Evaluation of Practice Self-Regulation
Condition: Teen Pregnancy Prevention
Study type: Interventional

Summary: 
      The purpose of the study is to determine the impact of the offer to participate in the
      Practice Self-Regulation (PS-R) (treatment) relative to the offer to participate in the
      Therapy Practice Group (control) on participants' reported number of sexual partners and
      reported number of times having sex without a condom nine months after the end of treatment.
    

Detailed description: 
      The Policy & Research Group (PRG) will be evaluating the Practice Self-Regulation (PSR)
      program. This intervention is designed to address gaps in the existing evidence, reduce
      disparities in teen pregnancy and associated sexual and reproductive health outcomes, and
      serve high-need populations. The intervention is composed of ten structured, individual
      therapy sessions intended to promote optimal sexual decision making. By increasing knowledge
      of sexual health and the impact of trauma on sexual decision-making, youth are encouraged and
      supported in practicing self-regulation. The primary focus of the study will be to
      investigate the impact of the intervention on participants' self-reported sexual behaviors
      (times having sex with no condom and number of sexual partners). In addition, the study will
      include exploratory investigations of the following theoretically relevant antecedents to
      behavior and pathways to behavior change: (1) perception of risk and severity for pregnancy
      and HIV/STIs; (2) intention to have sex; (3) importance of having sex; (4) intention to use
      effective contraceptive methods (including condoms); (5) affect regulation self-efficacy; (6)
      importance of using effective contraceptive methods; (7) intention to limit number of sexual
      partners; (8) importance to limiting the number of sexual partners; (9) intention to practice
      affect regulation; (10) self-esteem; (11) importance of using affect regulation; (12)
      intention to practice sexual self-regulation; (13) importance of practicing sexual
      self-regulation; (14) contraceptive use and negotiation (including condoms) self-efficacy;
      (15) sexual activity decision making and planning self-efficacy; (16) beliefs regarding the
      malleability of emotions; (17) beliefs regarding value of affect regulation; (18) use of
      effect regulation; and (19) distress . The control (counterfactual) condition, Therapy
      Practice Group, consists of therapy as usual without the incorporation of elements vital to
      the PSR intervention. All eligible individuals who provide the proper consent to participate
      are randomized and enrolled into the study at the time they attend their first scheduled
      study session. Outcomes will be assessed using self-reported, participant-level data gathered
      (by way of a questionnaire) at three time points: baseline (enrollment); post-program
      (immediately after the end of the intervention period, which is 18 weeks after baseline); and
      9-month follow-up (9 months following the end of the intervention period, which is 13 months
      after baseline). The study is taking place in California, Louisiana, New Mexico, Michigan,
      and Maine. Recruitment of study participants and delivery of the intervention is conducted by
      trained private practitioners and therapists working at participating agencies who are
      serving youth between the ages of 14 and 19 and are receiving outpatient mental health
      services.
    

Intervention name(s): Practice Self-Regulation; Therapy Practice Group
Intervention type(s): Behavioral; Behavioral
Intervention description(s): PS-R is an in-person, individual-level, clinic-based intervention implemented by mental health professionals trained in the intervention. It is intended to be implemented in ten structured, individual therapy sessions lasting approximately 50 minutes over the course of 18 weeks.; Therapy Practice Group is the control condition aimed at providing the youth a safe space to work on meeting their mental health goals. It is intended to be at least ten sessions over the course of 18 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention