Solanto 2010.
Methods | Randomised controlled trial | |
Participants |
Country: USA Setting: ambulatory Age: adults (18‐65 years old) Sample size: 88 Sex: 58 women, 30 men Inclusion criteria: DSM‐IV diagnosis of ADHD, predominantly inattentive or combined subtype; stabilised on a given drug for at least 2 months and on a given dose for at least 1 month Exclusion criteria: active substance abuse or dependence; suicidal ideation; overtly hostile or aggressive behaviour likely to alienate group members; 'asocial' characteristics (e.g. pervasive developmental disorder); cognitive disability (estimated intelligence quotient (IQ) < 80); psychosis; borderline personality disorder; Alzheimer's disease or other dementia; overt neurological disorder; and childhood history of abuse or trauma or other severe psychiatric condition that confounded ascertainment of childhood ADHD symptoms. |
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Interventions |
Intervention: meta‐cognitive therapy (12‐week manualised meta‐cognitive therapy group intervention; 2‐h sessions) (n = 45; 19 participants with pharmacotherapy and 26 without pharmacotherapy) Control: supportive therapy (12 weeks; 2‐h sessions) (n = 43; 20 participants with pharmacotherapy and 23 without pharmacotherapy) 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 (Solanto 2014 [pers comm]) Study start date: May 2005 Study end date: October 2008 Funding source: NIMH grant 1R34MH071721 to Dr Solanto Declarations of interest: Dr Solanto has served on the medical advisory board of Shire Pharmaceuticals and has served as a consultant and speaker for Ortho‐McNeil‐Janssen Pharmaceuticals. Dr Abikoff has received research funding from NIMH, the Hughes, Lemberg, and Heckscher Foundations, Ortho‐McNeil, Shire, and Eli Lilly, has served as a consultant to Shire, Eli Lilly, Cephalon, and Novartis, and has a financial interest in the Children's Organizational Skills Scale, published by Multi‐Health Systems. Dr Alvir is an employee of Pfizer. Drs Marks, Wasserstein, Mitchell, and Kofman report no financial relationships with commercial interests. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Comment: a random number sequence was electronically generated. |
Allocation concealment (selection bias) | Unclear risk | Comment:participants were stratified by whether or not they were currently receiving medication treatment for ADHD, and otherwise randomly assigned to either the CBT or the support group. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: although individuals were, of course, not told to which group they were assigned, most were able to ultimately discern this because of the very different nature of the intervention (i.e. the participants were savvy enough to know that formal CBT is much more structured than a supportive intervention). Also, it is not possible to maintain a blinding of personnel in a psychosocial intervention. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Comment: response was assessed via a structured interview completed by an independent (blind) evaluator, and by questionnaires completed by the patient and a significant other, immediately pre‐ and post‐treatment. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "The proportion of drop‐out was 11% for Meta‐cognitive therapy and 12% for Supportive Therapy. All data were analysed both with and without non‐completers and medication changers." "The pattern of treatment contrasts indicated that the larger the score at baseline (that is, the more severe the symptoms), the greater the differential improvement observed with meta‐cognitive therapy; this occurred whether the data were analyzed with or without those who did not complete the program and those who made proscribed medication changes (interaction coefficients, 0.66 and 0.72, respectively)." |
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 | Quote: "Dr. Solanto is currently on the Medical Advisory Board for Shire Pharmaceuticals. She has previously served as a consultant and speaker for Ortho‐McNeil‐Janssen Pharmaceuticals, Inc. During the past five years, Dr. Abikoff has received research funding from the National Institute of Mental Health, the Hughes, Lemberg and Heckscher Foundations, Ortho‐McNeil, Shire, and Eli Lilly; has consulted to Shire, Eli Lilly, Cephalon, and Novartis; and has a financial interest in the Childrens Organizational Skills Scale, published by Multi‐Health Systems. Drs. Marks, Wasserstein, Mitchell, Alvir, and Kofman have no competing interests." |