Autism or Autistic TraitsNCT06213194
The Effects of Executive Functions and Social Cognition on Mental Health
A study testing MindZone in people with Autism or Autistic Traits and Mental Health Disorder, run by Ibn Haldun University at 1 site in Turkey (Türkiye).
Trial summary
The objective of this study is to analyze the effects of executive functions (EFs) and social-cognitive abilities on the associations between autistic traits and mental health indicators (depression, anxiety, and stress). Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism or Autistic Traits, Mental Health Disorder, Executive Dysfunction
- What is being tested?
- MindZone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 May 2024to 21 Oct 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- aged 18 or above
- Fluent in writing and speaking in Turkish
- No record of any psychiatric disorders
- No record of neurological conditions
Who cannot join
- under age 18
- Have any record of psychiatric
- Have any neurological conditions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigating The Effects of Executive Functions and Social Cognition on the Relationship Between Autistic Traits and Mental Health
The objective of this study is to analyze the effects of executive functions (EFs) and social-cognitive abilities on the associations between autistic traits and mental health indicators (depression, anxiety, and stress). Moreover, the study will produce online training modules for executive functions and social cognition, aimed at reducing the likelihood of adverse mental health outcomes in individuals with and without elevated autistic traits.
Therefore, four main hypotheses will be addressed:
Read more
- Revealing the mediating role of executive functions (cognitive flexibility, inhibitory control, and working memory) will help predict the association between autistic traits and mental health symptoms (anxiety, depression, and stress).
- Revealing the mediating role of social cognitive skills (cognitive empathy and affective empathy) will help predict the association between autistic traits and mental health symptoms (anxiety, depression, and stress).
- Online training in executive functions and social cognitive skills will help develop executive functions (working memory, inhibitory control, and cognitive flexibility) and social cognitive skills (cognitive empathy and affective empathy) in the current sample.
- Online training in executive functions and social cognitive skills will promote mental health by reducing distress, depression, and anxiety symptoms in the current sample.
Participants will be between the ages of 18-35 because previous findings indicate that the age of onset of various mental health problems is between the ages of 17 and 35. Participants will be randomly assigned to the experimental and control groups. Using a longitudinal design including pre-test, post-test, and follow-up conditions to test the effectiveness of combined EFs and social cognition online training for mental health symptoms.
Read the detailed description
Autism spectrum disorder (ASD) refers to a neurodevelopmental condition that is associated with impairments in social and cognitive functions, repetitive behaviors, and restricted interests, while autistic traits refer to a subclinical level of ASD and its symptoms distributed in the general population. Previous studies have identified people with elevated autistic traits who show susceptibility to other mental health conditions such as anxiety disorders, mood disorders, borderline personality disorder, internet addiction, conduct disorder, substance abuse, and suicidal risk in the general population. Although there is no identifiable explanation of susceptibility to other mental health conditions, the presence of social and cognitive impairments including problems in executive functions and social cognitive skills might be contributing factors.
Previous research indicated that social cognitive skills such as cognitive and affective empathy and executive functions including working memory, inhibitory control and cognitive flexibility play important roles in physical and mental health, quality of life, social competence, school and job success, marital harmony, and public safety. Nevertheless, although autistic traits increase susceptibility to other mental health conditions, no study so far has focused on examining the relationships among autistic traits, executive functions, and social cognitive skills to design intervention and prevention programs for mental health conditions and quality of life in both general and clinical populations.
The primary purpose of the research is to investigate the effects of executive functions and social cognitive skills on the relationship between autistic traits and mental health symptoms that would be significant for designing intervention and prevention programs. The second purpose of the research is to design online executive functions and social cognitive training that might help to reduce vulnerability to negative effects on mental health symptoms in the general population regarding elevated autistic traits.
Using a longitudinal design including pre-test, post-test, and follow-up conditions to test the effectiveness of combined executive functions (EFs) and social cognition online training via computers, tablets, or smartphones for mental health symptoms (depression, anxiety, and stress). This study's independent variables are executive functions (cognitive flexibility, inhibition, and working memory) and social cognition (cognitive empathy and affective empathy). Dependent variables are mental health scores (depression, anxiety, and stress symptoms). Participants will be between the ages of 18 and 35 because previous findings indicate that the age of onset of various mental health problems is between the ages of 17 and 35. Participants will be randomly assigned to the experimental and control groups. Online-based training will consist of combined executive functions and social cognitive (i.e., cognitive empathy and affective empathy) tasks. The length of the training each week will be 75 minutes based on the previous studies. Three within conditions will be present: pre-test, post-test, and follow-up. The primary outcomes of the study are mental health symptoms (anxiety, depression, stress), EFs (working memory, cognitive flexibility, and inhibition), and social cognition (cognitive and affective empathy).
- Conditions
- Autism or Autistic Traits, Mental Health Disorder, Executive Dysfunction, Social Cognition
- Being tested
- MindZone
- Keywords
- Autism, Executive Functions, Online Training, Social Cognition, Mental Health
- Medical subject headings
- Autistic Disorder, Mental Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MindZoneOther
The name of the online training will be MindZone. It consists of combined game-based social cognitive and executive functions skills, and it will be presented on the training website. There is no consensus about the length of time for the training in the literature, so the average time for the training process will be used. This means that the training will last 6 weeks, 7.5 hours in total. To satisfy the training requirement, 1.15 hours (75 mins) of play will be expected from participants each week. Before each game, a brief introduction about the game will be presented and participants will get feedback about their progress. Each participant will conduct the tasks in a different random order. After 6 weeks, a post-test will be completed, and follow-up scores will be obtained after a month. All tasks were designed according to the five intervention areas: working memory, cognitive flexibility, inhibition, cognitive empathy and affective empathy based on the literature.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | It combines social cognitive and executive functions skills and it will be present on the designed website and they will participate in the intervention online. After participants are assigned the experimental group the 6-week training program will start and they cannot access the next week before completing the previous week. Each week's will last about 75 minutes. The training includes social cognitive skills including cognitive and affective empathy and executive functions. Receives: Other: MindZone |
| Control Group | No intervention | This group will not take the training until the follow-up test. After the study will be done, the training program will be offered to the control group as well. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression_1
Depression Anxiety Stress Scale 21 will be used to measure depression outcome. Higher scores mean higher depressive symptoms. The minimum and maximum scores are 0-21, respectively.
Measured: Pre-test (baseline), Post-test (immediately after the intervention)
Anxiety
Depression Anxiety Stress Scale - 21 will be used to measure anxiety outcome. Higher scores mean higher anxiety symptoms. The minimum and maximum scores are 0-21, respectively.
Measured: Pre-test (baseline), Post-test (immediately after the intervention)
Stress
Depression Anxiety Stress Scale - 21 will be used to measure stress outcome. Higher scores indicate higher stress. The minimum and maximum scores are 0-21, respectively.
Measured: Pre-test (baseline), Post-test (immediately after the intervention)
Cognitive Flexibility - Errors Rate
Cognitive flexibility - Errors Rate will be measured by the Wisconsin Card Sorting Task. Higher errors indicate lower scores on cognitive flexibility. During the task, 400 cards in two blocks are displayed on the screen and the sorting rule changes after every 10 cards. Maximum score is 400 and minimum score is 0.
Measured: Pre-test (baseline), Post-test (immediately after the intervention)
Working Memory - Errors Rate
Working memory - Errors Rate will be measured by the N-back task. Higher errors indicate lower working memory scores. Maximum score is 400, minimum score is 0
Measured: Pre-test (baseline), Post-test (immediately after the intervention)
Inhibition - Errors Rate
Inhibition - Errors Rate will be measured by Go/No Go task. Higher scores indicate lower inhibition. There are 12 blocks of 50 trials each. Commission errors (i.e., incorrectly responding to no-go trials) were measured. Maximum score is 600. Minimum score is 0.
Measured: Pre-test (baseline), Post-test (immediately after the intervention)
Secondary outcomes (2)
Cognitive Empathy
The Eyes Test were used to measure cognitive empathy. Higher scores indicate higher cognitive empathy scores. Maximum score is 36, minimum score is 0.
Measured: pretest and posttest conditions
Self-Assessment Manikin for Affective Empathy
Self Assessment Manikin was used to measure affective empathy. Valence scores for each emotion were obtained by summing responses for all images. The maximum score is 270, and the minimum score is 30. Higher scores indicate better affective empathy.
Measured: pretest and posttest conditions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2024
- Study start20 May 2024
- Primary completion10 Oct 2024
- Study completion21 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Autism or Autistic TraitsStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All participants would be assigned randomly to the experimental group and control group (wait-list condition) to see whether the combined training program is effective for the general population.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ibn Haldun University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilruba Sönmez, Ibn Haldun University
- Investigators
- Dilruba Sönmez, MA, Principal investigator, Ibn Haldun University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06213194
- Sponsor's protocol ID
- 2023/07-03
- Status last verified
- Mar 2025
- First submitted
- 14 Dec 2023
- Last updated
- 17 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To ensure the ethical rights of the participants, the data will be available only for current research unless the participants give permission.
Publications
Sonmez D, Jordan TR. Investigating associations between cognitive empathy, affective empathy and anxiety in adolescents with autism spectrum disorder. Int J Dev Disabil. 2023 Jan 9;70(5):957-965. doi: 10.1080/20473869.2022.2163605. eCollection 2024.
PubMed 39131758Albantakis L, Brandi ML, Zillekens IC, Henco L, Weindel L, Thaler H, Schliephake L, Timmermans B, Schilbach L. Alexithymic and autistic traits: Relevance for comorbid depression and social phobia in adults with and without autism spectrum disorder. Autism. 2020 Nov;24(8):2046-2056. doi: 10.1177/1362361320936024. Epub 2020 Jul 14.
PubMed 32662285Baron-Cohen S. The extreme male brain theory of autism. Trends Cogn Sci. 2002 Jun 1;6(6):248-254. doi: 10.1016/s1364-6613(02)01904-6.
PubMed 12039606Craig F, Margari F, Legrottaglie AR, Palumbi R, de Giambattista C, Margari L. A review of executive function deficits in autism spectrum disorder and attention-deficit/hyperactivity disorder. Neuropsychiatr Dis Treat. 2016 May 12;12:1191-202. doi: 10.2147/NDT.S104620. eCollection 2016.
PubMed 27274255Dell'Osso L, Carpita B, Muti D, Morelli V, Salarpi G, Salerni A, Scotto J, Massimetti G, Gesi C, Ballerio M, Signorelli MS, Luciano M, Politi P, Aguglia E, Carmassi C, Maj M. Mood symptoms and suicidality across the autism spectrum. Compr Psychiatry. 2019 May;91:34-38. doi: 10.1016/j.comppsych.2019.03.004. Epub 2019 Apr 3.
PubMed 31003723de Vries M, Prins PJ, Schmand BA, Geurts HM. Working memory and cognitive flexibility-training for children with an autism spectrum disorder: a randomized controlled trial. J Child Psychol Psychiatry. 2015 May;56(5):566-76. doi: 10.1111/jcpp.12324. Epub 2014 Sep 26.
PubMed 25256627Diamond A. Executive functions. Annu Rev Psychol. 2013;64:135-68. doi: 10.1146/annurev-psych-113011-143750. Epub 2012 Sep 27.
PubMed 23020641Fietz J, Valencia N, Silani G. Alexithymia and autistic traits as possible predictors for traits related to depression, anxiety, and stress: A multivariate statistical approach. J Eval Clin Pract. 2018 Aug;24(4):901-908. doi: 10.1111/jep.12961. Epub 2018 Jun 8.
PubMed 29882629Gambin M, Sharp C. Relations between empathy and anxiety dimensions in inpatient adolescents. Anxiety Stress Coping. 2018 Jul;31(4):447-458. doi: 10.1080/10615806.2018.1475868. Epub 2018 May 17.
PubMed 29772912Gardiner E, Iarocci G. Everyday executive function predicts adaptive and internalizing behavior among children with and without autism spectrum disorder. Autism Res. 2018 Feb;11(2):284-295. doi: 10.1002/aur.1877. Epub 2017 Sep 27.
PubMed 28960841Gokcen E, Frederickson N, Petrides KV. Theory of Mind and Executive Control Deficits in Typically Developing Adults and Adolescents with High Levels of Autism Traits. J Autism Dev Disord. 2016 Jun;46(6):2072-2087. doi: 10.1007/s10803-016-2735-3.
PubMed 26886468Lundstrom S, Chang Z, Kerekes N, Gumpert CH, Rastam M, Gillberg C, Lichtenstein P, Anckarsater H. Autistic-like traits and their association with mental health problems in two nationwide twin cohorts of children and adults. Psychol Med. 2011 Nov;41(11):2423-33. doi: 10.1017/S0033291711000377. Epub 2011 Mar 22.
PubMed 21426604Mason D, Happe F. The role of alexithymia and autistic traits in predicting quality of life in an online sample. Res Autism Spectr Disord. 2022 Feb;90:None. doi: 10.1016/j.rasd.2021.101887.
PubMed 35116075Nahum M, Lee H, Fisher M, Green MF, Hooker CI, Ventura J, Jordan JT, Rose A, Kim SJ, Haut KM, Merzenich MM, Vinogradov S. Online Social Cognition Training in Schizophrenia: A Double-Blind, Randomized, Controlled Multi-Site Clinical Trial. Schizophr Bull. 2021 Jan 23;47(1):108-117. doi: 10.1093/schbul/sbaa085.
PubMed 32614046Sandgreen H, Frederiksen LH, Bilenberg N. Digital Interventions for Autism Spectrum Disorder: A Meta-analysis. J Autism Dev Disord. 2021 Sep;51(9):3138-3152. doi: 10.1007/s10803-020-04778-9. Epub 2020 Nov 10.
PubMed 33170393
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating The Effects of Executive Functions and Social Cognition on the Relationship Between Autistic Traits and Mental Health
- ClinicalTrials.gov ID
- NCT06213194
- Acronym / sponsor ID
- 2023/07-03
- Conditions
- Autism or Autistic Traits, Mental Health Disorder, Executive Dysfunction, Social Cognition
- Keywords
- Autism, Executive Functions, Online Training, Social Cognition, Mental Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- Ibn Haldun UniversityUniversity, hospital or other
- Study start
- 20 May 2024 (actual)
- Primary completion
- 10 Oct 2024 (actual)
- Study completion
- 21 Oct 2024 (actual)
- First posted
- 19 Jan 2024 (actual)
- Results
- Posted 17 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to analyze the effects of executive functions (EFs) and social-cognitive abilities on the associations between autistic traits and mental health indicators (depression, anxiety, and stress). Moreover, the study will produce online training modules for executive functions and social cognition, aimed at reducing the likelihood of adverse mental health outcomes in individuals with and without elevated autistic traits.
Therefore, four main hypotheses will be addressed:
- Revealing the mediating role of executive functions (cognitive flexibility, inhibitory control, and working memory) will help predict the association between autistic traits and mental health symptoms (anxiety, depression, and stress).
- Revealing the mediating role of social cognitive skills (cognitive empathy and affective empathy) will help predict the association between autistic traits and mental health symptoms (anxiety, depression, and stress).
- Online training in executive functions and social cognitive skills will help develop executive functions (working memory, inhibitory control, and cognitive flexibility) and social cognitive skills (cognitive empathy and affective empathy) in the current sample.
- Online training in executive functions and social cognitive skills will promote mental health by reducing distress, depression, and anxiety symptoms in the current sample.
Participants will be between the ages of 18-35 because previous findings indicate that the age of onset of various mental health problems is between the ages of 17 and 35. Participants will be randomly assigned to the experimental and control groups. Using a longitudinal design including pre-test, post-test, and follow-up conditions to test the effectiveness of combined EFs and social cognition online training for mental health symptoms.
Detailed description
Autism spectrum disorder (ASD) refers to a neurodevelopmental condition that is associated with impairments in social and cognitive functions, repetitive behaviors, and restricted interests, while autistic traits refer to a subclinical level of ASD and its symptoms distributed in the general population. Previous studies have identified people with elevated autistic traits who show susceptibility to other mental health conditions such as anxiety disorders, mood disorders, borderline personality disorder, internet addiction, conduct disorder, substance abuse, and suicidal risk in the general population. Although there is no identifiable explanation of susceptibility to other mental health conditions, the presence of social and cognitive impairments including problems in executive functions and social cognitive skills might be contributing factors.
Previous research indicated that social cognitive skills such as cognitive and affective empathy and executive functions including working memory, inhibitory control and cognitive flexibility play important roles in physical and mental health, quality of life, social competence, school and job success, marital harmony, and public safety. Nevertheless, although autistic traits increase susceptibility to other mental health conditions, no study so far has focused on examining the relationships among autistic traits, executive functions, and social cognitive skills to design intervention and prevention programs for mental health conditions and quality of life in both general and clinical populations.
The primary purpose of the research is to investigate the effects of executive functions and social cognitive skills on the relationship between autistic traits and mental health symptoms that would be significant for designing intervention and prevention programs. The second purpose of the research is to design online executive functions and social cognitive training that might help to reduce vulnerability to negative effects on mental health symptoms in the general population regarding elevated autistic traits.
Using a longitudinal design including pre-test, post-test, and follow-up conditions to test the effectiveness of combined executive functions (EFs) and social cognition online training via computers, tablets, or smartphones for mental health symptoms (depression, anxiety, and stress). This study's independent variables are executive functions (cognitive flexibility, inhibition, and working memory) and social cognition (cognitive empathy and affective empathy). Dependent variables are mental health scores (depression, anxiety, and stress symptoms). Participants will be between the ages of 18 and 35 because previous findings indicate that the age of onset of various mental health problems is between the ages of 17 and 35. Participants will be randomly assigned to the experimental and control groups. Online-based training will consist of combined executive functions and social cognitive (i.e., cognitive empathy and affective empathy) tasks. The length of the training each week will be 75 minutes based on the previous studies. Three within conditions will be present: pre-test, post-test, and follow-up. The primary outcomes of the study are mental health symptoms (anxiety, depression, stress), EFs (working memory, cognitive flexibility, and inhibition), and social cognition (cognitive and affective empathy).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- All participants would be assigned randomly to the experimental group and control group (wait-list condition) to see whether the combined training program is effective for the general population.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: MindZoneIt combines social cognitive and executive functions skills and it will be present on the designed website and they will participate in the intervention online. After participants are assigned the experimental group the 6-week training program will start and they cannot access the next week before completing the previous week. Each week's will last about 75 minutes. The training includes social cognitive skills including cognitive and affective empathy and executive functions. |
| Control Group | No intervention | –This group will not take the training until the follow-up test. After the study will be done, the training program will be offered to the control group as well. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- aged 18 or above
- Fluent in writing and speaking in Turkish
- No record of any psychiatric disorders
- No record of neurological conditions
Key exclusion criteria (3 listed)
- under age 18
- Have any record of psychiatric
- Have any neurological conditions
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 |
|---|---|---|
| MindZoneThe name of the online training will be MindZone. It consists of combined game-based social cognitive and executive functions skills, and it will be presented on the training website. There is no consensus about the length of time for the training in the literature, so the average time for the training process will be used. This means that the training will last 6 weeks, 7.5 hours in total. To satisfy the training requirement, 1.15 hours (75 mins) of play will be expected from participants each week. Before each game, a brief introduction about the game will be presented and participants will get feedback about their progress. Each participant will conduct the tasks in a different random order. After 6 weeks, a post-test will be completed, and follow-up scores will be obtained after a month. All tasks were designed according to the five intervention areas: working memory, cognitive flexibility, inhibition, cognitive empathy and affective empathy based on the literature. | Other | Experimental Group |
Primary outcome
Depression_1
Time frame: Pre-test (baseline), Post-test (immediately after the intervention)
Depression Anxiety Stress Scale 21 will be used to measure depression outcome. Higher scores mean higher depressive symptoms. The minimum and maximum scores are 0-21, respectively.
Anxiety
Time frame: Pre-test (baseline), Post-test (immediately after the intervention)
Depression Anxiety Stress Scale - 21 will be used to measure anxiety outcome. Higher scores mean higher anxiety symptoms. The minimum and maximum scores are 0-21, respectively.
Stress
Time frame: Pre-test (baseline), Post-test (immediately after the intervention)
Depression Anxiety Stress Scale - 21 will be used to measure stress outcome. Higher scores indicate higher stress. The minimum and maximum scores are 0-21, respectively.
Cognitive Flexibility - Errors Rate
Time frame: Pre-test (baseline), Post-test (immediately after the intervention)
Cognitive flexibility - Errors Rate will be measured by the Wisconsin Card Sorting Task. Higher errors indicate lower scores on cognitive flexibility. During the task, 400 cards in two blocks are displayed on the screen and the sorting rule changes after every 10 cards. Maximum score is 400 and minimum score is 0.
Working Memory - Errors Rate
Time frame: Pre-test (baseline), Post-test (immediately after the intervention)
Working memory - Errors Rate will be measured by the N-back task. Higher errors indicate lower working memory scores. Maximum score is 400, minimum score is 0
Inhibition - Errors Rate
Time frame: Pre-test (baseline), Post-test (immediately after the intervention)
Inhibition - Errors Rate will be measured by Go/No Go task. Higher scores indicate lower inhibition. There are 12 blocks of 50 trials each. Commission errors (i.e., incorrectly responding to no-go trials) were measured. Maximum score is 600. Minimum score is 0.
2 secondary outcomes
Cognitive Empathy
Time frame: pretest and posttest conditions
Self-Assessment Manikin for Affective Empathy
Time frame: pretest and posttest conditions
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 39131758Sonmez D, Jordan TR. Investigating associations between cognitive empathy, affective empathy and anxiety in adolescents with autism spectrum disorder. Int J Dev Disabil. 2023 Jan 9;70(5):957-965. doi: 10.1080/20473869.2022.2163605. eCollection 2024.
- Results publication: PubMed 32662285Albantakis L, Brandi ML, Zillekens IC, Henco L, Weindel L, Thaler H, Schliephake L, Timmermans B, Schilbach L. Alexithymic and autistic traits: Relevance for comorbid depression and social phobia in adults with and without autism spectrum disorder. Autism. 2020 Nov;24(8):2046-2056. doi: 10.1177/1362361320936024. Epub 2020 Jul 14.
- Results publication: PubMed 12039606Baron-Cohen S. The extreme male brain theory of autism. Trends Cogn Sci. 2002 Jun 1;6(6):248-254. doi: 10.1016/s1364-6613(02)01904-6.
- Results publication: PubMed 27274255Craig F, Margari F, Legrottaglie AR, Palumbi R, de Giambattista C, Margari L. A review of executive function deficits in autism spectrum disorder and attention-deficit/hyperactivity disorder. Neuropsychiatr Dis Treat. 2016 May 12;12:1191-202. doi: 10.2147/NDT.S104620. eCollection 2016.
- Results publication: PubMed 31003723Dell'Osso L, Carpita B, Muti D, Morelli V, Salarpi G, Salerni A, Scotto J, Massimetti G, Gesi C, Ballerio M, Signorelli MS, Luciano M, Politi P, Aguglia E, Carmassi C, Maj M. Mood symptoms and suicidality across the autism spectrum. Compr Psychiatry. 2019 May;91:34-38. doi: 10.1016/j.comppsych.2019.03.004. Epub 2019 Apr 3.
- Results publication: PubMed 25256627de Vries M, Prins PJ, Schmand BA, Geurts HM. Working memory and cognitive flexibility-training for children with an autism spectrum disorder: a randomized controlled trial. J Child Psychol Psychiatry. 2015 May;56(5):566-76. doi: 10.1111/jcpp.12324. Epub 2014 Sep 26.
- Results publication: PubMed 23020641Diamond A. Executive functions. Annu Rev Psychol. 2013;64:135-68. doi: 10.1146/annurev-psych-113011-143750. Epub 2012 Sep 27.
- Results publication: PubMed 29882629Fietz J, Valencia N, Silani G. Alexithymia and autistic traits as possible predictors for traits related to depression, anxiety, and stress: A multivariate statistical approach. J Eval Clin Pract. 2018 Aug;24(4):901-908. doi: 10.1111/jep.12961. Epub 2018 Jun 8.
- Results publication: PubMed 29772912Gambin M, Sharp C. Relations between empathy and anxiety dimensions in inpatient adolescents. Anxiety Stress Coping. 2018 Jul;31(4):447-458. doi: 10.1080/10615806.2018.1475868. Epub 2018 May 17.
- Results publication: PubMed 28960841Gardiner E, Iarocci G. Everyday executive function predicts adaptive and internalizing behavior among children with and without autism spectrum disorder. Autism Res. 2018 Feb;11(2):284-295. doi: 10.1002/aur.1877. Epub 2017 Sep 27.
- Results publication: PubMed 26886468Gokcen E, Frederickson N, Petrides KV. Theory of Mind and Executive Control Deficits in Typically Developing Adults and Adolescents with High Levels of Autism Traits. J Autism Dev Disord. 2016 Jun;46(6):2072-2087. doi: 10.1007/s10803-016-2735-3.
- Results publication: PubMed 21426604Lundstrom S, Chang Z, Kerekes N, Gumpert CH, Rastam M, Gillberg C, Lichtenstein P, Anckarsater H. Autistic-like traits and their association with mental health problems in two nationwide twin cohorts of children and adults. Psychol Med. 2011 Nov;41(11):2423-33. doi: 10.1017/S0033291711000377. Epub 2011 Mar 22.
- Individual participant dataSharing planned: No. To ensure the ethical rights of the participants, the data will be available only for current research unless the participants give permission.
Related trials for Autism or Autistic Traits
Not yet recruitingObservational study
Relation Between Autistic Features and Fine Motor Abilities in Children With Autism Spectrum Disorder
Autism or Autistic Traits
Recruiting
Effects of Multiple-Session Transcranial Direct Current Stimulation (tDCS) on Behavioral, Physiological, and Electrophysiological Measures With Adults With Autism Spectrum Disorder (ASD)
Autism Spectrum Disorder, Autism or Autistic Traits
RecruitingObservational study
Baker Gordon Syndrome Natural History Study
Rare Diseases, Autism or Autistic Traits
RecruitingObservational study
Development of Prosocial Behaviors and Related Brain Network in Infants of High and Low Risk of ASD
Autism or Autistic Traits, Healthy
Recruiting
Autism Caregiver Coaching in Africa
Autism or Autistic Traits
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.
Dilruba Sönmez, MA principal investigator
Ibn Haldun University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MindZone in people with Autism or Autistic Traits and Mental Health Disorder, run by Ibn Haldun University at 1 site in Turkey (Türkiye).
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 4 inclusion and 3 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 17 Mar 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 Turkey (Türkiye). 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?
Yes. Results are posted in the registry (first posted 17 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Depression_1 (time frame: Pre-test (baseline), Post-test (immediately after the intervention)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06213194, which also lists 20 linked publications.
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 17 Mar 2025.