Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2025-12-26 @ 6:51 PM
Study NCT ID:
NCT06740760
Status:
COMPLETED
Last Update Posted:
2025-08-11
First Post:
2024-12-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Autism Genomics Sweden - Genetic Guidance and Information Trial
Sponsor:
Karolinska Institutet
Organization:
Study Overview
Official Title:
Autism Genomics Sweden - AuGeS - Genetic Information and Guidance in Autism and Related Psychiatric Conditions Trial
Status:
COMPLETED
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AuGeS-GV
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.
* 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: