Mental Health Wellness 1NCT06254924
Qoyangnuptu: Qoyangnuptu Intervention (QI) App
A study testing QI App Users and Parents/Guardians of QI App Users in people with Mental Health Wellness 1, run by Northern Arizona University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 14 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health Wellness 1
- What is being tested?
- QI App Users and Parents/Guardians of QI App Users
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Aug 2024to 1 Oct 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 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Marissa Adams, MPH contact
United States1 site, 1 recruiting
- Recruiting
Northern Arizona University
Flagstaff, Arizona, 86011
Marissa Adams, marissa.adams@nau.edu
Morgan Vigil-Hayes, PhD, morgan.vigil-hayes@nau.edu
About this study
Official title: Qoyangnuptu: QI App Pilot for Assessing Feasibility and Acceptability of a Mobile Health App for Adolescents in a Southwestern Tribal Community
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?
Read more
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
Read the 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.
- 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.
- 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.
- 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.
- Conditions
- Mental Health Wellness 1
- Being tested
- QI App Users, Parents/Guardians of QI App Users
- Keywords
- American Indian / Alaska Native, mHealth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QI App UsersBehavioural
QI App users will be asked to complete a daily, 2-question mood and stress survey. They will be encouraged to use the QI App to practice mindfulness skills including meditation, drawing, coloring, breathing, and walking. They will be encouraged to use the QI App to help them participate in asynchronous group running activities.
Parents/Guardians of QI App UsersBehavioural
Parents/Guardians of QI App users will be informed that their child is using the QI App for a 6-week period.
| Study group | Role | What they receive |
|---|---|---|
| QI App Users | Experimental | Participants will be asked to use the QI App once per day for 5-10 minutes per day for 6 weeks. Receives: Behavioral: QI App Users |
| Parents/Guardians of QI App Users | Experimental | Parents/guardians of QI App users will be aware that their child is using the QI App once per day for 5-10 minutes per day for 6 weeks. Receives: Behavioral: Parents/Guardians of QI App Users |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure the acceptability of the QI App.
Through qualitative interviews, the investigators will determine the acceptability of the QI App. 12 participants will be interviewed after they have used the app for 6 weeks.
Measured: Baseline, 6 weeks after starting the app, 12 weeks after starting the app
Secondary outcomes (8)
Impact of app usage on attitudes towards seeking professional mental health assistance.
Measured by the Attitudes Towards Seeking Professional Psychological Help - Short Form Scale before participating as a Peer Mentor, 6 weeks into participating as a Peer Mentor, and 12 weeks after starting as a peer mentor.
The Attitudes Towards Seeking Professional Psychological Help is a 10-item measure used to assess attitudes towards seeking professional psychological help on a 4-point Likert scale, ranging from 0 to 3. Higher total score indicates more positive attitudes towards seeking seeking professional psychological help and is associated with lower levels of stigma against mental illness.
Measured: Baseline, 6 weeks after starting the app, 12 weeks after starting the app
Impact of app usage on measures of depression.
Patient Health Questionnaire-9 before participating as a Peer Mentor, 6 weeks into participation as a Peer Mentor, and 12 weeks after starting as a peer mentor.
The Patient Health Questionnaire-9 is a 9-item measure used to assess frequency that a participant experiences depressive symptoms. Each item is score on a 4-point scale from 0 ("not at all") to 3 ("every day"). Higher total scores indicate more frequent experience of depressive symptoms.
Measured: Baseline, 6 weeks after starting the app, 12 weeks after starting the app
Impact of app usage on measures of stress.
Perceived Stress Scale 4 before participating as a Peer Mentor, 6 weeks into participation as a Peer Mentor, and 12 weeks after starting as a peer mentor.
The Perceived Stress Scale 4 measures participant perceptions of their thoughts and feelings over the past month on 4 items. Each item is scored on a 5-point scale from from 0 ("Never") to 4 ("Very Often"). Higher scores indicate higher levels of stress.
Measured: Baseline, 6 weeks after starting the app, 12 weeks after starting the app
Impact of app usage on measures of mindfulness.
State Mindfulness Scale Physical Activity before participating as a Peer Mentor, 6 weeks into participation as a Peer Mentor, and 12 weeks after starting as a peer mentor.
The State Mindfulness Physical Activity scale is a 12 item measure with six items assessing state mindfulness of the mind (i.e., thoughts and emotions) and six items assessing state mindfulness of the body (i.e., movement, body sensations, muscle engagement). The response scale is 0 - 4, with anchors of Not at all (0) and Very much (4). Initial evidence supports a bi-factor structure of the measure in which both a general state mindfulness factor and two specific factors (mind and body) are supported. The bi-factor structure supports the use of using a single score to capture overall state mindfulness, but also the use of two scores capture mindfulness of the mind and mindfulness of the body.
Measured: Baseline, 6 weeks after starting the app, 12 weeks after starting the app
Impact of app usage on measures of quiet ego.
Quiet Ego Scale before participating as a Peer Mentor, 6 weeks into participation as a Peer Mentor, and 12 weeks after starting as a peer mentor.
The Quiet Ego Scale is a 14 item measure that assesses detached awareness, inclusive identity, perspective taking, and growth. Each item is assessed on a 5-point Likert scale from 1 ("strongly disagree") to 5 ("strongly agree"). A higher score indicates a stronger quiet ego.
Measured: Baseline, 6 weeks after starting the app, 12 weeks after starting the app
Impact of app usage on measures of social connectedness.
University of California Los Angeles Loneliness Scale 3 before participating as a Peer Mentor, 6 weeks into participation as a Peer Mentor, and 12 weeks after starting as a peer mentor.
The Loneliness Scale 3 comprises 3 questions that measure 3 dimensions of loneliness: relational connectedness, social connectedness, and self-perceived isolation. Each item is measured on a 3-point scale from 1 ("Hardly Ever") to 3 ("Often"). Higher scores indicate greater perceptions of loneliness.
Measured: Baseline, 6 weeks after starting the app, 12 weeks after starting the app
Impact of child's usage of QI App on parent/guardian attitudes towards seeking professional mental health assistance.
Measured by the Attitudes Towards Seeking Professional Psychological Help - Short Form Scale before participant's child starts using the QI App, 6 weeks after participant's child starts using the QI App, and 12 weeks after the participant's child starts using the QI App.
The Attitudes Towards Seeking Professional Psychological Help is a 10-item measure used to assess attitudes towards seeking professional psychological help on a 4-point Likert scale, ranging from 0 to 3. Higher total score indicates more positive attitudes towards seeking seeking professional psychological help and is associated with lower levels of stigma against mental illness.
Measured: Baseline, 6 weeks after starting the app, 12 weeks after child starts using the app
Impact of child's usage of QI App on parent/guardian perceptions of their child's behavior and emotions.
Measured by the Child Behavior Checklist.
The Child Behavior Checklist 6-18 has parents assess both child adaptive behaviors and problem behaviors. There are 112 items that assess problem behaviors and 20 items that assess adaptive behavior. Response format for problem behaviors is from 0 ("not true") to 2 ("very true"). A Total Competence and Total Behavior Problems score are also provided. Higher scores of Total Competence indicate that the child being evaluated has a greater number of adaptive behaviors. Higher scores of Total Behavior Problems indicate greater incidence of problem behaviors observed associated with the child being evaluated.
Measured: Baseline, 6 weeks after starting the app, 12 weeks after participant's child starts using the app.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2024
- Study start30 Aug 2024
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Mental Health Wellness 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northern Arizona University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Morgan Vigil-Hayes, PhD, Principal investigator, Northern Arizona University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06254924
- Sponsor's protocol ID
- 2125143
- Status last verified
- Aug 2024
- First submitted
- 29 Jan 2024
- Last updated
- 23 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Given the small population from which we will be recruiting, releasing IPD could inadvertently compromise confidentiality.
Publications
Vigil-Hayes M, Collier AF, Hagemann S, Castillo G, Mikkelson K, Dingman J, Munoz A, Luther J, McLaughlin A. Integrating Cultural Relevance into a Behavioral mHealth Intervention for Native American Youth. Proc ACM Hum Comput Interact. 2021 Apr;5(CSCW1):165. doi: 10.1145/3449239.
PubMed 34676359Vigil-Hayes M, Futterman Collier A, Castillo G, Blackhorse D, Awbery N, Abrahim JP. Designing a Mobile Game That Develops Emotional Resiliency in Indian Country. Ext Abstr Hum Factors Computing Syst. 2019 May;2019:LBW2122. doi: 10.1145/3290607.3312790.
PubMed 32455346Picco L, Abdin E, Chong SA, Pang S, Shafie S, Chua BY, Vaingankar JA, Ong LP, Tay J, Subramaniam M. Attitudes Toward Seeking Professional Psychological Help: Factor Structure and Socio-Demographic Predictors. Front Psychol. 2016 Apr 25;7:547. doi: 10.3389/fpsyg.2016.00547. eCollection 2016.
PubMed 27199794Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
PubMed 6668417Hughes ME, Waite LJ, Hawkley LC, Cacioppo JT. A Short Scale for Measuring Loneliness in Large Surveys: Results From Two Population-Based Studies. Res Aging. 2004;26(6):655-672. doi: 10.1177/0164027504268574.
PubMed 18504506Cox AE, Ullrich-French S, Howe HS, Cole AN. A pilot yoga physical education curriculum to promote positive body image. Body Image. 2017 Dec;23:1-8. doi: 10.1016/j.bodyim.2017.07.007. Epub 2017 Aug 14.
PubMed 28818786Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
PubMed 11556941Achenbach TM, Ruffle TM. The Child Behavior Checklist and related forms for assessing behavioral/emotional problems and competencies. Pediatr Rev. 2000 Aug;21(8):265-71. doi: 10.1542/pir.21-8-265. No abstract available.
PubMed 10922023
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Qoyangnuptu: QI App Pilot for Assessing Feasibility and Acceptability of a Mobile Health App for Adolescents in a Southwestern Tribal Community
- ClinicalTrials.gov ID
- NCT06254924
- Acronym / sponsor ID
- 2125143
- Conditions
- Mental Health Wellness 1
- Keywords
- American Indian / Alaska Native, mHealth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Northern Arizona UniversityUniversity, hospital or other
- Study start
- 30 Aug 2024 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 12 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| QI App Users | Experimental | Behavioral: QI App UsersParticipants will be asked to use the QI App once per day for 5-10 minutes per day for 6 weeks. |
| Parents/Guardians of QI App Users | Experimental | Behavioral: Parents/Guardians of QI App UsersParents/guardians of QI App users will be aware that their child is using the QI App once per day for 5-10 minutes per day for 6 weeks. |
Who may qualify
- Ages
- 14 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QI App UsersQI App users will be asked to complete a daily, 2-question mood and stress survey. They will be encouraged to use the QI App to practice mindfulness skills including meditation, drawing, coloring, breathing, and walking. They will be encouraged to use the QI App to help them participate in asynchronous group running activities. | Behavioural | QI App Users |
| Parents/Guardians of QI App UsersParents/Guardians of QI App users will be informed that their child is using the QI App for a 6-week period. | Behavioural | Parents/Guardians of QI App Users |
Primary outcome
To measure the acceptability of the QI App.
Time frame: Baseline, 6 weeks after starting the app, 12 weeks after starting the app
Through qualitative interviews, the investigators will determine the acceptability of the QI App. 12 participants will be interviewed after they have used the app for 6 weeks.
8 secondary outcomes
Impact of app usage on attitudes towards seeking professional mental health assistance.
Time frame: Baseline, 6 weeks after starting the app, 12 weeks after starting the app
Impact of app usage on measures of depression.
Time frame: Baseline, 6 weeks after starting the app, 12 weeks after starting the app
Impact of app usage on measures of stress.
Time frame: Baseline, 6 weeks after starting the app, 12 weeks after starting the app
Impact of app usage on measures of mindfulness.
Time frame: Baseline, 6 weeks after starting the app, 12 weeks after starting the app
Impact of app usage on measures of quiet ego.
Time frame: Baseline, 6 weeks after starting the app, 12 weeks after starting the app
Impact of app usage on measures of social connectedness.
Time frame: Baseline, 6 weeks after starting the app, 12 weeks after starting the app
Impact of child's usage of QI App on parent/guardian attitudes towards seeking professional mental health assistance.
Time frame: Baseline, 6 weeks after starting the app, 12 weeks after child starts using the app
Impact of child's usage of QI App on parent/guardian perceptions of their child's behavior and emotions.
Time frame: Baseline, 6 weeks after starting the app, 12 weeks after participant's child starts using the app.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2025.
- Background: PubMed 34676359Vigil-Hayes M, Collier AF, Hagemann S, Castillo G, Mikkelson K, Dingman J, Munoz A, Luther J, McLaughlin A. Integrating Cultural Relevance into a Behavioral mHealth Intervention for Native American Youth. Proc ACM Hum Comput Interact. 2021 Apr;5(CSCW1):165. doi: 10.1145/3449239.
- Background: PubMed 32455346Vigil-Hayes M, Futterman Collier A, Castillo G, Blackhorse D, Awbery N, Abrahim JP. Designing a Mobile Game That Develops Emotional Resiliency in Indian Country. Ext Abstr Hum Factors Computing Syst. 2019 May;2019:LBW2122. doi: 10.1145/3290607.3312790.
- Background: PubMed 27199794Picco L, Abdin E, Chong SA, Pang S, Shafie S, Chua BY, Vaingankar JA, Ong LP, Tay J, Subramaniam M. Attitudes Toward Seeking Professional Psychological Help: Factor Structure and Socio-Demographic Predictors. Front Psychol. 2016 Apr 25;7:547. doi: 10.3389/fpsyg.2016.00547. eCollection 2016.
- Background: PubMed 6668417Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
- Background: PubMed 18504506Hughes ME, Waite LJ, Hawkley LC, Cacioppo JT. A Short Scale for Measuring Loneliness in Large Surveys: Results From Two Population-Based Studies. Res Aging. 2004;26(6):655-672. doi: 10.1177/0164027504268574.
- Background: PubMed 28818786Cox AE, Ullrich-French S, Howe HS, Cole AN. A pilot yoga physical education curriculum to promote positive body image. Body Image. 2017 Dec;23:1-8. doi: 10.1016/j.bodyim.2017.07.007. Epub 2017 Aug 14.
- Background: PubMed 11556941Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
- Background: PubMed 10922023Achenbach TM, Ruffle TM. The Child Behavior Checklist and related forms for assessing behavioral/emotional problems and competencies. Pediatr Rev. 2000 Aug;21(8):265-71. doi: 10.1542/pir.21-8-265. No abstract available.
- Individual participant dataSharing planned: No. Given the small population from which we will be recruiting, releasing IPD could inadvertently compromise confidentiality.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marissa Adams, MPH contact
Morgan Vigil-Hayes, PhD principal investigator
Northern Arizona University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing QI App Users and Parents/Guardians of QI App Users in people with Mental Health Wellness 1, run by Northern Arizona University 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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 23 Jan 2025. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Morgan Vigil-Hayes, PhD (9285234863, morgan.vigil-hayes@nau.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To measure the acceptability of the QI App. (time frame: Baseline, 6 weeks after starting the app, 12 weeks after starting the app). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06254924, which also lists 8 linked publications.
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 23 Jan 2025.