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. 2015 Apr 7;2015(4):CD003406. doi: 10.1002/14651858.CD003406.pub4

Nezu 1991.

Methods Randomised controlled trial
  • Setting: study conducted in the USA; participants recruited from an outpatient clinic setting

  • No study dates are given

Participants
  • Eligibility criteria: mild ID, concomitant mental health problem and maladaptive behaviour (e.g. anger control, verbal or physical aggression, destructive behaviour). No chnages in medication one month prior to participation in the study. Participants were excluded if they had organic brain syndrome, substance misuse, active psychotic sysmptoms or were receiving psychological therapies

  • 28 adults (mean age 36 years) were included; 18 were men and most were White caucasian but two were Black. 9 were receiving antipsychotic medication. Baseline characteristics according to allocation group were not provided

Interventions Treatment 1: Problem‐solving‐assertiveness (n = 9)
Treatment 2: Assertiveness‐problem‐solving (n = 9)
Treatment 3: waiting list (n = 10)
  • The interventions were delivered by psychologists and were based on established treatment manuals. For the purposes of the review, the 2 arms of the intervention were grouped as 1: assertiveness training and problem solving

  • The control group went into treatment at the end of the intervention

  • In order to assess adherence to therapy manual, each therapy session was videotaped and independently assessed by 2 research assistants

Outcomes
  • Brief Symptom Inventory, Problem‐Solving Task, Adaptive Behaviour Scale‐Revised (part II), Role‐Play Test of Anger Arousing Situations, Subjective Units of Distress

  • Assessments were carried out mid‐treatment, post‐treatment, and at three‐month follow‐up (treatment group only and therefore not included in the analysis)

Notes
  • Participants had comorbid mental disorders but data were available on the behavioural problems separately from the mental disorders. The authors used widely‐known instruments for measuring behaviour change and diagnosing mental illness

  • No information in source of funding

  • No declaration of conflicts of interest statement

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomisation using coin tossing (This information is not reported in the published paper, but communicated via email to reviewers, Nezu 2000 [pers comm]).
Allocation concealment (selection bias) Unclear risk Not reported in the paper; authors contacted but did not respond
Blinding of participants and personnel (performance bias) 
 All outcomes High risk No blinding of participants and personnel
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Outcome assessors are reported as being unaware of the treatment status of participants
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Not reported in paper; authors contacted but did not respond
Selective reporting (reporting bias) Low risk We believe that all prespecified outcomes were reported
Other bias Unclear risk Effects of co‐morbidity and psychotropic medication on treatment response is unclear