The Healthy Families Bright Futures Program

An Online Family-based Program to Prevent Alcohol Use and Dating and Sexual Violence Among Sexual and Gender Minority Youth

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Alcohol Drinking; Violence in Adolescence
• Intervention / Treatment: Behavioral: Healthy Families Bright Futures Program

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 (Aim 2a) 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) (Aim 2b) 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.

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Heather Littleton, PhD; Phone Number: 17192553108; Email: hlittlet@uccs.edu

Study Locations

• United States
  • Colorado
    • Colorado Springs, Colorado, United States, 80918-3733
      • University of Colorado Colorado Springs
      • Contact: Heather Littleton, PhD; Phone Number: 719-255-3108; Email: hlittlet@uccs.edu
      • Principal Investigator: Heather Littleton, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Healthy Families Bright Futures Program; This arm will complete the intervention. Assessments will occur at pre-intervention, post-intervention, and three month follow up.	Behavioral: Healthy Families Bright Futures Program; Seven weekly online group sessions with separate sessions for teens and caregivers. Sessions focus on increasing knowledge and acceptance of LGBTQ+ identities, alcohol use and dating violence social norms correction, bystander intervention, assertive communication skills, social emotional skills, family problem solving, and parenting behaviors.
No Intervention: Waitlist; Waitlist control. This arm will complete assessments on the same schedule as the experimental condition.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure of Adolescent Relationships and Harassment and Abuse - Victimization	Teens only- both dichotomous scores and mean scores calculated for each subscale administered (privacy control, social control, intimidation). Items refer to frequency of past month victimization (0 times [0], 1-3 times [1], 4-10 times [2], more than 10 times [3]). Higher scores reflect greater victimization.	Baseline, 8 weeks, 3 months
Measure of Adolescent Relationships and Harassment and Abuse - Perpetration	Teens only- both dichotomous scores and mean scores calculated for each subscale administered (cyber control, social control, intimidation). Items refer to frequency of past month perpetration (0 times [0], 1-3 times [1], 4-10 times [2], more than 10 times [3]). Higher scores reflect greater perpetration.	Baseline, 8 weeks, 3 months
Monitoring the future alcohol use intentions	Teens only, two items that query about intentions to drink alcohol in the next 3 months and the next 30 days. Rating scale responses ranging from 1- Definitely will and 5- Definitely won't. Mean score of both items are calculated. Possible range 1 to 5, higher scores reflect lower intentions to use alcohol.	Baseline, 8 weeks, 3 months
Monitoring the future alcohol use items	Teens only- Items assesses frequency of alcohol use and frequency of getting drunk in past 30 days. Response options are: 0, 1, 2, 3, 4, 5, 6-9, 10-19, 20-39, 40+. Mean scores across both items are calculated. Higher scores reflect more frequent alcohol use.	Baseline, 8 weeks, 3 months
Drinking Refusal Self-Efficacy Questionnaire- Shortened adolescent version	Teens only- both total and subscale (opportunistic, social pressure, emotional relief) scores are calculated. Items are summed. Higher scores reflect greater alcohol refusal self-efficacy. Possible total range 9- 54.	Baseline, 8 weeks, 3 months
Conflict Tactics Scale- 2 (SGM Specific IPV Perpetration)	Teens only- both a dichotomous and mean score calculated. For each item, teens indicate how often in the past month they engaged in the SGM specific dating violence behavior with options of 0 times (0), 1-3 times (1), 4-10 times (2), more than 10 times (3). Higher scores reflect greater engagement in SGM specific IPV.	Baseline, 8 weeks, 3 months
Conflict Tactics Scale- 2 (SGM Specific IPV Victimization)	Teens only- both a dichotomous and mean score calculated. For each item, teens indicate how often in the past month they experience the SGM specific dating violence behavior with options of 0 times (0), 1-3 times (1), 4-10 times (2), more than 10 times (3). Higher scores reflect greater SGM specific IPV victimization.	Baseline, 8 weeks, 3 months
Program acceptability, appropriateness, and feasibility ratings (drawn from Weiner)	Teens and caregivers- subscales consist of 6 items each with one assessing appropriateness (e.g., the program was a good match to my needs), one assessing acceptability (e.g., I liked the program), and one assessing feasibility (e.g., The skills I learned in the program are easy to use). Mean scores are calculated for each subscale. For each item, participants rate their agreement with the statement on a 5 point scale ranging from 1 strongly disagree to 5 strongly agree. Mean subscale scores are compared to scale midpoint (3). Scores significantly above the midpoint are evidence of intervention acceptability, appropriateness, and feasibility.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PHQ-8 (modified for adolescents)	Teens only-Total scores are calculated. Higher scores reflect greater depression symptoms. Possible range 0-24.	Baseline, 8 weeks, 3 months
LGBTQ+ teen perceived drinking norms	Teens only- two items assessing perceptions of on how many occasions participants believed LGBTQ+ teens on average drank and got drunk in the past 30 days. Response options are: 0, 1, 2, 3, 4, 5, 6-9, 10-19, 20-39, 40+ Mean scores are calculated across both items. Higher scores represent greater perceived drinking norms.	Baseline, 8 weeks, 3 months
LGBTQ+ teen perceived dating violence norms	Teens only- 18 items assessing participants' perceptions of the percentage of LGBTQ+ teens who engaged in a variety of dating violence perpetration behaviors. For each item, participants estimate percentage of teens who engaged in each behavior in the past month, ranging from 0 to 100%. Mean scores are calculated for each subscale: social control, physical abuse, sexual abuse, isolation, cyber control, intimidation. Higher scores reflect greater perceived dating violence norms.	Baseline, 8 weeks, 3 months
Sexual communication self-efficacy scale	Teens only- mean scores are calculated for both subscales: positive sexual messages, negative sexual messages. Higher scores reflect greater sexual communication self-efficacy. Subscale scores can range from 1 to 4.	Baseline, 8 weeks, 3 months
Communication skills test (modified to assess self-efficacy)	Teens only- 9 items that assess participants' self-efficacy to engage in healthy communication strategies with their dating partners. Mean scores across all items are calculated. Higher scores reflect greater healthy communication self-efficacy. Scores can range from 1 to 4.	Baseline, 8 weeks, 3 months
Short Internalized Homonegativity Scale.	Teens only- 11 items assess internalized homonegativity. One item that assesses comfort in LGBTQ+ bars was omitted. Items were modified to refer to LGBTQ+ identities. Total scores are calculated. Higher scores reflect greater internalized homonegativity. Scores can range from 11 to 55.	Baseline, 8 weeks, 3 months
Self-Efficacy for Parenting Adolescents Scale	Caregivers only- three subscales administered: physical and sexual development, emotional responsivity and communication, and discipline and behavior management. Mean scores are calculated for each subscale. Higher scores reflect greater self-efficacy. Scores for each subscale can range from 1 to 4.	Baseline, 8 weeks, 3 months
Parental Monitoring Short Scale	Teens and caregivers- mean scores are calculated for caregivers and teens for each subscale: parental knowledge, parental control, comunication. Higher scores on each subscale reflect greater use of each parental monitoring strategy. Scores on each subscale can range from 1 to 5.	Baseline, 8 weeks, 3 months
Parent Adolescent Communication Scale	Teens and caregivers- total scores for each subscale are calculated separately for teens and caregivers: open communication and problem free communication. Higher scores reflect less perceived communication problems. Scores can range from 10 to 100 for each subscale.	Baseline, 8 weeks, 3 months
Alabama Parenting Questionnaire- Short form	Caregivers only- Total score are calculated for each subscale (positive parenting, inconsistent discipline, poor supervision). Higher subscale scores reflect greater engagement in that parenting behavior. Scores on each subscale can range from 5 to 15.	Baseline, 8 weeks, 3 months
Social and Emotional Competencies Questionnaire	Teens only- Total scores are calculated for each subscale (self-awareness, self-management and motivation, social awareness and prosocial behavior, decision making). Higher scores reflect greater perceived competence. Scores for self awareness subscale range from 4 to 20, scores for the self-management and decision making subscales range from 3 to 15, scores for the social awareness subscale range from 6 to 30.	Baseline, 8 weeks, 3 months
LGBTQ+ Microaggressions and Microaffirmations in Families	Teens and caregivers- mean scores are calculated for each subscale separately for teens and caregivers (interpersonal positive, interpersonal negative). For each subscale, higher scores reflect greater engagement in that behavior by the caregiver. Scores on each subscale can range from 0 to 4.	Baseline, 8 weeks, 3 months

Collaborators and Investigators

• Sponsor: University of Colorado, Colorado Springs
• Collaborators: University of Nebraska Lincoln
• Investigators: Principal Investigator: Heather Littleton, PhD, UCCS

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2024
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: February 23, 2024
• First Submitted That Met QC Criteria: March 6, 2024
• First Posted (Actual): March 13, 2024

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 6, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: alcohol use; minority stress; dating violence; teen drinking; parenting behaviors
• Additional Relevant MeSH Terms: Drinking Behavior; Alcohol Drinking
• Other Study ID Numbers: R34AA030662 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD will be deposited into NIMH Data Archive. Participants will be identified by pseudoGUIDS
• IPD Sharing Time Frame: Data will be available within 6 months of collection and will be available in perpetuity.
• IPD Sharing Access Criteria: Access to data can be requested in accordance with NIMH Data Archive policies and procedures.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No