Trial · NCT01908205
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Efficacy of Intranasal Oxytocin vs. Placebo on Measures of Social Function | 12 and 24 weeks | This will be measured by a change in score on the Aberrant Behavior Checklist (ABC) - Social Withdrawal Subscale (0-48, where lower scores indicate improvement) |
| Secondary | Efficacy of Intranasal Oxytocin vs. Placebo on Measures of Social Cognition | 12 Weeks | This will be measured by a change in score the Revised Eyes Test (0- 28; where higher scores indicate better performance/improvement) Baseline to Week 12 |
| Secondary | Efficacy of Intranasal Oxytocin vs. Placebo on Measures of Social Cognition | 12 Weeks | This will be measured by improvement on the Let's Face it! Skills Battery from Baseline to Week 12 Social Cognition (higher score=better outcome) a. Let's Face It Skills Battery; i. Matchmaker (0-100); ii. Faces (0-100); iii. Houses (0-100) |
| Secondary | Efficacy of Intranasal Oxytocin vs. Placebo on Measures of Social Function | 12 Weeks | This will be measured by improvement on the Behavioral Assessment System for Children (BASC-2) from Baseline to Week 12 Behavioral Assessment System for Children (higher score=positive response); i. \*Social Skills: age 6 to 11 (18-69); age 12 to 17 (21-70); ii. Functional Communication: age 6 to 11 (10-66); age 12 to 17 (10-64); iii. Withdrawal age 6-11 (21- 62) ; age 12-17 (14-42) \* only social subscales of BASC-2 reported |
| Secondary | Number of Participant Considered Social Responders | 12 Weeks | This will be measured by the Clinical Global Impressions - Improvement Scale - Social (CGI-I-Social) a) Clinical Global Impressions - Social Scale (1-7) (lower score=positive response). The results will be reported as the number of participants that were classified as a social responder (achieving a score of 1 or 2 on the scale). |
| Secondary | Efficacy of Intranasal Oxytocin vs. Placebo on Measures of Repetitive Behaviors | 12 Weeks | This will be measured by improvement on the Child Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) from Baseline to Week 12 -lower score= positive response (0-20) |
| Secondary | Efficacy of Intranasal Oxytocin vs. Placebo on Measures of Repetitive Behaviors | 12 Weeks | This will be measured by improvement on the Repetitive Behavior Scale (RBS-R)(0-129; where lower score= positive response) from Baseline to Week 12 |
| Secondary | Efficacy of Intranasal Oxytocin vs. Placebo on Measures of Anxiety | 12 Weeks | This will be measured by the Child and Adolescent Symptom Inventory (CASI-4R) Generalized anxiety score (male (40-101); female (41-96) -where lower score= positive response) from Baseline to Week 12 |
| Secondary | Efficacy of Intranasal Oxytocin vs. Placebo on Measures of Quality of Life | 12 Weeks | This will be measured by improvement on the Pediatric Quality of Life Inventory (PedsQL) (0-100, where higher scores indicate positive response) from Baseline to Week 12 |
| Secondary | Number of Participant Considered Overall Responders | 12 Weeks | This will be measured by the Clinical Global Impressions - Improvement Scale - Global (CGI-I-Global) (1-7) (lower score=positive response). The results will be reported as the number of participants that were classified as an overall responder (achieving a score of 1 or 2 on the scale). |
| Secondary | Safety and Tolerability of Intranasal Oxytocin in Children and Adolescents With ASD | 12 Weeks | This will be measured by the Safety Monitoring Uniform Report Form (SMURF) |
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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