Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02957669 |
| Other study ID # |
5 TP1AH000003-02-00 PS-R |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2016 |
| Est. completion date |
August 27, 2020 |
Study information
| Verified date |
February 2021 |
| Source |
The Policy & Research Group |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
