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

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.

Study Overview

• Status: Recruiting
• Conditions: Sex Chromosome Disorders
• Intervention / Treatment: Behavioral: Social Management Training

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Krister W Fjermestad, PhD; Phone Number: +4794201947; Email: kristefj@uio.no
• Study Contact Backup: Name: Ida Sønderby, PhD; Phone Number: +4795552695; Email: i.e.sonderby@medisin.uio.no

Study Locations

• Norway
  • Oslo, Norway, 0424
    • Recruiting
    • Oslo University Hospital
    • Contact: Ida Sønderby, PhD; Phone Number: +4795552695; Email: i.e.sonderby@medisin.uio.no
    • Contact: Samuel Askjer, MSc; Phone Number: +4745448668; Email: samueas@uio.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Social Management Training; A 10.-session psychosocial digital group intervention

Behavioral: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptom Checklist 25 (SCL-25)	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Social Responsiveness Scale - Second edition (SRS-2).	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).	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

Collaborators and Investigators

• Sponsor: University of Oslo

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2026
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: July 14, 2026
• First Submitted That Met QC Criteria: July 14, 2026
• First Posted (Actual): July 22, 2026

Study Record Updates

• Last Update Posted (Actual): July 22, 2026
• Last Update Submitted That Met QC Criteria: July 14, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Turner syndrome; Klinefelter syndrome; XYY syndrome; XXX syndrome; Social Management Training
• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Cardiovascular Diseases; Male Urogenital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Heart Diseases; Genetic Diseases, Inborn; Gonadal Disorders; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Defects, Congenital; Disorders of Sex Development; Urogenital Abnormalities; Chromosome Disorders; Sex Chromosome Disorders of Sex Development; Gonadal Dysgenesis; Hypogonadism; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Turner Syndrome; Klinefelter Syndrome; Sex Chromosome Disorders; 47, XYY syndrome; Triple X syndrome
• Other Study ID Numbers: UniversityofOslo

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The samples are very small since these disorders are rare, so they are too easily identifiable

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No