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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
33

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Sweden
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

11 years to 16 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Social skills group training SKOLKONTAKT
Manualised social skills group training.
Behavioral: SKOLKONTAKT
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.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Karolinska Institutet

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Marcus och Amalia Wallenbergs minnesfond

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 2, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 12, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 10, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 29, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 28, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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