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Oxytocin and Social Cognitive Skills Groups (ION-ASD)

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ClinicalTrials.gov Identifier: NCT02918864
Recruitment Status : Recruiting
First Posted : September 29, 2016
Last Update Posted : October 8, 2020
Sponsor:
Collaborators:
University of Illinois at Chicago
University of Chicago
Northwestern University
Eotvos Lorand University
Information provided by (Responsible Party):
Latha Soorya, Rush University Medical Center

Brief Summary:
The purpose of this study is to evaluate the feasibility, safety, and preliminary efficacy of integrating targeted dosing of intranasal oxytocin with a social cognitive skills group therapy for school-aged children with autism spectrum disorder (ASD).

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Drug: Oxytocin and social cognitive skills group Behavioral: Facilitated Play Therapy Phase 2

Detailed Description:
The study is a proof-of-concept, combination intervention designed to address individual treatment targets presumed to influence social learning in school-aged children with autism spectrum disorder (ASD). This proposal builds upon prior research on an empirically supported social cognitive skills training curriculum, NETT (Nonverbal communication, Emotion recognition, and Theory of mind Training). NETT is a cognitive-behavioral intervention (CBI) for nonverbal communication, emotion recognition, and theory of mind deficits in youth with ASD. In this two-phase, 3 year, single-blind, contact controlled study, school-aged children with ASD (n=60) will be randomized into a 12-session, parallel group design of Integrated Oxytocin and NETT (ION) or a control social group condition (facilitated play). The study aims to evaluate the safety, tolerability, and efficacy of integrating the neuropeptide, oxytocin (OT), with the social cognitive curriculum, as well as to identify targets of change and pre-treatment factors predictive of response to ION-ASD. Maintenance of treatment effects will also be assessed 1 month and 3 months post-treatment.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Integrated Oxytocin and Nonverbal, Emotion Recognition, and Theory of Mind Training for Children With Autism Spectrum Disorder
Actual Study Start Date : June 15, 2016
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Oxytocin

Arm Intervention/treatment
Experimental: ION-ASD
ION-ASD integrates targeted dosing of intranasal oxytocin and social cognitive skills group training curriculum, Seaver-NETT (Nonverbal communication, Emotion recognition, Theory of mind Training).
Drug: Oxytocin and social cognitive skills group
This is an integrated pharmacological-behavioral intervention targeting social cognitive skills for school-aged children with ASD. Four doses of intranasal oxytocin (24 IUs/dose) will be delivered each week before weekly homework and group therapy sessions. Social cognitive skills training utilize cognitive behavioral strategies such as problem identification, affective education, performance feedback, and weekly homework activities to target impairments in nonverbal synchrony, emotional expression, and interpretation of intent. The NETT curriculum is manualized and anchored in CBI strategies, such as problem identification, affective education, performance feedback, and weekly homework activities. Parent education sessions run concurrently with child groups to help facilitate generalization.

Active Comparator: Facilitated Play
The active comparison condition is a facilitated play therapy group.
Behavioral: Facilitated Play Therapy
The facilitated play therapy group is a manualized treatment designed to tailor play to the interests and abilities of group members. Therapists use general therapeutics strategies such as reflective functioning statements to foster communication with therapists as well as between peers. Standard educational practices for children with ASD such as visual supports, schedules, and short-directed statements are also used. The concurrent parent group is supportive in nature.




Primary Outcome Measures :
  1. Change from Baseline in Social Behavior Composite [ Time Frame: Week 12 (Endpoint) ]
    This domain will be measured by a composite score developed through a factor analysis of the following caregiver report measures: Children's Communication Checklist (CCC) and the Griffith Empathy Scale.

  2. Change from Baseline in Social Behavior Composite [ Time Frame: Week 16 (follow-up) ]
    This domain will be measured by a composite score developed through a factor analysis of the following caregiver report measures: Children's Communication Checklist (CCC) and the Griffith Empathy Scale.

  3. Change from Baseline in Social Behavior Composite [ Time Frame: Week 24 (follow-up) ]
    This domain will be measured by a composite score developed through a factor analysis of the following caregiver report measures: Children's Communication Checklist (CCC) and the Griffith Empathy Scale.

  4. Change from Baseline in Social Cognition Composite [ Time Frame: Week 12 (Endpoint) ]
    This domain will be measured by a composite score developed through a factor analysis of the following caregiver report measures: Reading Mind in the Eyes Test (RMET) and the Diagnostic Analysis of Nonverbal Accuracy-2 (DANVA2)

  5. Change from Baseline in Social Cognition Composite [ Time Frame: Week 16 (follow-up) ]
    This domain will be measured by a composite score developed through a factor analysis of the following caregiver report measures: Reading Mind in the Eyes Test (RMET) and the Diagnostic Analysis of Nonverbal Accuracy-2 (DANVA2)

  6. Change from Baseline in Social Cognition Composite [ Time Frame: Week 24 (follow-up) ]
    This domain will be measured by a composite score developed through a factor analysis of the following caregiver report measures: Reading Mind in the Eyes Test (RMET) and the Diagnostic Analysis of Nonverbal Accuracy-2 (DANVA2)


Secondary Outcome Measures :
  1. Change from Baseline in Global Functioning [ Time Frame: Week 12 (Endpoint) ]
    Global Functioning will be assessed using the Clinical Global Impressions-Improvement Scale. The CGI-I employs a seven point (1 = very much improved to 7 = very much worse) to determine the patient's improvement in response to treatment.

  2. Change from Baseline in Global Functioning [ Time Frame: Week 16 (follow-up) ]
    Global Functioning will be assessed using the Clinical Global Impressions-Improvement Scale. The CGI-I employs a seven point (1 = very much improved to 7 = very much worse) to determine the patient's improvement in response to treatment.

  3. Change from Baseline in Global Functioning [ Time Frame: Week 24 (follow-up) ]
    Global Functioning will be assessed using the Clinical Global Impressions-Improvement Scale. The CGI-I employs a seven point (1 = very much improved to 7 = very much worse) to determine the patient's improvement in response to treatment.

  4. Change from Baseline in Social Functioning [ Time Frame: Week 12 (Endpoint) ]
    Social Functioning will be assessed using the Social Responsiveness Scale

  5. Change from Baseline in Social Functioning [ Time Frame: Week 16 (follow-up) ]
    Social Functioning will be assessed using the Social Responsiveness Scale

  6. Change from Baseline in Social Functioning [ Time Frame: Week 24 (follow-up) ]
    Social Functioning will be assessed using the Social Responsiveness Scale

  7. Change from Baseline in Quality of Life [ Time Frame: Week 12 (Endpoint) ]
    Quality of Life will be assessed using the Caregiver Strain Questionnaire

  8. Change from Baseline in Quality of Life [ Time Frame: Week 16 (follow-up) ]
    Quality of Life will be assessed using the Caregiver Strain Questionnaire

  9. Change from Baseline in Quality of Life [ Time Frame: Week 24 (follow-up) ]
    Quality of Life will be assessed using the Caregiver Strain Questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  1. Male or female outpatients, 8-11 years of age inclusive
  2. Meet Diagnostic and Statistical Manual of Mental Disorders, 5th Edition for Autism Spectrum Disorder. DSM-V criteria will be established by a clinician with expertise with individuals with ASD. Best estimate Diagnosis will be reached using DSM-V criteria, the Autism Diagnostic Observation Schedule (ADOS-2) and the Autism Diagnostic Interview (ADI-R), or Autism Screening Interview.
  3. Mean score of 9 or less on mentalizing items of Strange Stories Test (Highest possible score = 12, items 21-25, 27).
  4. Have a Clinician's Global Impression-Severity (CGI-S) score ≥ 4 (moderately ill) at Baseline.
  5. Verbal and performance scale IQ ≥ 80 (both subtests of the WISC-V ≥ 70).
  6. If already receiving stable concomitant medications, have continuous participation during the preceding 30 days prior to Screening, and not electively initiate new or modify ongoing medications for the duration of the study. For serotonergic agents, 6 months on a stable dose is required.
  7. If already receiving stable non-pharmacologic educational, behavioral, and/or dietary interventions, have continuous participation during the preceding 3 months prior to Screening, and not electively initiate new or modify ongoing interventions for the duration of the study.
  8. Have normal physical examination and laboratory test results at Screening. If abnormal, the finding(s) must be deemed not clinically significant by the Treating Clinician.
  9. Ability to speak and understand English sufficiently to allow for the completion of all study assessments.
  10. Ability to obtain written assent from the participant as well as written informed consent from their parent(s)/legal guardian.

Exclusion Criteria

  1. Patients born prior to 35 weeks gestational age.
  2. Patients with a primary psychiatric diagnosis other than ASD.
  3. Patients with a medical history of neurological disease, including, but not limited to, epilepsy/seizure disorder (except simple febrile seizures), movement disorder, tuberous sclerosis, fragile X, and any other known genetic syndromes, or known abnormal brain MRI/structural lesion.
  4. Pregnant female patients, sexually active female patients on hormonal birth control and sexually active females who do not use at least two types of non-hormonal birth control.
  5. Patients with evidence or history of malignancy or any significant hematological, endocrine, cardiovascular (including any rhythm disorder), respiratory, renal, hepatic, or gastrointestinal disease.
  6. Patients with one or more of the following: hemophilia (bleeding problems, recent nose and brain injuries), abnormal blood pressure (hypotension or hypertension), drug abuse, immunity disorder or severe depression.
  7. Patients who are currently taking OXT or have taken IN-OXT in the past with no response.
  8. Patients who have an Aberrant Behavior Checklist (ABC) Irritability subscale score > 19 at screening
  9. Patients with sensitivity to OXT or any components of its formulation.
  10. Patients unable to tolerate venipuncture procedures for blood sampling.
  11. Patients in foster care for whom the state is defined as a legal guardian.
  12. If they have an arrhythmia present on ECG, that upon consultation with a cardiologist, is deemed to be clinically significant.
  13. Patients with any of the following clinical lab results

    1. ALT/AST levels of ≥ 5 times the upper limit of normal, or if clinical jaundice occurs
    2. Sodium levels of > 152 mmol/L or < 128 mmol/L
    3. Potassium levels of > 6 mmol/L in a non-hemolyzed sample
    4. Glucose levels of > 11 mmol/L or < 2.8 mmol/L
    5. Hemoglobin levels of < 100 g/L
    6. BUN levels of > 100 mmol/L
    7. Creatinine levels of > 100 µmol/L
    8. Osmolality levels of > 330 mmol/kg

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02918864


Contacts
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Contact: Sarely Licona, BS 312-942-6331 Sarely_Licona@rush.edu

Locations
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United States, Illinois
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Sarely Licona, BS    312-942-6331    Sarely_Licona@rush.edu   
Principal Investigator: Latha Soorya, PhD, BCBA         
Sub-Investigator: Mark Pollack, MD         
Sub-Investigator: Adrienne Adams, MD         
Sponsors and Collaborators
Rush University Medical Center
University of Illinois at Chicago
University of Chicago
Northwestern University
Eotvos Lorand University
Investigators
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Principal Investigator: Latha Soorya, PhD, BCBA Rush University Medical Center
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Responsible Party: Latha Soorya, Assistant Professor of Psychiatry, Rush University Medical Center
ClinicalTrials.gov Identifier: NCT02918864    
Other Study ID Numbers: 14062403
First Posted: September 29, 2016    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data from this study may be submitted to the National Database for Autism Research (NDAR), a computer system run by the National Institutes of Health that allows researchers studying autism to collect and share information. Data will be shared with study collaborators as well.
Keywords provided by Latha Soorya, Rush University Medical Center:
Autism Spectrum Disorder
Oxytocin
Social Skills
Social cognitive skills
Cognitive Behavioral Intervention
Combination treatment
Syntocinon
NETT (Nonverbal communication, Emotion recognition, Theory of mind Training)
emotion recognition
theory of mind
Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs