An interventional study of Healthy futures ("Futuros Saludables") in Pregnancy in Adolescence, Rural Health and Hispanic or Latino, sponsored by Children's Mercy Hospital Kansas City. Completed at 1 site in United States. Open to participants aged 14 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-10.
Sponsored by Children's Mercy Hospital Kansas City · Not applicable, Interventional, and Prevention
The study will utilize an exploratory study design, applying formative research methods to inform the development and pilot testing of an unintended teen pregnancy prevention intervention.
The study uses questionnaires and interviews with youth and community members, to co-develop and pilot test an unintended teen pregnancy prevention intervention in an emerging immigrant Latino rural community, aiming to decrease reproductive health disparities in marginalized communities across the country. To achieve this objective, the team will conduct interviews and co-development sessions, to ensure input from key stakeholders in the community, when developing an intervention.
Delineation of Activities:
Research Activities
Those currently enrolled are only from non-trial aims in this module.
Children's Mercy Hospital Kansas City is the lead sponsor of 209 studies on the registry; 22 are open to participants now.
Of its 18 completed or terminated interventional studies of FDA-regulated products, 14 (78%) have results posted.
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Exclusion Criteria:
The developed intervention will be delivered in a workshop format by facilitators, over 8 sessions for teens and 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. Teens and parent/guardian(s) will complete a 20-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.
Behavioral: Healthy futures ("Futuros Saludables")
The developed intervention will be delivered in a workshop format by facilitators, over 8 sessions for teens and parent/guardian(s). Feedback 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.). Participants will complete sessions, in either Spanish or English depending on participants' preference, using video conference tools. After the delivery of the intervention, facilitators will take field notes and complete a debriefing questionnaire to assess practicality and fidelity. Teens and parent/guardian(s) will complete a 20-minute survey pre-intervention, immediately post-intervention, three-month, six-month, and twelve-month post-intervention. Surveys will assess acceptability and risk behaviors.
A survey analysis of participant degree of acceptance of conducted intervention using a Likert Scale.
This outcome measure identifies the degree in which the intervention is accepted by the participant. Acceptability refers to the extent at which the intervention is perceived as agreeable, or satisfactory to the participant. Acceptability is measured using a Likert Scale in a survey immediately after the 8 session intervention is administered. The Likert Scale ranges from 1-4: 1) Newly Approved Intervention Meets my approval, 2) Newly Approved Intervention is appealing to me, 3) I like the Newly Approved Intervention, 4) I welcome the Newly Approved Intervention.
Time frame: Immediately after intervention
A survey to determine the participants perception of intervention applicability of conducted intervention using a Likert Scale.
This outcome measure identifies the extent in which a participant assesses the appropriateness of the conducted intervention. Appropriateness refers to the perceived ft, relevance, or compatibility of the innovation for a given practice setting, provider, or consumer; and/or perceived ft of the innovation to address a particular issue or problem. Appropriateness is measured using a Likert Scale in a survey immediately after the 2-day intervention is administered. The Likert Scale ranges from 1-4: 1) Newly Approved Intervention seems fitting, 2) Newly Approved Intervention seems suitable, 3) Newly Approved Intervention seems applicable, 4) Newly Approved Intervention seems like a good match.
Time frame: Immediately after intervention.
A survey to determine the facilitators perception of the difficulty of implementing the intervention.
This outcome measure identifies the feasibility for facilitators to conduct the intervention. Feasibility refers to the extent to which an innovation "can be success- fully used or carried out within a given agency or setting". Feasibility will be measured using the facilitator survey that employs a Likert Scale. The Likert Scale ranges from 1-4: 1) Newly Approved Intervention seems implementable, 2) Newly Approved Intervention seems doable, 3) Newly Approved seems easy to use. Feasibility will also be measured using ethnographic field notes that are analyzed using inductively using a grounded theory approach. Weekly meetings will allow for resolution of discrepancies and to establish inter-rater reliability.
Time frame: Facilitator surveys will occur immediately post intervention. Field notes will be collected during the delivery of the intervention.
A survey analysis of teen sexual behavior risk pre and post intervention.
This outcome measure analyzes teens' sexual behaviors, to determine their overall sexual risk. The outcome measure analyzes participant condom usage and multiple partners as identities of risk over the last 90 days. The survey is designed to identify if sexual risk is decreased post-intervention for participants (Increase in condom usage and decrease in the number of sexual partners).
Time frame: Average of 20-minute survey pre-intervention, immediately after intervention, three-month, six-month, and twelve-month post-intervention
A survey analysis of teen sexual intention pre and post intervention.
The survey will analyze the following: "Attitudes towards protection, Attitudes towards risky behavior, Knowledge of pregnancy risk, Knowledge of sexually transmitted infections risk, Motivation to delay childbearing, Intention measures, Refusal skills, condom negotiation skills". This survey aims to examine if sexual intentions and knowledge have changed between pre and post intervention.
Time frame: Average of 20-minute survey pre-intervention, immediately after intervention, three-month, six-month, and twelve-month post-intervention
Pregnancy risk/prevention self-efficacy
Survey analysis of "history of teen pregnancy" and "pregnancy prevention self -efficacy". This survey aims to examine if history of teen pregnancy and self-efficacy in preventing pregnancy have changed between pre and post intervention.
Time frame: Average of 20-minute survey pre-intervention, immediately after intervention, three-month, six-month, and twelve-month post-intervention
Cultural Pride
A survey analysis of teen and adult Latino cultural pride. The survey will analyze the following: "Cultural pride and Family interactions" This survey aims to examine the extent of the individual's pride in Latino background and participation in family activities that reflect Latino values and if changes from pre to post intervention.
Time frame: Average of 20-minute survey pre-intervention, immediately after intervention, three-month, six-month, and twelve-month post-intervention
For teens Healthy Relationships
The survey will analyze "teen knowledge of healthy relationships" and "communication with parents about healthy relationships" . This survey aims to examine if teen knowledge of healthy relationships and their communication with parents about healthy relationships changes from pre to post intervention.
Time frame: Average of 20-minute survey pre-intervention, immediately after intervention, three-month, six-month, and twelve-month post-intervention
For Adults difficult conversations
The survey will analyze the following: " Difficult conversations". This survey aims to examine if parent's perceived competence and self-efficacy to approach difficult conversations with their teen changes from pre to post intervention.
Time frame: Average of 20-minute survey pre-intervention, immediately after intervention, three-month, six-month, and twelve-month post-intervention
Family Connections
A survey analysis of motivation to interact with their teen/adult. The survey will analyze the following: "Family connections". This survey aims to examine change in knowledge, attitudes and intentions about interaction with their teen/adult from pre to post intervention.
Time frame: Average of 20-minute survey pre-intervention, immediately after intervention, three-month, six-month, and twelve-month post-intervention
Communication
A survey analysis of parent/teen attachment. The survey will analyze the following "parent-teen relationship". This survey aims to examine if there is a change in general parent/teen attachment pre and post intervention.
Time frame: Average of 20-minute survey pre-intervention, immediately after intervention, three-month, six-month, and twelve-month post-intervention
Mental health: Parent Adolescent Communication scale
The Parent-Adolescent Communication Scale (PACS) is a measure used to evaluate the quality of communication between parents and adolescents. The measure consists of two subscales, the Open Family Communication subscale, which addresses the degree of openness in communication, and the Problems in Family Communication subscale, which addresses difficulties in communication. This survey aims to examine if there is a change in parent-teen communication about mental health pre and post intervention.
Time frame: Average of 20-minute survey pre-intervention, immediately after intervention, three-month, six-month, and twelve-month post-intervention
Health care utilization and access
A survey analysis of healthcare utilization. The survey will analyze if participants have received care in the past 3 months and the type of care received. This survey aims to examine if there is a change in healthcare use and access to health care in general, and in particular for mental and sexual health, pre and post intervention.
Time frame: Average of 20-minute survey pre-intervention, immediately after intervention, three-month, six-month, and twelve-month post-intervention
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Children's Mercy Hospital Kansas City