Carey 2002.
Study characteristics | ||
Methods | 48‐week cross‐over trial of secretin versus placebo | |
Participants | Inclusion criteria:
Exclusion criteria: not reported Location/setting: Developmental and Behavioral Pediatrics Division at the Medical College of Ohio, USA Sample size: 8 in total Number of withdrawals/dropouts: not reported Gender: 8 boys Mean age: 5 years IQ: "general developmental level based on parent report on the Child Development Inventory ranged from 16 to 39 months". Baseline ABC‐I or other BoC: ABC‐I secretin 24.5, placebo 15.5 Concurrent drug use: details not provided History of previous medications: details not provided |
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Interventions | Intervention (single dose of secretin): single dose of 2 IU of secretin/kg of body weight Comparator (single dose of placebo): equivalent single dose of placebo |
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Outcomes | Primary outcomes: irritability, measured using the ABC‐I subscale (Aman 1985); AEs Secondary outcomes: none reported Timing of outcome assessment: ABC‐I: prior to infusion and then weekly for 8 weeks |
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Notes | Study start date: not reported Study end date: not reported Funding source: not reported Conflicts of interest: none declared |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | All participants were randomised into 2 groups. |
Allocation concealment (selection bias) | Unclear risk | Details not provided |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Double‐blinded, however no further details provided |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Details not provided |
Incomplete outcome data (attrition bias) All outcomes | High risk | Complete parent and teacher data were obtained for 8 of the total 21 project participants. |
Selective reporting (reporting bias) | Unclear risk | Protocol was not provided so unclear if all outcomes were reported |
Other bias | High risk | Participants were recruited from a list of children whose parents contacted the Developmental and Behavioral Pediatrics Division at the Medical College of Ohio to request a trial of secretin for their child. |