Parker 2017.

Study characteristics
Methods	4‐week parallel trial of oxytocin versus placebo
Participants	Inclusion criteria: children aged 6‐12 years met diagnostic criteria for ASD medically healthy outpatients IQ > 40 (as determined by the Stanford‐Binet Intelligence Scales, fifth edition) CGI‐S rating of ≥ 4 had a care provider who could reliably bring them to clinic visits, provide trustworthy ratings, and interact with the participant on a regular basis on stable medications for at least 4 weeks no planned changes in psychosocial interventions during the trial willing to provide blood samples Exclusion criteria: prior or current use of oxytocin DSM‐4‐TR or DSM‐5 diagnosis of schizophrenia, schizoaffective disorder, or psychotic disorder regular nasal obstruction or nosebleeds active medical problems (unstable seizures or significant physical illness e.g. serious liver, renal, or cardiac pathology) sensitivity to preservatives (e.g. chlorobutanol hemihydrate) evidence of a genetic mutation known to cause ASD (e.g., fragile X Syndrome) significant hearing or vision impairments habitual consumption of large volumes of water pregnant, breastfeeding, or childbirth within the last 6 months sexually active female participants not using a reliable method of contraception Location/setting: study was conducted in the Autism and Developmental Disabilities Clinic in the Division of Child and Adolescent Psychiatry at Stanford University, USA Sample size: 32 Number of withdrawals/dropouts: 2/16; 0/18 (1 LTFU, 1 withdrew) Gender: 27 male, 5 female Mean age: 6‐12 years IQ: approx 35‐90 Baseline ABC‐I or other BoC: baseline scores not reported Concomitant medications: participants were allowed to take concurrent psychotropic medications provided they do not interact with oxytocin, were on a stable dose before study entry and medication use did not differ between groups. History of previous medications: details not provided
Interventions	Intervention (oxytocin): twice‐daily each participant will have 3 puffs per nostril of 4 IU/puff (24 IU twice daily) for 4 weeks Comparator (placebo): placebo nasal spray 3 puffs per nostril of 4 IU/puff (24 IU twice daily) for 4 weeks
Outcomes	Primary outcomes: irritability, measured using the ABC‐I subscale (Aman 1985) AEs Secondary outcomes: tolerability Timing of outcome assessments: baseline, week 4 (endpoint)
Notes	Study start date: June 2012 Study end date: April 2016 Funding: "K.J.P. and A.Y.H. provided funding for the research" Conflicts of interest: "The authors declare no conflict of interest" Trial registry: NCT01624194
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"Randomization was performed by an IDS pharmacist using www.randomization.com, which allocates each participant to an intervention by using the method of randomly permuted blocks"
Allocation concealment (selection bias)	Low risk	"Randomization was performed by an IDS pharmacist using www.randomization.com, which allocates each participant to an intervention by using the method of randomly permuted blocks"
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Double‐blind. Quote: "the research team to remain blinded throughout the trial’s duration"
Blinding of outcome assessment (detection bias) All outcomes	Low risk	"This practice allowed the research team to remain blinded throughout the trial’s duration... A technician blinded to treatment condition performed sample preparation and OXT quantification following established procedures"
Incomplete outcome data (attrition bias) All outcomes	Low risk	All participants were accounted for.
Selective reporting (reporting bias)	High risk	Some outcomes from clinicaltrials.gov not reported in the peer‐reviewed paper
Other bias	Low risk	No other sources of bias identified