Translating Neuroprediction Into Precision Medicine Via Brain Priming

Autism Spectrum Disorder Clinical Trial

Official title:

Translating Neuroprediction Into Precision Medicine Via Brain Priming

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03370510
• Other study ID #: 2000021581
• Status: Terminated
• Phase: Phase 2
• Start date: December 7, 2018
• Est. completion date: July 28, 2021

Study information

• Verified date: August 2022
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: July 28, 2021
• Est. primary completion date: July 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 9 Years

Eligibility

Inclusion Criteria:

1. Fit the age requirement: age 5-9

2. Have been diagnosed previously with an ASD and meet criteria for ASD when characterized by research team

3. Be in good medical health

4. Be cooperative with testing

5. Speak English in the family

6. Successfully complete an fMRI scan

7. Full-scale intelligence quotient (IQ)>70

Exclusion Criteria:

1. Any metal or electromagnetic implants, including:

1. Cardiac pacemaker

2. Defibrillator

3. Artificial heart valve

4. Aneurysm clip

5. Cochlear implants

6. Shrapnel

7. Neurostimulators

8. History of metal fragments in eyes or skin

2. Significant hearing loss or other severe sensory impairment

3. A fragile health status.

4. Current use of prescription psychotropic medications that may affect cognitive processes under study.

5. A history of significant head trauma or serious brain or psychiatric illness

Related Conditions & MeSH terms

• Autism Spectrum Disorder

Intervention

Drug:
• Oxytocin
Oxytocin nasal spray.

Behavioral:
• Pivotal Response Treatment
An evidence-based manualized treatment for individuals with autism, which was specifically designed to improve social communication.

Drug:
• Placebo
Placebo nasal spray.

Locations

Country	Name	City	State
United States	Yale School of Medicine	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Autism Diagnostic Observation Schedule - 2nd Edition (ADOS-2)	The ADOS-2 is a diagnostic assessment for ASD performed by a clinician.	Change from Baseline to post-treatment, 16 weeks
Other	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
Other	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
Other	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
Other	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
Other	Aberrant Behavior Checklist (ABC)	The ABC is a 58-item parent report behavior rating scale.	Change from Baseline to post-treatment, 16 weeks
Other	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
Other	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
Other	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
Other	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
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.	Change from Baseline to post-treatment, 16 weeks
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.	Change from Baseline to post-treatment, 16 weeks