Fantuzzo 2007.

Methods	Parallel randomised controlled trial.
Participants	Participants: parents of the Head Start children recruited from 10 central‐city Head Start centres. Sex: 111 mothers; 5 fathers. Age of parents: mean 30.8 years. Unit of allocation: individual participant. Number randomised: 116 (61 treatment; 55 control). Number used in analysis: 76 (39 treatment; 37 control). Country & setting: USA; multi‐site (n=10); recruited from community settings; intervention delivered in the community. Inclusion criteria: socially isolated parents, who were given a rating of 'low' engagement in term of their adult social interaction in Head Start activities by the teacher of their child. Exclusion criteria: not stated. Ethnicity: 100% African‐American. Baseline characteristics: 84% were the Head Start child's mother, 13% grandmothers or aunts, 3% fathers; 70% families headed by single mothers; average number of children per household 2.78; 40 parents (34.4%) had a history of maltreatment involving their Head Start child.
Interventions	Two conditions: Community outreach through parent empowerment (COPE); treatment as usual control. Duration of intervention: 10 sessions (duration not stated). Length of follow up: none.
Outcomes	Stress (Uplifts and Hassles Scales).
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Information reported insufficient for a judgement to be made. We requested clarification from the trial investigators, but no further information was available at the time this review was prepared.
Allocation concealment (selection bias)	Unclear risk	Information reported insufficient for a judgement to be made. We requested clarification from the trial investigators, but no further information was available at the time this review was prepared.
Blinding (performance bias and detection bias) Participants	High risk	Review authors judge that it would not be possible to fully blind participants in this type of study, and found no indication of any specific additional measures taken to reduce the risk of bias that might result from differential behaviours by participants.
Blinding (performance bias and detection bias) Personnel	Unclear risk	Information reported insufficient for a judgement to be made. We requested clarification from the trial investigators, but no further information was available at the time this review was prepared.
Blinding (performance bias and detection bias) Outcome assessors	Low risk	Trial investigators report that outcome assessors were blind to allocation status of participants (page 84, col 2).
Incomplete outcome data (attrition bias) All outcomes	Low risk	There were no missing data.
Selective reporting (reporting bias)	Low risk	Review authors judge that the published report includes all expected outcomes, including those that were pre‐specified.
Other bias	Low risk	The study appears to be free of other forms of bias.