Trial · NCT07801833
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Executive Function as Assessed by the Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2) | Baseline, immediately after the 12-week intervention, and 12 weeks after completion of the intervention | The BRIEF-2 is a parent-report questionnaire that assesses executive function behaviors in children's everyday life. The Global Executive Composite (GEC), index scores, and individual clinical scale scores will be analyzed to evaluate changes in different aspects of executive functioning. Higher T-scores indicate greater difficulties with executive functioning, whereas lower T-scores indicate fewer difficulties. |
| Secondary | Adaptive Behavior as Assessed by the Vineland Adaptive Behavior Scales, Third Edition (Vineland-3) | Baseline, immediately after the 12-week intervention, and 12 weeks after completion of the intervention | The Vineland-3 is a standardized measure of adaptive functioning in everyday life. The Adaptive Behavior Composite (ABC) score will be used as the primary outcome measure. Domain scores for Communication, Daily Living Skills, and Socialization will also be analyzed. Higher scores indicate better adaptive functioning. |
| Secondary | Emotion Regulation as Assessed by the Emotion Regulation Checklist (ERC) | Baseline, immediately after the 12-week intervention, and 12 weeks after completion of the intervention | The Emotion Regulation Checklist (ERC) is a 24-item questionnaire that assesses children's emotional regulation and emotional lability/negativity. Items are rated on a 4-point scale from 1 (Never) to 4 (Always). Scores for the Emotion Regulation and Lability/Negativity subscales will be analyzed, with higher Emotion Regulation scores indicating better emotion regulation and higher Lability/Negativity scores indicating greater emotional dysregulation. |
| Secondary | Academic Self-Regulation as Assessed by the Academic Self-Regulation Questionnaire (SRQ-A) | Baseline, immediately after the 12-week intervention, and 12 weeks after completion of the intervention | The Academic Self-Regulation Questionnaire (SRQ-A) is a child-report measure that assesses children's reasons for engaging in school-related behaviors. It includes four regulatory styles: external regulation, introjected regulation, identified regulation, and intrinsic motivation. Items are rated on a 4-point scale, with higher subscale scores indicating greater endorsement of the corresponding regulatory style. Subscale scores and the Relative Autonomy Index (RAI) will be analyzed, with higher RAI scores indicating more autonomous or self-determined regulation. |
| Secondary | Prosocial Self-Regulation as Assessed by the Prosocial Self-Regulation Questionnaire (SRQ-P) | Baseline, immediately after the 12-week intervention, and 12 weeks after completion of the intervention | The Prosocial Self-Regulation Questionnaire (SRQ-P) is a child-report measure that assesses children's reasons for engaging in prosocial behaviors. It includes three regulatory styles: external regulation, introjected regulation, and identified regulation. Items are rated on a 4-point scale, with higher subscale scores indicating greater endorsement of the corresponding regulatory style. Subscale scores will be analyzed to assess changes in the regulation of prosocial behavior. |
| Other | Inhibitory Control as Assessed by the Stroop Test | Baseline, immediately after the 12-week intervention, and 12 weeks after completion of the intervention | The Stroop Test is a performance-based measure used to assess inhibitory control and cognitive interference. Performance indices derived from the Stroop task will be analyzed, with better performance reflecting greater inhibitory control and ability to manage cognitive interference. |
| Other | Cognitive Flexibility as Assessed by the Children's Color Trails Test (CCTT) | Baseline, immediately after the 12-week intervention, and 12 weeks after completion of the intervention | The CCTT is a performance-based measure of attention, sequencing, and cognitive flexibility in children. Performance indices from the CCTT will be analyzed to assess changes in attentional control and cognitive flexibility, including the ability to shift between task demands. |
| Other | Cognitive Flexibility as Assessed by the Wisconsin Card Sorting Test (WCST) | Baseline, immediately after the 12-week intervention, and 12 weeks after completion of the intervention | The WCST is a performance-based measure of executive functioning that assesses cognitive flexibility, concept formation, and the ability to shift cognitive sets in response to changing feedback. Performance indices from the WCST will be analyzed to assess changes in cognitive flexibility. |
| Other | Autism-Related Social Functioning as Assessed by the Social Responsiveness Scale, Second Edition (SRS-2) | Baseline, immediately after the 12-week intervention, and 12 weeks after completion of the intervention | The SRS-2 is a questionnaire that assesses social functioning and autism-related social difficulties. Total and subscale scores will be analyzed. Higher scores indicate greater difficulties in social functioning and greater severity of autism-related social characteristics. |
| Other | Emotional and Behavioral Problems as Assessed by the Child Behavior Checklist (CBCL) | Baseline, immediately after the 12-week intervention, and 12 weeks after completion of the intervention | Description: range of emotional and behavioral problems in children. Composite and syndrome scale scores will be analyzed. Higher scores indicate greater emotional and behavioral difficulties. |
| Other | Depressive Symptoms as Assessed by the Children's Depression Inventory (CDI) | Baseline, immediately after the 12-week intervention, and 12 weeks after completion of the intervention | The CDI is a child-report questionnaire used to assess depressive symptoms in children. The total score will be analyzed, with higher scores indicating greater depressive symptoms. |
| Other | Anxiety Symptoms as Assessed by the State-Trait Anxiety Inventory for Children (STAIC) | Baseline, immediately after the 12-week intervention, and 12 weeks after completion of the intervention | The STAIC is a child-report questionnaire that assesses state anxiety and trait anxiety in children. State Anxiety and Trait Anxiety scores will be analyzed separately, with higher scores indicating greater anxiety. |
| Other | Parenting Stress as Assessed by the Korean Parenting Stress Index, Fourth Edition, Short Form (K-PSI-4-SF) | Baseline, immediately after the 12-week intervention, and 12 weeks after completion of the intervention | The K-PSI-4-SF is a parent-report questionnaire that assesses parenting stress. The Total Stress score and subscale scores will be analyzed, with higher scores indicating greater levels of parenting stress. |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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