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Autism Spectrum DisorderSKOLKONTAKTNCT04302818

SKOLKONTAKT - Social Skills Training in a School Setting

A study testing SKOLKONTAKT and Social activity group in people with Autism Spectrum Disorder and Attention Deficit Hyperactivity Disorder, run by Karolinska Institutet at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 15 to 20 yearsHealthy volunteers can take part
What is being tested?
SKOLKONTAKT and Social activity group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
1 siteSweden
Study dates
2 Sep 2019to 31 Mar 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 20 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Sweden1 site

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

    Stockholm, 113 30

Other trials in Sweden

About this study

Official title: 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).

Read the 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").

Being tested
SKOLKONTAKT, Social activity group
Keywords
Social skills group training, School-based intervention, Evidenced-based intervention
Medical subject headings
Autism Spectrum Disorder, Attention Deficit Disorder with Hyperactivity, Anxiety Disorders, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SKOLKONTAKTBehavioural

    Also called SKOLKONTAKT Social skills training, SKOLKONTAKT Social skills group training, SKOLKONTAKT School-based social skills training

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

  • Social activity groupBehavioural

    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.

Study groups in NCT04302818
Study groupRoleWhat they receive
Social skills group training SKOLKONTAKTExperimentalManualised social skills group training.
Receives: Behavioral: SKOLKONTAKT
Active control comparison groupActive comparatorSocial activities in a group setting.
Receives: Behavioral: Social activity group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Social Skills Group Questionnaire (SSGQ)

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

    Measured: 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)

  1. Social Responsiveness Scale-2 (SRS-ll)

    Autistic symptoms (parent-reported), decrease in scores indicating less clinical symptoms.

    Measured: 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.

  2. KIDSCREEN-27 (short version)

    Health-related Quality of Life (self-reported).

    Measured: 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.

  3. Worlds Health Organisation Disability Assessment Schedule 2.0 (WHODAS 2.0)

    Daily functioning as affected by functional disability (parent-reported).

    Measured: 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.

  4. Conners 3-F

    ADHD-related symptoms (parent-reported), decrease in scores indicating less clinical symptoms.

    Measured: 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.

  5. Negative Effects Questionnaire (NEQ)

    Record of adverse events during intervention (parent-reported).

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

  6. Goal Attainment Scaling (GAS)

    Personalised goal-setting (self-reported). Goal attaingment reported on a five-point scale, where higher score indicates better outcome.

    Measured: Change in score from baseline immediately after the intervention (12-13 weeks after baseline). Total time frame 3 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Mar 2020
  2. Study start2 Sep 2019
  3. Primary completion31 Mar 2021
  4. Study completion31 Mar 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04302818
Sponsor's protocol ID
SKOLKONTAKT
Acronym
SKOLKONTAKT
Status last verified
Mar 2022
First submitted
12 Feb 2020
Last updated
29 Mar 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 26912485

  • 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.

    PubMed 28647010

  • 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.

    PubMed 29748736

Questions about this trial

What is this clinical trial studying?

A study testing SKOLKONTAKT and Social activity group in people with Autism Spectrum Disorder and Attention Deficit Hyperactivity Disorder, run by Karolinska Institutet at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04302818, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2022.

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