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Completed

NCT Number: NCT04302818

SKOLKONTAKT - Social Skills Training in a School Setting

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).

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Key information

Age range

15 year–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Stockholm, 113 30, Sweden

About this study

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").

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SKOLKONTAKT

Behavioral

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

Social activity group

Behavioral

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 outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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).

  3. 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).

  4. 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.

  5. 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).

  6. 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.

Other outcomes

  1. Pre-assessment questionnaire

    Time frame: At baseline.

    Expectations and person characteristics (parent and participant reported together) reported in a qualitative queastionnaire.

  2. Evaluation questionnaire

    Time frame: Reported immediately after the intervention.

    Qualitative questionnaire for intervention evaluation (parent and participant reported together)

  3. Evaluation questionnaire (school-staff)

    Time frame: Reported immediately after the intervention.

    Qualitative questionnaire for intervention evaluation (school-staff reported)

  4. Evaluation questionnaire (principal)

    Time frame: Reported immediately after the intervention.

    Qualitative questionnaire for intervention evaluation (school principal-reported)

  5. 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)

  6. School attendance

    Time frame: Change in score from baseline immediately after the intervention. Total time frame 3 months.

    Percent of school attendance (teacher-reported)

  7. 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)

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Marcus och Amalia Wallenbergs minnesfond

Registry information

Official study title

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

Acronym: SKOLKONTAKT

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Mar 10, 2020
Registry last updated
Mar 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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