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Pregnancy in AdolescenceNCT06105905

Latino Teen Pregnancy Prevention K23

A study testing Healthy futures ("Futuros Saludables") in people with Pregnancy in Adolescence and Rural Health, run by Children's Mercy Hospital Kansas City at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 14 to 18 yearsHealthy volunteers can take part
What is being tested?
Healthy futures ("Futuros Saludables")
Could I receive a placebo?
No, everyone receives an active treatment
How many people
94 participants
Where
1 siteUnited States
Study dates
23 Sep 2022to 30 Jun 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 to 18 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Childrens Mercy Hospital and Clinics

    Kansas City, Missouri, 64108

Other trials in United States

About this study

Official title: Reducing Reproductive Health Disparities Among Latino Youth Living in Rural Communities

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.

Read the 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.

Being tested
Healthy futures ("Futuros Saludables")

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Healthy futures ("Futuros Saludables")Behavioural

    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.

Study groups in NCT06105905
Study groupRoleWhat they receive
One arm pilot trialExperimentalThe 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.
Receives: Behavioral: Healthy futures ("Futuros Saludables")

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Immediately after intervention

  2. 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.

    Measured: Immediately after intervention.

  3. 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.

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

Secondary outcomes (10)
  1. 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).

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

  5. 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.

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

  6. 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.

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

  7. 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.

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

  8. 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.

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

  9. 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.

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

  10. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Oct 2023
  2. Study start23 Sep 2022
  3. Primary completion30 Jun 2026
  4. Study completion30 Jun 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
94 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06105905
Sponsor's protocol ID
STUDY00002128
Other IDs
1K23HD109464-01
Status last verified
Aug 2026
First submitted
12 Oct 2023
Last updated
10 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Healthy futures ("Futuros Saludables") in people with Pregnancy in Adolescence and Rural Health, run by Children's Mercy Hospital Kansas City at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

A survey analysis of participant degree of acceptance of conducted intervention using a Likert Scale. (time frame: Immediately after intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.

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