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Completed

NCT Number: NCT06740760

Autism Genomics Sweden - Genetic Guidance and Information Trial

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.

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Key information

Conditions

Autism ADHD - Attention Deficit Disorder With Hyperactivity Anxiety Anxiety Disorders Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Autism Spectrum Disorder Autistic Disorder Child Development Disorders, Pervasive Depression - Major Depressive Disorder Depression Anxiety Disorder Mental Disorders Neurodevelopmental Disorders

Age range

15 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karolinska Institutet

Stockholm, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Genetic counselling

Behavioral

Behavioral: genetic counselling

Leaflet

Behavioral

Genetic information as a form of a leaflet

Primary outcomes

  1. modified Genetic Counselling Scale - 24 (mGCOS-24)

    Time frame: 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 outcomes

  1. Generalised Anxiety Disorder Questionnaire (GAD-7)

    Time frame: Pre - Post (1-2 weeks)

    We will monitor the change in GAD-7 from pre to post.

  2. Patient Health Questionnaire (PHQ-9)

    Time frame: Pre - Post (1-2 weeks)

    Evaluates changes in participants' depression symptoms

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

Autism Genomics Sweden - AuGeS - Genetic Information and Guidance in Autism and Related Psychiatric Conditions Trial

Acronym: AuGeS-GV

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 18, 2024
Registry last updated
Aug 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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