About this 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. We 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, we will assess the acceptability and feasibility of the FAP via program observations, post-session surveys, and exit interviews.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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 design
Parallel
Treatments tested in this trial
Adapted Lakota Family Acceptance Program
BehavioralTiwahe 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
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
Secondary outcomes
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
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.
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.
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.
Other outcomes
(Intermediary Outcome) Caregiver Accepting and Rejecting Behaviors (Youth and Caregivers)
FAP-Reactions, Advocacy, Feelings/Experiences is a 34 item measure with a 4 point scale for items 1-30 0=Never to 3=Many times. Higher scores indicate more accepting behavior in the past 30 days. A 5 point scale for items 31-32 1=Very Upset to 5=Very Happy with higher scores indicating accepting behavior for item 31 and rejecting behavior for item 32; items 33-34 1=Extremely to 5=Not At All with higher scores indicating accepting behavior for item 33 and rejecting behavior for item 34 in the past 30 days. LGBTQ microaggressions and anti-LGBTQ attitudes (reactions and feelings from microaggressions) subscale is 8 items with a 5 point scale 0=Never to 4=All the time. Higher scores suggest experiencing more interpersonal microaggressions in the past 30 days.
(Intermediary Outcome) Harsh Parenting (Youth and Caregivers)
Items from the Brief Family Relationship Scale to assess family conflict. The 6-item scale includes response options using a continuous slider scale ranging from 1 to 20. Higher scores indicate greater conflict.
(Intermediary Outcome) Connection to Lakota Culture (Youth and Caregivers)
Participant responses to items on the Lakota Cultural Identity Scale. The 9-item scale includes likert response options ranging from 1 = Not at all to 4 = A lot. Higher scores indicate greater connection to Lakota culture.
(Intermediary Outcome) Connection to Community (Youth and Caregivers)
Participant responses to the Sense of Community Index. The 25-item scale includes likert response options ranging from 1 = Not at all to 4 = Very Important. Higher scores indicate greater sense of community.
Sponsors and contacts
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University of Michigan
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
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