Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:59 AM
Study NCT ID:
NCT04302818
Status:
COMPLETED
Last Update Posted:
2022-03-29
First Post:
2020-02-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
SKOLKONTAKT - Social Skills Training in a School Setting
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}, {'id': 'D001289', 'term': 'Attention Deficit Disorder with Hyperactivity'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Teacher-assessors are blinded pre-, post, and follow-up.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2021-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-28', 'studyFirstSubmitDate': '2020-02-12', 'studyFirstSubmitQcDate': '2020-03-06', 'lastUpdatePostDateStruct': {'date': '2022-03-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Pre-assessment questionnaire', 'timeFrame': 'At baseline.', 'description': 'Expectations and person characteristics (parent and participant reported together) reported in a qualitative queastionnaire.'}, {'measure': 'Evaluation questionnaire', 'timeFrame': 'Reported immediately after the intervention.', 'description': 'Qualitative questionnaire for intervention evaluation (parent and participant reported together)'}, {'measure': 'Evaluation questionnaire (school-staff)', 'timeFrame': 'Reported immediately after the intervention.', 'description': 'Qualitative questionnaire for intervention evaluation (school-staff reported)'}, {'measure': 'Evaluation questionnaire (principal)', 'timeFrame': 'Reported immediately after the intervention.', 'description': 'Qualitative questionnaire for intervention evaluation (school principal-reported)'}, {'measure': 'School grade', 'timeFrame': 'Change in score from baseline immediately after the intervention. Total time frame 3 months.', 'description': 'Percent of grades indicating typical progress in subjects (teacher-reported)'}, {'measure': 'School attendance', 'timeFrame': 'Change in score from baseline immediately after the intervention. Total time frame 3 months.', 'description': 'Percent of school attendance (teacher-reported)'}, {'measure': 'Attendance in intervention-group', 'timeFrame': 'Summary score of attended sessions. Scored immediately following every session of the intervention (3 sessions/week; 12 weeks). Total time frame 3 months.', 'description': 'Number of sessions attended by participant (group-leader reported)'}], 'primaryOutcomes': [{'measure': 'Social Skills Group Questionnaire (SSGQ)', 'timeFrame': 'Change in score from baseline after 12 weeks of social skills training and at 3 months follow-up. Total time frame 6 months.', 'description': 'Social skills (parent-, self- and (blinded) teacher-reported), higher score indicating improvement in skills'}], 'secondaryOutcomes': [{'measure': 'Social Responsiveness Scale-2 (SRS-ll)', 'timeFrame': '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.', 'description': 'Autistic symptoms (parent-reported), decrease in scores indicating less clinical symptoms.'}, {'measure': 'KIDSCREEN-27 (short version)', 'timeFrame': '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.', 'description': 'Health-related Quality of Life (self-reported).'}, {'measure': 'Worlds Health Organisation Disability Assessment Schedule 2.0 (WHODAS 2.0)', 'timeFrame': '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.', 'description': 'Daily functioning as affected by functional disability (parent-reported).'}, {'measure': 'Conners 3-F', 'timeFrame': '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.', 'description': 'ADHD-related symptoms (parent-reported), decrease in scores indicating less clinical symptoms.'}, {'measure': 'Negative Effects Questionnaire (NEQ)', 'timeFrame': 'Change from baseline immediately after the intervention. Total time frame 3 months.', 'description': 'Record of adverse events during intervention (parent-reported).'}, {'measure': 'Goal Attainment Scaling (GAS)', 'timeFrame': 'Change in score from baseline immediately after the intervention (12-13 weeks after baseline). Total time frame 3 months.', 'description': 'Personalised goal-setting (self-reported). Goal attaingment reported on a five-point scale, where higher score indicates better outcome.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Social skills group training', 'School-based intervention', 'Evidenced-based intervention'], 'conditions': ['Autism Spectrum Disorder', 'Attention Deficit Hyperactivity Disorder', 'Anxiety', 'Depression']}, 'referencesModule': {'references': [{'pmid': '26912485', 'type': 'BACKGROUND', 'citation': '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': '28647010', 'type': 'BACKGROUND', 'citation': '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': '29748736', 'type': 'BACKGROUND', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'http://ki.se/kind/center-of-neurodevelopmental-disorders-at-karolinska-institutet-kind', 'label': 'Homepage KIND.'}]}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': '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").'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '20 Years', 'minimumAge': '15 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Formally diagnosed autism spectrum disorder\n* Formally diagnosed attention deficit hyperactivity disorder\n* Teacher-reported subclinical social-communication special needs\n\nExclusion Criteria:\n\n* Severe psychiatric comorbidity that challenges administration of the group-intervention, including but not limited to severe oppositional defiant disorder\n* Severe psychiatric comorbidity that makes the participant to vulnerable to participate in the group-intervention, including but not limited to suicidality, severe depression'}, 'identificationModule': {'nctId': 'NCT04302818', 'acronym': 'SKOLKONTAKT', 'briefTitle': 'SKOLKONTAKT - Social Skills Training in a School Setting', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'SKOLKONTAKT - Social Skills Training in a School Setting, a Randomized Controlled Pilot', 'orgStudyIdInfo': {'id': 'SKOLKONTAKT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Social skills group training SKOLKONTAKT', 'description': 'Manualised social skills group training.', 'interventionNames': ['Behavioral: SKOLKONTAKT']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Active control comparison group', 'description': 'Social activities in a group setting.', 'interventionNames': ['Behavioral: Social activity group']}], 'interventions': [{'name': 'SKOLKONTAKT', 'type': 'BEHAVIORAL', 'otherNames': ['SKOLKONTAKT Social skills training', 'SKOLKONTAKT Social skills group training', 'SKOLKONTAKT School-based social skills training'], 'description': 'N=21 participants are offered manualized and structured group training SKOLKONTAKT. The intervention includes 12 weeks, 3 sessions (50 minutes) per week.', 'armGroupLabels': ['Social skills group training SKOLKONTAKT']}, {'name': 'Social activity group', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Active control comparison group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '113 30', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'CAP Research Center, Center of Neurodevelopmental disorders at Karolinska Institutet (KIND)', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'Sven Bölte, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CAP Research center, Karolinska Institutet'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska Institutet', 'class': 'OTHER'}, 'collaborators': [{'name': 'Marcus och Amalia Wallenbergs minnesfond', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Sven Bölte', 'investigatorAffiliation': 'Karolinska Institutet'}}}}