NCT04302818

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 2, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 12, 2020

Completed
27 days until next milestone

First Posted

Study publicly available on registry

March 10, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2021

Completed
Last Updated

March 29, 2022

Status Verified

March 1, 2022

Enrollment Period

1.6 years

First QC Date

February 12, 2020

Last Update Submit

March 28, 2022

Conditions

Autism Spectrum DisorderAttention Deficit Hyperactivity DisorderAnxietyDepression

Keywords

Social skills group trainingSchool-based interventionEvidenced-based intervention

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Social Responsiveness Scale-2 (SRS-ll)

    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)

    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)

    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

    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)

    Change from baseline immediately after the intervention. Total time frame 3 months.

  • +1 more secondary outcomes

Other Outcomes (7)

  • Pre-assessment questionnaire

    At baseline.

  • Evaluation questionnaire

    Reported immediately after the intervention.

  • Evaluation questionnaire (school-staff)

    Reported immediately after the intervention.

  • +4 more other outcomes

Study Arms (2)

Social skills group training SKOLKONTAKT

EXPERIMENTAL

Manualised social skills group training.

Behavioral: SKOLKONTAKT

Active control comparison group

ACTIVE COMPARATOR

Social activities in a group setting.

Behavioral: Social activity group

Interventions

SKOLKONTAKTBEHAVIORAL

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

Also known as: SKOLKONTAKT Social skills training, SKOLKONTAKT Social skills group training, SKOLKONTAKT School-based social skills training
Social skills group training SKOLKONTAKT
Social activity groupBEHAVIORAL

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.

Active control comparison group

Eligibility Criteria

Age15 Years - 20 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Formally diagnosed autism spectrum disorder
  • Formally diagnosed attention deficit hyperactivity disorder
  • Teacher-reported subclinical social-communication special needs

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Stockholm, 113 30, Sweden

Location

Related Publications (3)

  • 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.

    PMID: 26912485BACKGROUND

  • 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.

    PMID: 28647010BACKGROUND

  • 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.

    PMID: 29748736BACKGROUND

Related Links

MeSH Terms

Conditions

Autism Spectrum DisorderAttention Deficit Disorder with HyperactivityAnxiety DisordersDepression

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersAttention Deficit and Disruptive Behavior DisordersBehavioral SymptomsBehavior

Study Officials

  • Sven Bölte, Professor

    CAP Research center, Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Teacher-assessors are blinded pre-, post, and follow-up.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 12, 2020

First Posted

March 10, 2020

Study Start

September 2, 2019

Primary Completion

March 31, 2021

Study Completion

March 31, 2021

Last Updated

March 29, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)