The Gender Inclusive Sexuality Talks Program

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-100
SponsorUniversity of Pennsylvania

About this trial

The study is centered on helping parents answer and meet the sexuality-specific questions and needs of transgender, gender diverse, lesbian or bisexual female youth. This study seeks to test the efficacy of the GIST Program as a parent-child sexuality communication intervention that educates and trains parents to be purveyors of inclusive health information as transgender, gender diverse, lesbian or bisexual female youth come of age at home.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Crossover

Treatments tested in this trial

  • The Gender Inclusive Sexuality Talks Program

    Behavioral

    The GIST Program is a 5-session intervention where an interventionist will facilitate sessions that will include 8-12 parents per group. Each parent will have access to intervention content (e.g., videos, activities) across five synchronous sessions. Session I will focus on the issue of coming out and its impact on the family as well as on youth mental health. Session II centers on communication-based content. Sessions III and IV focuses on topic-centered content to address the knowledge gap parents have reported regarding general LGBTQ concerns and builds on the communication skills learned in Session I. Session V provides a communication recap and focuses on how parents may have follow-up conversations with healthcare providers. In between the sessions, asynchronous interactive homework assignments will be provided to review concepts learned in the previous sessions and to initiate joint activities between parents and youth.

  • GIST Control

    Behavioral

    The control arm consists of access to five online modules. Parents in this condition will be able to view video content focused on health issues germane for LGBTQ youth that are not focused on sexual health. These outcomes are on bullying, alcohol and tobacco use, sleep hygiene and body image concerns.

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: GIST Intervention ArmExperimental treatment 1 intervention
Group B: Control ArmActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Parent-Adolescent Communication Quantity

The Parent- Teen Sexual Risk Communication Topic Scale will be adopted and used to measure the quantity of topics discussed. Participants are asked if they had ever discussed the topics with their child/parent, and if so, which ones. To measure quantity, sample questions would be "To what extent have you ever discussed any of the following topics with your mother/father?" Sample items: coming out/disclosure of sexual orientation, using a condom, peer pressure and sexual pressure from dating partners, penilevaginal or other types of intercourse. Response options: (1) none, (2) a little, (3) some, (4) a lot, or (5) extensive. (8 items; alpha = .85-.95)

Time frame
Baseline, 1 week, 3 months, 6 months
2

Parent-Adolescent Communication Quality

The quality of sexuality-sensitive communication will be determined using the Family Sexuality Communication Quotient - a measure of a general family orientation to discussion about sexuality between parents and children; this is an 18-item scale with options (1-Strongly Agree to 5-Strongly Disagree). The first subscale on comfort measures the perceived degree of openness with which sexuality is discussed in the family (e.g., I feel free to ask my parents questions about sexuality). The second subscale on information measures perception of the amount of information learned and shared during discussions (e.g., I feel better informed about sexuality if I talk to my parents.) (18 items; alpha = .91)

Time frame
Baseline, 1 week, 3 months, 6 months

Secondary outcomes

1

Adolescent and Parent Mental Health (Depression)

The PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression. In addition to making criteria-based diagnoses of depressive disorders, the PHQ-9 is also a reliable and valid measure of depression severity. These characteristics plus its brevity make the PHQ-9 a useful clinical and research tool. This 9-item questionnaire lists varying depression symptoms and inquires about how much each depression symptom has been noted as bothersome within the past two weeks. Response options are: (0) not at all, (1) several days a week, (2) more than half the days, (3) nearly every day. (9 items; alpha = .95)

Time frame
Baseline, 1 week, 3 months, 6 months
2

Adolescent and Parent Mental Health (Anxiety)

The GAD-7 is a valid and efficient tool for screening for Generalized Anxiety Disorder and assessing its severity in clinical practice and research. There was good agreement between self-report and interviewer-administered versions of the scale. This 7-item questionnaire lists varying anxiety symptoms and inquires about how much each symptom has been noted as bothersome within the past two weeks. Response options are: (0) not at all, (1) several days a week, (2) more than half the days, (3) nearly every day. (7 items; alpha = .92)

Time frame
Baseline, 1 week, 3 months, 6 months
3

Parent-Adolescent Health Behavior (Wellness Appointment)

We will measure successful setting up by both parent and child of screening appointments with an LGBTQ-competent provider during each follow-up survey. Three questions will asked: (1) Since the last survey, have you and your parent/child looked up LGBTQ-friendly health providers in your area? (Yes/No); (2) Since the last survey, have you and your parent/child made an appointment for a wellness appointment? (Yes/No); and (3) Since the last survey, have you and your parent/child seek out a healthcare provider to be screened for a sexually-transmitted infection? (Yes/No).

Time frame
Baseline, 1 week, 3 months, 6 months
4

Family Functioning

The Family Assessment Device (FAD) is based on the McMaster Model of Family Functioning (MMFF), a clinically oriented conceptualization of families. It is a screening instrument consisting of 60-items. The model identifies seven dimensions of family functioning and this study will use the questions from three subscales (affective response, communication and general functioning). Response categories are as follows: strongly agree, agree, disagree, and strongly disagree. Scores range from 1 to 4 with 1 reflecting healthy functioning and 4 reflecting unhealthy functioning. (24 items; alpha = .92)

Time frame
Baseline, 1 week, 3 months, 6 months

Other outcomes

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