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Covid-19 Pandemic
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The present study examines the impact of oxytocin (OXT) and Pivotal Response Treatment (PRT) on the development of language, social, and play skills in young children with Autism Spectrum Disorder (ASD). The purpose of this study is to examine the impact of OXT as an enhancer of response to PRT. Participants will be randomly assigned to either an intranasal OXT group or a placebo group. Neither the research team nor the participants will know or choose which group the participant is assigned to. Children in both groups will participate in a 16-week trial of PRT. The trial will test the hypothesis that children with lower levels of activity in and functional connectivity among certain PRT-response brain regions will benefit more from the administration of OXT vs. placebo as an enhancer to a 16-week trial of PRT.
This project investigates the effectiveness of a new intervention approach for Autism Spectrum Disorder (ASD) to optimize the effects of an evidence-based behavioral intervention, Pivotal Response Treatment (PRT) by attempting to enhance it with oxytocin (OXT). We will integrate fMRI, eye tracking, and behavioral outcomes to measure how OXT may create a neural background for individuals with ASD to bolster their motivation to interact socially and facilitate their biological preparedness for learning social communication skills during behavioral treatments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pivotal Response Treatment (PRT)/oxytocin (OXT) nasal spray | Experimental | Participants will receive oxytocin nasal spray 45 minutes prior to each PRT session. |
|
| Pivotal Response Treatment (PRT)/placebo nasal spray | Placebo Comparator | Participants will receive a placebo nasal spray 45 minutes prior to each PRT session. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxytocin | Drug | Oxytocin nasal spray. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Social Responsiveness Scale, 2nd Edition (SRS-2) | The SRS-2 is a 65-item measure of social responsiveness. The SRS-2 is filled out by a parent. The SRS-2 has a minimum raw score of 0 and a maximum raw score of 195. Higher raw scores on the SRS-2 mean a worse outcome. | Change from Baseline to post-treatment, 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Vineland Adaptive Behavior Scale, 3rd Edition (Vineland-III) | The Vineland-III is a parent interview administered by a member of the research team. The interview lasts approximately one hour and measures four domains of the child's adaptive behavior. | Change from Baseline to post-treatment, 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Gaze Patterns | Gaze patterns will be tracked using eye tracking technology as participants watch videos for approximately one hour. | Change from Baseline to post-treatment, 16 weeks |
| Autism Diagnostic Observation Schedule - 2nd Edition (ADOS-2) |
Inclusion Criteria:
Exclusion Criteria:
Any metal or electromagnetic implants, including:
Significant hearing loss or other severe sensory impairment
A fragile health status.
Current use of prescription psychotropic medications that may affect cognitive processes under study.
A history of significant head trauma or serious brain or psychiatric illness
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| Name | Affiliation | Role |
|---|---|---|
| Denis Sukhodolsky, Ph.D. | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale School of Medicine | New Haven | Connecticut | 06520 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pivotal Response Treatment (PRT)/Oxytocin (OXT) Nasal Spray | Participants will receive oxytocin nasal spray 45 minutes prior to each PRT session. Oxytocin: Oxytocin nasal spray. Pivotal Response Treatment: An evidence-based manualized treatment for individuals with autism, which was specifically designed to improve social communication. |
| FG001 | Pivotal Response Treatment (PRT)/Placebo Nasal Spray | Participants will receive a placebo nasal spray 45 minutes prior to each PRT session. Pivotal Response Treatment: An evidence-based manualized treatment for individuals with autism, which was specifically designed to improve social communication. Placebo: Placebo nasal spray. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pivotal Response Treatment (PRT)/Oxytocin (OXT) Nasal Spray | Participants will receive oxytocin nasal spray 45 minutes prior to each PRT session. Oxytocin: Oxytocin nasal spray. Pivotal Response Treatment: An evidence-based manualized treatment for individuals with autism, which was specifically designed to improve social communication. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Social Responsiveness Scale, 2nd Edition (SRS-2) | The SRS-2 is a 65-item measure of social responsiveness. The SRS-2 is filled out by a parent. The SRS-2 has a minimum raw score of 0 and a maximum raw score of 195. Higher raw scores on the SRS-2 mean a worse outcome. | Only 1/3 participants completed treatment in the oxytocin group. Therefore, the mean raw score for the oxytocin group is based off of that subject's data only. | Posted | Mean | Full Range | score on a scale | Change from Baseline to post-treatment, 16 weeks |
|
16 weeks
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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 | Pivotal Response Treatment (PRT)/Oxytocin (OXT) Nasal Spray | Participants will receive oxytocin nasal spray 45 minutes prior to each PRT session. Oxytocin: Oxytocin nasal spray. Pivotal Response Treatment: An evidence-based manualized treatment for individuals with autism, which was specifically designed to improve social communication. |
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This study was terminated early due to issues related to the covid-19 pandemic. Only 3 participants completed the trial- 1 out of 3 in the oxytocin group and 2 in the placebo group. As such, the mean score for the oxytocin group is based off of one subjects data only.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Pamela Ventola | Yale Child Study Center | (203) 737-4378 | ventolalab@yale.edu |
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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 | Aug 5, 2021 | Jun 10, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D010121 | Oxytocin |
| ID | Term |
|---|---|
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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Eighty children will be randomly assigned to receive PRT with either oxytocin (forty children) or a placebo (forty children).
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| Pivotal Response Treatment |
| Behavioral |
An evidence-based manualized treatment for individuals with autism, which was specifically designed to improve social communication. |
|
| Placebo | Drug | Placebo nasal spray. |
|
The ADOS-2 is a diagnostic assessment for ASD performed by a clinician.
| Change from Baseline to post-treatment, 16 weeks |
| Clinical Global Impressions - Severity (CGI-S) | The CGI-S is a 7-point Likert Scale completed by a clinician, which measures clinical impressions of symptom severity. | Change from Baseline to post-treatment, 16 weeks |
| Social Responsiveness Scale - 2 (Teacher Form) | The SRS-2 is a 65-item measure of social responsiveness. The SRS-2 Teacher is filled out by the participant's teacher. | Change from Baseline to post-treatment, 16 weeks |
| Child Behavior Checklist (CBCL) | The CBCL is a parent report measure of problem behaviors. The form for children ages 1.5-5 has 100 items, and the form for children ages 6-18 has 113 items. | Change from Baseline to post-treatment, 16 weeks |
| Child and Adolescent Symptom Inventory - 5 (CASI-5) | The CASI-5 is a behavior inventory measuring symptoms of several mental health problems among children. The CASI-5 is a 173-item parent report measure. | Change from Baseline to post-treatment, 16 weeks |
| Aberrant Behavior Checklist (ABC) | The ABC is a 58-item parent report behavior rating scale. | Change from Baseline to post-treatment, 16 weeks |
| Repetitive Behavior Scale - Revised (RBS-R) | The RBS-R is a 49-item, parent report measure of restricted and repetitive behaviors. | Change from Baseline to post-treatment, 16 weeks |
| Behavior Rating Inventory of Executive Function (BRIEF) | The BRIEF is an 86-item parent report measure of executive function. | Change from Baseline to post-treatment, 16 weeks |
| Neural Activity/Connectivity During Videos of Biological Motion | Neural activity while viewing videos of biological motion will be measured using fMRI. | Change from Baseline to post-treatment, 16 weeks |
| Brief Observation of Social Communication Change (BOSCC) | The BOSCC is a coding scheme that measures social communication change. Codes are based on videos of play session between children and parents. | Change from Baseline to post-treatment, 16 weeks |
| BG001 |
| Pivotal Response Treatment (PRT)/Placebo Nasal Spray |
Participants will receive a placebo nasal spray 45 minutes prior to each PRT session. Pivotal Response Treatment: An evidence-based manualized treatment for individuals with autism, which was specifically designed to improve social communication. Placebo: Placebo nasal spray. |
| BG002 | Total | Total of all reporting groups |
| Months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Pivotal Response Treatment (PRT)/Placebo Nasal Spray | Participants will receive a placebo nasal spray 45 minutes prior to each PRT session. Pivotal Response Treatment: An evidence-based manualized treatment for individuals with autism, which was specifically designed to improve social communication. Placebo: Placebo nasal spray. |
|
|
| Secondary | Vineland Adaptive Behavior Scale, 3rd Edition (Vineland-III) | The Vineland-III is a parent interview administered by a member of the research team. The interview lasts approximately one hour and measures four domains of the child's adaptive behavior. | Data were not collected due to COVID-19 related termination of study. | Posted | Change from Baseline to post-treatment, 16 weeks |
|
|
| Other Pre-specified | Gaze Patterns | Gaze patterns will be tracked using eye tracking technology as participants watch videos for approximately one hour. | Data were not collected due to COVID-19 related termination of study. | Posted | Change from Baseline to post-treatment, 16 weeks |
|
|
| Other Pre-specified | Autism Diagnostic Observation Schedule - 2nd Edition (ADOS-2) | The ADOS-2 is a diagnostic assessment for ASD performed by a clinician. | Data were not collected due to COVID-19 related termination of study. | Posted | Change from Baseline to post-treatment, 16 weeks |
|
|
| Other Pre-specified | Clinical Global Impressions - Severity (CGI-S) | The CGI-S is a 7-point Likert Scale completed by a clinician, which measures clinical impressions of symptom severity. | Data were not collected due to COVID-19 related termination of study. | Posted | Change from Baseline to post-treatment, 16 weeks |
|
|
| Other Pre-specified | Social Responsiveness Scale - 2 (Teacher Form) | The SRS-2 is a 65-item measure of social responsiveness. The SRS-2 Teacher is filled out by the participant's teacher. | Data were not collected due to COVID-19 related termination of study. | Posted | Change from Baseline to post-treatment, 16 weeks |
|
|
| Other Pre-specified | Child Behavior Checklist (CBCL) | The CBCL is a parent report measure of problem behaviors. The form for children ages 1.5-5 has 100 items, and the form for children ages 6-18 has 113 items. | Data were not collected due to COVID-19 related termination of study. | Posted | Change from Baseline to post-treatment, 16 weeks |
|
|
| Other Pre-specified | Child and Adolescent Symptom Inventory - 5 (CASI-5) | The CASI-5 is a behavior inventory measuring symptoms of several mental health problems among children. The CASI-5 is a 173-item parent report measure. | Data were not collected due to COVID-19 related termination of study. | Posted | Change from Baseline to post-treatment, 16 weeks |
|
|
| Other Pre-specified | Aberrant Behavior Checklist (ABC) | The ABC is a 58-item parent report behavior rating scale. | Data were not collected due to COVID-19 related termination of study. | Posted | Change from Baseline to post-treatment, 16 weeks |
|
|
| Other Pre-specified | Repetitive Behavior Scale - Revised (RBS-R) | The RBS-R is a 49-item, parent report measure of restricted and repetitive behaviors. | Data were not collected due to COVID-19 related termination of study. | Posted | Change from Baseline to post-treatment, 16 weeks |
|
|
| Other Pre-specified | Behavior Rating Inventory of Executive Function (BRIEF) | The BRIEF is an 86-item parent report measure of executive function. | Data were not collected due to COVID-19 related termination of study. | Posted | Change from Baseline to post-treatment, 16 weeks |
|
|
| Other Pre-specified | Neural Activity/Connectivity During Videos of Biological Motion | Neural activity while viewing videos of biological motion will be measured using fMRI. | Data were not collected due to COVID-19 related termination of study. | Posted | Change from Baseline to post-treatment, 16 weeks |
|
|
| Other Pre-specified | Brief Observation of Social Communication Change (BOSCC) | The BOSCC is a coding scheme that measures social communication change. Codes are based on videos of play session between children and parents. | Data were not collected due to COVID-19 related termination of study. | Posted | Change from Baseline to post-treatment, 16 weeks |
|
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| 0 |
| 3 |
| 0 |
| 3 |
| 0 |
| 3 |
| EG001 | Pivotal Response Treatment (PRT)/Placebo Nasal Spray | Participants will receive a placebo nasal spray 45 minutes prior to each PRT session. Pivotal Response Treatment: An evidence-based manualized treatment for individuals with autism, which was specifically designed to improve social communication. Placebo: Placebo nasal spray. | 0 | 2 | 0 | 2 | 0 | 2 |
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| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |