Autism Genomics Sweden - Genetic Guidance and Information Trial

Not Applicable

Recruiting

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

• Registration Number: NCT06740760
• Lead Sponsor: Karolinska Institutet

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.

Study Timeline

• Study Start: 2024-06-15
• Status Verified: 2024-12
• Study First Submitted: 2024-12-14
• Study First Submitted QC: 2024-12-14
• Last Update Submitted: 2024-12-14
• Study First Posted: 2024-12-18
• Last Update Posted: 2024-12-18
• Primary Completion: 2025-08-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 to Swedish based on the GCOS validated swedish translation.; Change in the primary outcome will be compared between the groups of two active interventions. Subgroup analyses will be performed based on those receiving their personal genetic information vs those receiving only general population level information.

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Karolinska Institutet; 🇸🇪 Stockholm, Sweden