Teen PregnancyNCT05889689
Evaluation of an Adolescent Pregnancy Prevention Program; Relationship Smarts+ With Lessons From Mind Matters
A study testing Relationship Smarts Plus & Mind Matters, Relationship Smarts Plus alone and Preparing Adolescents for Young Adulthood (PAYA). in people with Teen Pregnancy and Contraception Behavior, run by Trinity Church Inc. at 1 site in United States.
Trial summary
The goal of this randomized control trial (RCT) is to assess an innovative adolescent pregnancy prevention program among youth that are at the highest risk of adolescent pregnancy, to prevent pregnancy and Sexually Transmitted Infections (STIs), including HIV/AIDS in the greater Miami area in Florida. Read more about this study
- Who is it for?
- Ages 13 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Teen Pregnancy, Contraception Behavior, Sexually Transmitted Diseases
- What is being tested?
- Relationship Smarts Plus & Mind Matters, Relationship Smarts Plus alone and Preparing Adolescents for Young Adulthood (PAYA).
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 945 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Sep 2023to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 13 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- For schools to be included in the study:
- They have to be located within the greater Miami area.
- For individuals:
- Students enrolled in either 9th,10th, 11th and 12th grade
- Students who do not have severe cognitive, mental health, or behavioral impairment.
- Students with Individualized Education Plans who are part of the mainstream classrooms.
- Youth aged 13-19 residing in the greater Miami-Dade Communities
Who cannot join
- Students who do not consent to be in the study
- Students who are part of the pilot study
- Students who have been randomized in a previous cohort of the study
- Students with an Individualized Education Plan (IEP) who are in restricted placement will not be able to participate in the program as they will not be part of the mainstream classrooms where the program is implemented.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Relationship Smarts Plus and Mind Matters: A Randomized Control Trial of a Youth Intervention to Reduce Sexual Risk Behaviors.
The goal of this randomized control trial (RCT) is to assess an innovative adolescent pregnancy prevention program among youth that are at the highest risk of adolescent pregnancy, to prevent pregnancy and Sexually Transmitted Infections (STIs), including HIV/AIDS in the greater Miami area in Florida. The primary research question it aims to answer is:
(RQ1a): What is the effect of adding 4.5-hours from the Mind Matters trauma-coping skills curriculum to the Relationship Smarts Plus curriculum, on rates of unprotected sex among 13-19-year-old youth compared to those receiving only the Relationship Smarts Plus curriculum? (RQ1b): What is the effect of the Relationship Smarts Plus curriculum on rates of unprotected sex among 13-19-year-old youth compared to the control group receiving only financial literacy? Participants will complete program lessons and complete surveys for data collection.
The RCT will assess behavioral health outcomes and other psychological outcomes at four-time points (baseline, post-program, 3 months, and 12 months)
Read the detailed description
The intervention combines the pregnancy prevention curriculum, Relationship Smarts Plus (RSP+) with lessons from the trauma coping skills curriculum, Mind Matters (MM). The mental health component was added to assess the importance of mental health as a risk factor for teen pregnancy. Researchers will estimate the effect of Mind Matters (MM) by comparing the RSP+ \& MM treatment arm with the RSP+ treatment arm. This answers RQ1a: If MM has an impact, then researchers will answer RQ1b by comparing the RSP+ treatment arm with the control arm. If there's no impact, then RQ1b will be answered by comparing the pooled RSP+ and RSP+ \& MM treatment arms with the control arm.
This study is funded through the Personal Responsibility Education Program Innovative Strategies (PREIS), which is administered by the Family and Youth Services Bureau, part of Health and Human Services,
Trinity Church, Miami Gardens, is responsible for site and participant recruitment as well as the implementation of the intervention. Participants are randomized at the classroom level. All control group participants will only receive a financial literacy program.
AMTC \& Associates is the external evaluator, The Dibble Institute is the curricula developer.
- Conditions
- Teen Pregnancy, Contraception Behavior, Sexually Transmitted Diseases, Reproductive Health, Sexual Risk Behavior
- Being tested
- Relationship Smarts Plus & Mind Matters, Relationship Smarts Plus alone, Preparing Adolescents for Young Adulthood (PAYA).
- Medical subject headings
- Contraception Behavior, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relationship Smarts Plus & Mind MattersBehavioural
18.5 hours long intervention that combines the Relationship Smarts Plus teen pregnancy prevention curriculum with lessons from the Mind Matters trauma-coping skills curriculum
Relationship Smarts Plus aloneBehavioural
14-hour-long curriculum that addresses pregnancy prevention within the context of teaching relationship skills for young teens.
Preparing Adolescents for Young Adulthood (PAYA).Behavioural
A financial literacy curriculum
| Study group | Role | What they receive |
|---|---|---|
| Relationship Smarts Plus & Mind Matters | Experimental | Relationship Smarts Plus (RSP+) is an adolescent pregnancy prevention curriculum that will be combined with lessons from a trauma-coping skills curriculum, Mind Matters (MM). Receives: Behavioral: Relationship Smarts Plus & Mind Matters |
| Relationship Smarts Plus | Experimental | Relationship Smarts Plus (RSP+) is an adolescent pregnancy prevention curriculum. Receives: Behavioral: Relationship Smarts Plus alone |
| Control Group | Active comparator | Financial literacy curriculum, Preparing Adolescents for Young Adulthood (PAYA) Receives: Behavioral: Preparing Adolescents for Young Adulthood (PAYA). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unprotected sex as measured by 4 items from the survey. The 4 items will be combined to create a binary variable as an indicator of either protected sex or unprotected sex.
The proportion of youth who, in comparison to the control group, report lower rates of unprotected sex
Measured: At 12 months after baseline data collection
Secondary outcomes (25)
Unprotected sex as measured by 4 items from the survey. The 4 items will be combined to create a binary variable as an indicator of either protected sex or unprotected sex.
The proportion of youth who, in comparison to the control group, report lower rates of unprotected sex.
Measured: At 3 months after baseline data collection.
Sexual intercourse as measured by a binary indicator asking participants if they ever engaged in sexual intercourse
The proportion of youth who, in comparison to the control group, report lower rates of sexual intercourse
Measured: At 12 months after baseline data collection
Sexual intercourse as measured by a binary indicator asking participants if they ever engaged in sexual intercourse
The proportion of youth who, in comparison to the control group, report lower rates of sexual intercourse
Measured: At 3 months after baseline data collection
Oral sex as measured by a single binary indicator asking participants if they ever engaged in oral sex
The proportion of youth who, in comparison to the control group, report lower rates of oral sex
Measured: At 12 months after baseline data collection
Oral sex as measured by a single binary indicator asking participants if they ever engaged in oral sex
The proportion of youth who, in comparison to the control group, report lower rates of oral sex
Measured: At 3 months after baseline data collection
Sexual Initiation as measured by a 7- item 5 response ordinal scale categorical indicator of when individuals intent to start engaging in different sexual activities
The proportion of youth who, in comparison to the control group, report lower rates of sexual initiation
Measured: At 3 months and at 12 months after baseline data collection
Sexual Initiation as measured by a 7- item 5 response ordinal scale categorical indicator of when individuals intent to start engaging in different sexual activities
The proportion of youth who, in comparison to the control group, report lower rates of sexual initiation
Measured: At 12 months after baseline data collection
Skills to negotiate abstinence & resist pressure to have sex measured by a 10-item scale on a 5-point scale showing how confident they are in answering each of the 10 items. A score will be calculated by averaging their responses.
The proportion of youth who, in comparison to the control group, report they have the skills to negotiate abstinence and resist pressure to have sex.
Measured: At 12 months after baseline data collection
Skills to negotiate abstinence & resist pressure to have sex measured by a 10-item scale on a 5-point scale showing how confident they are in answering each of the 10 items. A score will be calculated by averaging their responses.
The proportion of youth who, in comparison to the control group, report they have the skills to negotiate abstinence and resist pressure to have sex.
Measured: At 3 months after baseline data collection
Intent to use condoms as measured by a binary indicator that asks participants if they will use condoms and other contraceptives
The proportion of youth who, in comparison to the control group, report intent to consistently use condoms.
Measured: At 3 months and at 12 months after baseline data collection
Intent to use condoms as measured by a binary indicator that asks participants if they will use condoms and other contraceptives
The proportion of youth who, in comparison to the control group, report intent to consistently use condoms.
Measured: At 12 months after baseline data collection
Knowledge of HIV/STIs as measured by 8-item True/False/Unsure responses to survey items. Items will be scored as 1 if correct & 0 if incorrect. Composite scores of correct items will be calculated. Scores range from 0 to 8
The proportion of youth who, in comparison to the control group, report higher knowledge of HIV/STIs.
Measured: At 12 months after baseline data collection
Knowledge of HIV/STIs as measured by 8-item True/False/Unsure responses to survey items. Items will be scored as 1 if correct & 0 if incorrect. Composite scores of correct items will be calculated. Scores range from 0 to 8
The proportion of youth who, in comparison to the control group, report higher knowledge of HIV/STIs.
Measured: At 3 months after baseline data collection
Future-oriented goals as measured by a 10-item 6-point response scale, respondents will show how much they agree or disagree with each of the 10 statements. A score will be calculated for each of the respondents by averaging their responses.
The proportion of youth who, in comparison to the control group, report having future-oriented goals
Measured: At 12 months after baseline data collection
Future-oriented goals as measured by a 10-item 6-point response scale, respondents will show how much they agree or disagree with each of the 10 statements. A score will be calculated for each of the respondents by averaging their responses.
The proportion of youth who, in comparison to the control group, report having future-oriented goals
Measured: At 3 months after baseline data collection
Healthy life skills measured by a 12-item 6-point response scale, respondents will show how much they agree or disagree with each of the 12 items. A score will be calculated for each of the respondents by averaging their responses.
The proportion of youth who, in comparison to the control group, report more health life skills
Measured: At 12 months after baseline data collection
Healthy life skills measured by a 12-item 6-point response scale, respondents will show how much they agree or disagree with each of the 12 items. A score will be calculated for each of the respondents by averaging their responses.
The proportion of youth who, in comparison to the control group, report more health life skills
Measured: At 3 months after baseline data collection
Awareness of healthy relationships as measured by a 10-item 6-point response scale, respondents will show how much they agree or disagree with each of the 10 statements. A score will be calculated for each of the respondents by averaging their responses.
The proportion of youth who, in comparison to the control group, report higher awareness of healthy relationships
Measured: At 12 months after baseline data collection
Awareness of healthy relationships as measured by a 10-item 6-point response scale, respondents will show how much they agree or disagree with each of the 10 statements. A score will be calculated for each of the respondents by averaging their responses.
The proportion of youth who, in comparison to the control group, report higher awareness of healthy relationships
Measured: At 3 months after baseline data collection
General communication skills as measured by a 7-item scale on a 5-point scale, respondents will show how much they agree or disagree with each of the 7 statements. A score will be calculated for each of the respondents by averaging their responses.
The proportion of youth who, in comparison to the control group, report more communication skills
Measured: At 12 months after baseline data collection
General communication skills as measured by a 7-item scale on a 5-point scale, respondents will show how confident they are with each of the 7 statements. A score will be calculated for each of the respondents by averaging their responses.
The proportion of youth who, in comparison to the control group, report more communication skills
Measured: At 3 months after baseline data collection
Conflict resolution skills as measured using 8 items on a 5-point scale, respondents will show how confident they are in answering each of the 8 statements. A score will be calculated for each of the respondents by averaging their responses.
The proportion of youth who, in comparison to the control group, report more conflict resolution skills
Measured: At 3 months and at 12 months after baseline data collection
Conflict resolution skills as measured using 8 items on a five-point response scale, respondents will show how confident they are in answering each of the 8 statements. A score will be calculated for each of the respondents by averaging their responses.
The proportion of youth who, in comparison to the control group, report more conflict resolution skills
Measured: At 12 months after baseline data collection
Resilience as measured by the Connor-Davidson Resilience Scale (CD-RISC). A 5 point rating of how participants have felt over the past month. Scores range from 0-4. An average score will be calculated.
The proportion of youth who, in comparison to the control group, report higher resiliency
Measured: At 12 months after baseline data collection
Resilience as measured by the Connor-Davidson Resilience Scale (CD-RISC). A 5 point rating of how participants have felt over the past month. Scores range from 0-4. An average score will be calculated.
The proportion of youth who, in comparison to the control group, report higher resiliency
Measured: At 3 months after baseline data collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2023
- Study start23 Sep 2023
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Teen PregnancyStudies 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
- 945 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Trinity Church Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- AMTC & Associates, Department of Health and Human Services
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05889689
- Sponsor's protocol ID
- 90AP2700-01-00
- Status last verified
- May 2025
- First submitted
- 12 May 2023
- Last updated
- 30 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: At this time, there is no plan to share Individual Participant Data with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Smarts Plus and Mind Matters: A Randomized Control Trial of a Youth Intervention to Reduce Sexual Risk Behaviors.
- ClinicalTrials.gov ID
- NCT05889689
- Acronym / sponsor ID
- 90AP2700-01-00
- Conditions
- Teen Pregnancy, Contraception Behavior, Sexually Transmitted Diseases, Reproductive Health, Sexual Risk Behavior
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 945 participants (estimated)
- Lead sponsor
- Trinity Church Inc.University, hospital or other
- Collaborators
- AMTC & Associates, Department of Health and Human Services
- Study start
- 23 Sep 2023 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 5 Jun 2023 (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 goal of this randomized control trial (RCT) is to assess an innovative adolescent pregnancy prevention program among youth that are at the highest risk of adolescent pregnancy, to prevent pregnancy and Sexually Transmitted Infections (STIs), including HIV/AIDS in the greater Miami area in Florida. The primary research question it aims to answer is:
(RQ1a): What is the effect of adding 4.5-hours from the Mind Matters trauma-coping skills curriculum to the Relationship Smarts Plus curriculum, on rates of unprotected sex among 13-19-year-old youth compared to those receiving only the Relationship Smarts Plus curriculum? (RQ1b): What is the effect of the Relationship Smarts Plus curriculum on rates of unprotected sex among 13-19-year-old youth compared to the control group receiving only financial literacy? Participants will complete program lessons and complete surveys for data collection.
The RCT will assess behavioral health outcomes and other psychological outcomes at four-time points (baseline, post-program, 3 months, and 12 months)
Detailed description
The intervention combines the pregnancy prevention curriculum, Relationship Smarts Plus (RSP+) with lessons from the trauma coping skills curriculum, Mind Matters (MM). The mental health component was added to assess the importance of mental health as a risk factor for teen pregnancy. Researchers will estimate the effect of Mind Matters (MM) by comparing the RSP+ \& MM treatment arm with the RSP+ treatment arm. This answers RQ1a: If MM has an impact, then researchers will answer RQ1b by comparing the RSP+ treatment arm with the control arm. If there's no impact, then RQ1b will be answered by comparing the pooled RSP+ and RSP+ \& MM treatment arms with the control arm.
This study is funded through the Personal Responsibility Education Program Innovative Strategies (PREIS), which is administered by the Family and Youth Services Bureau, part of Health and Human Services,
Trinity Church, Miami Gardens, is responsible for site and participant recruitment as well as the implementation of the intervention. Participants are randomized at the classroom level. All control group participants will only receive a financial literacy program.
AMTC \& Associates is the external evaluator, The Dibble Institute is the curricula developer.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Relationship Smarts Plus & Mind Matters | Experimental | Behavioral: Relationship Smarts Plus & Mind MattersRelationship Smarts Plus (RSP+) is an adolescent pregnancy prevention curriculum that will be combined with lessons from a trauma-coping skills curriculum, Mind Matters (MM). |
| Relationship Smarts Plus | Experimental | Behavioral: Relationship Smarts Plus aloneRelationship Smarts Plus (RSP+) is an adolescent pregnancy prevention curriculum. |
| Control Group | Active comparator | Behavioral: Preparing Adolescents for Young Adulthood (PAYA).Financial literacy curriculum, Preparing Adolescents for Young Adulthood (PAYA) |
Who may qualify
- Ages
- 13 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- They have to be located within the greater Miami area.
- Students enrolled in either 9th,10th, 11th and 12th grade
- Students who do not have severe cognitive, mental health, or behavioral impairment.
- Students with Individualized Education Plans who are part of the mainstream classrooms.
- Youth aged 13-19 residing in the greater Miami-Dade Communities
Key exclusion criteria (4 listed)
- Students who do not consent to be in the study
- Students who are part of the pilot study
- Students who have been randomized in a previous cohort of the study
- Students with an Individualized Education Plan (IEP) who are in restricted placement will not be able to participate in the program as they will not be part of the mainstream classrooms where the program is implemented.
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 |
|---|---|---|
| Relationship Smarts Plus & Mind Matters18.5 hours long intervention that combines the Relationship Smarts Plus teen pregnancy prevention curriculum with lessons from the Mind Matters trauma-coping skills curriculum | Behavioural | Relationship Smarts Plus & Mind Matters |
| Relationship Smarts Plus alone14-hour-long curriculum that addresses pregnancy prevention within the context of teaching relationship skills for young teens. | Behavioural | Relationship Smarts Plus |
| Preparing Adolescents for Young Adulthood (PAYA).A financial literacy curriculum | Behavioural | Control Group |
Primary outcome
Unprotected sex as measured by 4 items from the survey. The 4 items will be combined to create a binary variable as an indicator of either protected sex or unprotected sex.
Time frame: At 12 months after baseline data collection
The proportion of youth who, in comparison to the control group, report lower rates of unprotected sex
25 secondary outcomes
Unprotected sex as measured by 4 items from the survey. The 4 items will be combined to create a binary variable as an indicator of either protected sex or unprotected sex.
Time frame: At 3 months after baseline data collection.
Sexual intercourse as measured by a binary indicator asking participants if they ever engaged in sexual intercourse
Time frame: At 12 months after baseline data collection
Sexual intercourse as measured by a binary indicator asking participants if they ever engaged in sexual intercourse
Time frame: At 3 months after baseline data collection
Oral sex as measured by a single binary indicator asking participants if they ever engaged in oral sex
Time frame: At 12 months after baseline data collection
Oral sex as measured by a single binary indicator asking participants if they ever engaged in oral sex
Time frame: At 3 months after baseline data collection
Sexual Initiation as measured by a 7- item 5 response ordinal scale categorical indicator of when individuals intent to start engaging in different sexual activities
Time frame: At 3 months and at 12 months after baseline data collection
Sexual Initiation as measured by a 7- item 5 response ordinal scale categorical indicator of when individuals intent to start engaging in different sexual activities
Time frame: At 12 months after baseline data collection
Skills to negotiate abstinence & resist pressure to have sex measured by a 10-item scale on a 5-point scale showing how confident they are in answering each of the 10 items. A score will be calculated by averaging their responses.
Time frame: At 12 months after baseline data collection
Skills to negotiate abstinence & resist pressure to have sex measured by a 10-item scale on a 5-point scale showing how confident they are in answering each of the 10 items. A score will be calculated by averaging their responses.
Time frame: At 3 months after baseline data collection
Intent to use condoms as measured by a binary indicator that asks participants if they will use condoms and other contraceptives
Time frame: At 3 months and at 12 months after baseline data collection
Intent to use condoms as measured by a binary indicator that asks participants if they will use condoms and other contraceptives
Time frame: At 12 months after baseline data collection
Knowledge of HIV/STIs as measured by 8-item True/False/Unsure responses to survey items. Items will be scored as 1 if correct & 0 if incorrect. Composite scores of correct items will be calculated. Scores range from 0 to 8
Time frame: At 12 months after baseline data collection
Knowledge of HIV/STIs as measured by 8-item True/False/Unsure responses to survey items. Items will be scored as 1 if correct & 0 if incorrect. Composite scores of correct items will be calculated. Scores range from 0 to 8
Time frame: At 3 months after baseline data collection
Future-oriented goals as measured by a 10-item 6-point response scale, respondents will show how much they agree or disagree with each of the 10 statements. A score will be calculated for each of the respondents by averaging their responses.
Time frame: At 12 months after baseline data collection
Future-oriented goals as measured by a 10-item 6-point response scale, respondents will show how much they agree or disagree with each of the 10 statements. A score will be calculated for each of the respondents by averaging their responses.
Time frame: At 3 months after baseline data collection
Healthy life skills measured by a 12-item 6-point response scale, respondents will show how much they agree or disagree with each of the 12 items. A score will be calculated for each of the respondents by averaging their responses.
Time frame: At 12 months after baseline data collection
Healthy life skills measured by a 12-item 6-point response scale, respondents will show how much they agree or disagree with each of the 12 items. A score will be calculated for each of the respondents by averaging their responses.
Time frame: At 3 months after baseline data collection
Awareness of healthy relationships as measured by a 10-item 6-point response scale, respondents will show how much they agree or disagree with each of the 10 statements. A score will be calculated for each of the respondents by averaging their responses.
Time frame: At 12 months after baseline data collection
Awareness of healthy relationships as measured by a 10-item 6-point response scale, respondents will show how much they agree or disagree with each of the 10 statements. A score will be calculated for each of the respondents by averaging their responses.
Time frame: At 3 months after baseline data collection
General communication skills as measured by a 7-item scale on a 5-point scale, respondents will show how much they agree or disagree with each of the 7 statements. A score will be calculated for each of the respondents by averaging their responses.
Time frame: At 12 months after baseline data collection
General communication skills as measured by a 7-item scale on a 5-point scale, respondents will show how confident they are with each of the 7 statements. A score will be calculated for each of the respondents by averaging their responses.
Time frame: At 3 months after baseline data collection
Conflict resolution skills as measured using 8 items on a 5-point scale, respondents will show how confident they are in answering each of the 8 statements. A score will be calculated for each of the respondents by averaging their responses.
Time frame: At 3 months and at 12 months after baseline data collection
Conflict resolution skills as measured using 8 items on a five-point response scale, respondents will show how confident they are in answering each of the 8 statements. A score will be calculated for each of the respondents by averaging their responses.
Time frame: At 12 months after baseline data collection
Resilience as measured by the Connor-Davidson Resilience Scale (CD-RISC). A 5 point rating of how participants have felt over the past month. Scores range from 0-4. An average score will be calculated.
Time frame: At 12 months after baseline data collection
Resilience as measured by the Connor-Davidson Resilience Scale (CD-RISC). A 5 point rating of how participants have felt over the past month. Scores range from 0-4. An average score will be calculated.
Time frame: At 3 months after baseline data collection
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Individual participant dataSharing planned: No. At this time, there is no plan to share Individual Participant Data with other researchers
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Relationship Smarts Plus & Mind Matters, Relationship Smarts Plus alone and Preparing Adolescents for Young Adulthood (PAYA). in people with Teen Pregnancy and Contraception Behavior, run by Trinity Church Inc. 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 7 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: under way, not looking for participants, as of the sponsor's last update on 30 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Unprotected sex as measured by 4 items from the survey. The 4 items will be combined to create a binary variable as an indicator of either protected sex or unprotected sex. (time frame: At 12 months after baseline data collection). 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 30 Apr 2026.