- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06482242
My Best Alaskan Life: A Community-Designed Intervention to Improve Youth/Young Adults' Sexual and Mental Health (MBAL)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
SPECIFIC AIMS. Alaskan (AK) youth/young adults (Y/YA) face significant sexual and reproductive health disparities, leading the nation in sexually transmitted infections (STI), which increases risk of contracting HIV. (1-5) AK has the third and fourth highest rates of chlamydia and gonorrhea in the US, a 14% increase in syphilis cases compared to national rates between 2010-2020, and an estimated HIV prevalence of 142.3 per 100,000 (versus 80.7 nationally). (1, 2, 6-11) Concurrently, AK Y/YA experience disproportionately high levels of hopelessness and depression, increasing the likelihood of high-risk sexual behaviors. (12-15) Some 35.8% of AK Y/YA did not use a condom during their last sexual intercourse, and 16.9% do not use any pregnancy prevention method. (12-14) The Centers for Disease Control and American College of Obstetricians and Gynecologists recommend use of Reproductive Life Plan (RLP) tools, goal-setting guides for family planning. (16, 17) However, in previous pilot studies Y/YAs expressed need for an interactive tool to go beyond pregnancy intentions and address sexual and mental health disparities and diverse gender and sexuality identities.(18) Gaps: No RLP tools target sexual & gender minority (SGM) Y/YA and the factors impacting their reproductive goals, including mental health, substance use, or relationship health. Recent systematic reviews of RLP tools note positive reception but lack evidence of efficacy in initiating knowledge or behavioral outcomes. (19) Proposed Project: To address these challenges, the team will employ "My Best Alaskan Life" (MBAL), an online decision-making tool crafted through a 4-year youth-centered, community-based participatory research effort (CBPR). Based on the Health Belief Model, MBAL integrates motivational interviewing to empower Y/YA to define priorities, identify supportive individuals, and enhance health literacy for discussions with healthcare providers and trusted adults. (20-28) This builds on two foundation and two implementation pilot studies where MBAL was refined by three youth advisory committees, five focus groups, and survey responses from 760 Y/YA (14-26) across AK.(18) Pilot outcomes endorsed MBAL's acceptability, appropriateness, feasibility, and capacity to enhance healthy sexual and mental beliefs, particularly for SGM participants. The proposed project builds on the CBPR approach, an established 4-year relationship with Y/YA and supportive adult partners across state and local health agencies, clinic and education health agencies across Alaska. This randomized controlled trial (RCT) will use a step-wedge design to assess MBAL's impact on Alaskan Y/YA through 8 clinical sites in rural and urban communities (n=40 participants per site, total n=320). This project will directly increase research capacity through annual cohorts of Y/YA co-investigators (5 undergraduate and 1 PhD student), recruited from the University of Alaska, who will be trained in qualitative research methods and mentored to lead the qualitative tool development, analysis, and dissemination.
Central hypothesis: MBAL has strong potential to effectively improve sexual & mental health literacy and behavioral outcomes among Alaskan Y/YA through a self-guided, personalized assessment of health motivations, perceived threats, behavior evaluations, & cultural factors that impact one's sexual choices, inclusive of SGM. (Measures with * are utilizing validated scales listed in Table 5 in C4.) AIM 1. Evaluate Short- and Long-Term Impact of MBAL Methods: Pre/Post Survey collected at enrollment/30 days/6 months (1A-1D). Analysis: Quantify changes in sexual health behaviors (measures: sexual health literacy*; condom/contraception use; HIV/STI testing; intention to delay sexual initiation.) Quantify changes in emotional/behavioral health (measures: mental health and well-being*; self-efficacy*; hopelessness*.) Quantify changes in commitment to factors impacting sexual health (measures: locus of control/perceived behavioral control*; motivation for change*; substance use*.) Conduct analyses to identify potential variations in effectiveness of MBAL for diverse groups. (measures: all.) AIM 2. Perform Process Evaluation Methods: Y/YA co-investigator coordinated interviews; semiannual, anonymous surveys with all stakeholders; feedback gathered at meetings; annual anonymous survey with Y/YA co-investigators. Analysis: Understand participant experience and perception of MBAL tool (measures: cultural competence; qualitative data (Y/YA co-investigator interviews). Understand experiences of research and community partners. (measures: Investment in Process and Product*; qualitative feedback. Understand experiences of Y/YA co-investigators. Measures: Student outcomes in research*.
AIM 3. Refine MBAL on Project Findings Methods: Feedback gathered at meetings; collaboration of research partners. 3A. Engage stakeholders in a collaborative process to make changes to MBAL based on RCT outcomes, to ensure it addresses multifaceted aspects of sexual and mental health. 3B. Y/YA co-investigators will integrate insights from MBAL and evaluation to finalize MBAL for dissemination as 1) a free state-wide tool, 2) for use by tribal and private health clinics, and 3) by school integrated health providers.
IMPACT: The MBAL tool, youth-developed dissemination and promotion campaign, and the evidence provided for RLP adaptations may serve as a framework for similar regions (ex. low provider access, multicultural and Indigenous youth, high sexual/mental health needs) to improve health outcomes. This proposal will also strengthen research opportunities by and for Alaskan Y/YA.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Delayed access
The step wedge design ensures that everyone has access to the intervention but data will be collected prior to the intervention being implemented at each site.
|
MBAL's combination of digital innovation, inclusive content, and youth-driven design positions it as a leading-edge intervention in the field of sexual health, with the potential to significantly impact the lives of Y/YA in AK and beyond.
The open-access digital website enhances the reach and engagement of MBAL, particularly among adolescents who may prefer to seek information and support online in a private, self-paced setting.
By allowing youth to fill out this tool at their own pace and return to their home page as they want to reflect/change answers, they can update it as their lives change.
Additionally, MBAL incorporates interactive elements (question types of open response, ranking, scales, drag/drop; journaling prompts & space) and personalized features (ex.
avatars of common AK animals designed by Y/YA), allowing users to tailor their life planning experience according to their individual needs and preferences and return to their answers.
|
|
Other: Immediate access
Sites will be randomized to receive intervention and those who receive intervention initially, will then be compared to those who do not at the same time period.
|
MBAL's combination of digital innovation, inclusive content, and youth-driven design positions it as a leading-edge intervention in the field of sexual health, with the potential to significantly impact the lives of Y/YA in AK and beyond.
The open-access digital website enhances the reach and engagement of MBAL, particularly among adolescents who may prefer to seek information and support online in a private, self-paced setting.
By allowing youth to fill out this tool at their own pace and return to their home page as they want to reflect/change answers, they can update it as their lives change.
Additionally, MBAL incorporates interactive elements (question types of open response, ranking, scales, drag/drop; journaling prompts & space) and personalized features (ex.
avatars of common AK animals designed by Y/YA), allowing users to tailor their life planning experience according to their individual needs and preferences and return to their answers.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Motivation for Change
Time Frame: Baseline, immediate post, and 6 months post
|
This validated shortened tool includes 3 questions per topic area, with four topics areas: sexual and reproductive health, emotional and behavioral health, life planning, & sub-stance use.
|
Baseline, immediate post, and 6 months post
|
|
Sexual Health
Time Frame: Baseline, immediate post, and 6 months post
|
Condom/contraception use; HIV/STI testing; & intention to delay sexual initiation (if not sexually active).
|
Baseline, immediate post, and 6 months post
|
|
Mental Health & Well-being
Time Frame: Baseline, immediate post, and 6 months post
|
The Ryff Psychological Wellbeing Scale is an 18-item scale measuring six aspects of wellbeing and happiness: autonomy, environmental mastery, personal growth, positive relations with others, purpose in life, and self-acceptance.
|
Baseline, immediate post, and 6 months post
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UAlaskaAnchorage
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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