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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in United States

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.

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 groups in NCT04798248
Study groupRoleWhat they receive
Momentary Affect Regulation - Safer Sex InterventionExperimentalMomentary 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 GroupSham comparatorThe 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.

  1. 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

  2. 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

  3. 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.

  1. First posted15 Mar 2021
  2. Study start19 Jun 2021
  3. Primary completion10 May 2024
  4. Study completion30 Jun 2024

Resources

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)
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

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.

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