Sieving 2012.
Methods | Design: pilot project to refine intervention protocols and determine preliminary efficacy. Phase 1, random assignment; Phase 2, purposive assignment. Location: Midwestern metropolitan area (USA). Enrollment: Phase I, Sept 1999 to May 2001; Phase II, Oct 2001 to Dec 2002. Sample size calculation (and outcome of focus): not specified |
|
Participants | General with N: 128 girls, sexually active. Source: 3 clinics in a Midwestern metropolitan area Inclusion criteria: clinic visit involving negative pregnancy test, post‐abortion exam, or emergency contraception; age 13 to 14 years; elevated scores on 7‐item screening tool indicating high‐risk sexual behaviors. Exclusion criteria: did not understand consent materials; married, pregnant or had given birth. |
|
Interventions | Study focus: reduce sexual risk behaviors among girls at high risk for early pregnancy
Theory or model: social cognitive theory, resilience paradigm, and research on antecedents of sexual risk behaviors among adolescent girls.
Treatment: clinic‐based, youth development program provided case management with standardized topic guidelines plus peer leadership program (peer education, which included contraceptive use skills, and service learning) Comparison or control: not specified; presumably received usual clinic services Duration: 18 months |
|
Outcomes | Consistency of dual‐method use (hormonal + condoms) as well as of condom use and of hormonal contraceptive use. Consistency = # months (of past 6) reportedly used method every time had sex with recent partner / # months had sex with that partner; scored on continuum (0 to 1). |
|
Notes | Pilot project for Sieving 2013. Desire to use birth control and beliefs supporting birth control use were not specific to dual‐method use. |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Phase 1: Clinics 1 and 2, participants were randomly assigned. Phase 2: Clinic 3, participants were assigned to intervention for 10 months (for sample size to test expanded intervention); for remainder of recruitment, participants were assigned to control. |
Allocation concealment (selection bias) | High risk | No mention; presume none since main study (Sieving 2013) did not use any. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | None, according to investigator |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Self‐report survey at baseline and at 12 and 18 months; paper‐pencil survey, according to investigator. Investigator communicated that separate groups of research staff were responsible for intervention and evaluation. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Intervention group: outcome data for 89% at 12 months and 83% at 18 months. Control group: outcome data 82% at 12 and 18 months. |
Selective reporting (reporting bias) | Low risk | Not apparent |