Clinical trial NCT06254924: Qoyangnuptu: Qoyangnuptu Intervention (QI) App
Official title: Qoyangnuptu: QI App Pilot for Assessing Feasibility and Acceptability of a Mobile Health App for Adolescents in a Southwestern Tribal Community
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mental Health Wellness 1
Keywords: American Indian / Alaska Native
mHealth
Lead sponsor: Northern Arizona University
Sponsor class: OTHER
First posted: 2024-02-12
Enrollment: 24
Sex: ALL
Minimum age (years): 14
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to learn about the impacts of using a mobile health app, the Qoyangnuptu Intervention App (QI App) a Southwestern Tribal Community. The main questions it aims to answer are:

In American Indian/Alaska Native communities with unique cultural characteristics, how should a youth-focused sociotechnical behavioral health intervention be designed to encourage sustained engagement and positively impact indicators of behavioral health?; How can interactive technical interventions be designed to best support sustained community engagement in a challenged network environment?

Participants will:

* Receive daily guidance and encouragement to use the app from an anonymous, trained peer mentor
* Be able to ask their peer mentors questions in a monitored one-on-one chat in the QI app or in a monitored group chat in the QI app
* Log their mood and stress level on the app once per day
* Practice mindfulness skills as directed in the QI app, including guided breathing, meditation, drawing, coloring, and walking
* Practice Hopi cultural activities like running using the QI app to help track progress towards team mileage goals

Detailed description: Indigenous youth face behavioral health challenges at much higher rates than non-Indigenous youth in the United States. Some of the reasons for these disparities include lack of culturally responsive behavioral health training and coping resources and lack of access to in-person behavioral health resources and interventions. This research seeks to investigate the impact that a mobile phone app that teaches mindfulness and provides opportunities for mindfulness practice might help adolescents from a Southwestern Tribal community increase measures of resilience. The mobile phone app, called the QI App, has been designed with members of the Southwestern Tribal community to ensure cultural appropriateness and responsiveness. It has also been designed with research experts from clinical psychology, serious game design, and computer networking to ensure that it uses evidence-based best practices.

1. Recruitment The investigators will use a multipronged recruitment strategy. Recruitment will be carried out by the study team's Community Research Coordinator.

   Because the QI App was designed with members of the Southwestern Tribal community as consultants, the investigators already have individual contact information for people who have stated they would like to be reached out to when the investigators are ready to recruit for the pilot. The investigators will use a direct email approach with these individuals.

   Through the QI App design process, the study team encountered a number of individuals and organizations who indicated that they would like to share the recruitment posts on their social media when the time came for the pilot. The investigators will prepare a social media post that potential participants can share on their networks.

   The investigators will work with their community research coordinator and their Senior Personnel and project consultants to help them post flyers strategically in the community.

   When working with Indigenous communities, developing trust is paramount. One of the best ways for the investigators to successfully recruit is for individuals who have come to know and trust the study team reach out to others in their community to share information about the study and have them reach out to contact the study team to be formally recruited. Individuals who reach out to the study team via word-of-mouth will be followed up with using the Email Recruitment message.
2. Consent Process

   Once individuals have made contact with the study team via recruitment effort, the investigators will plan to have a Zoom meeting with potential participants or in a reserved community meeting room to review the study details, answer questions, and obtain informed consent. This meeting will also require the participant to download and install the QI App to demonstrate that they can use it on their personal iPhone or Android device.
   * If meeting over Zoom: The investigators will obtain consent through a Zoom oral consent statement. The investigators will email the consent form to participants or send to them via postal mail if they prefer.
   * If meeting in-person: The investigators will reserve a community room where potential participants can meet with the study team's community researcher at a scheduled time to review the research process in a space that allows for confidentiality to be maintained. Participants will physically sign the consent form and be provided with a copy.
3. Research Activities

   * QI App Users. The participants will be asked to complete a short demographic questionnaire and baseline survey. The participants will be asked to use the QI App for a total for 6 weeks. After the participants have completed the 6-week cohort, they will again complete the QI App user questionnaire (which combines all questionnaire measures for Secondary Study Objectives 1-6 in "Project Purpose" Section). They will also be asked to participate in a focus group with semi-structured interview questions where they will explain what they liked and did not like about the QI App and what they would change about the app and user experience. 12 weeks after the completion of the program (12 weeks from when they started using the app), participants will complete the QI App user questionnaire for the third time. Surveys can be distributed either as electronic surveys sent via email OR via physical delivery and pickup by the community research coordinator, whichever the subject prefers. Focus groups will be conducted either as Zoom sessions or in-person in a reserved community room, depending on the collective preference of participants.
   * Parents of QI App Users. The participants will be asked to complete a short demographic questionnaire and baseline survey.. After the participant's child has completed the 6-week cohort, they will again complete the Parents of QI App user survey (which combines all questionnaire measures for Secondary Study Objectives 7-8 in "Project Purpose" Section). They will also be asked to participate in a focus group with semi-structured interview questions where they will explain what they liked and did not like about the QI App and what they would change about the app and user experience.12 weeks after the completion of the program (12 weeks from when they started using the app), participants will complete the QI App user questionnaire for the third time. Surveys can be distributed either as electronic surveys sent via email OR via physical delivery and pickup by the community research coordinator, whichever the subject prefers. Focus groups will be conducted either as Zoom sessions or in-person in a reserved community room, depending on the collective preference of participants.

Eligibility criteria: Inclusion Criteria:

* 14-25 years old
* Belongs to Southwestern Tribal community
* Has a smartphone capable of running the QI App
* Is able to access the Internet with smartphone at least once per day

Exclusion Criteria:

* Younger than 14 or older than 25
* Does not belong to Southwestern Tribal Community
* Does not have a smartphone capable of running the QI App
* Is not able to access the Internet with smartphone at least once per day

Primary outcomes:
measure: To measure the acceptability of the QI App.
timeFrame: Baseline, 6 weeks after starting the app, 12 weeks after starting the app
Secondary outcomes:
measure: Impact of app usage on attitudes towards seeking professional mental health assistance.
timeFrame: Baseline, 6 weeks after starting the app, 12 weeks after starting the app
measure: Impact of app usage on measures of depression.
timeFrame: Baseline, 6 weeks after starting the app, 12 weeks after starting the app
measure: Impact of app usage on measures of stress.
timeFrame: Baseline, 6 weeks after starting the app, 12 weeks after starting the app
measure: Impact of app usage on measures of mindfulness.
timeFrame: Baseline, 6 weeks after starting the app, 12 weeks after starting the app
measure: Impact of app usage on measures of quiet ego.
timeFrame: Baseline, 6 weeks after starting the app, 12 weeks after starting the app
measure: Impact of app usage on measures of social connectedness.
timeFrame: Baseline, 6 weeks after starting the app, 12 weeks after starting the app
measure: Impact of child's usage of QI App on parent/guardian attitudes towards seeking professional mental health assistance.
timeFrame: Baseline, 6 weeks after starting the app, 12 weeks after child starts using the app
measure: Impact of child's usage of QI App on parent/guardian perceptions of their child's behavior and emotions.
timeFrame: Baseline, 6 weeks after starting the app, 12 weeks after participant's child starts using the app.
Other outcomes:
Locations:
city: Flagstaff
country: United States
facility: Northern Arizona University
state: Arizona
Study officials:
affiliation: Northern Arizona University
name: Morgan Vigil-Hayes, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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