Clinical trial NCT06309134: The Healthy Families Bright Futures Program
Official title: An Online Family-based Program to Prevent Alcohol Use and Dating and Sexual Violence Among Sexual and Gender Minority Youth
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alcohol Drinking
Violence in Adolescence
Keywords: dating violence
teen drinking
alcohol use
minority stress
parenting behaviors
Lead sponsor: University of Colorado, Colorado Springs
Sponsor class: OTHER
Collaborators: name: University of Nebraska Lincoln
First posted: 2024-03-13
Enrollment: 160
Sex: ALL
Minimum age (years): 15
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned by algorithm to either complete the program or to waitlist. Allocation to conditions will be 50/50. Randomization will occur at the dyad level.
Primary purpose: PREVENTION

Brief summary: The goal of this clinical trial is to learn about an online group program (Healthy Families Bright Futures program) for LGBTQ+ teens and their caregivers. The main question\[s\] it aims to answer are: • is this program acceptable, appropriate, and feasible for LGBTQ+ youth and their caregivers • does the program affect teen (alcohol use, dating violence, alcohol use refusal self-efficacy, healthy communication self-efficacy) and caregiver (accepting behaviors, parenting self-efficacy, parenting behaviors) outcomes associated with risk for dating violence and alcohol use among LGBTQ+ teens. Participants will participate in a one-hour weekly online group for seven weeks with separate groups for teens and caregivers.

Detailed description: Research documents concerning rates of alcohol use (AU) and dating violence (DV) among sexual and gender minority youth (SGMY), likely related to a combination of population-specific risk factors (e.g., caregiver rejection, internalized homo/bi/transphobia), universal risk factors (e.g., deficits in social emotional skills and alcohol refusal skills, inaccurate perceptions of alcohol norms) and lack of protective factors (e.g., parenting and family relational skills). To date, however, little is known about how to concurrently prevent AU and DV among SGMY. This study will develop and evaluate an online family-based program (Healthy Families Bright Future program \[HFBFP\]) to prevent AU and DV among SGMY ages 15 to 18. The HFBFP is a group-based intervention that includes seven weekly separate caregiver and youth sessions. Programming for caregivers focuses on fostering acceptance and support for SGMY and enhancing relevant caregiving/positive parenting skills. Programming for SGMY focuses on reducing internalized homo/bi/transphobia and enhancing social-emotional skills, increasing accurate perceptions of alcohol and dating violence norms, increasing alcohol refusal skills, and improving conflict resolution strategies/improving assertive communication. SGMY and caregiver programming is designed to be complementary in content to enhance the potency of programming components, and program skills will be practiced as a family between sessions. The program is co-facilitated by an SGM young adult and SGMY caregiver. During the Pilot Evaluation Phase, the investigators will via a randomized controlled trial of caregiver-SGMY dyads (40 dyads assigned to the HFBFP and 40 dyads to a waitlist), assess the acceptability, appropriateness, and feasibility of the HFBFP via program observations, post-session surveys (n = 80), and exit interviews (n = 28) with participants. The study will test the HFBFP's efficacy in improving relevant family/caregiver outcomes (e.g., family communication skills, parenting self-efficacy, affirming behaviors) as well as relevant SGMY outcomes (e.g., alcohol use intentions, alcohol use, dating violence victimization and perpetration, minority stress, perceived DV/alcohol use norms, communication self-efficacy) via surveys completed at baseline, immediate post-test, and 3-month follow-up. Participants will be recruited from across the U.S. via social media and from LGBTQ+ organizations.

Eligibility criteria: Inclusion Criteria:

* Age between 15 and 18 years
* Self-identify as a sexual and/or gender minority or questioning identity
* In dating/sexual/hook up relationship in past three months
* Ability to read, write, and speak English
* Current residence in United States
* Regular Internet access
* Ability to complete program and assessments
* Has caregiver willing to complete program who is eligible to participate (18 +, sees teen at least once per week, can read/write/speak English, residence in US, Internet access, no current suicidality, psychotic symptoms, or symptoms of serious mental illness)

Exclusion Criteria:

* Current enrollment as a college student
* Current suicidality
* Current psychotic symptoms
* Current symptoms of serious mental illness

Primary outcomes:
measure: Measure of Adolescent Relationships and Harassment and Abuse - Victimization
timeFrame: Baseline, 8 weeks, 3 months
measure: Measure of Adolescent Relationships and Harassment and Abuse - Perpetration
timeFrame: Baseline, 8 weeks, 3 months
measure: Monitoring the future alcohol use intentions
timeFrame: Baseline, 8 weeks, 3 months
measure: Monitoring the future alcohol use items
timeFrame: Baseline, 8 weeks, 3 months
measure: Drinking Refusal Self-Efficacy Questionnaire- Shortened adolescent version
timeFrame: Baseline, 8 weeks, 3 months
measure: Conflict Tactics Scale- 2 (SGM Specific IPV Perpetration)
timeFrame: Baseline, 8 weeks, 3 months
measure: Conflict Tactics Scale- 2 (SGM Specific IPV Victimization)
timeFrame: Baseline, 8 weeks, 3 months
measure: Program acceptability, appropriateness, and feasibility ratings (drawn from Weiner)
timeFrame: 8 weeks
Secondary outcomes:
measure: PHQ-8 (modified for adolescents)
timeFrame: Baseline, 8 weeks, 3 months
measure: LGBTQ+ teen perceived drinking norms
timeFrame: Baseline, 8 weeks, 3 months
measure: LGBTQ+ teen perceived dating violence norms
timeFrame: Baseline, 8 weeks, 3 months
measure: Sexual communication self-efficacy scale
timeFrame: Baseline, 8 weeks, 3 months
measure: Communication skills test (modified to assess self-efficacy)
timeFrame: Baseline, 8 weeks, 3 months
measure: Short Internalized Homonegativity Scale.
timeFrame: Baseline, 8 weeks, 3 months
measure: Self-Efficacy for Parenting Adolescents Scale
timeFrame: Baseline, 8 weeks, 3 months
measure: Parental Monitoring Short Scale
timeFrame: Baseline, 8 weeks, 3 months
measure: Parent Adolescent Communication Scale
timeFrame: Baseline, 8 weeks, 3 months
measure: Alabama Parenting Questionnaire- Short form
timeFrame: Baseline, 8 weeks, 3 months
measure: Social and Emotional Competencies Questionnaire
timeFrame: Baseline, 8 weeks, 3 months
measure: LGBTQ+ Microaggressions and Microaffirmations in Families
timeFrame: Baseline, 8 weeks, 3 months
Other outcomes:
Locations:
city: Colorado Springs
country: United States
facility: University of Colorado Colorado Springs
state: Colorado
Study officials:
affiliation: UCCS
name: Heather Littleton, PhD
role: PRINCIPAL_INVESTIGATOR
References: