reported together)
Reported immediately after the intervention.
Evaluation questionnaire (school-staff)
Time Frame: Reported immediately after the intervention.
Qualitative questionnaire for intervention evaluation (school-staff reported)
Reported immediately after the intervention.
Evaluation questionnaire (principal)
Time Frame: Reported immediately after the intervention.
Qualitative questionnaire for intervention evaluation (school principal-reported)
Reported immediately after the intervention.
School grade
Time Frame: Change in score from baseline immediately after the intervention. Total time frame 3 months.
Percent of grades indicating typical progress in subjects (teacher-reported)
Change in score from baseline immediately after the intervention. Total time frame 3 months.
School attendance
Time Frame: Change in score from baseline immediately after the intervention. Total time frame 3 months.
Percent of school attendance (teacher-reported)
Change in score from baseline immediately after the intervention. Total time frame 3 months.
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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.

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

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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