AutismAuGeS-GVNCT06740760
Autism Genomics Sweden - Genetic Guidance and Information Trial
A study testing Genetic counselling and Leaflet in people with Autism and Autism Spectrum Disorder, run by Karolinska Institutet at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 30 years
- Conditions the study is for
- Autism, Autism Spectrum Disorder, ADHD - Attention Deficit Disorder With Hyperactivity
- What is being tested?
- Genetic counselling and Leaflet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteSweden
- Study dates
- 15 Jun 2024to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- Participants unwilling to complete pre- or post-intervention surveys.
- Participants unwilling to participate in either form of genetic counseling
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Autism Genomics Sweden - AuGeS - Genetic Information and Guidance in Autism and Related Psychiatric Conditions 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.
Read the 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.
- Conditions
- Autism, Autism Spectrum Disorder, ADHD - Attention Deficit Disorder With Hyperactivity, Depression Anxiety Disorder, Depression - Major Depressive Disorder, Anxiety
- Being tested
- Genetic counselling, Leaflet
- Keywords
- genetic information, polygenic scores, rare variants, genetic counselling, genetic knowledge
- Medical subject headings
- Autistic Disorder, Autism Spectrum Disorder, Attention Deficit Disorder with Hyperactivity, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genetic counsellingBehavioural
Behavioral: genetic counselling
LeafletBehavioural
Genetic information as a form of a leaflet
| Study group | Role | What they receive |
|---|---|---|
| Clinician led genetic information session | Active comparator | Clinician-led structured genetic information session in person or through an online video link. Participants with genetic information available (clinically significant rare variants from exome sequencing and copy number variant analysis, and polygenic scores (autism, ADHD, depression, and anxiety), these will also be communicated as the last part of the session. Receives: Behavioral: Genetic counselling |
| Leaflet genetic information | Active comparator | The participants receive a leaflet with genetic information without in-person contact Receives: Behavioral: Leaflet |
What is being measured
The primary outcome is the main question the study is designed to answer.
modified Genetic Counselling Scale - 24 (mGCOS-24)
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.
Measured: At enrollment (pre), 1-2 weeks after intervention (post)
Secondary outcomes (2)
Generalised Anxiety Disorder Questionnaire (GAD-7)
We will monitor the change in GAD-7 from pre to post.
Measured: Pre - Post (1-2 weeks)
Patient Health Questionnaire (PHQ-9)
Evaluates changes in participants' depression symptoms
Measured: Pre - Post (1-2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start15 Jun 2024
- Primary completion30 Jun 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutismStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristiina Tammimies, Karolinska Institutet
- Investigators
- Kristiina Tammimies, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06740760
- Sponsor's protocol ID
- 2023-06737-01
- Other IDs
- 2023
- Acronym
- AuGeS-GV
- Status last verified
- Aug 2025
- First submitted
- 14 Dec 2024
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data dictionary will be shared openly; however, the individual-level data will be restricted to necessary clearance from the Karolinska Institutet and the Swedish Ethical Review Authority through the KI Data Repository.
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autism Genomics Sweden - AuGeS - Genetic Information and Guidance in Autism and Related Psychiatric Conditions Trial
- ClinicalTrials.gov ID
- NCT06740760
- Acronym / sponsor ID
- AuGeS-GV / 2023-06737-01
- Conditions
- Autism, Autism Spectrum Disorder, ADHD - Attention Deficit Disorder With Hyperactivity, Depression Anxiety Disorder, Depression - Major Depressive Disorder, Anxiety
- Keywords
- genetic information, polygenic scores, rare variants, genetic counselling, genetic knowledge
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 15 Jun 2024 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 18 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinician led genetic information session | Active comparator | Behavioral: Genetic counsellingClinician-led structured genetic information session in person or through an online video link. Participants with genetic information available (clinically significant rare variants from exome sequencing and copy number variant analysis, and polygenic scores (autism, ADHD, depression, and anxiety), these will also be communicated as the last part of the session. |
| Leaflet genetic information | Active comparator | Behavioral: LeafletThe participants receive a leaflet with genetic information without in-person contact |
Who may qualify
- Ages
- 15 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Participants unwilling to complete pre- or post-intervention surveys.
- Participants unwilling to participate in either form of genetic counseling
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Genetic counsellingBehavioral: genetic counselling | Behavioural | Clinician led genetic information session |
| LeafletGenetic information as a form of a leaflet | Behavioural | Leaflet genetic information |
Primary outcome
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.
2 secondary outcomes
Generalised Anxiety Disorder Questionnaire (GAD-7)
Time frame: Pre - Post (1-2 weeks)
Patient Health Questionnaire (PHQ-9)
Time frame: Pre - Post (1-2 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
- Individual participant dataSharing planned: Yes. The data dictionary will be shared openly; however, the individual-level data will be restricted to necessary clearance from the Karolinska Institutet and the Swedish Ethical Review Authority through the KI Data Repository.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristiina Tammimies, PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Genetic counselling and Leaflet in people with Autism and Autism Spectrum Disorder, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
modified Genetic Counselling Scale - 24 (mGCOS-24) (time frame: At enrollment (pre), 1-2 weeks after intervention (post)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2025.