Latino Teen Pregnancy Prevention K23

NCT06105905 | Enrolling By Invitation DMC

• 2 other identifiers: STUDY000021281K23HD109464-01
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pregnancy in Adolescence; Rural Health; Hispanic or Latino

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Facilitator surveys will occur immediately post intervention. Field notes will be collected during the delivery of the intervention.

Secondary Outcomes (10)

• A survey analysis of teen sexual behavior risk pre and post intervention.

  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.

  Average of 20-minute survey pre-intervention, immediately after intervention, three-month, six-month, and twelve-month post-intervention

• Pregnancy risk/prevention self-efficacy

  Average of 20-minute survey pre-intervention, immediately after intervention, three-month, six-month, and twelve-month post-intervention

• Cultural Pride

  Average of 20-minute survey pre-intervention, immediately after intervention, three-month, six-month, and twelve-month post-intervention

• For teens Healthy Relationships

  Average of 20-minute survey pre-intervention, immediately after intervention, three-month, six-month, and twelve-month post-intervention

Study Arms (1)

One arm pilot trial

EXPERIMENTAL

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")

Interventions

Healthy futures ("Futuros Saludables") BEHAVIORAL

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.

One arm pilot trial

Eligibility Criteria

• Age: 14 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• years old,
• speak English or Spanish,
• Parents/LARs.

You may not qualify if:

• non-English or non-Spanish speaking
• developmental delayed
• have significant behavioral health issues which may interfere with study participation
• incarcerated minors
• minors in foster care.

Sponsors & Collaborators

• Children's Mercy Hospital Kansas City: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Childrens Mercy Hospital and Clinics

Kansas City, Missouri, 64108, United States

Location

Study Officials

• Romina L Barral, M.D.

  Children's Mercy Hospital Kansas City

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics, UMKC School of Medicine; Research Assistant Professor of Pediatrics, University of Kansas Medical Center; Faculty, Division of Adolescent Medicine, Children's Mercy Hospital Kansas City

Study Record Dates

• First Submitted: October 12, 2023
• First Posted: October 30, 2023
• Study Start: September 23, 2022
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: October 24, 2025

Record last verified: 2025-10

Locations

US (1)