Sex Chromosome DisordersPhase 1TRICXY-SMTNCT07718997
A Multiple Baseline Feasibility Trial of Social Management Training for People With Sex Chromosome Aneuploidies
A Phase 1 study testing Social Management Training in people with Sex Chromosome Disorders, run by University of Oslo at 1 site in Norway.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Sex Chromosome Disorders
- What is being tested?
- Social Management Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteNorway
- Study dates
- 1 Jun 2026to Dec 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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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Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
Oslo University Hospital
Oslo, 0424
Ida Sønderby, PhD, +4795552695, i.e.sonderby@medisin.uio.no
Samuel Askjer, MSc, +4745448668, samueas@uio.no
About this study
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.
Read the 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.
- Conditions
- Sex Chromosome Disorders
- Being tested
- Social Management Training
- Keywords
- Klinefelter syndrome, Turner syndrome, XYY syndrome, XXX syndrome, Social Management Training
- Medical subject headings
- Sex Chromosome Disorders, Klinefelter Syndrome, Turner Syndrome, 47, XYY syndrome, Triple X syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social Management TrainingBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Social Management Training | Experimental | A 10.-session psychosocial digital group intervention Receives: Behavioral: Social Management Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Measured three times during 8 weeks prior to the intervention and then three times during 8 weeks after the intervention
Secondary outcomes (2)
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: 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: Measured three times during 8 weeks prior to the intervention and three times during 8 weeks after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study start1 Jun 2026
- Primary completionSep 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sex Chromosome DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Mutiple baseline design
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oslo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Krister W Fjermestad, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07718997
- Sponsor's protocol ID
- UniversityofOslo
- Acronym
- TRICXY-SMT
- Status last verified
- Jul 2026
- First submitted
- 14 Jul 2026
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The samples are very small since these disorders are rare, so they are too easily identifiable
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multiple Baseline Feasibility Trial of Social Management Training for People With Sex Chromosome Aneuploidies
- ClinicalTrials.gov ID
- NCT07718997
- Acronym / sponsor ID
- TRICXY-SMT / UniversityofOslo
- Conditions
- Sex Chromosome Disorders
- Keywords
- Klinefelter syndrome, Turner syndrome, XYY syndrome, XXX syndrome, Social Management Training
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of OsloUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- Sep 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 22 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Mutiple baseline design
| Arm | Type | Receives |
|---|---|---|
| Social Management Training | Experimental | Behavioral: Social Management TrainingA 10.-session psychosocial digital group intervention |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Social Management TrainingThe 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 | Behavioural | Social Management Training |
Primary outcome
Symptom Checklist 25 (SCL-25)
Time frame: 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).
2 secondary outcomes
The Social Responsiveness Scale - Second edition (SRS-2).
Time frame: 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).
Time frame: Measured three times during 8 weeks prior to the intervention and three times during 8 weeks after the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Individual participant dataSharing planned: No. The samples are very small since these disorders are rare, so they are too easily identifiable
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Social Management Training in people with Sex Chromosome Disorders, run by University of Oslo at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: looking for participants now, as of the sponsor's last update on 22 Jul 2026. 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 Norway. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Krister W Fjermestad, PhD (+4794201947, kristefj@uio.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom Checklist 25 (SCL-25) (time frame: Measured three times during 8 weeks prior to the intervention and then three times during 8 weeks after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jul 2026.