Safren 2005.
Methods | Randomised controlled trial | |
Participants |
Country: USA Setting: ambulatory Age: adults (18‐65 years old) Sample size: 31 Sex: 17 women, 14 men Inclusion criteria: have had a principal diagnosis of Attention‐Deficit Hyperactivity Disorder with external validation of childhood onset and clinical severity of at least a moderate level (Clinical Global Impression; CGI of 4 or above); have been able to give informed consent and comply with study procedures; and have been stabilised on medications for ADHD or related symptoms. Stabilisation on medications was defined as no more than 10% change in medication dose over a 2‐month period with clinical evidence of improvement compared to the patients' unmedicated status. Exclusion criteria: moderate to severe major depression; clinically significant panic disorder; organic mental disorders, psychotic spectrum disorders, bipolar disorders, active substance abuse or dependence (past three months), pervasive developmental disorder; active suicidal ideation; history of cognitive‐behavioral therapy (CBT); estimated or documented verbal intelligence quotient (IQ) of less than 90 |
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Interventions |
Intervention: CBT (12‐15 weekly sessions) + continued psychopharmacology (n = 16) Control: continued psychopharmacology alone (n = 15) Dosage, timing of dosage and administration of pharmacotherapy were not specified. |
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Outcomes |
Primary outcome
Secondary outcomes
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Notes | We contacted authors to get the information about random sequence generation and allocation concealment that we included in this table (Safren 2014 [pers comm]) Study start date: September 2001 Study end date: August 2003 Funding source: this study was supported by grant NIMH 60940 (Steven A Safren, PhD). Declarations of interest: not reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Comment: the study authors created a randomisation table in blocks of 2, stratified by severity (CGI scale) and sex. After the person was assessed and the team agreed that they met the inclusion/criteria, they were randomised based on the table. |
Allocation concealment (selection bias) | Low risk | Comment: the interventionist was blinded to randomisation until the team had met and it was deemed that the person met criteria. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: it is not possible to blind personnel in a psychosocial intervention. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "The baseline and outcome assessments consisted of a clinician‐administered interview by an evaluator who was blind to treatment condition, and a battery of self‐report measures". |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: no dropouts |
Selective reporting (reporting bias) | Low risk | Comment: the study protocol is not available, but it is clear that the published reports include all expected outcomes, including those that were prespecified. |
Other bias | Low risk | Comment: there was no evidence of other bias. |
Conflict of interest | Low risk | Comment: no evidence of conflicts of interest. |