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"Healthy Futures" Program for Preventing Teen Pregnancy in Latinos
N/A
Waitlist Available
Led By Romina L Barral, M.D.
Research Sponsored by Children's Mercy Hospital Kansas City
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
14-18 years old
Be younger than 65 years old
Must not have
Non-English or non-Spanish speaking
Incarcerated minors
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15-minute survey pre-intervention, three-month, six-month, and twelve-month post-intervention
Awards & highlights
No Placebo-Only Group
Summary
This trial will study how to prevent teen pregnancy and test an intervention plan.
Who is the study for?
This trial is for Latino teens aged 14-18 who speak English or Spanish. It's focused on preventing unintended pregnancies in rural areas. Teens with developmental delays, significant behavioral health issues, those who are incarcerated, or in foster care cannot participate.
What is being tested?
The 'Healthy futures' ('Futuros Saludables') program is being tested to see if it can help prevent teen pregnancy among Latinos. The study will develop and try out this new intervention using exploratory research methods.
What are the potential side effects?
Since this trial involves educational interventions rather than medical treatments, there are no traditional side effects; however, participants may experience emotional or psychological impacts from the discussions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 14 and 18 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not speak English or Spanish.
Select...
I am a minor currently in detention.
Select...
I am a minor currently in foster care.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 15-minute survey pre-intervention, three-month, six-month, and twelve-month post-intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15-minute survey pre-intervention, three-month, six-month, and twelve-month post-intervention
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
A survey analysis of participant degree of acceptance of conducted intervention using a Likert Scale.
A survey to determine the facilitators perception of the difficulty of implementing the intervention.
A survey to determine the participants perception of intervention applicability of conducted intervention using a Likert Scale.
Secondary study objectives
A survey analysis of teen sexual behavior risk pre and post intervention.
A survey analysis of teen sexual intention pre and post intervention.
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: One arm pilot trialExperimental Treatment1 Intervention
The developed intervention will be delivered in a workshop format by facilitators, over 8 sessions for teens and 2 sessions for parent/guardian(s). Feedback will be elicited on delivery mode (virtual, in-person, or hybrid) during the co-development sessions. If in-person/hybrid is suggested, feedback will be elicited about preferred location (e.g., a local community center, sports club, etc.). Sessions will be hosted in either Spanish or English depending on participants' preference, using video conference tools. Parent/guardian(s) will complete a 5-minute survey pre-intervention and immediately post-intervention. Teens will complete a 15-minute survey pre-intervention, immediately after the 8 session intervention, three-month post-intervention, six-month post-intervention, and twelve-month post-intervention. Surveys will assess acceptability and risk behaviors. As in the published Cuidate trials, previously used measures will be used to document validity and comparability.
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Who is running the clinical trial?
Children's Mercy Hospital Kansas CityLead Sponsor
256 Previous Clinical Trials
940,235 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
2,055 Previous Clinical Trials
2,731,794 Total Patients Enrolled
Romina L Barral, M.D.Principal InvestigatorChildren's Mercy Hospital Kansas City
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