Teen Pregnancy PreventionNCT03242447
Evaluation of e-Practice Self-Regulation (e-PS-R)
A study testing e-Practice Self-Regulation and Video Health Group in people with Teen Pregnancy Prevention, run by The Policy & Research Group at 1 site in United States.
Trial summary
The purpose of the study is to determine the impact of the offer to participate in the e-Practice Self-Regulation (e-PS-R) (treatment) relative to the control condition on increasing knowledge of sexual health and the impact of trauma on sexual decision-making and preventing teen pregnancy and high-risk behaviors 12… 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?
- e-Practice Self-Regulation and Video Health Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 631 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Aug 2017to 31 Jan 2021
- 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
- Be aged 14-19
- Be involved with the juvenile justice system
- Be deemed appropriate for study by site staff and study facilitator (no acute illness or behavioral problems; psychiatrically stable; cognitively capable of internalizing and comprehending content of intervention)
- Possess adequate English-language comprehension (be able to read and comprehend the on-line intervention materials, which are available only in English)
- Consent/assent to participating in study
Who cannot join
- Not be residing in or scheduled to enter a secure facility
- Not be currently pregnant
- Not be trying to get pregnant
- Not be an enrolled participant (former or current) in the Teen Health Study (Teen Pregnancy Prevention study funded by the Office of Adolescent Health, being conducted in Albuquerque, New Mexico)
- Not have previously participated in e-PS-R
Trial locations and contacts
1 site in 1 country.
United States1 site
The Policy & Research Group
New Orleans, Louisiana, 70118
About this study
The purpose of the study is to determine the impact of the offer to participate in the e-Practice Self-Regulation (e-PS-R) (treatment) relative to the control condition on increasing knowledge of sexual health and the impact of trauma on sexual decision-making and preventing teen pregnancy and high-risk behaviors 12 months after enrollment.
Read the detailed description
The Policy \& Research Group (PRG) will be conducting a rigorous evaluation of an innovative intervention designed to prevent adolescent pregnancy, births, and STIs among high-risk youth populations, entitled online Practice Self-Regulation (e-PS-R). e-PS-R is the online adaptation of the Practice Self-Regulation (PS-R); both PS-R and e-PS-R were developed through grant funding by Joann Schladale of Resources for Resolving Violence, Inc. The original PS-R intervention is a 10-session therapeutic program designed for youth ages 14-19 who have experienced trauma; each session is intended to be offered by a masters-level therapist during one-on-one weekly therapy sessions. The online adaptation e-PS-R utilizes 'blended learning', the combination of online and face-to-face instruction, and incorporates online videos and interactive elements that have been shown to be effective with high-risk youth. e-PS-R consists of eight 30-minute e-learning sessions for youth participants and four 30-45 minute one-on-one in-person meetings between youth and a trained facilitator. The following Adulthood Preparation Subjects are covered during both the online sessions and the in-person meetings: Adolescent Development, Healthy Life Skills, and Healthy Relationships. By increasing knowledge of sexual health and the impact of trauma on sexual decision-making, the program is designed to encourage and support youth in practicing self-regulation.
The Policy \& Research Group (PRG) will conduct an implementation evaluation and an impact evaluation, using a randomized controlled trial, to test the effectiveness of this new intervention. The study will target juvenile justice-involved youth ages 14-19 who have experienced trauma. The primary focus of the study will be to investigate the impact of the intervention on two self-reported sexual behaviors: (1) inconsistency of condom use, and (2) number of sexual partners. In addition, the study will include exploratory investigations of the following self-reported sexual behaviors and theoretically relevant antecedents to behavior and pathways to behavior change: (1) use of contraception; (2) use of dual methods of protection; (3) incidence of pregnancy; (4) self-efficacy to engage in affect regulation; (5) sexual self-efficacy; (6) intentions to engage in affect-regulation; (7) intentions to engage in sexual self-regulation; and (8) use of affect regulation. Outcomes will be assessed using self-reported, participant-level data gathered (by way of a questionnaire) at four time points: baseline (enrollment); post-program (immediately after the end of the intervention period; 3 months after baseline); short-term (3 months post-intervention period) follow-up; and long-term (nine months post-intervention period) follow-up.
Starting in July 2017 and continuing for two years, 600 participants will be enrolled into the study at partner implementation sites within the juvenile justice systems in New Mexico and West Virginia. The third and fourth years of the grant will be used to complete the following tasks: collect follow-up data from study participants; conduct implementation and impact evaluation analysis, reporting, and dissemination efforts; and manualize and package the curriculum and training materials.
- Conditions
- Teen Pregnancy Prevention
- Being tested
- e-Practice Self-Regulation, Video Health Group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
e-Practice Self-RegulationBehavioural
e-PS-R utilizes 'blended learning', the combination of online and face-to-face instruction, and incorporates online videos and interactive elements that have been shown to be effective with high-risk youth. e-PS-R consists of eight 30-minute e-learning sessions for youth participants and four 30-45 minute one-on-one in-person meetings between youth and a trained facilitator.
Video Health GroupBehavioural
The video for the control condition will be The Toxic Life Cycle of a Cigarette, a 17-minute video that details the negative effects that cigarettes have on the environment and on people who manufacture and use cigarettes.
| Study group | Role | What they receive |
|---|---|---|
| e-Practice Self-Regulation (e-PS-R) | Experimental | e-Practice Self-Regulation (e-PSR) is the treatment condition. e-PS-R is a 'blended learning' intervention, combining online and face-to-face instruction. e-PS-R aims to increase knowledge of sexual health and the impact of trauma on sexual decision-making. Receives: Behavioral: e-Practice Self-Regulation |
| Video Health Group | Active comparator | The Video Health Group is the control counterfactual condition. Youth assigned to the control group will view a video on a non-sexual health topic (the hazards of smoking).The video for the control condition will be The Toxic Life Cycle of a Cigarette, a 17-minute video that details the negative effects that cigarettes have on the environment and on people who manufacture and use cigarettes. The informational video uses both narration and interviews to educate viewers on the dangers that cigarettes pose. Receives: Behavioral: Video Health Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
participants' self-reported sexual behaviors
The primary outcome will be the mean differences between the treatment and control group participants in self-reported sexual behaviors at 12-month follow-up; exploratory analyses will examine differences in sexual behaviors post-program and differences in other theoretically relevant outcomes (e.g., attitudes, self-efficacies, self-regulatory behaviors) at both post-program and 12-month follow-up.
The independent variable of interest will be the treatment assignment, which will be operationalized as being randomly assigned to the active treatment (1) or the control condition (0).
Measured: 12 months after enrollment into the study
Secondary outcomes (2)
consistency of contraceptive use
The risk outcome is operationalized as the proportion of times a person reports having sexual intercourse without using any form of birth control (including condoms). The measure is calculated from the following items:
The measure is calculated by dividing the total number of times a person reported having sexual intercourse without using any contraception by the total number of times she reported having sexual intercourse.
The resulting variable is a continuous proportion with values that range from 0 to 1, where 0 indicates that a person has not engaged in sexual intercourse without birth control in the past three months, and 1 indicates that the person has engaged in sexual intercourse without birth control (risk behavior) 100% of the times they had sex in the past three months.
Measured: 12 months after enrollment
frequency of sexual activity
The risk outcome is operationalized as the number of times in the past three months a person reports having any type of sex.
The measure is taken directly from the following item:
- In total, how many times have you had any type of sex in the past 3 months?
The variable is continuous, with values ranging from 0 to k, where 0= no sexual activity reported in past 3 months and k = number of times sex reported.
Measured: 12 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2017
- Study start2 Aug 2017
- Primary completion30 Apr 2020
- Study completion31 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Model description
- participants are assigned to one of two or more groups in parallel for the duration of the study
- Masking
- None (open label)
- Enrolment
- 631 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Policy & Research Group
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Health and Human Services
- Responsible party
- Sponsor
- Investigators
- Eric Jenner, PhD, Principal investigator, The Policy & Research Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03242447
- Sponsor's protocol ID
- 90AP2679-01-00
- Status last verified
- Dec 2022
- First submitted
- 25 Jul 2017
- Last updated
- 9 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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.
Publications
Qaragholi N, Gallo JJ, Beres LK, Nguyen TQ, Walsh S, Stuart EA. CACE-MM: using mixed methods to strengthen causal inference in medicine and public health. BMC Med Res Methodol. 2026 Jun 19;26(1):161. doi: 10.1186/s12874-026-02908-y.
PubMed 42321632
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of e-Practice Self-Regulation (e-PS-R)
- ClinicalTrials.gov ID
- NCT03242447
- Acronym / sponsor ID
- 90AP2679-01-00
- Conditions
- Teen Pregnancy Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 631 participants (actual)
- Lead sponsor
- The Policy & Research GroupUniversity, hospital or other
- Collaborators
- Department of Health and Human Services
- Study start
- 2 Aug 2017 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 31 Jan 2021 (actual)
- First posted
- 8 Aug 2017 (actual)
- 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 e-Practice Self-Regulation (e-PS-R) (treatment) relative to the control condition on increasing knowledge of sexual health and the impact of trauma on sexual decision-making and preventing teen pregnancy and high-risk behaviors 12 months after enrollment.
Detailed description
The Policy \& Research Group (PRG) will be conducting a rigorous evaluation of an innovative intervention designed to prevent adolescent pregnancy, births, and STIs among high-risk youth populations, entitled online Practice Self-Regulation (e-PS-R). e-PS-R is the online adaptation of the Practice Self-Regulation (PS-R); both PS-R and e-PS-R were developed through grant funding by Joann Schladale of Resources for Resolving Violence, Inc. The original PS-R intervention is a 10-session therapeutic program designed for youth ages 14-19 who have experienced trauma; each session is intended to be offered by a masters-level therapist during one-on-one weekly therapy sessions. The online adaptation e-PS-R utilizes 'blended learning', the combination of online and face-to-face instruction, and incorporates online videos and interactive elements that have been shown to be effective with high-risk youth. e-PS-R consists of eight 30-minute e-learning sessions for youth participants and four 30-45 minute one-on-one in-person meetings between youth and a trained facilitator. The following Adulthood Preparation Subjects are covered during both the online sessions and the in-person meetings: Adolescent Development, Healthy Life Skills, and Healthy Relationships. By increasing knowledge of sexual health and the impact of trauma on sexual decision-making, the program is designed to encourage and support youth in practicing self-regulation.
The Policy \& Research Group (PRG) will conduct an implementation evaluation and an impact evaluation, using a randomized controlled trial, to test the effectiveness of this new intervention. The study will target juvenile justice-involved youth ages 14-19 who have experienced trauma. The primary focus of the study will be to investigate the impact of the intervention on two self-reported sexual behaviors: (1) inconsistency of condom use, and (2) number of sexual partners. In addition, the study will include exploratory investigations of the following self-reported sexual behaviors and theoretically relevant antecedents to behavior and pathways to behavior change: (1) use of contraception; (2) use of dual methods of protection; (3) incidence of pregnancy; (4) self-efficacy to engage in affect regulation; (5) sexual self-efficacy; (6) intentions to engage in affect-regulation; (7) intentions to engage in sexual self-regulation; and (8) use of affect regulation. Outcomes will be assessed using self-reported, participant-level data gathered (by way of a questionnaire) at four time points: baseline (enrollment); post-program (immediately after the end of the intervention period; 3 months after baseline); short-term (3 months post-intervention period) follow-up; and long-term (nine months post-intervention period) follow-up.
Starting in July 2017 and continuing for two years, 600 participants will be enrolled into the study at partner implementation sites within the juvenile justice systems in New Mexico and West Virginia. The third and fourth years of the grant will be used to complete the following tasks: collect follow-up data from study participants; conduct implementation and impact evaluation analysis, reporting, and dissemination efforts; and manualize and package the curriculum and training materials.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- participants are assigned to one of two or more groups in parallel for the duration of the study
| Arm | Type | Receives |
|---|---|---|
| e-Practice Self-Regulation (e-PS-R) | Experimental | Behavioral: e-Practice Self-Regulatione-Practice Self-Regulation (e-PSR) is the treatment condition. e-PS-R is a 'blended learning' intervention, combining online and face-to-face instruction. e-PS-R aims to increase knowledge of sexual health and the impact of trauma on sexual decision-making. |
| Video Health Group | Active comparator | Behavioral: Video Health GroupThe Video Health Group is the control counterfactual condition. Youth assigned to the control group will view a video on a non-sexual health topic (the hazards of smoking).The video for the control condition will be The Toxic Life Cycle of a Cigarette, a 17-minute video that details the negative effects that cigarettes have on the environment and on people who manufacture and use cigarettes. The informational video uses both narration and interviews to educate viewers on the dangers that cigarettes pose. |
Who may qualify
- Ages
- 14 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Be aged 14-19
- Be involved with the juvenile justice system
- Be deemed appropriate for study by site staff and study facilitator (no acute illness or behavioral problems; psychiatrically stable; cognitively capable of internalizing and comprehending content of intervention)
- Possess adequate English-language comprehension (be able to read and comprehend the on-line intervention materials, which are available only in English)
- Consent/assent to participating in study
Key exclusion criteria (5 listed)
- Not be residing in or scheduled to enter a secure facility
- Not be currently pregnant
- Not be trying to get pregnant
- Not be an enrolled participant (former or current) in the Teen Health Study (Teen Pregnancy Prevention study funded by the Office of Adolescent Health, being conducted in Albuquerque, New Mexico)
- Not have previously participated in e-PS-R
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 |
|---|---|---|
| e-Practice Self-Regulatione-PS-R utilizes 'blended learning', the combination of online and face-to-face instruction, and incorporates online videos and interactive elements that have been shown to be effective with high-risk youth. e-PS-R consists of eight 30-minute e-learning sessions for youth participants and four 30-45 minute one-on-one in-person meetings between youth and a trained facilitator. | Behavioural | e-Practice Self-Regulation (e-PS-R) |
| Video Health GroupThe video for the control condition will be The Toxic Life Cycle of a Cigarette, a 17-minute video that details the negative effects that cigarettes have on the environment and on people who manufacture and use cigarettes. | Behavioural | Video Health Group |
Primary outcome
participants' self-reported sexual behaviors
Time frame: 12 months after enrollment into the study
The primary outcome will be the mean differences between the treatment and control group participants in self-reported sexual behaviors at 12-month follow-up; exploratory analyses will examine differences in sexual behaviors post-program and differences in other theoretically relevant outcomes (e.g., attitudes, self-efficacies, self-regulatory behaviors) at both post-program and 12-month follow-up. The independent variable of interest will be the treatment assignment, which will be operationalized as being randomly assigned to the active treatment (1) or the control condition (0).
2 secondary outcomes
consistency of contraceptive use
Time frame: 12 months after enrollment
frequency of sexual activity
Time frame: 12 months after enrollment
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 9 Dec 2022.
- Derived from this study: PubMed 42321632Qaragholi N, Gallo JJ, Beres LK, Nguyen TQ, Walsh S, Stuart EA. CACE-MM: using mixed methods to strengthen causal inference in medicine and public health. BMC Med Res Methodol. 2026 Jun 19;26(1):161. doi: 10.1186/s12874-026-02908-y.
- 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.
Related trials for Teen Pregnancy Prevention
Not yet recruitingPhase 3
To Assess the Efficacy and Safety of Pegcetacoplan for the Prevention of Recurrent C3G or Primary IC-MPGN in Kidney Transplant Recipients
C3 Glomerulopathy (C3G), Primary Immune-Complex Membranoproliferative
Recruiting
Scaling Effective Behavioral Interventions With MPC Avatar-Based Virtual Training
Education, Sex
Active, not recruiting
Evaluation of a Mobile Health Intervention to Improve Sexual and Reproductive Health Outcomes Among Kenyan Adolescents Living in Urban Informal Settlements
mHealth Intervention
Not yet recruiting
#TranscendentHealth: A Text Messaging Pregnancy Prevention Program for Transgender Boys
Pregnancy (Unwanted), Sexually Transmitted Disease (STD)
Recruiting
Evaluation of Peer Group Connection - Middle School
Teen Pregnancy Prevention
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 principal investigator
The Policy & Research Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing e-Practice Self-Regulation and Video Health Group in people with Teen Pregnancy Prevention, run by The Policy & Research Group at 1 site in United States.
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 5 inclusion and 5 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 9 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
participants' self-reported sexual behaviors (time frame: 12 months after enrollment into the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03242447, which also lists 1 linked publication.
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 9 Dec 2022.