An analysis of blinding success in a randomised controlled trial of fish oil omega-3 fatty acids

<p><b>INTRODUCTION</b>Incidental reports collected in clinical trials suggest that amongst participants, omega-3 fatty acids derived from fish oil ('omega-3') may be difficult to blind.</p><p><b>MATERIALS AND METHODS</b>We conducted a systematic evaluation of blinding success in a 24-week trial of omega-3 versus an oil-based placebo. Within 1 week of supplement commencement (Week 1), a blinding questionnaire was completed by 131 children enrolled in a trial of omega-3 for the treatment of disruptive behaviour disorders. A version of the questionnaire was also completed by their parents at Week 1, and by the children at the end of supplement administration (Week 24).</p><p><b>RESULTS</b>Participants were unable to differentiate omega-3 from placebo, and accuracy did not improve as a function of: the confidence of guesses, reason for guesses, notice of any change, beliefs about what should change, or time. Child and parent guesses also showed high concordance.</p><p><b>CONCLUSION</b>Taken together, these data provide strong evidence that the identity of omega-3 can be blinded to participants.</p>

Effects of CBT on children with disruptive behaviour disorders: findings from a Singapore study

Objective: The study examines the effectiveness of a CBT treatment programme over and above that of Treatment As Usual (TAU), with children who were referred to an outpatient child psychiatric clinic for disruptive behaviour disorders in Singapore. Methods: One hundred and three children aged 8 to 12 (mean±SD=10.22±1.31) who participated in the study were assigned to either the CBT+TAU (n= 51) or TAU group (n=52). Children in both the CBT+TAU and TAU groups received a standard and typical service offered to children at the outpatient child psychiatric clinic. In addition, children in the CBT+TAU group attended the CBT treatment programme that consisted of nine 1.5 hour weekly sessions. Results: Findings from ANCOVA indicated that children in the CBT+TAU treatment group showed significantly lower levels of aggression and significantly lower levels of parental stress at posttreatment and at 3-month follow-up in comparison to the TAU group. Conclusions: Findings from the present study provided some evidence of the effects of CBT in reducing aggressive behaviour and parental stress among children with disruptive behaviour disorders. Interpretation of the findings, recommendations for future research, and implications of the present study were presented.