Trial · Interventional

CompletedPhase 2Results postedRegistry data

Oxytocin and Social Cognitive Skills Groups

Short name ION-ASD

NCTNCT02918864Other id14062403

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 2
Enrollment: 40 participants (actual)
Sponsor: Rush University Medical Center · Other
Design: Randomized · Single masking
Countries: 1 country
United States
Start: 15 Jun 2016
Primary completion: Sept 2021
Completion: Sept 2021
First posted: 29 Sept 2016 (estimated)
Last update posted: 5 Apr 2024
Conditions: Autism Spectrum Disorder

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2016201720182019202020212022

Ph 2
ION-ASD
NCT02918864
15 Jun 2016 to Sept 2021

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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).

Interventions

OxytocinDrug
Social Cognitive Skills TrainingBehavioral
Facilitated Play TherapyBehavioral

Arms2

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).
Active comparator
Facilitated Play
The active comparison condition is a facilitated play therapy group.

Primary outcomes12

Outcomes the sponsor listed as primary.

Change From Baseline in Social Behavior Impairment (SBI) Composite
Time frame · Baseline and Week 12 (Endpoint)
Registry description
The change from baseline in SBI is represented by the slope of each group. The primary outcome is the difference between groups in this rate of change or the group\*time interaction. SBI is a composite score based on Soorya et al. (2015) which identified measures that comprise this metric. Scores from the Children's Communication Checklist-2 (CCC-2) Social Relations and Nonverbal Communication subscales and the Griffith Empathy Measure (GEM) were standardized as z-scores using the sample means and standard deviations at baseline. CCC-2 subscale scores and reversed GEM total scores were used so higher z-scores reflect more impairment across measures. The SBI outcome was subsequently derived by averaging the z-scores. At baseline, the sample average SBI z-score equals 0; higher individual scores indicate relatively more impairment in social behavior skills. Larger, negative slopes represent improvement.
Rate of Change From Baseline in Social Behavior Impairment (SBI) Composite
Time frame · Baseline and Week 12 (Endpoint)
Registry description
The change from baseline in SBI is represented by the slope of each group. The primary outcome is the difference between groups in this rate of change or the group\*time interaction. SBI is a composite score based on Soorya et al. (2015) which identified measures that comprise this metric. Scores from the Children's Communication Checklist-2 (CCC-2) Social Relations and Nonverbal Communication subscales and the Griffith Empathy Measure (GEM) were standardized as z-scores using the sample means and standard deviations at baseline. CCC-2 subscale scores and reversed GEM total scores were used so higher z-scores reflect more impairment across measures. The SBI outcome was subsequently derived by averaging the z-scores. At baseline, the sample average SBI z-score equals 0; higher individual scores indicate relatively more impairment in social behavior skills. Larger, negative slopes represent improvement.
Change From Baseline in Social Behavior Impairment (SBI) Composite
Time frame · Baseline and Week 16 (1-month follow-up)
Registry description
The change from baseline in SBI is represented by the slope of each group. The primary outcome is the difference between groups in this rate of change or the group\*time interaction. SBI is a composite score based on Soorya et al. (2015) which identified measures that comprise this metric. Scores from the Children's Communication Checklist-2 (CCC-2) Social Relations and Nonverbal Communication subscales and the Griffith Empathy Measure (GEM) were standardized as z-scores using the sample means and standard deviations at baseline. CCC-2 subscale scores and reversed GEM total scores were used so higher z-scores reflect more impairment across measures. The SBI outcome was subsequently derived by averaging the z-scores. At baseline, the sample average SBI z-score equals 0; higher individual scores indicate relatively more impairment in social behavior skills. Larger, negative slopes represent improvement.
Rate of Change From Baseline in Social Behavior Impairment (SBI) Composite
Time frame · Baseline and Week 16 (1-month follow-up)
Registry description
The change from baseline in SBI is represented by the slope of each group. The primary outcome is the difference between groups in this rate of change or the group\*time interaction. SBI is a composite score based on Soorya et al. (2015) which identified measures that comprise this metric. Scores from the Children's Communication Checklist-2 (CCC-2) Social Relations and Nonverbal Communication subscales and the Griffith Empathy Measure (GEM) were standardized as z-scores using the sample means and standard deviations at baseline. CCC-2 subscale scores and reversed GEM total scores were used so higher z-scores reflect more impairment across measures. The SBI outcome was subsequently derived by averaging the z-scores. At baseline, the sample average SBI z-score equals 0; higher individual scores indicate relatively more impairment in social behavior skills. Larger, negative slopes represent improvement.
Change From Baseline in Social Behavior Impairment (SBI) Composite
Time frame · Baseline and Week 24 (3-month follow-up)
Registry description
The change from baseline in SBI is represented by the slope of each group. The primary outcome is the difference between groups in this rate of change or the group\*time interaction. SBI is a composite score based on Soorya et al. (2015) which identified measures that comprise this metric. Scores from the Children's Communication Checklist-2 (CCC-2) Social Relations and Nonverbal Communication subscales and the Griffith Empathy Measure (GEM) were standardized as z-scores using the sample means and standard deviations at baseline. CCC-2 subscale scores and reversed GEM total scores were used so higher z-scores reflect more impairment across measures. The SBI outcome was subsequently derived by averaging the z-scores. At baseline, the sample average SBI z-score equals 0; higher individual scores indicate relatively more impairment in social behavior skills. Larger, negative slopes represent improvement.
Rate of Change From Baseline in Social Behavior Impairment (SBI) Composite
Time frame · Baseline and Week 24 (3-month follow-up)
Registry description
The change from baseline in SBI is represented by the slope of each group. The primary outcome is the difference between groups in this rate of change or the group\*time interaction. SBI is a composite score based on Soorya et al. (2015) which identified measures that comprise this metric. Scores from the Children's Communication Checklist-2 (CCC-2) Social Relations and Nonverbal Communication subscales and the Griffith Empathy Measure (GEM) were standardized as z-scores using the sample means and standard deviations at baseline. CCC-2 subscale scores and reversed GEM total scores were used so higher z-scores reflect more impairment across measures. The SBI outcome was subsequently derived by averaging the z-scores. At baseline, the sample average SBI z-score equals 0; higher individual scores indicate relatively more impairment in social behavior skills. Larger, negative slopes represent improvement.
Change From Baseline in Social Cognition (SC) Composite
Time frame · Baseline and Week 12 (Endpoint)
Registry description
The change from baseline in SC is represented by the slope of each group. The primary outcome is the difference between groups in this rate of change or the group\*time interaction. SC is a composite score, including the Reading the Mind in the Eyes Test (RMET) and the Diagnostic Analysis of Nonverbal Accuracy-2 (DANVA2), based on Soorya et al. (2015). RMET has 28 items rated correct/incorrect (total 0-28). DANVA2 contains 4 sets of 24 items rated correct/incorrect (total 0-96). Percent correct was calculated for each measure given the difference in denominators and to allow for administrative omissions. Percentages were standardized as z-scores using the sample means and standard deviations at baseline. The SC outcome was subsequently derived by averaging the z-scores. At baseline, the sample average SC z-score equals 0; higher individual scores reflect stronger skills on social cognitive tasks compared to lower scores. Larger, positive slopes indicate skill improvement.
Rate of Change From Baseline in Social Cognition (SC) Composite
Time frame · Baseline and Week 12 (Endpoint)
Registry description
The change from baseline in SC is represented by the slope of each group. The primary outcome is the difference between groups in this rate of change or the group\*time interaction. SC is a composite score, including the Reading the Mind in the Eyes Test (RMET) and the Diagnostic Analysis of Nonverbal Accuracy-2 (DANVA2), based on Soorya et al. (2015). RMET has 28 items rated correct/incorrect (total 0-28). DANVA2 contains 4 sets of 24 items rated correct/incorrect (total 0-96). Percent correct was calculated for each measure given the difference in denominators and to allow for administrative omissions. Percentages were standardized as z-scores using the sample means and standard deviations at baseline. The SC outcome was subsequently derived by averaging the z-scores. At baseline, the sample average SC z-score equals 0; higher individual scores reflect stronger skills on social cognitive tasks compared to lower scores. Larger, positive slopes indicate skill improvement.
Change From Baseline in Social Cognition (SC) Composite
Time frame · Baseline and Week 16 (1-month follow-up)
Registry description
The change from baseline in SC is represented by the slope of each group. The primary outcome is the difference between groups in this rate of change or the group\*time interaction. SC is a composite score, including the Reading the Mind in the Eyes Test (RMET) and the Diagnostic Analysis of Nonverbal Accuracy-2 (DANVA2), based on Soorya et al. (2015). RMET has 28 items rated correct/incorrect (total 0-28). DANVA2 contains 4 sets of 24 items rated correct/incorrect (total 0-96). Percent correct was calculated for each measure given the difference in denominators and to allow for administrative omissions. Percentages were standardized as z-scores using the sample means and standard deviations at baseline. The SC outcome was subsequently derived by averaging the z-scores. At baseline, the sample average SC z-score equals 0; higher individual scores reflect stronger skills on social cognitive tasks compared to lower scores. Larger, positive slopes indicate skill improvement.
Rate of Change From Baseline in Social Cognition (SC) Composite
Time frame · Baseline and Week 16 (1-month follow-up)
Registry description
The change from baseline in SC is represented by the slope of each group. The primary outcome is the difference between groups in this rate of change or the group\*time interaction. SC is a composite score, including the Reading the Mind in the Eyes Test (RMET) and the Diagnostic Analysis of Nonverbal Accuracy-2 (DANVA2), based on Soorya et al. (2015). RMET has 28 items rated correct/incorrect (total 0-28). DANVA2 contains 4 sets of 24 items rated correct/incorrect (total 0-96). Percent correct was calculated for each measure given the difference in denominators and to allow for administrative omissions. Percentages were standardized as z-scores using the sample means and standard deviations at baseline. The SC outcome was subsequently derived by averaging the z-scores. At baseline, the sample average SC z-score equals 0; higher individual scores reflect stronger skills on social cognitive tasks compared to lower scores. Larger, positive slopes indicate skill improvement.
Change From Baseline in Social Cognition (SC) Composite
Time frame · Baseline and Week 24 (3-month follow-up)
Registry description
The change from baseline in SC is represented by the slope of each group. The primary outcome is the difference between groups in this rate of change or the group\*time interaction. SC is a composite score, including the Reading the Mind in the Eyes Test (RMET) and the Diagnostic Analysis of Nonverbal Accuracy-2 (DANVA2), based on Soorya et al. (2015). RMET has 28 items rated correct/incorrect (total 0-28). DANVA2 contains 4 sets of 24 items rated correct/incorrect (total 0-96). Percent correct was calculated for each measure given the difference in denominators and to allow for administrative omissions. Percentages were standardized as z-scores using the sample means and standard deviations at baseline. The SC outcome was subsequently derived by averaging the z-scores. At baseline, the sample average SC z-score equals 0; higher individual scores reflect stronger skills on social cognitive tasks compared to lower scores. Larger, positive slopes indicate skill improvement.
Rate of Change From Baseline in Social Cognition (SC) Composite
Time frame · Baseline and Week 24 (3-month follow-up)
Registry description
The change from baseline in SC is represented by the slope of each group. The primary outcome is the difference between groups in this rate of change or the group\*time interaction. SC is a composite score, including the Reading the Mind in the Eyes Test (RMET) and the Diagnostic Analysis of Nonverbal Accuracy-2 (DANVA2), based on Soorya et al. (2015). RMET has 28 items rated correct/incorrect (total 0-28). DANVA2 contains 4 sets of 24 items rated correct/incorrect (total 0-96). Percent correct was calculated for each measure given the difference in denominators and to allow for administrative omissions. Percentages were standardized as z-scores using the sample means and standard deviations at baseline. The SC outcome was subsequently derived by averaging the z-scores. At baseline, the sample average SC z-score equals 0; higher individual scores reflect stronger skills on social cognitive tasks compared to lower scores. Larger, positive slopes indicate skill improvement.

Secondary outcomes(15)

Number of Responder and Non-responder Participants Based on CGI-I Scores at Week 12 (Endpoint)
Time frame · Week 12 (Endpoint)
Registry description
Global Functioning will be assessed using the Clinical Global Impressions-Improvement (CGI-I) Scale. A study physician followed standard CGI protocols to evaluate global improvement at each time point based on all available sources of information (e.g., caregiver interviews, behavior rating forms). The CGI-I employs a 7-point scale with the lowest score, 1, indicating the best outcome and the highest score, 7, indicating the worst outcome. Participants receiving scores of 1 (very much improved) or 2 (much improved) were considered responders. Participants receiving scores of 5 (minimally worse), 6 (much worse), or 7 (very much worse) were considered non-responders; note, no participant received a score worse than 5 which was used as the cut-off for non-responders. Participants receiving scores of 3 (minimally improved) or 4 (no change) were considered to show no significant change and omitted from the analysis.
Number of Responder and Non-responder Participants Based on CGI-I Scores at Week 16 (1-month Follow-up)
Time frame · Week 16 (1-month follow-up)
Registry description
Global Functioning will be assessed using the Clinical Global Impressions-Improvement (CGI-I) Scale. A study physician followed standard CGI protocols to evaluate global improvement at each time point based on all available sources of information (e.g., caregiver interviews, behavior rating forms). The CGI-I employs a 7-point scale with the lowest score, 1, indicating the best outcome and the highest score, 7, indicating the worst outcome. Participants receiving scores of 1 (very much improved) or 2 (much improved) were considered responders. Participants receiving scores of 5 (minimally worse), 6 (much worse), or 7 (very much worse) were considered non-responders; note, no participant received a score worse than 5 which was used as the cut-off for non-responders. Participants receiving scores of 3 (minimally improved) or 4 (no change) were considered to show no significant change and omitted from the analysis.
Number of Responder and Non-responder Participants Based on CGI-I Scores at Week 24 (3-month Follow-up)
Time frame · Week 24 (3-month follow-up)
Registry description
Global Functioning will be assessed using the Clinical Global Impressions-Improvement (CGI-I) Scale. A study physician followed standard CGI protocols to evaluate global improvement at each time point based on all available sources of information (e.g., caregiver interviews, behavior rating forms). The CGI-I employs a 7-point scale with the lowest score, 1, indicating the best outcome and the highest score, 7, indicating the worst outcome. Participants receiving scores of 1 (very much improved) or 2 (much improved) were considered responders. Participants receiving scores of 5 (minimally worse), 6 (much worse), or 7 (very much worse) were considered non-responders; note, no participant received a score worse than 5 which was used as the cut-off for non-responders . Participants receiving scores of 3 (minimally improved) or 4 (no change) were considered to show no significant change and omitted from the analysis.
Change From Baseline in Social Functioning (SRS-2)
Time frame · Baseline and Week 12 (Endpoint)
Registry description
The change from baseline in the Social Responsiveness Scale (SRS-2) is represented by the slope of each group. The primary outcome is the difference between groups in this rate of change or the group\*time interaction. The SRS-2 is a caregiver reported measure of social behavior in the general population (3-18 yo) used to assess social functioning. The SRS-2 contains 65 items rated on a 4-point scale (1/not true to 4/almost always true). Scores are recoded 0-3 and totaled for a raw score. Raw scores are converted to T-scores based on age and sex. T-scores have a population mean of 50 with a standard deviation of 10. T-scores 60-65 indicate mild social impairment, 66-75 moderate deficits, and above 76 severe deficits strongly associated with autism. Higher SRS-2 T-scores indicate greater severity of social impairment. Larger, negative slopes reflect a greater reduction in severity.
Rate of Change From Baseline in Social Functioning (SRS-2)
Time frame · Baseline and Week 12 (Endpoint)
Registry description
The change from baseline in the Social Responsiveness Scale (SRS-2) is represented by the slope of each group. The primary outcome is the difference between groups in this rate of change or the group\*time interaction. The SRS-2 is a caregiver reported measure of social behavior in the general population (3-18 yo) used to assess social functioning. The SRS-2 contains 65 items rated on a 4-point scale (1/not true to 4/almost always true). Scores are recoded 0-3 and totaled for a raw score. Raw scores are converted to T-scores based on age and sex. T-scores have a population mean of 50 with a standard deviation of 10. T-scores 60-65 indicate mild social impairment, 66-75 moderate deficits, and above 76 severe deficits strongly associated with autism. Higher SRS-2 T-scores indicate greater severity of social impairment. Larger, negative slopes reflect a greater reduction in severity.
Change From Baseline in Social Functioning (SRS-2)
Time frame · Baseline and Week 16 (1-month follow-up)
Registry description
The change from baseline in the Social Responsiveness Scale (SRS-2) is represented by the slope of each group. The primary outcome is the difference between groups in this rate of change or the group\*time interaction. The SRS-2 is a caregiver reported measure of social behavior in the general population (3-18 yo) used to assess social functioning. The SRS-2 contains 65 items rated on a 4-point scale (1/not true to 4/almost always true). Scores are recoded 0-3 and totaled for a raw score. Raw scores are converted to T-scores based on age and sex. T-scores have a population mean of 50 with a standard deviation of 10. T-scores 60-65 indicate mild social impairment, 66-75 moderate deficits, and above 76 severe deficits strongly associated with autism. Higher SRS-2 T-scores indicate greater severity of social impairment. Larger, negative slopes reflect a greater reduction in severity.
Rate of Change From Baseline in Social Functioning (SRS-2)
Time frame · Baseline and Week 16 (1-month follow-up)
Registry description
The change from baseline in the Social Responsiveness Scale (SRS-2) is represented by the slope of each group. The primary outcome is the difference between groups in this rate of change or the group\*time interaction. The SRS-2 is a caregiver reported measure of social behavior in the general population (3-18 yo) used to assess social functioning. The SRS-2 contains 65 items rated on a 4-point scale (1/not true to 4/almost always true). Scores are recoded 0-3 and totaled for a raw score. Raw scores are converted to T-scores based on age and sex. T-scores have a population mean of 50 with a standard deviation of 10. T-scores 60-65 indicate mild social impairment, 66-75 moderate deficits, and above 76 severe deficits strongly associated with autism. Higher SRS-2 T-scores indicate greater severity of social impairment. Larger, negative slopes reflect a greater reduction in severity.
Change From Baseline in Social Functioning (SRS-2)
Time frame · Baseline and Week 24 (3-month follow-up)
Registry description
The change from baseline in the Social Responsiveness Scale (SRS-2) is represented by the slope of each group. The primary outcome is the difference between groups in this rate of change or the group\*time interaction. The SRS-2 is a caregiver reported measure of social behavior in the general population (3-18 yo) used to assess social functioning. The SRS-2 contains 65 items rated on a 4-point scale (1/not true to 4/almost always true). Scores are recoded 0-3 and totaled for a raw score. Raw scores are converted to T-scores based on age and sex. T-scores have a population mean of 50 with a standard deviation of 10. T-scores 60-65 indicate mild social impairment, 66-75 moderate deficits, and above 76 severe deficits strongly associated with autism. Higher SRS-2 T-scores indicate greater severity of social impairment. Larger, negative slopes reflect a greater reduction in severity.
Rate of Change From Baseline in Social Functioning (SRS-2)
Time frame · Baseline and Week 24 (3-month follow-up)
Registry description
The change from baseline in the Social Responsiveness Scale (SRS-2) is represented by the slope of each group. The primary outcome is the difference between groups in this rate of change or the group\*time interaction. The SRS-2 is a caregiver reported measure of social behavior in the general population (3-18 yo) used to assess social functioning. The SRS-2 contains 65 items rated on a 4-point scale (1/not true to 4/almost always true). Scores are recoded 0-3 and totaled for a raw score. Raw scores are converted to T-scores based on age and sex. T-scores have a population mean of 50 with a standard deviation of 10. T-scores 60-65 indicate mild social impairment, 66-75 moderate deficits, and above 76 severe deficits strongly associated with autism. Higher SRS-2 T-scores indicate greater severity of social impairment. Larger, negative slopes reflect a greater reduction in severity.
Change From Baseline in Quality of Life (CGSQ)
Time frame · Baseline and Week 12 (Endpoint)
Registry description
The change from baseline in the Caregiver Strain Questionnaire (CGSQ) is represented by the slope of each group. The primary outcome is the difference between groups in this rate of change or the group\*time interaction. The CGSQ was used to assess quality of life. The CGSQ is a parent-rated questionnaire designed for parents of children and adolescents with emotional and behavioral disorders. It includes 21 items rated on a 5-point problem scale (1 = not at all to 5 = very much) rating subjective internal, subjective external, and objective strain. A global measure of strain can be calculated by averaging the scores together. Higher CGSQ scores indicate greater strain. Larger, negative slopes reflect a greater reduction in strain (i.e., improvement in score).
Rate of Change From Baseline in Quality of Life (CGSQ)
Time frame · Baseline and Week 12 (Endpoint)
Registry description
The change from baseline in the Caregiver Strain Questionnaire (CGSQ) is represented by the slope of each group. The primary outcome is the difference between groups in this rate of change or the group\*time interaction. The CGSQ was used to assess quality of life. The CGSQ is a parent-rated questionnaire designed for parents of children and adolescents with emotional and behavioral disorders. It includes 21 items rated on a 5-point problem scale (1 = not at all to 5 = very much) rating subjective internal, subjective external, and objective strain. A global measure of strain can be calculated by averaging the scores together. Higher CGSQ scores indicate greater strain. Larger, negative slopes reflect a greater reduction in strain (i.e., improvement in score).
Change From Baseline in Quality of Life (CGSQ)
Time frame · Baseline and Week 16 (1-month follow-up)
Registry description
The change from baseline in the Caregiver Strain Questionnaire (CGSQ) is represented by the slope of each group. The primary outcome is the difference between groups in this rate of change or the group\*time interaction. The CGSQ was used to assess quality of life. The CGSQ is a parent-rated questionnaire designed for parents of children and adolescents with emotional and behavioral disorders. It includes 21 items rated on a 5-point problem scale (1 = not at all to 5 = very much) rating subjective internal, subjective external, and objective strain. A global measure of strain can be calculated by averaging the scores together. Higher CGSQ scores indicate greater strain. Larger, negative slopes reflect a greater reduction in strain (i.e., improvement in score).
Rate of Change From Baseline in Quality of Life (CGSQ)
Time frame · Baseline and Week 16 (1-month follow-up)
Registry description
The change from baseline in the Caregiver Strain Questionnaire (CGSQ) is represented by the slope of each group. The primary outcome is the difference between groups in this rate of change or the group\*time interaction. The CGSQ was used to assess quality of life. The CGSQ is a parent-rated questionnaire designed for parents of children and adolescents with emotional and behavioral disorders. It includes 21 items rated on a 5-point problem scale (1 = not at all to 5 = very much) rating subjective internal, subjective external, and objective strain. A global measure of strain can be calculated by averaging the scores together. Higher CGSQ scores indicate greater strain. Larger, negative slopes reflect a greater reduction in strain (i.e., improvement in score).
Change From Baseline in Quality of Life (CGSQ)
Time frame · Baseline and Week 24 (3-month follow-up)
Registry description
The change from baseline in the Caregiver Strain Questionnaire (CGSQ) is represented by the slope of each group. The primary outcome is the difference between groups in this rate of change or the group\*time interaction. The CGSQ was used to assess quality of life. The CGSQ is a parent-rated questionnaire designed for parents of children and adolescents with emotional and behavioral disorders. It includes 21 items rated on a 5-point problem scale (1 = not at all to 5 = very much) rating subjective internal, subjective external, and objective strain. A global measure of strain can be calculated by averaging the scores together. Higher CGSQ scores indicate greater strain. Larger, negative slopes reflect a greater reduction in strain (i.e., improvement in score).
Rate of Change From Baseline in Quality of Life (CGSQ)
Time frame · Baseline and Week 24 (3-month follow-up)
Registry description
The change from baseline in the Caregiver Strain Questionnaire (CGSQ) is represented by the slope of each group. The primary outcome is the difference between groups in this rate of change or the group\*time interaction. The CGSQ was used to assess quality of life. The CGSQ is a parent-rated questionnaire designed for parents of children and adolescents with emotional and behavioral disorders. It includes 21 items rated on a 5-point problem scale (1 = not at all to 5 = very much) rating subjective internal, subjective external, and objective strain. A global measure of strain can be calculated by averaging the scores together. Higher CGSQ scores indicate greater strain. Larger, negative slopes reflect a greater reduction in strain (i.e., improvement in score).

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Baseline and Week 12 (Endpoint)

Change From Baseline in Social Behavior Impairment (SBI) Composite

Group	Value (z-score)	Spread
ION-ASD	0.12	0.14
Facilitated Play	-0.14	0.14

Primary outcomeMean· Baseline and Week 12 (Endpoint)

Rate of Change From Baseline in Social Behavior Impairment (SBI) Composite

Group	Value (scores/week)	Spread
ION-ASD	-0.03	0.01
Facilitated Play	0.00	0.01

Primary outcomeMean· Baseline and Week 16 (1-month follow-up)

Change From Baseline in Social Behavior Impairment (SBI) Composite

Group	Value (z-score)	Spread
ION-ASD	0.11	0.13
Facilitated Play	-0.14	0.14

Primary outcomeMean· Baseline and Week 16 (1-month follow-up)

Rate of Change From Baseline in Social Behavior Impairment (SBI) Composite

Group	Value (scores/week)	Spread
ION-ASD	-0.03	0.01
Facilitated Play	0.00	0.01

Primary outcomeMean· Baseline and Week 24 (3-month follow-up)

Change From Baseline in Social Behavior Impairment (SBI) Composite

Group	Value (z-score)	Spread
ION-ASD	0.04	0.14
Facilitated Play	-0.16	0.14

Primary outcomeMean· Baseline and Week 24 (3-month follow-up)

Rate of Change From Baseline in Social Behavior Impairment (SBI) Composite

Group	Value (scores/week)	Spread
ION-ASD	-0.01	0.01
Facilitated Play	0.00	0.00

Primary outcomeMean· Baseline and Week 12 (Endpoint)

Change From Baseline in Social Cognition (SC) Composite

Group	Value (z-score)	Spread
ION-ASD	0.06	0.18
Facilitated Play	-0.08	0.18

Primary outcomeMean· Baseline and Week 12 (Endpoint)

Rate of Change From Baseline in Social Cognition (SC) Composite

Group	Value (scores/week)	Spread
ION-ASD	0.03	0.01
Facilitated Play	0.02	0.01

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
ION-ASDION-ASD integrates targeted dosing of intranasal oxytocin and social cognitive skills group training curriculum, Seaver-NETT (Nonverbal communication, Emotion recognition, Theory of mind Training). Oxytocin: 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: 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.	0 / 20	0 / 20	20 / 20
Facilitated PlayThe active comparison condition is a facilitated play therapy group. 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.	0 / 20	1 / 20	20 / 20

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

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Eligibility

Who could join, as posted.

Sex: All
Age: from 8 Years up to 11 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria 1. Male or female outpatients, 8-11 years of age inclusive 2. Meet Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) 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-5 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 intelligence quotient (IQ) ≥ 80 (both subtests of the Wechsler Intelligence Scale for Children-V (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 oxytocin (OXT) or have taken intranasal oxytocin (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. Alanine transaminase (ALT) or aspartate transaminase (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. Blood urea nitrogen (BUN) levels of \> 100 mmol/L 7. Creatinine levels of \> 100 µmol/L 8. Osmolality levels of \> 330 mmol/kg

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