Parker 2019.
Study characteristics | ||
Methods | 4‐week trial of vasopressin versus placebo | |
Participants | Inclusion criteria:
Exclusion criteria:
Location/setting: autism disorders clinic, USA Sample size: 30 Number of withdrawals/dropouts: none reported Gender: 25 male, 5 female Mean age: 6‐12.9 years of age (outpatients) IQ: approximately 77‐98 Baseline ABC‐I or other BoC: baseline ABC‐I 8.29 (7.4); baseline QoL 64.53 (13.86) Concomitant medications: details not provided History of previous medications: details not provided |
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Interventions | Intervention (vasopressin nasal spray): 4 IU twice daily of vasopressin during week 1 and 8 IU twice daily of vasopressin during week 2. Participants aged 6‐9.5 years then received 12 IU twice daily of vasopressin during weeks 3 and 4, whereas participants aged 9.6‐12.9 years received 16 IU twice daily of vasopressin during weeks 3 and 4. Comparator (placebo nasal spray): matching placebo for 4 weeks |
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Outcomes | Primary outcomes:
Secondary outcomes:
Timing of outcome assessments: ABC‐I and QoL were measured at baseline and week 4 (endpoint). Participants underwent weekly safety/tolerability assessments in the clinic to monitor for AEs. |
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Notes | Study start date: December 2013 Study end date: May 2017 Funding: various grants to the researchers Conflicts of interest: financial compensation by pharmaceutical companies and other involvement with pharmaceutical companies Trial registry: NCT01962870 |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomisation was performed by an unblinded investigator using a machine‐generated treatment schedule, which allocated each participant to an intervention. |
Allocation concealment (selection bias) | Unclear risk | Details not provided |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Research team, parents/legal guardians, and child participants remained blind throughout the trial's duration. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Research team, parents/legal guardians, and child participants remained blind throughout the trial's duration. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | There were no dropouts reported and all were included in the analysis. |
Selective reporting (reporting bias) | High risk | PedsQL and ABC not reported in peer‐reviewed paper. The Overt Aggression Scale was mentioned as an outcome but not reported. |
Other bias | Low risk | No other sources identified |