An interventional study of Practice Self-Regulation and Therapy Practice Group in Teen Pregnancy Prevention, sponsored by The Policy & Research Group. Completed. Open to participants aged 14 Years to 19 Years. Per ClinicalTrials.gov, last updated 2021-02-18.
Sponsored by The Policy & Research Group · Not applicable, Interventional, and Prevention
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.
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.
The Policy & Research Group is the lead sponsor of 12 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Practice Self-Regulation (PS-R) is the treatment condition. PS-R is an in-person, individual-level, clinic-based intervention that aims to increase knowledge of sexual health and the impact of trauma on sexual decision-making.
Behavioral: Practice Self-Regulation
Therapy Practice Group is the control counterfactual condition. It is an individual-level, therapy as usual in which the therapist addresses mental health concerns of the participant.
Behavioral: Therapy Practice Group
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.
Number of sexual partners
Participant self-report of the number of sexual partners in the past three months. Measured through two survey questions which ask the participant with whom they have had sexual contact during their life, and if sexual contact with any gender is reported are subsequently asked how many sexual partners they have had in the past three months.
Time frame: 9 months after the end of the intervention
Times having sex without a condom
Participant self-report on the number of times they have had vaginal, oral, or anal sex without a condom in the last three months. Measured through three survey questions which ask the participant how many times they have had vaginal, oral, and anal sex in the past three months.
Time frame: 9 months after the end of the intervention
No study locations are listed for this record.
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — A dataset will be prepared at the conclusion of the study, which includes de-identified individual-level data on all study participants who contributed self-report data. Respondents will be represented only by a research ID number. Included in the dataset will be self-report data collected across all survey administrations (including demographic characteristics, sexual behaviors, and theoretical antecedents to those behaviors) and select information on program participation (e.g., which program sessions were attended). Basic data cleaning steps will be taken in order to ensure data are unidentifiable and to increase usability.
This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
The Policy & Research Group