Teen Pregnancy PreventionPS-RNCT02957669
Evaluation of Practice Self-Regulation
A study testing Practice Self-Regulation and Therapy Practice Group in people with Teen Pregnancy Prevention, run by The Policy & Research Group.
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… Read more about this study
- Who is it for?
- Ages 14 to 19 years
- Conditions the study is for
- Teen Pregnancy Prevention
- What is being tested?
- Practice Self-Regulation and Therapy Practice Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 432 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2016to 27 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Evaluation of Practice Self-Regulation (PS-R)
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.
Read the 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.
- Conditions
- Teen Pregnancy Prevention
- Being tested
- Practice Self-Regulation, Therapy Practice Group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Practice Self-RegulationBehavioural
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 GroupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Practice Self-Regulation (PS-R) | Experimental | 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. Receives: Behavioral: Practice Self-Regulation |
| Therapy Practice Group | Active comparator | 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. Receives: Behavioral: Therapy Practice Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 9 months after the end of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2016 (estimated)
- Study start1 Jun 2016
- Primary completion27 Aug 2020
- Study completion27 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Teen Pregnancy PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 432 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Policy & Research Group
- Sponsor type
- University, hospital or other
- Collaborators
- The Office of Adolescent Health, HHS
- Responsible party
- Sponsor
- Investigators
- Eric Jenner, PhD, MMC, BA, Principal investigator, The Policy & Research Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02957669
- Sponsor's protocol ID
- 5 TP1AH000003-02-00 PS-R
- Acronym
- PS-R
- Status last verified
- Feb 2021
- First submitted
- 3 Nov 2016
- Last updated
- 18 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Practice Self-Regulation (PS-R)
- ClinicalTrials.gov ID
- NCT02957669
- Acronym / sponsor ID
- PS-R / 5 TP1AH000003-02-00 PS-R
- Conditions
- Teen Pregnancy Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 432 participants (actual)
- Lead sponsor
- The Policy & Research GroupUniversity, hospital or other
- Collaborators
- The Office of Adolescent Health, HHS
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 27 Aug 2020 (actual)
- Study completion
- 27 Aug 2020 (actual)
- First posted
- 8 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Practice Self-Regulation (PS-R) | Experimental | Behavioral: Practice Self-RegulationPractice 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. |
| Therapy Practice Group | Active comparator | Behavioral: Therapy Practice GroupTherapy 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. |
Who may qualify
- Ages
- 14 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Practice Self-RegulationPS-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. | Behavioural | Practice Self-Regulation (PS-R) |
| Therapy Practice GroupTherapy 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. | Behavioural | Therapy Practice Group |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
- The Policy \& Research Group websiteLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Jenner, PhD, MMC, BA principal investigator
The Policy & Research Group
Questions about this trial
What is this clinical trial studying?
A study testing Practice Self-Regulation and Therapy Practice Group in people with Teen Pregnancy Prevention, run by The Policy & Research Group.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of sexual partners (time frame: 9 months after the end of the intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2021.