Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

A Multiple Baseline Feasibility Trial of Social Management Training for People With Sex Chromosome Aneuploidies (TRICXY-SMT)

14 juli 2026 uppdaterad av: Krister W Fjermestad, University of Oslo
We will examine is Social Management Training, a 10-session group-based psychosocial intervention will improve the primary outcome mental health, and secondary outcomes executive functions and autism symptoms, in a multiple baseline design with 3 pre-measurement points and 3 post-measurement points spanning 30 weeks, including the 10 weeks of intervention. Participants will be adults (16-65 years) with sex chromosome aneuploidies.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

Background: Persons with sex chromosome aneuploidies (SCAs, i.e., a number of sex chromosomes that is different from the most common 46,XX and 46,XY), often struggle with social interactions. A Dutch pilot study examined Social Management Training (SMT), an intervention designed to help people develop their abilities to navigate interactions with others in men with Klinefelter syndrome (KS; 47,XXY). SMT was adapted to target executive functions, emotion regulation, and social cognition in a novel neurocognitive-behavioral program tailored to the specific vulnerabilities of men with KS, and showed promising outcomes. The current study aims to expand on the Dutch pilot study by (1) Adapting SMT to Norwegian individuals with SCAs in an online-delivered format enabling wide geographic reach; (2) Testing the feasibility, acceptability, and potential benefits of SMT; and (3) Examine the use of SMT on SCAs beyond KS. Methods: The intervention comprises 10 group sessions. Through a single-group multiple baseline design, measures are collected at six time points; three pre- and three post-intervention. The main effect to be examined is the difference between pre- and post-intervention. The primary outcome is mental health, and the secondary outcomes are social and executive functioning. Participants are recruited through the Norwegian National Center for Rare Diseases, the Norwegian Klinefelter association, and endocrinologists. We plan to include 20-30 participants by the end of 2028. Discussion: SMT aims to evaluate the feasibility of a digitally based psychosocial intervention designed to improve mental health, as well as social, emotional and executive functioning among individuals with SCAs. The findings will inform intervention refinement and the design of a future definitive randomized controlled trial. The development of such interventions can lead to socio-economic benefits in the form of long-term improved health outcomes for people by improving overall functioning.

Studietyp

Interventionell

Inskrivning (Beräknad)

30

Fas

  • Fas 1

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

  • Namn: Krister W Fjermestad, PhD
  • Telefonnummer: +4794201947
  • E-post: kristefj@uio.no

Studera Kontakt Backup

Studieorter

  • Norge
      • Oslo, Norge, 0424
        • Rekrytering
        • Oslo University Hospital
        • Kontakt:
        • Kontakt:
          • Samuel Askjer, MSc
          • Telefonnummer: +4745448668
          • E-post: samueas@uio.no

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Barn
  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

The inclusion criteria are: (a) Proficiency in a Scandinavian language. Participants must state that they have satisfactory skills to participate in group discussions, and answer questionnaires in Norwegian; (b) Age 16 to 69 years. The age range is set to include adults of the age of consent for participation in health research. The upper age limit was set to prevent measurements from being affected by age-related factors; (c) Access to a computer (or smartphone) with internet connection - but note that we can lend a computer to participants who may require this; (d) Genetically confirmed SCA. Participants provide medical confirmation of diagnosis, unless participants are recruited via Frambu (where medical confirmation is available in the user registry for KS 47,XXY karyotype; Jacobs 47,XYY karyotype; Triple X, 47,XXX karyotype; and Turner 45,X karyotype).

There are no explicit exclusion criteria. Ongoing assessments are made during eligibility screening and when conducting training program regarding appropriateness of the training program, both individually and in groups. If the group leader becomes aware of information that indicates the need for specialist health services (e.g., indication of severe mental illness or acute suicidality), this is handled on a case-by-case basis, and the person concerned is then put in contact with the appropriate health care services.

-

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Social Management Training
A 10.-session psychosocial digital group intervention
Beteende: Social Management Training
The 10 sessions focus on (1) Introduction and learning targets; (2) Information processing in a social context; (3) Attention and emotions in a social context; (4) Inhibition and emotions in a social context; (5) Flexibility and planning in a social context; (6) Working memory in a social context; (7) Parent/friend/partner session; (8&9) Individual learning targets; (10) Summary/Integration

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Symptom Checklist 25 (SCL-25)
Tidsram: Measured three times during 8 weeks prior to the intervention and then three times during 8 weeks after the intervention
The SCL-25 is a 25 item measure of mental health that compiles into an anxiety and a depression dimension (compared to nine dimensions in the full 90-item version).
Measured three times during 8 weeks prior to the intervention and then three times during 8 weeks after the intervention

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
The Social Responsiveness Scale - Second edition (SRS-2).
Tidsram: Measured three times during 8 weeks prior to the intervention and three times during 8 weeks after the intervention
The SRS-2 is a 65-item measure of social impairments associated with autism spectrum disorders
Measured three times during 8 weeks prior to the intervention and three times during 8 weeks after the intervention
Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A).
Tidsram: Measured three times during 8 weeks prior to the intervention and three times during 8 weeks after the intervention
The BRIEF-A is a 75-item measure of executive and self-regulation in everyday situations for adults
Measured three times during 8 weeks prior to the intervention and three times during 8 weeks after the intervention

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University of Oslo

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 juni 2026

Primärt slutförande (Beräknad)

1 september 2029

Avslutad studie (Beräknad)

1 december 2029

Studieregistreringsdatum

Först inskickad

14 juli 2026

Först inskickad som uppfyllde QC-kriterierna

14 juli 2026

Första postat (Faktisk)

22 juli 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

22 juli 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

14 juli 2026

Senast verifierad

1 juli 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • UniversityofOslo

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

IPD-planbeskrivning

The samples are very small since these disorders are rare, so they are too easily identifiable

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Prenumerera