NCT06309134

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
4mo left

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress81%
Jan 2025Aug 2026

First Submitted

Initial submission to the registry

February 23, 2024

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 13, 2024

Completed
10 months until next milestone

Study Start

First participant enrolled

January 7, 2025

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2026

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2026

Expected
Last Updated

July 17, 2025

Status Verified

July 1, 2025

Enrollment Period

1.2 years

First QC Date

February 23, 2024

Last Update Submit

July 14, 2025

Conditions

Keywords

dating violenceteen drinkingalcohol useminority stressparenting behaviors

Outcome Measures

Primary Outcomes (8)

  • 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 Outcomes (12)

  • PHQ-8 (modified for adolescents)

    Baseline, 8 weeks, 3 months

  • LGBTQ+ teen perceived drinking norms

    Baseline, 8 weeks, 3 months

  • LGBTQ+ teen perceived dating violence norms

    Baseline, 8 weeks, 3 months

  • Sexual communication self-efficacy scale

    Baseline, 8 weeks, 3 months

  • Communication skills test (modified to assess self-efficacy)

    Baseline, 8 weeks, 3 months

  • +7 more secondary outcomes

Study Arms (2)

Healthy Families Bright Futures Program

EXPERIMENTAL

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

Waitlist

NO INTERVENTION

Waitlist control. This arm will complete assessments on the same schedule as the experimental condition.

Interventions

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.

Healthy Families Bright Futures Program

Eligibility Criteria

Age15 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Colorado Springs

Colorado Springs, Colorado, 80918-3733, United States

RECRUITING

MeSH Terms

Conditions

Alcohol DrinkingUnderage Drinking

Condition Hierarchy (Ancestors)

Drinking BehaviorBehaviorAdolescent Behavior

Study Officials

  • Heather Littleton, PhD

    UCCS

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Heather Littleton, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 23, 2024

First Posted

March 13, 2024

Study Start

January 7, 2025

Primary Completion

March 31, 2026

Study Completion (Estimated)

August 31, 2026

Last Updated

July 17, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

IPD will be deposited into NIMH Data Archive. Participants will be identified by pseudoGUIDS

Shared Documents
STUDY PROTOCOL, ANALYTIC CODE
Time Frame
Data will be available within 6 months of collection and will be available in perpetuity.
Access Criteria
Access to data can be requested in accordance with NIMH Data Archive policies and procedures.
More information

Locations