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Behavioural Intervention
Adolescent Pregnancy Prevention Programs for Reproductive Health
N/A
Recruiting
Research Sponsored by Trinity Church Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 3 months and at 12 months after baseline data collection
Awards & highlights
No Placebo-Only Group
Summary
This trial will assess an innovative program to prevent pregnancy and STIs among youth at risk in Miami, to answer the question of how it affects unprotected sex.
Who is the study for?
This trial is for 9th and 10th graders in the greater Miami area who are at high risk of pregnancy and STIs. Participants should be able to attend mainstream classes without severe cognitive, mental health, or behavioral impairments.
What is being tested?
The study tests if adding Mind Matters trauma-coping skills curriculum to Relationship Smarts Plus reduces unprotected sex rates among teens compared to just Relationship Smarts Plus or financial literacy (PAYA).
What are the potential side effects?
Since this trial involves educational programs rather than medical interventions, traditional side effects like those from medication are not expected. However, participants may experience emotional discomfort discussing personal topics.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 3 months and at 12 months after baseline data collection
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 3 months and at 12 months after baseline data collection
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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.
Secondary study objectives
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.
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.
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.
+11 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Relationship Smarts Plus & Mind MattersExperimental Treatment1 Intervention
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).
Group II: Relationship Smarts PlusExperimental Treatment1 Intervention
Relationship Smarts Plus (RSP+) is an adolescent pregnancy prevention curriculum.
Group III: Control GroupActive Control1 Intervention
Financial literacy curriculum, Preparing Adolescents for Young Adulthood (PAYA)
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Who is running the clinical trial?
Trinity Church Inc.Lead Sponsor
AMTC & AssociatesUNKNOWN
1 Previous Clinical Trials
2,600 Total Patients Enrolled
Department of Health and Human ServicesFED
232 Previous Clinical Trials
933,453 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have severe cognitive, mental health, or behavioral issues.I am a student with an Individualized Education Plan in a mainstream classroom.I am a high school student in grades 9 through 12.
Research Study Groups:
This trial has the following groups:- Group 1: Control Group
- Group 2: Relationship Smarts Plus & Mind Matters
- Group 3: Relationship Smarts Plus
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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