Clinical trial NCT06740760: Autism Genomics Sweden - Genetic Guidance and Information Trial
Official title: Autism Genomics Sweden - AuGeS - Genetic Information and Guidance in Autism and Related Psychiatric Conditions Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autism
Autism Spectrum Disorder
ADHD - Attention Deficit Disorder with Hyperactivity
Depression Anxiety Disorder
Depression - Major Depressive Disorder
Anxiety
Keywords: genetic information
polygenic scores
rare variants
genetic counselling
genetic knowledge
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2024-12-18
Enrollment: 60
Sex: ALL
Minimum age (years): 15
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This observational clinical trial aims to evaluate whether providing genetic information about the origins of autism and related psychiatric disorders enhances understanding, well-being, and empowerment in adolescents and young adults with autism. The study will compare the outcomes of two groups: one receiving a 1.5-hour genetic counseling session with a clinician and the other receiving general genetic information via leaflet. Participants will be assessed using pre- and post-intervention questionnaires, including measures of understanding of their condition (mGCOS-24) and mental health (GAD-7 and PHQ-9). The study also explores whether mental health factors like anxiety and depression influence the effectiveness of the interventions.

Detailed description: The goal of this observational clinical study is to assess whether receiving genetic information about the origins of autism and related neuropsychiatric disorders, either at a population level or as individual information after genetic testing, can improve understanding of their condition, well-being, and empowerment in adolescents and young adults with autism spectrum condition (ASC). The main questions to answer are:

* Does a genetic counseling session improve participants' understanding of autism and its origins, well-being, and empowerment as measured by the modified Genetic Counseling Outcome Scale (mGCOS-24)?
* Is the outcome modified by mental health indicators such as anxiety and depression measures, and does the information improve these?
* We will also assess how genetic knowledge and beliefs prior the genetic information session affect the main outcome mGCOS-24 change.

The comparsion will be made between the group receiving a 1.5-hour genetic counseling session with a clinician to a group receiving general genetic information via leaflet by email to see if the genetic information session by the clinician leads to greater improvements in understanding, empowerment, and well-being.

Participants will:

* Answer basic demographic questionnaire as well as a questionnaire about genetic knowledge and beliefs
* Be randomized to receive a 1-1.5 hour genetic counseling session in person or through online, or general genetic information via leaflet.
* Complete pre-and post-intervention questionnaires, including the mGCOS-24, GAD-7 and PHQ-9.

Eligibility criteria: Inclusion Criteria:

* Participants aged 15 - 30 years of age.
* Living in Sweden.
* Able to consent independently or with guardian consent if necessary.
* Understanding of Swedish-language questions.
* Interest in receiving genetic counselling information on autism.

Exclusion Criteria:

* Participants unwilling to complete pre- or post-intervention surveys.
* Participants unwilling to participate in either form of genetic counseling

Primary outcomes:
measure: modified Genetic Counselling Scale - 24 (mGCOS-24)
timeFrame: At enrollment (pre), 1-2 weeks after intervention (post)
Secondary outcomes:
measure: Generalised Anxiety Disorder Questionnaire (GAD-7)
timeFrame: Pre - Post (1-2 weeks)
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Pre - Post (1-2 weeks)
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet
Study officials:
affiliation: Karolinska Institutet
name: Kristiina Tammimies, PhD
role: PRINCIPAL_INVESTIGATOR
References: