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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:
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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MindZone | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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 | Pre-test (baseline), Post-test (immediately after the intervention) |
| Inhibition - Errors Rate |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | pretest and posttest conditions |
| Self-Assessment Manikin for Affective Empathy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dilruba Sönmez, MA | Ibn Haldun University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dilruba Sönmez | Istanbul | Basaksehir | 34480 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39131758 | Background | 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. | |
| 32662285 | Result | Albantakis 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. |
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To ensure the ethical rights of the participants, the data will be available only for current research unless the participants give permission.
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Participants are under the age of 18, and who have any record of psychiatric or physical conditions excluded from the study.
Online data collection were used.
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental Group | 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. MindZone: 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, 5 hours in total. To satisfy the training requirement, 50 mins for each week 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. |
| FG001 | Control Group | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental Group | 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. MindZone: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Experimental and control groups | Posted | Mean | Standard Deviation | score on a scale | Pre-test (baseline), Post-test (immediately after the intervention) |
|
Adverse Events were not monitored/assessed.
Adverse Events were not monitored/assessed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Experimental Group | 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. MindZone: 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, 5 hours in total. To satisfy the training requirement, 50 mins for each week 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Dilruba Sönmez | Ibn Haldun University | 905365646640 | dilrubasonmez@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 7, 2025 | Mar 7, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001321 | Autistic Disorder |
| D001523 | Mental Disorders |
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D010549 | Personal Satisfaction |
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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.
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To reduce biases, a single-blind procedure will be applied. It will be provided basic information about topics including social-cognitive skills and mental health but no detailed description of training will be given.
|
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.
| Pre-test (baseline), Post-test (immediately after the intervention) |
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.
| pretest and posttest conditions |
| 12039606 | Result | Baron-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. |
| 27274255 | Result | Craig 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. |
| 31003723 | Result | Dell'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. |
| 25256627 | Result | de 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. |
| 23020641 | Result | Diamond A. Executive functions. Annu Rev Psychol. 2013;64:135-68. doi: 10.1146/annurev-psych-113011-143750. Epub 2012 Sep 27. |
| 29882629 | Result | Fietz 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. |
| 29772912 | Result | Gambin 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. |
| 28960841 | Result | Gardiner 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. |
| 26886468 | Result | Gokcen 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. |
| 21426604 | Result | Lundstrom 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. |
| 35116075 | Result | Mason 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. |
| 32614046 | Result | Nahum 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. |
| 33170393 | Result | Sandgreen 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. |
| 26407521 | Result | Sari BA, Koster EH, Pourtois G, Derakshan N. Training working memory to improve attentional control in anxiety: A proof-of-principle study using behavioral and electrophysiological measures. Biol Psychol. 2016 Dec;121(Pt B):203-212. doi: 10.1016/j.biopsycho.2015.09.008. Epub 2015 Sep 25. |
| 32075434 | Result | Zelazo PD. Executive Function and Psychopathology: A Neurodevelopmental Perspective. Annu Rev Clin Psychol. 2020 May 7;16:431-454. doi: 10.1146/annurev-clinpsy-072319-024242. Epub 2020 Feb 19. |
| 24684661 | Result | Allemand M, Steiger AE, Fend HA. Empathy development in adolescence predicts social competencies in adulthood. J Pers. 2015 Apr;83(2):229-41. doi: 10.1111/jopy.12098. Epub 2014 May 4. |
| 22917843 | Result | Eussen ML, Van Gool AR, Verheij F, De Nijs PF, Verhulst FC, Greaves-Lord K. The association of quality of social relations, symptom severity and intelligence with anxiety in children with autism spectrum disorders. Autism. 2013 Nov;17(6):723-35. doi: 10.1177/1362361312453882. Epub 2012 Aug 23. |
| 34079068 | Result | Solmi M, Radua J, Olivola M, Croce E, Soardo L, Salazar de Pablo G, Il Shin J, Kirkbride JB, Jones P, Kim JH, Kim JY, Carvalho AF, Seeman MV, Correll CU, Fusar-Poli P. Age at onset of mental disorders worldwide: large-scale meta-analysis of 192 epidemiological studies. Mol Psychiatry. 2022 Jan;27(1):281-295. doi: 10.1038/s41380-021-01161-7. Epub 2021 Jun 2. |
| BG001 | Control Group | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | We included participants who completed the post-test condition. | Mean | Standard Deviation | years |
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| Sex: Female, Male | We included the participants who completed the post-test condition. | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Units | Counts |
|---|---|
| Participants |
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| Primary | 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. | experimental and control groups | Posted | Mean | Standard Deviation | score on a scale | Pre-test (baseline), Post-test (immediately after the intervention) |
|
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|
| Primary | 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. | experimental group | Posted | Mean | Standard Deviation | score on a scale | Pre-test (baseline), Post-test (immediately after the intervention) |
|
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| Primary | 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. | experimental group vs. control group | Posted | Mean | Standard Deviation | score on a scale | Pre-test (baseline), Post-test (immediately after the intervention) |
|
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| Primary | 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 | experimental group | Posted | Mean | Standard Deviation | score on a scale | Pre-test (baseline), Post-test (immediately after the intervention) |
|
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| Primary | 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. | experimental group vs. control group | Posted | Mean | Standard Deviation | score on a scale | Pre-test (baseline), Post-test (immediately after the intervention) |
|
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| Secondary | 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. | experimental and control groups | Posted | Mean | Standard Deviation | score on a scale | pretest and posttest conditions |
|
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| Secondary | 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. | experimental and control groups | Posted | Mean | Standard Deviation | score on a scale | pretest and posttest conditions |
|
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Control Group | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
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| D001519 | Behavior |