Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2025-12-25 @ 2:13 AM
NCT ID:
NCT06740760
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.
Study:
NCT06740760
Study Brief:
Protocol Section:
NCT06740760