Robins 2005.
Methods | RCT with usual care control Follow‐up: postintervention (3 months), 6 months' and 12 months' follow‐up |
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Participants |
Location: USA Setting: recruited from paediatric gastroenterology clinics Sample size: 86 children (46 intervention, 40 control) Sex: 30 boys, 39 girls (data reported for completers only) Dropouts/withdrawals: 11 control Diagnosis: RAP diagnosed using Apley criteria (Apley 1958) Mean age: intervention: 10.8 (SD 2.5; range not reported) years; control: 11.9 (SD 2.3; range not reported) years. Overall range for both groups: 6 to 16 years |
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Interventions |
Intervention: cognitive behavioural therapy, for child and parent (non‐group format), 40 minutes x 5, every 2 weeks, as well as usual medical care Control: usual medical care (usual individualised care including visits with physicians and advice on diet) |
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Outcomes |
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Notes |
Study dates: August 1998 to April 2000 Funding: grant from the Nemours Research Programs Declarations of Interest: not reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Comment: coin flip status, with a witness, but procedure unclear |
Allocation concealment (selection bias) | Unclear risk | Comment: no details provided of how coin flip was managed, or whether done in advance |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: only clinicians delivering usual medical care were blinded |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Comment: self report outcomes and participants aware of intervention |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Comment: clear numbers at follow‐up not reported |
Selective reporting (reporting bias) | Low risk | Comment: all outcomes reported |
Other bias | Unclear risk | Comment: issues relate to differences at baseline, sufficient numbers not recruited, larger loss to follow‐up than expected, and merged results |