NCT06482242

Brief Summary

This project addresses critical public health disparities among Alaskan youth and young adults by developing and evaluating "My Best Alaskan Life" (MBAL), an innovative online tool aimed at improving sexual and mental health literacy and behaviors. By integrating motivational interviewing and the Health Belief Model, MBAL empowers individuals to make informed health decisions, thereby potentially reducing rates of sexually transmitted infections, HIV, and associated mental health issues. Long-term, this project aims to enhance overall health outcomes, particularly in underserved multicultural and Indigenous communities, while building local research capacity through undergraduate and graduate student engagement and mentorship.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
320

participants targeted

Target at P75+ for not_applicable

Timeline
17mo left

Started May 2025

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress42%
May 2025Oct 2027

First Submitted

Initial submission to the registry

June 25, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 1, 2024

Completed
10 months until next milestone

Study Start

First participant enrolled

May 1, 2025

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

July 1, 2024

Status Verified

June 1, 2024

Enrollment Period

1.8 years

First QC Date

June 25, 2024

Last Update Submit

June 25, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • Motivation for Change

    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

    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

    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

Study Arms (2)

Delayed access

OTHER

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.

Behavioral: My Best Alaska Life

Immediate access

OTHER

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.

Behavioral: My Best Alaska Life

Interventions

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.

Delayed accessImmediate access

Eligibility Criteria

Age14 Years - 26 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Adolescent BehaviorDepression

Condition Hierarchy (Ancestors)

BehaviorBehavioral Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: The research team will utilize a stepped wedge randomized clinical trial with 8 clinic/community sites, each recruiting 40 participants, for a total of 320 participants. Each site will transition from control (pre-intervention) to intervention (post-intervention) in a randomized, stepwise fashion. Sites are randomly assigned to different start times (in 4-week intervals) for the intervention, ensuring that every site eventually receives the intervention, while maintaining methodological rigor. From Weeks 0-4, baseline recruitment and pre-intervention survey administration will occur at all 8 sites. In Weeks 5-8 (Time Period 1), participants at Site 1 will start the intervention (each consented participant will be emailed a link to MBAL and the post-intervention survey upon completion.) In Weeks 9-12 (Time Period 2), participants at Site 2 will start the intervention, while Site 1 continues to recruit until 40 participants are enrolled in the study, and this pattern will continue.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 25, 2024

First Posted

July 1, 2024

Study Start

May 1, 2025

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

October 1, 2027

Last Updated

July 1, 2024

Record last verified: 2024-06