Autism, Autism Spectrum Disorder, ADHD - Attention Deficit Disorder With Hyperactivity, Depression Anxiety Disorder, Depression - Major Depressive Disorder, Anxiety
Conditions
Keywords
genetic information, polygenic scores, rare variants, genetic counselling, genetic knowledge
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 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.
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 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.
Interventions
BEHAVIORALGenetic counselling
Behavioral: genetic counselling
BEHAVIORALLeaflet
Genetic information as a form of a leaflet
Sponsors
Karolinska Institutet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to 30 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| modified Genetic Counselling Scale - 24 (mGCOS-24) | At enrollment (pre), 1-2 weeks after intervention (post) | Measures changes in empowerment, understanding, and ability to use genetic information. Additional information: The mGCOS has been translated into Swedish based on the GCOS-validated Swedish translation. Change in the primary outcome will be compared between the two groups of active interventions. Subgroup analyses will be performed based on those receiving their personal genetic information vs those receiving only general population-level information. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Generalised Anxiety Disorder Questionnaire (GAD-7) | Pre - Post (1-2 weeks) | We will monitor the change in GAD-7 from pre to post. |
| Patient Health Questionnaire (PHQ-9) | Pre - Post (1-2 weeks) | Evaluates changes in participants' depression symptoms |
Countries
Sweden
Outcome results
None listed