The Healthy Families Bright Futures Program

August 27, 2026 updated by: Heather Littleton, University of Colorado, Colorado Springs

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
122

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Colorado
      • Colorado Springs, Colorado, United States, 80918-3733
        • University of Colorado Colorado Springs

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Measure of Adolescent Relationships and Harassment and Abuse - Victimization
Time Frame: Baseline, 8 weeks, 3 months
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
Time Frame: Baseline, 8 weeks, 3 months
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
Time Frame: Baseline, 8 weeks, 3 months
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
Time Frame: Baseline, 8 weeks, 3 months
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
Time Frame: Baseline, 8 weeks, 3 months
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)
Time Frame: Baseline, 8 weeks, 3 months
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)
Time Frame: Baseline, 8 weeks, 3 months
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)
Time Frame: 8 weeks
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
PHQ-8 (modified for adolescents)
Time Frame: Baseline, 8 weeks, 3 months
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
Time Frame: Baseline, 8 weeks, 3 months
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
Time Frame: Baseline, 8 weeks, 3 months
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
Time Frame: Baseline, 8 weeks, 3 months
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)
Time Frame: Baseline, 8 weeks, 3 months
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.
Time Frame: Baseline, 8 weeks, 3 months
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
Time Frame: Baseline, 8 weeks, 3 months
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
Time Frame: Baseline, 8 weeks, 3 months
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
Time Frame: Baseline, 8 weeks, 3 months
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
Time Frame: Baseline, 8 weeks, 3 months
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
Time Frame: Baseline, 8 weeks, 3 months
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
Time Frame: Baseline, 8 weeks, 3 months
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Colorado, Colorado Springs

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Nebraska Lincoln

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Heather Littleton, PhD, UCCS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 7, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 4, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 4, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 23, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 13, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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