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. 2016 Nov 23;2016(11):CD007249. doi: 10.1002/14651858.CD007249.pub5

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
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
  1. Treatment: home‐based curriculum for adolescent mothers, maximum of 19 lessons; participants seen twice per month until infant's first birthday. Intervention included information about access to birth control; condoms provided at each visit. After first 2 visits, facilitators could vary order of sessions, as well as combine or repeat them.

  2. Comparison or control: usual care


Duration: maximum of 19 visits for intervention group at 2 per month
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
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