Teen Pregnancy PreventionMARSSINCT04798248
Evaluation of Momentary Affect Regulation - Safer Sex Intervention
A study testing Momentary Affect Regulation - Safer Sex Intervention (MARSSI) and Podcast Health Group in people with Teen Pregnancy Prevention, run by The Policy & Research Group at 2 sites in United States.
Trial summary
The purpose of the study is to determine the impact of the offer to participate in the Momentary Affect Regulation - Safer Sex Intervention (treatment) relative to the offer to participate in the control condition on participants' reported condom use, use of effective contraception, and number of sexual partners three… Read more about this study
- Who is it for?
- Ages 16 to 21 years, women only
- Conditions the study is for
- Teen Pregnancy Prevention
- What is being tested?
- Momentary Affect Regulation - Safer Sex Intervention (MARSSI) and Podcast Health Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 405 participants
- Where
- 2 sitesUnited States
- Study dates
- 19 Jun 2021to 30 Jun 2024
- 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 16 to 21 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Visited reproductive health care provider in the past two years
- Own a smartphone
- Have the technical capacity to participate
- Be fluent in English
- Be 16 to 21 years of age
- Be biologically able to become pregnant (to the best of their knowledge)
Show all 10Show fewer
- Score at least 8 on the PHQ-8
- Have had penile-vaginal sex in the past 3 months
- Have had penile-vaginal sex at least once a week, on average
- Report having done at least one of the following during the 3 months preceding eligibility screening: 1) Not using a condom every time they have sexual intercourse; 2) Used condoms, a diaphragm, cervical cap, spermicide, sponge, fertility awareness, or withdrawal as a primary form of birth control; 3) Had sexual intercourse with more than one person; 4) Had sexual intercourse within 2 hours after using drugs and alcohol; and/or 5) Been treated for an STI/STD
Who cannot join
- Trying to get pregnant or currently pregnant at the time of eligibility screening
- Have given birth during the 6 months preceding eligibility screening
- Married or engaged to be married at the time of eligibility screening
- Identified as fraudulent
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Planned Parenthood of Wisconsin
Madison, Wisconsin, 53713
Planned Parenthood Great Northwest, Hawai'i, Alaska, Indiana, Kentucky
Seattle, Washington, 98122
About this study
The purpose of the study is to determine the impact of the offer to participate in the Momentary Affect Regulation - Safer Sex Intervention (treatment) relative to the offer to participate in the control condition on participants' reported condom use, use of effective contraception, and number of sexual partners three months after the end of the treatment intervention.
Read the detailed description
The Policy \& Research Group (PRG) will be conducting a rigorous evaluation of an innovative intervention designed to reduce unplanned pregnancy and sexually transmitted infections in young women with depression, entitled Momentary Affect Regulation - Safer Sex Intervention (MARSSI). MARSSI was developed by Dr. Lydia Shrier of Boston Children's Hospital. MARSSI has three components. The first is a manualized session with a sexual and reproductive health counselor, who uses motivational interviewing (MI) techniques to help the young woman identify a risk-reducing goal for her sexual behavior, develop a change plan, and provide depression education and skills, based on cognitive behavioral therapy. The second component is a mobile health (mhealth) application that the young woman loads on her smartphone and, for four weeks, uses to complete app-prompted reports 3 times a day and a scheduled report once a day. When she reports poor affect, low contraceptive or condom self-efficacy, pregnancy desire, or desire for sex to regulate affect, she receives personalized messages prompting healthy behaviors and cognitive behavioral skill use. The third component is a booster session that occurs after 4 weeks of app use. The young woman meets with the counselor again to review her behavior and relationships, discuss progress toward her goal, and learn a new skill. Through these components, MARSSI aims to enhance motivation to change risk behaviors, provides skills to address depression's effects on behavior, and prompts and reinforces healthy affect regulation, cognitive behavioral skill use, and behavior change in daily life.
The Policy \& Research Group (PRG) will conduct an implementation evaluation and an impact evaluation, using an individual randomized controlled trial, to test the efficacy of this new intervention. The study will target young women ages 16-21 who have depressive symptoms and are recent clients of sexual and reproductive health clinics. The primary focus of the study will be to investigate the impact of the intervention on three self-reported sexual behaviors: 1) condom use; 2) use of effective contraception; and 3) number of sexual partners. The study will also include exploratory investigations of a number of other sexual behaviors and theoretically relevant antecedents to change in behavior and sexual health, including but not limited to: 1) engagement in protective sexual behavior; 2) condom use at last vaginal sex; 3) effective contraceptive use at last vaginal sex; 4) dual methods of protection; 5) frequency of vaginal, anal, and oral sex; 6) substance use before any type of sex; 7) types of sexual partners/relationships; 8) depressive symptoms; 9) sexual communication self-efficacy; 10) motivation to change risky sexual behaviors; 11) contraceptive and condom knowledge; 12) contraceptive and condom planning self-efficacy; and 13) use of cognitive restructuring.
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; 1 month post baseline); short-term (4 months post-baseline) follow-up; and long-term (7 months post baseline) follow-up.
Starting in June 2021 and continuing for 23 months, 600 participants who have received reproductive health care in the past two years (nationally) will be recruited and enrolled into the study by trained Planned Parenthood research coordinators. The final year 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
- Momentary Affect Regulation - Safer Sex Intervention (MARSSI), Podcast Health Group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Momentary Affect Regulation - Safer Sex Intervention (MARSSI)Behavioural
MARSSI is an individual-level intervention that involves a one-hour manualized session with a sexual reproductive health (SRH) counselor, followed by one-month of daily use of a mobile health app and a final 20-minute booster session with the SRH counselor.
Podcast Health GroupBehavioural
Participants assigned to the Podcast Health Group will listen to ~20 minute podcast episode put out by the Susan G. Komen Foundation about family history of breast cancer; the podcast does not include information related to the outcomes of interest for the study.
| Study group | Role | What they receive |
|---|---|---|
| Momentary Affect Regulation - Safer Sex Intervention | Experimental | Momentary Affect Regulation - Safer Sex Intervention (MARSSI) is the treatment condition. MARSSI aims to enhance an individual's motivation to change risk behaviors, provides skills to address depression's effects on behavior, and prompts and reinforces healthy affect regulation, cognitive behavioral skill use, and behavior change in daily life. Receives: Behavioral: Momentary Affect Regulation - Safer Sex Intervention (MARSSI) |
| Podcast Health Group | Sham comparator | The Podcast Health Group is the control counterfactual condition. Receives: Behavioral: Podcast Health Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Times having vaginal sex without a condom
Participant self-report on the number of times having vaginal sex without using a condom during the past 30 days
Measured: Assessed three months after the intervention period has ended
Number of sexual partners
Participant self-report of the number of sexual partners in the the past three months
Measured: Assessed three months after the intervention period has ended
Effective contraceptive use
Participant self-report on whether or not they are currently using effective (prescription) contraception or not
Measured: Assessed three months after the intervention period has ended
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2021
- Study start19 Jun 2021
- Primary completion10 May 2024
- Study completion30 Jun 2024
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
- Masking
- None (open label)
- Enrolment
- 405 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Policy & Research Group
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Health and Human Services, Mathematica Policy Research, Inc.
- Responsible party
- Sponsor
- Investigators
- Eric Jenner, PhD, Principal investigator, The Policy & Research Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04798248
- Sponsor's protocol ID
- 1 TP2AH000076-01-00
- Acronym
- MARSSI
- Status last verified
- Jul 2025
- First submitted
- 9 Mar 2021
- Last updated
- 29 Jul 2025
- 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 components were completed). Basic data cleaning steps will be taken in order to ensure data are unidentifiable and to increase usability.
Publications
Shrier LA, Milliren CE, Ciriello B, O'Connell MM, Harris SK. Patterns of Engagement With the mHealth Component of a Sexual and Reproductive Health Risk Reduction Intervention for Young People With Depression: Latent Trajectory Analysis. JMIR Mhealth Uhealth. 2025 Jul 11;13:e70219. doi: 10.2196/70219.
PubMed 40644628
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Momentary Affect Regulation - Safer Sex Intervention
- ClinicalTrials.gov ID
- NCT04798248
- Acronym / sponsor ID
- MARSSI / 1 TP2AH000076-01-00
- Conditions
- Teen Pregnancy Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 405 participants (actual)
- Lead sponsor
- The Policy & Research GroupUniversity, hospital or other
- Collaborators
- Department of Health and Human Services, Mathematica Policy Research, Inc.
- Study start
- 19 Jun 2021 (actual)
- Primary completion
- 10 May 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 15 Mar 2021 (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 Momentary Affect Regulation - Safer Sex Intervention (treatment) relative to the offer to participate in the control condition on participants' reported condom use, use of effective contraception, and number of sexual partners three months after the end of the treatment intervention.
Detailed description
The Policy \& Research Group (PRG) will be conducting a rigorous evaluation of an innovative intervention designed to reduce unplanned pregnancy and sexually transmitted infections in young women with depression, entitled Momentary Affect Regulation - Safer Sex Intervention (MARSSI). MARSSI was developed by Dr. Lydia Shrier of Boston Children's Hospital. MARSSI has three components. The first is a manualized session with a sexual and reproductive health counselor, who uses motivational interviewing (MI) techniques to help the young woman identify a risk-reducing goal for her sexual behavior, develop a change plan, and provide depression education and skills, based on cognitive behavioral therapy. The second component is a mobile health (mhealth) application that the young woman loads on her smartphone and, for four weeks, uses to complete app-prompted reports 3 times a day and a scheduled report once a day. When she reports poor affect, low contraceptive or condom self-efficacy, pregnancy desire, or desire for sex to regulate affect, she receives personalized messages prompting healthy behaviors and cognitive behavioral skill use. The third component is a booster session that occurs after 4 weeks of app use. The young woman meets with the counselor again to review her behavior and relationships, discuss progress toward her goal, and learn a new skill. Through these components, MARSSI aims to enhance motivation to change risk behaviors, provides skills to address depression's effects on behavior, and prompts and reinforces healthy affect regulation, cognitive behavioral skill use, and behavior change in daily life.
The Policy \& Research Group (PRG) will conduct an implementation evaluation and an impact evaluation, using an individual randomized controlled trial, to test the efficacy of this new intervention. The study will target young women ages 16-21 who have depressive symptoms and are recent clients of sexual and reproductive health clinics. The primary focus of the study will be to investigate the impact of the intervention on three self-reported sexual behaviors: 1) condom use; 2) use of effective contraception; and 3) number of sexual partners. The study will also include exploratory investigations of a number of other sexual behaviors and theoretically relevant antecedents to change in behavior and sexual health, including but not limited to: 1) engagement in protective sexual behavior; 2) condom use at last vaginal sex; 3) effective contraceptive use at last vaginal sex; 4) dual methods of protection; 5) frequency of vaginal, anal, and oral sex; 6) substance use before any type of sex; 7) types of sexual partners/relationships; 8) depressive symptoms; 9) sexual communication self-efficacy; 10) motivation to change risky sexual behaviors; 11) contraceptive and condom knowledge; 12) contraceptive and condom planning self-efficacy; and 13) use of cognitive restructuring.
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; 1 month post baseline); short-term (4 months post-baseline) follow-up; and long-term (7 months post baseline) follow-up.
Starting in June 2021 and continuing for 23 months, 600 participants who have received reproductive health care in the past two years (nationally) will be recruited and enrolled into the study by trained Planned Parenthood research coordinators. The final year 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
| Arm | Type | Receives |
|---|---|---|
| Momentary Affect Regulation - Safer Sex Intervention | Experimental | Behavioral: Momentary Affect Regulation - Safer Sex Intervention (MARSSI)Momentary Affect Regulation - Safer Sex Intervention (MARSSI) is the treatment condition. MARSSI aims to enhance an individual's motivation to change risk behaviors, provides skills to address depression's effects on behavior, and prompts and reinforces healthy affect regulation, cognitive behavioral skill use, and behavior change in daily life. |
| Podcast Health Group | Sham comparator | Behavioral: Podcast Health GroupThe Podcast Health Group is the control counterfactual condition. |
Who may qualify
- Ages
- 16 to 21 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- Visited reproductive health care provider in the past two years
- Own a smartphone
- Have the technical capacity to participate
- Be fluent in English
- Be 16 to 21 years of age
Key exclusion criteria (4 listed)
- Trying to get pregnant or currently pregnant at the time of eligibility screening
- Have given birth during the 6 months preceding eligibility screening
- Married or engaged to be married at the time of eligibility screening
- Identified as fraudulent
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 |
|---|---|---|
| Momentary Affect Regulation - Safer Sex Intervention (MARSSI)MARSSI is an individual-level intervention that involves a one-hour manualized session with a sexual reproductive health (SRH) counselor, followed by one-month of daily use of a mobile health app and a final 20-minute booster session with the SRH counselor. | Behavioural | Momentary Affect Regulation - Safer Sex Intervention |
| Podcast Health GroupParticipants assigned to the Podcast Health Group will listen to ~20 minute podcast episode put out by the Susan G. Komen Foundation about family history of breast cancer; the podcast does not include information related to the outcomes of interest for the study. | Behavioural | Podcast Health Group |
Primary outcome
Times having vaginal sex without a condom
Time frame: Assessed three months after the intervention period has ended
Participant self-report on the number of times having vaginal sex without using a condom during the past 30 days
Number of sexual partners
Time frame: Assessed three months after the intervention period has ended
Participant self-report of the number of sexual partners in the the past three months
Effective contraceptive use
Time frame: Assessed three months after the intervention period has ended
Participant self-report on whether or not they are currently using effective (prescription) contraception or not
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 29 Jul 2025.
- Derived from this study: PubMed 40644628Shrier LA, Milliren CE, Ciriello B, O'Connell MM, Harris SK. Patterns of Engagement With the mHealth Component of a Sexual and Reproductive Health Risk Reduction Intervention for Young People With Depression: Latent Trajectory Analysis. JMIR Mhealth Uhealth. 2025 Jul 11;13:e70219. doi: 10.2196/70219.
- 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 components were completed). 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 principal investigator
The Policy & Research Group
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Momentary Affect Regulation - Safer Sex Intervention (MARSSI) and Podcast Health Group in people with Teen Pregnancy Prevention, run by The Policy & Research Group at 2 sites 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 10 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 29 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
Times having vaginal sex without a condom (time frame: Assessed three months after the intervention period has ended). The study lists 3 primary outcomes in all. 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 NCT04798248, 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 29 Jul 2025.