LGBTQL-FAPNCT07865858
Lakota Family Acceptance Project Pilot RCT
A study testing Adapted Lakota Family Acceptance Program in people with LGBTQ and Racial Disparities, run by University of Michigan at 2 sites in United States.
Trial summary
Although research documents the concerning rates of mental and behavioral health problems (e.g., substance use/initiation) among Indigenous LGBTQ2S+ youth, there is very little known about how to prevent these deleterious issues that devastate Indigenous communities. Read more about this study
- Who is it for?
- Ages 13 years and olderHealthy volunteers can take part
- Conditions the study is for
- LGBTQ, Racial Disparities, Family Relationships
- What is being tested?
- Adapted Lakota Family Acceptance Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Oct 2026to 31 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 13 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Youth Inclusion Criteria:
- Identify as 2SLGBTQ+ (and their identity must be known to their participating caregiver)
- Identify as Indigenous (multiracial youth who are also Indigenous are eligible)
- Youth should be between the ages of 13 and 18 years old
- Read and speak English
- Report moderate to high levels of caregiver/family rejection (as evidenced by agreement on items that assess the presence and frequency of specific family rejecting behaviors [includes ambivalent and moderately and highly rejecting caregivers] AND/OR report the absence of supportive/advocacy behaviors (as evidenced by lack of agreement on one or more items assessing supportive/advocacy behaviors) [if caregivers report this and youth do not, the dyad still meets criteria].
Show all 14Show fewer
- Report an ability and commitment to attending eight sessions at two hours a week over eight weeks with their caregiver.
- Participating Caregiver Inclusion Criteria:
- Caregivers are broadly defined and may include a biological parent, stepparent, grandparent, aunt/uncle, or other adult who provides care to the Indigenous 2SLGBTQ+ youth. It may also include older siblings who are 28 years old or older if they care for and make decisions for the minor.
- Must be over the age of 18
- Read and speak English
- Be aware of the SGM identity of their Indigenous 2SLGBTQ+ youth
- Report an ability and commitment to attending eight sessions at two hours a week over eight weeks with their teen
- Report moderate to high levels of caregiver rejection (as evidenced by agreement on one or more items that assess the presence and frequency of specific caregiver rejecting behaviors [includes ambivalent and moderately and highly rejecting caregivers] AND/OR report the absence of supportive/advocacy behaviors (as evidenced by lack of agreement on one or more items assessing supportive/advocacy behaviors) [if youth report this and caregivers do not, the dyad still meets criteria].
Who cannot join
- We will exclude Indigenous 2SLGBTQ+ youth and caregivers at imminent risk for suicide and/or who are experiencing current psychosis symptoms as determined by results on the safety items screener.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Wahwala Iyohlogya/Peaceful Means
Pine Ridge, South Dakota, 57770
University of Michigan
Rapid City, South Dakota, 57701
About this study
Official title: Development and Evaluation of an Indigenized Family Acceptance Project for Lakota 2SLGBTQ+ Teens (PHASE III: PILOT RANDOMIZED CONTROLLED TRIAL )
Although research documents the concerning rates of mental and behavioral health problems (e.g., substance use/initiation) among Indigenous LGBTQ2S+ youth, there is very little known about how to prevent these deleterious issues that devastate Indigenous communities. The study will include ~40 families (Lakota LGBTQ2S+ youth and caregivers) in Rapid City, SD (20 families (10 FAP; 10 wait-list control) and on the nearby Pine Ridge Indian Reservation (10 FAP; 10 wait-list control). Following the baseline survey, families will be randomly assigned to the treatment or wait-list control. Participants will complete an immediate post-test and 6-month follow-up survey to test the hypotheses that FAP will lead to changes in targets, specifically increases in caregiver accepting behaviors, youth and caregiver connection to Lakota culture, family bonding, and youth future orientation and decreases in caregiver rejecting behaviors, caregiver harsh parenting, and youth internalized homo/bi/transphobia compared to the control condition. The researchers will also examine the hypotheses that there will be reductions in deleterious primary outcomes (depressive symptoms, anxiety symptoms, suicidality) and secondary outcomes (alcohol and drug use/initiation and dating and sexual violence victimization and perpetration) among youth in the treatment conditions compared to the control condition. Additionally, the researchers will assess the acceptability and feasibility of the FAP via program observations, post-session surveys, and exit interviews.
Read the detailed description
Indigenous LGBTQ2S+ youth experience disproportionately high rates of mental health problems including depression, anxiety, and suicidality as well as related issues such as alcohol and drug initiation/use and dating and sexual violence. Our preliminary research also shows that Lakota LGBTQ2S+ youth and their adult caretakers perceived the Family Acceptance Project (FAP)-a family support approach that seeks to reduce family rejecting behaviors and increase family accepting behaviors in the context of the family's cultural world-as highly acceptable and likely to be impactful in reducing mental health and related problems of Indigenous LGBTQ2S+ youth. To date, despite its promise for reducing mental health and related problems among LGBTQ2S+ youth, FAP has not been rigorously evaluated. The purpose of the proposed study is to pilot evaluate FAP for Lakota youth (ages 13 to 18) and their families. The researchers have assembled an interdisciplinary team of experts and Elders/Traditional Knowledge Keepers (TKKs), and the team will be comprised of ~10 Lakota LGBTQ2S+ youth on a Youth Advisory Board (YAB) and ~10 caregivers to Lakota LGBTQ2S+ youth on a Caregiver Advisory Board (CAB). The study will include ~40 families (Lakota LGBTQ2S+ youth and caregivers) in Rapid City, SD (20 families (10 FAP; 10 wait-list control) and on the nearby Pine Ridge Indian Reservation (10 FAP; 10 wait-list control). Following the baseline survey, families will be randomly assigned to the treatment or wait-list control. Participants will complete an immediate post-test and 6-month follow-up survey to test the hypotheses that FAP will lead to changes in targets, specifically increases in caregiver accepting behaviors, youth and caregiver connection to Lakota culture, family bonding, and youth future orientation and decreases in caregiver rejecting behaviors, caregiver harsh parenting, and youth internalized homo/bi/transphobia compared to the control condition. The researchers will also examine the hypotheses that there will be reductions in deleterious primary outcomes (depressive symptoms, anxiety symptoms, suicidality) and secondary outcomes (alcohol and drug use/initiation and dating and sexual violence victimization and perpetration) among youth in the treatment conditions compared to the control condition. Additionally, the researchers will assess the acceptability and feasibility of the FAP via program observations, post-session surveys, and exit interviews. The proposed project aligns Goal 3 of the NIMH to identify targets for intervention via a rigorous pilot RCT with a highly marginalized and underserved population and the Healthy People 2030 Goals to eliminate health disparities, which includes reductions in violence and injury among LGBTQ2S+ youth and youth of color.
- Conditions
- LGBTQ, Racial Disparities, Family Relationships, Minority Stress, Depression, Anxiety
- Being tested
- Adapted Lakota Family Acceptance Program
- Keywords
- family acceptance, LGBTQ, 2SLGBTQ+, youth, family support, parents of LGBTQ youth, Racial/Ethnic Minority, health equity, Native American/Indigenous, Two Spirit
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adapted Lakota Family Acceptance ProgramBehavioural
Tiwahe Tewichaglapi ("The Family Loves Them") Program Overview Tiwahe Tewichaglapi is a culturally grounded, family-centered intervention adapted from the Family Acceptance Project® (FAP) to promote caregiver acceptance, respect, support, and family bonding for 2SLGBTQ+ Lakota youth. The program was developed in partnership with the Lakota Oyate to address family rejection rooted in colonization and historical trauma and to honor traditional Two Spirit roles that have long held important and respected places within Lakota communities. The program aims to strengthen families, increase youth pride and hope for the future, and reduce mental health risks such as depression, anxiety, substance use, dating violence, and suicide among 2SLGBTQ+ Lakota youth. The program includes eight family group sessions 2.5 hrs. each delivered by Lakota facilitators that include Lakota cultural and spiritual practices - including smudging, a Lakota prayer, and a shared meal.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | The intervention group that will participate in the 8-session LFAP intervention Receives: Behavioral: Adapted Lakota Family Acceptance Program |
| Waitlist Control | No intervention | Waitlisted Control group- Provide check-ins, provide resources, and offer participants in this arm the same intervention program as the intervention group after 6-month follow-ups and measurements have been completed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Suicidality (Youth and Caregivers)
Participant responses to items from the Suicidal Ideation Attributes Scale to measure suicide and life-threatening behavior in the past month. The 5-item scale includes likert response options ranging from 0 = Never to 10 = Always with higher scores indicating an elevated risk for suicide planning or behavior.
Measured: Enrollment (baseline), immediate post-test (2 months from baseline), and 6-month follow-up (8 months from baseline).
Depression (Youth and Caregivers)
Participant responses to depressive symptoms in the past two weeks using items from the Patient Health Questionnaire (PHQ-9). The 9-item scale includes likert options ranging from 0 = Not at all to 3 = Nearly every day. Higher scores indicate more depressive symptoms
Measured: Enrollment (baseline), immediate post-test (2 months after baseline), and 6-month follow-up (8 months after baseline)
Secondary outcomes (6)
Adolescent Dating Violence (Youth)
Participant responses to victimization and perpetration experiences in the past 30 days using items from the Adolescent Relationship Harassment and Abuse Scale on the Youth Risk Behavior Survey. The victimization scale is 3 items and the perpetration scale is 3 items. Likert response options range from 0 = 0 times to 4-6 or more times. Higher scores indicate greater dating violence
Measured: Enrollment (baseline), immediate post-test (2 months from baseline, and 6-month follow-up (8 months from baseline)
Alcohol Use (Youth)
Participant responses to alcohol use items on the Youth Risk Behavior Survey. The 3-item scale assesses alcohol use in the past 30 days. Likert response options for items 1 and 2 range from 0 = 0 days to 6 = all 30 days. Item 3 is an 8 point scale ranging from 0 = I did not drink alcohol in the past 30 days to 8 = 10 or more drinks. Higher scores indicate greater alcohol use.
Measured: Enrollment (baseline), immediate post-test (2 months from baseline, and 6-month follow-up (8 months from baseline).
Drug Use (Youth)
Participant responses to items on drug use in the past 30 days from the Youth Risk Behavior Survey. The 8-item scale incudes likert response options ranging from 0 = 0 times to 5 = 40 or more times. Higher scores indicate greater drug use.
Measured: Enrollment (baseline), immediate post-test (2 months from baseline, and 6-month follow-up (8 months from baseline).
Anxiety (Youth and Caregivers)
Participant responses to items from the Generalized Anxiety Disorder Screener (GAD-7) to measure anxiety symptoms in the past two weeks. The 7-item scale includes likert response options ranging from 0 = not at all to 3 = Nearly every day. Higher scores indicate greater anxiety severity.
Measured: Enrollment (baseline), immediate post-test (2 months from baseline, and 6-month follow-up (8 months from baseline)
School Engagement (Youth)
Participant response to school engagement items from the Hulsey et al., 2018 measure. The 5-item scale includes likert response options ranging from 1= Not at all true of me to 4 = Extremely true of me. Higher scores indicate increased school engagement.
Measured: Enrollment (baseline), immediate post-test (2 months from baseline, and 6-month follow-up (8 months from baseline).
Sexual Risk Taking (Youth)
Risky Sexual Behavioral Items from the Youth Risk Behavior Survey with participants using a slider to indicate response options ranging from 0 to 100. Higher scores indicate greater sexual risk behavior in the past 30 days.
Measured: Enrollment (baseline), immediate post-test (2 months from baseline, and 6-month follow-up (8 months from baseline).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2026
- Study start10 Oct 2026 (estimated)
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LGBTQStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Katie M Edwards, University of Michigan
- Investigators
- Katie Edwards, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07865858
- Sponsor's protocol ID
- HUM00291670
- Other IDs
- 5R34MH134937-03
- Acronym
- L-FAP
- Status last verified
- Oct 2026
- First submitted
- 3 Oct 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of an Indigenized Family Acceptance Project for Lakota 2SLGBTQ+ Teens (PHASE III: PILOT RANDOMIZED CONTROLLED TRIAL )
- ClinicalTrials.gov ID
- NCT07865858
- Acronym / sponsor ID
- L-FAP / HUM00291670
- Conditions
- LGBTQ, Racial Disparities, Family Relationships, Minority Stress, Depression, Anxiety
- Keywords
- family acceptance, LGBTQ, 2SLGBTQ+, youth, family support, parents of LGBTQ youth, Racial/Ethnic Minority, health equity
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 10 Oct 2026 (estimated)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 8 Oct 2026 (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.
Although research documents the concerning rates of mental and behavioral health problems (e.g., substance use/initiation) among Indigenous LGBTQ2S+ youth, there is very little known about how to prevent these deleterious issues that devastate Indigenous communities. The study will include ~40 families (Lakota LGBTQ2S+ youth and caregivers) in Rapid City, SD (20 families (10 FAP; 10 wait-list control) and on the nearby Pine Ridge Indian Reservation (10 FAP; 10 wait-list control). Following the baseline survey, families will be randomly assigned to the treatment or wait-list control. Participants will complete an immediate post-test and 6-month follow-up survey to test the hypotheses that FAP will lead to changes in targets, specifically increases in caregiver accepting behaviors, youth and caregiver connection to Lakota culture, family bonding, and youth future orientation and decreases in caregiver rejecting behaviors, caregiver harsh parenting, and youth internalized homo/bi/transphobia compared to the control condition. The researchers will also examine the hypotheses that there will be reductions in deleterious primary outcomes (depressive symptoms, anxiety symptoms, suicidality) and secondary outcomes (alcohol and drug use/initiation and dating and sexual violence victimization and perpetration) among youth in the treatment conditions compared to the control condition. Additionally, the researchers will assess the acceptability and feasibility of the FAP via program observations, post-session surveys, and exit interviews.
Detailed description
Indigenous LGBTQ2S+ youth experience disproportionately high rates of mental health problems including depression, anxiety, and suicidality as well as related issues such as alcohol and drug initiation/use and dating and sexual violence. Our preliminary research also shows that Lakota LGBTQ2S+ youth and their adult caretakers perceived the Family Acceptance Project (FAP)-a family support approach that seeks to reduce family rejecting behaviors and increase family accepting behaviors in the context of the family's cultural world-as highly acceptable and likely to be impactful in reducing mental health and related problems of Indigenous LGBTQ2S+ youth. To date, despite its promise for reducing mental health and related problems among LGBTQ2S+ youth, FAP has not been rigorously evaluated. The purpose of the proposed study is to pilot evaluate FAP for Lakota youth (ages 13 to 18) and their families. The researchers have assembled an interdisciplinary team of experts and Elders/Traditional Knowledge Keepers (TKKs), and the team will be comprised of ~10 Lakota LGBTQ2S+ youth on a Youth Advisory Board (YAB) and ~10 caregivers to Lakota LGBTQ2S+ youth on a Caregiver Advisory Board (CAB). The study will include ~40 families (Lakota LGBTQ2S+ youth and caregivers) in Rapid City, SD (20 families (10 FAP; 10 wait-list control) and on the nearby Pine Ridge Indian Reservation (10 FAP; 10 wait-list control). Following the baseline survey, families will be randomly assigned to the treatment or wait-list control. Participants will complete an immediate post-test and 6-month follow-up survey to test the hypotheses that FAP will lead to changes in targets, specifically increases in caregiver accepting behaviors, youth and caregiver connection to Lakota culture, family bonding, and youth future orientation and decreases in caregiver rejecting behaviors, caregiver harsh parenting, and youth internalized homo/bi/transphobia compared to the control condition. The researchers will also examine the hypotheses that there will be reductions in deleterious primary outcomes (depressive symptoms, anxiety symptoms, suicidality) and secondary outcomes (alcohol and drug use/initiation and dating and sexual violence victimization and perpetration) among youth in the treatment conditions compared to the control condition. Additionally, the researchers will assess the acceptability and feasibility of the FAP via program observations, post-session surveys, and exit interviews. The proposed project aligns Goal 3 of the NIMH to identify targets for intervention via a rigorous pilot RCT with a highly marginalized and underserved population and the Healthy People 2030 Goals to eliminate health disparities, which includes reductions in violence and injury among LGBTQ2S+ youth and youth of color.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Adapted Lakota Family Acceptance ProgramThe intervention group that will participate in the 8-session LFAP intervention |
| Waitlist Control | No intervention | –Waitlisted Control group- Provide check-ins, provide resources, and offer participants in this arm the same intervention program as the intervention group after 6-month follow-ups and measurements have been completed. |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (14 listed)
- Identify as 2SLGBTQ+ (and their identity must be known to their participating caregiver)
- Identify as Indigenous (multiracial youth who are also Indigenous are eligible)
- Youth should be between the ages of 13 and 18 years old
- Read and speak English
- Report moderate to high levels of caregiver/family rejection (as evidenced by agreement on items that assess the presence and frequency of specific family rejecting behaviors [includes ambivalent and moderately and highly rejecting caregivers] AND/OR report the absence of supportive/advocacy behaviors (as evidenced by lack of agreement on one or more items assessing supportive/advocacy behaviors) [if caregivers report this and youth do not, the dyad still meets criteria].
Key exclusion criteria (1 listed)
- We will exclude Indigenous 2SLGBTQ+ youth and caregivers at imminent risk for suicide and/or who are experiencing current psychosis symptoms as determined by results on the safety items screener.
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 |
|---|---|---|
| Adapted Lakota Family Acceptance ProgramTiwahe Tewichaglapi ("The Family Loves Them") Program Overview Tiwahe Tewichaglapi is a culturally grounded, family-centered intervention adapted from the Family Acceptance Project® (FAP) to promote caregiver acceptance, respect, support, and family bonding for 2SLGBTQ+ Lakota youth. The program was developed in partnership with the Lakota Oyate to address family rejection rooted in colonization and historical trauma and to honor traditional Two Spirit roles that have long held important and respected places within Lakota communities. The program aims to strengthen families, increase youth pride and hope for the future, and reduce mental health risks such as depression, anxiety, substance use, dating violence, and suicide among 2SLGBTQ+ Lakota youth. The program includes eight family group sessions 2.5 hrs. each delivered by Lakota facilitators that include Lakota cultural and spiritual practices - including smudging, a Lakota prayer, and a shared meal. | Behavioural | Intervention Group |
Primary outcome
Suicidality (Youth and Caregivers)
Time frame: Enrollment (baseline), immediate post-test (2 months from baseline), and 6-month follow-up (8 months from baseline).
Participant responses to items from the Suicidal Ideation Attributes Scale to measure suicide and life-threatening behavior in the past month. The 5-item scale includes likert response options ranging from 0 = Never to 10 = Always with higher scores indicating an elevated risk for suicide planning or behavior.
Depression (Youth and Caregivers)
Time frame: Enrollment (baseline), immediate post-test (2 months after baseline), and 6-month follow-up (8 months after baseline)
Participant responses to depressive symptoms in the past two weeks using items from the Patient Health Questionnaire (PHQ-9). The 9-item scale includes likert options ranging from 0 = Not at all to 3 = Nearly every day. Higher scores indicate more depressive symptoms
6 secondary outcomes
Adolescent Dating Violence (Youth)
Time frame: Enrollment (baseline), immediate post-test (2 months from baseline, and 6-month follow-up (8 months from baseline)
Alcohol Use (Youth)
Time frame: Enrollment (baseline), immediate post-test (2 months from baseline, and 6-month follow-up (8 months from baseline).
Drug Use (Youth)
Time frame: Enrollment (baseline), immediate post-test (2 months from baseline, and 6-month follow-up (8 months from baseline).
Anxiety (Youth and Caregivers)
Time frame: Enrollment (baseline), immediate post-test (2 months from baseline, and 6-month follow-up (8 months from baseline)
School Engagement (Youth)
Time frame: Enrollment (baseline), immediate post-test (2 months from baseline, and 6-month follow-up (8 months from baseline).
Sexual Risk Taking (Youth)
Time frame: Enrollment (baseline), immediate post-test (2 months from baseline, and 6-month follow-up (8 months from baseline).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
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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.
Katie Edwards, PhD principal investigator
University of Michigan
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adapted Lakota Family Acceptance Program in people with LGBTQ and Racial Disparities, run by University of Michigan at 2 sites 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 14 inclusion and 1 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: opening soon, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katie Edwards (Principal Investigator), PhD (734-647-8812, edkatie@umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Suicidality (Youth and Caregivers) (time frame: Enrollment (baseline), immediate post-test (2 months from baseline), and 6-month follow-up (8 months from baseline).). The study lists 2 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 13 Oct 2026.