Farran 2004.

Methods	Randomised clinical trial. Study duration 18 months.
Participants	295 care recipients (CR) with Alzheimer’s disease (AD) or other dementia syndrome, with MMSE < 24, and their family caregiver (CG), who provided a minimum of 6 months care, with four hours direct contact per day. CR mean MMSE score was 12.6, CR mean age was not reported. CGs had a mean age of 64.4, 225 were female and 70 male.
Interventions	Caregiver skill (CSB) Intervention Information and Support Orientated Group Intervention (ISO) (Comparison Condition) Primary aim of intervention: Reducing emotional distress in CG & improving CG management of behaviour problems. (See Table 2)
Outcomes	The Center for Epidemiologic studies‐Depression Scale (CES‐D) for CG Behaviour Management Skill Revised (BMS‐R) The Revised Memory and Problem Behaviour Checklist (RMPBC) Time to Institutionalisation (see Table 3)
Notes	Country of Origin: Chicago, USA 12 weekly sessions, 5 group sessions, 7 individualised telephone contact sessions, 2 group booster sessions (6 and 12 months after enrolment) and as needed telephone contact during 12 month period.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	'Participants were randomly assigned to treatment condition'
Allocation concealment (selection bias)	Low risk	Statistician generated randomised sequence of binary codes (1 or 2) for each block of 10 to 20 participants. Sequence position determined by an alphabetically ordered list of participant names within each block. Coin toss to determine group 1 or 2 as intervention or control.
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Participant assignment list and identification number exclusive to project director. Trained interviewers blind to assignment. Treatment protocol for intervention. To assure fidelity, each staff member received 40 hours training and followed a detailed manual of prescribed material for each session. Supervised implementation, corrective feedback and group sessions taped and reviewed. Intervention staff remained blind to baseline and follow‐up assessment data.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Assessments conducted over the telephone. Assessment of key outcomes by reviewers blind to treatment condition.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Attrition reported (23 participants terminated early, reasons included: transportation/schedule difficulties (30%), health status (22%), nursing home placement or death (13%) and other reasons/not interested (26%)).
Selective reporting (reporting bias)	Low risk	Only coefficients reported, however, full data set supplied by author.
Other bias	Low risk	No crossover or carryover effects reported.