Clinical trial NCT06105905: Latino Teen Pregnancy Prevention K23
Official title: Reducing Reproductive Health Disparities Among Latino Youth Living in Rural Communities
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Pregnancy in Adolescence
Rural Health
Hispanic or Latino
Lead sponsor: Children's Mercy Hospital Kansas City
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2023-10-30
Enrollment: 200
Sex: ALL
Minimum age (years): 14
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Detailed description: 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

• Aim 1: Through stakeholder-engaged research, the team will identify key factors (at multiple levels of influence as defined by NIMHD) needed for the co-development of an acceptable and effective teen pregnancy prevention intervention for rural Latino teens: The team will conduct up to 60 key informant interviews to identify barriers to and facilitators of teen pregnancy prevention programming, such as cultural and social norms. Participants will complete a survey to collect demographic data before participating in the interview. Interviews will last 45 to 60 minutes, in either Spanish or English depending on participants' preference, and will be done using video conference tools at the interviewee's location and times of preference to accommodate participants' schedules.

• Aim 2: Using the transcreation framework, co-develop with community partners a teen pregnancy prevention intervention that best fits the community's unique needs and context: Up to 50 key stakeholders will participate in approximately 8 co-development hybrid sessions to discuss, draft, and redraft each module of the Cuidate intervention syllabus, interactive course materials, and activities. The goal of the workgroup is to discuss recommendations and unique needs of local Latino teens (Specific Aim 1) and modify Cuidate in response to local insights. These sessions will be facilitated by the study research team in either Spanish or English depending on the participants' preference. The sessions will be done using a hybrid method that could include in-person interactions and/or video conference tools at the interviewee's location and times of preference to accommodate participants' schedules. Virtual co-development sessions will be conducted via Microsoft Teams. University of Kansas (KU) will utilize Zoom as an alternative option for virtual meetings. In that instance, KU will initiate the Zoom call. In-person, interviews may be conducted at a local church, and/or at a location managed by a Juntos Community Health Specialists.

• Aim 3: Conduct a pilot study to evaluate the feasibility of a co-created teen pregnancy prevention intervention in target Latino rural communities: The co-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) will be elicited during the co-development sessions. If in-person/hybrid is suggested, information will be collected 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 post-intervention, six-month post-intervention, and twelve-month post-intervention (computer-assisted, self-administered, online via Research Electronic Data Capture - REDCap). Surveys will assess acceptability and risk behaviors. As in the published Cuidate trials, previously used measures will be used to document validity and comparability. Surveys will be de-identified; participants will create a code to match surveys without using identifying data.

Those currently enrolled are only from non-trial aims in this module.

Eligibility criteria: Inclusion Criteria:

* 14-18 years old,
* speak English or Spanish,
* Parents/LARs.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: A survey analysis of participant degree of acceptance of conducted intervention using a Likert Scale.
timeFrame: Immediately after intervention
measure: A survey to determine the participants perception of intervention applicability of conducted intervention using a Likert Scale.
timeFrame: Immediately after intervention.
measure: A survey to determine the facilitators perception of the difficulty of implementing the intervention.
timeFrame: Facilitator surveys will occur immediately post intervention. Field notes will be collected during the delivery of the intervention.
Secondary outcomes:
measure: A survey analysis of teen sexual behavior risk pre and post intervention.
timeFrame: Average of 20-minute survey pre-intervention, immediately after intervention, three-month, six-month, and twelve-month post-intervention
measure: A survey analysis of teen sexual intention pre and post intervention.
timeFrame: Average of 20-minute survey pre-intervention, immediately after intervention, three-month, six-month, and twelve-month post-intervention
measure: Pregnancy risk/prevention self-efficacy
timeFrame: Average of 20-minute survey pre-intervention, immediately after intervention, three-month, six-month, and twelve-month post-intervention
measure: Cultural Pride
timeFrame: Average of 20-minute survey pre-intervention, immediately after intervention, three-month, six-month, and twelve-month post-intervention
measure: For teens Healthy Relationships
timeFrame: Average of 20-minute survey pre-intervention, immediately after intervention, three-month, six-month, and twelve-month post-intervention
measure: For Adults difficult conversations
timeFrame: Average of 20-minute survey pre-intervention, immediately after intervention, three-month, six-month, and twelve-month post-intervention
measure: Family Connections
timeFrame: Average of 20-minute survey pre-intervention, immediately after intervention, three-month, six-month, and twelve-month post-intervention
measure: Communication
timeFrame: Average of 20-minute survey pre-intervention, immediately after intervention, three-month, six-month, and twelve-month post-intervention
measure: Mental health: Parent Adolescent Communication scale
timeFrame: Average of 20-minute survey pre-intervention, immediately after intervention, three-month, six-month, and twelve-month post-intervention
measure: Health care utilization and access
timeFrame: Average of 20-minute survey pre-intervention, immediately after intervention, three-month, six-month, and twelve-month post-intervention
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Childrens Mercy Hospital and Clinics
state: Missouri
Study officials:
affiliation: Children's Mercy Hospital Kansas City
name: Romina L Barral, M.D.
role: PRINCIPAL_INVESTIGATOR
References: