Trial · NCT07598643
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number and percentage of subjects experiencing treatment-emergent adverse events. | From screening to 1 month after end of treatment | Number, percentage, type, and severity of treatment-emergent adverse events (TEAEs) will be annotated over the 6-month period in the treatment arm and placebo arm. |
| Primary | Change in Kaufman Brief Intelligence Test, 2nd Edition Revised (KBIT-2 Revised) - Verbal Intelligence | Baseline, 6 months | Verbal Intelligence score, made up of the Verbal Knowledge and Riddles subtest, is a standardized measure of verbal cognitive ability. Raw scores,will be employed. Increase in scores indicate improvement in verbal cognitive performance. |
| Primary | Change in Kaufman Brief Intelligence Test, 2nd Edition Revised (KBIT-2 Revised) - Nonverbal Intelligence | Baseline, 6 months | The KBIT-2 Revised Nonverbal Intelligence score is a standardized measure of nonverbal reasoning ability and is made up of the Matrices subtest. We will be using the raw score. Increase in scores indicate improvement in nonverbal cognitive performance. |
| Primary | Change in Leiter 3 - Attention Sustained subtest | Baseline, 6 months | The Leiter-3 Attention Sustained subtest is a measure of inhibitory control. The raw score, calculated as the correct number of targets minus errors made across four trials, will be used. Increase in scores indicate improvement. |
| Primary | Change in Vineland Adaptive Behavior Scales 3 (VABS-3) - Sum of Domain Raw Scores | Baseline, 6 months | The Vineland Adaptive Behavior Scales, Third Edition (VABS-3) assesses adaptive functioning across communication, daily living skills, socialization, and motor domains. Domain raw scores will be summed to produce a composite raw score. . Increase in scores indicate improvement in adaptive functioning. |
| Primary | Change in Clinical Global Impressions (CGI) Scale - Improvement in Health (CGI-I-H) | Baseline, 6 months | The CGI-I scale, which ranges from 1 to 7, with 1 being "very much improved" and 7 being "very much worse" to assess changes in global health during the 6-month intervention period. Noteworthy, we will also collect the CGI-S score (severity) at each time point (baseline, 3 months - midpoint visit, and 6 months - endpoint visit). The CGI-I will be collected at 3 months and 6 months. |
| Secondary | Change in Peabody Picture Vocabulary Test, Fifth Edition (PPVT-5) | Baseline, 6 months | The Peabody Picture Vocabulary Test, Fifth Edition (PPVT-5) assesses receptive vocabulary. Growth Scale Values (GSV) are used to determine an individual's absolute progress over time and is sensitive to small changes . Increase in scores indicate improvement in receptive vocabulary ability. A Naturalistic Language Sample will be utilized to measure spontaneous expressive language. We will analyze total utterances and mean length of utterance. Increase in scores indicate improvement in expressive language skills |
| Secondary | Change in Naturalistic Language Sample | Baseline, 6 months | This measure evaluates spontaneous expressive language narration. We will analyze total utterances and mean length of utterance. |
| Secondary | Change in Developmental Behavior Checklist 2 (DBC-2) or Achenbach Child (or Adult) Behavior Checklist | Baseline, 6 months | The DBC-2 reports a statistically significant change in Developmental Behavioral Checklist-2 (DBC-2) T-scores within or between treatment arms. A decrease in score indicates improvement. Or the Achenbach is a caregiver-report measure of maladaptive behavior. This is a standardized questionnaire with available score norms by chronological age resulting in T-scores. We will analyze change in the internalizing and externalizing T-scores. |
| Secondary | Change in Social Responsiveness Scale 2 (SRS-2), School Age and Adult | Baseline, 6 months | The Social Responsiveness Scale, Second Edition (SRS-2) generates T-scores with a mean of 50 and a standard deviation of 10. . Increase in scores indicates greater severity of autism-related symptoms (worse outcome). Both total and social communication T-scores will be analyzed. |
| Secondary | Change in Modified Corsi Test | Baseline, 6 months | The Modified Corsi Test assesses working memory. Scores are summed based on total performance across all trials. Increase in scores indicates improvement in working memory performance. |
| Secondary | Change in Dimensional Change Card Sort test | Baseline, 6 months | The Dimensional Change Card Sort Test measures cognitive flexibility. The total number of correct post-switch responses will be calculated across the last two trials. Increase in scores indicates improvement in cognitive flexibility. |
| Secondary | Change in Beery Visual Motor Integration Scales (Beery VMI) | Baseline, 6 months | The Beery VMI, assesses visual-motor integration skills. Increase in scores indicates improvement in visual-motor integration ability. |
| Secondary | Change in Vineland Adaptive Behavior Scales, Third Edition (VABS-3) - Sum of Raw Scores | Baseline, 6 months | The Vineland-3 is composed of four domains: Communication, Daily Living Skills, Socialization, and Motor. Each domain score represents summed raw scores from subdomains. We will evaluate changes in the raw scores of the four domains.. Increase in scores indicate improvement of adaptive skills in communication, daily living skills, socialization, and motor skills. |
| Secondary | Change in Composite Neurodevelopmental Improvement Scores | Baseline, 6 months | This composite score aggregates standardized changes across multiple assessments. Individual measures are transformed into standardized differences before averaging. The composite score is not bounded by a fixed range. Higher values indicate greater overall improvement in neurodevelopmental functioning |
| Secondary | Change in Clinical Global Impression - Improvement in Neurodevelopment (CGI-I-ND) | Baseline, 6 months | This composite score aggregates standardized changes across multiple assessments. Individual measures are transformed into standardized differences before averaging. The composite score is not bounded by a fixed range. Higher values indicate greater overall improvement in neurodevelopmental functioning. CGI-I-ND is a scale to rate improvement. |
| Other | Change in Pediatric Quality of Life Inventory (PedsQL) | Baseline, 6 months | The Pediatric Quality of Life Inventory (PedsQL) produces scores ranging from 0 to 100. Scores indicate improvement in health-related quality of life. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license 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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