Autism Genomics Sweden - Genetic Guidance and Information Trial (AuGeS-GV)

Karolinska Institute

Status: Completed

Conditions: ADHD - Attention Deficit Disorder With Hyperactivity; Autism Spectrum Disorder; Depression Anxiety Disorder; Anxiety; Autism; Depression - Major Depressive Disorder

Treatments: Behavioral: Genetic counselling; Behavioral: Leaflet

Study type: Interventional

Funder types: Other

Identifiers

NCT06740760

2023-06737-01

Details and patient eligibility

About

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 a 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.

Full 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 before the genetic information session affect the main outcome of the mGCOS-24 change.

The comparison will be made between the group receiving a 1.5-hour genetic counseling session with a clinician and 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 online, or general genetic information via leaflet.
• Complete pre- and post-intervention questionnaires, including the mGCOS-24, GAD-7, and PHQ-9.

Enrollment: 63 patients

Sex: All

Ages: 15 to 30 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

63 participants in 2 patient groups

Clinician led genetic information session

Active Comparator group

Description:

Clinician-led structured genetic information session in person or through an online video link. Participants with genetic information available (clinically significant rare variants from exome sequencing and copy number variant analysis, and polygenic scores (autism, ADHD, depression, and anxiety), these will also be communicated as the last part of the session.

Treatment:

Behavioral: Genetic counselling

Leaflet genetic information

Active Comparator group

Description:

The participants receive a leaflet with genetic information without in-person contact

Treatment:

Behavioral: Leaflet