Black 2006.
Methods | Design: individually randomized Time frame: recruitment September 1997 through December 1999 Location: Baltimore, MD (USA) Sample size calculation (and outcome of focus): no mention |
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Participants | General with N: 181 adolescents Source: 3 urban hospitals Inclusion criteria: low income (< 185% poverty level); < 18 years old; first‐time delivery; black race; no indication of cocaine or heroin use in chart; no chronic illness that would interfere with parenting or adolescent development; infant was term (≥ 37 weeks) and > 2500 g; infant had no congenital problem, chronic illness, or disability | |
Interventions | Study focus: delaying second births; parenting, contraception Theory or model: primarily Social Cognitive Theory
Duration: maximum of 19 visits for intervention group at 2 per month |
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Outcomes | Primary: second birth (not pregnancy); contraceptive use (report presented by second birth rather than randomized group)
Secondary: NA Follow‐up assessments: 6, 13, 24 months |
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Notes | 2008: unable to obtain information from investigator about contraceptive use by study arm | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | 'Randomization procedure' stratified on maternal age and child's gender |
Allocation concealment (selection bias) | Unclear risk | No mention |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Presume no blinding of participants; not feasible due to type of intervention |
Blinding of outcome assessment (detection bias) | Unclear risk | No mention |
Outcome measures | Unclear risk | Second birth assessed at home visit (low risk); contraceptive use reported by second birth and not randomized group (high risk) |
Incomplete outcome data (attrition bias) All outcomes | High risk | Loss to follow‐up: overall, 18%; by group, intervention 20% (17/87); control 16% (15/94) Exclusions after randomization: excluded from analysis 32 mothers who did not have 24‐month evaluation (17 treatment and 15 control), because intent was to assess second births. May have had 6‐month or 13‐month evaluations. |
Other bias | Unclear risk | Analysis for cluster randomized trial: NA |