A Multiple Baseline Feasibility Trial of Social Management Training for People With Sex Chromosome Aneuploidies

Phase 1RecruitingNCT07718997

University of Oslo30 enrolled

Overview

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.

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

Allocation

Conditions

Sex Chromosome Disorders

Interventions

Social Management TrainingBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 16 YearsMax age: 65 Years

Medical Language ↔ Plain English

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. \-

Locations (1)

Oslo University Hospital

Oslo, Norway

RECRUITING

Outcomes

Primary Outcomes

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).

Time frame: Measured three times during 8 weeks prior to the intervention and then three times during 8 weeks after the intervention

Secondary Outcomes

The Social Responsiveness Scale - Second edition (SRS-2).

The SRS-2 is a 65-item measure of social impairments associated with autism spectrum disorders

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).

The BRIEF-A is a 75-item measure of executive and self-regulation in everyday situations for adults

Time frame: Measured three times during 8 weeks prior to the intervention and three times during 8 weeks after the intervention

Central Contacts

Krister W Fjermestad, PhD

CONTACT

+4794201947 kristefj@uio.no

Ida Sønderby, PhD

CONTACT

+4795552695 i.e.sonderby@medisin.uio.no

Data from ClinicalTrials.gov

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