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Evaluation of Practice Self-Regulation (PS-R)

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ClinicalTrials.gov Identifier: NCT02957669
Recruitment Status : Active, not recruiting
First Posted : November 8, 2016
Last Update Posted : May 7, 2019
Sponsor:
Collaborator:
The Office of Adolescent Health, HHS
Information provided by (Responsible Party):
The Policy & Research Group

Brief 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.

Condition or disease Intervention/treatment Phase
Teen Pregnancy Prevention Behavioral: Practice Self-Regulation Behavioral: Therapy Practice Group Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 432 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Evaluation of Practice Self-Regulation (PS-R)
Actual Study Start Date : July 2016
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Arm Intervention/treatment
Experimental: Practice Self-Regulation (PS-R)
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
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.

Active Comparator: Therapy Practice Group
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
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.




Primary Outcome Measures :
  1. Number of sexual partners [ Time Frame: 9 months after the end of the intervention ]
    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.

  2. Times having sex without a condom [ Time Frame: 9 months after the end of the intervention ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Between the ages of 14-19
  • Provide parental consent (if under age 18) and participant assent to participate in the study
  • Deemed appropriate for the study by the agency staff
  • Receiving individual outpatient counseling services at one of the study's implementation sites

Exclusion Criteria:

  • Previous participation in the study
  • Previous use of the Trauma Outcome Process (TOP) workbook in therapy
  • Self-report of previous participation in other TPP-funded programs
  • Self-report of roommate who participated in the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02957669


Sponsors and Collaborators
The Policy & Research Group
The Office of Adolescent Health, HHS
Investigators
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Principal Investigator: Eric Jenner, PhD, MMC, BA The Policy & Research Group
  Study Documents (Full-Text)

Documents provided by The Policy & Research Group:

Additional Information:
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Responsible Party: The Policy & Research Group
ClinicalTrials.gov Identifier: NCT02957669     History of Changes
Other Study ID Numbers: 5 TP1AH000003-02-00 PS-R
First Posted: November 8, 2016    Key Record Dates
Last Update Posted: May 7, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Time Frame: The individual participant dataset will become available twelve months after the study has concluded.