- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07672067
Intervention to Improve Parent Communication About Sexuality
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Dalmacio D Flores, PhD
- Phone Number: 4043944593
- Email: dalmacio@nursing.upenn.edu
Study Locations
-
-
Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Recruiting
- University of Pennsylvania
-
Contact:
- Dalmacio D Flores, PhD
- Phone Number: 404-394-4593
- Email: dalmacio@nursing.upenn.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Youth participants (1) identify as a cisgender sexual minority male (e.g., gay, bisexual or queer) who has disclosed sexual orientation to parent or trusted caregiver (2) be aged 14-18 years; (3) able to comprehend spoken English; (4) resides in the United States; (5) consents or assents to study participation
Parent participants (1) parent, legal guardians, legal custodians (hereinafter "parent") of GBQ adolescent; (2) age 18 or older; (3) able to comprehend spoken English; (4) resides in the United States; (5) knows their GBQ child's sexual orientation (6) consents to study participation; and (7) consents to their GBQ child's study participation.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention Arm
Parents randomized to receive the intervention (n=238) will be assigned to a 5-session online intervention that comprise 8-12 parents per cohort.
They will register their profiles via our secure, password-protected Parents ASSIST website.
Parents in the intervention arm will complete one session per week where they watch two videos focused on sexual health and family communication.
They will also be asked to complete homework tasks with their GBQ child.
GBQ adolescents will not be intervened upon directly; rather, we will instruct parents to engage their sons based on the information and skills learned weekly through the intervention.
|
Parents ASSIST 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 the i 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 specific GBQ issues 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.
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 GBQ youth.
Other Names:
|
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Active Comparator: Control Arm
Control group participants (n=238 parents) will be assigned to the health promotion arm and similarly asked to register into our secure Parents ASSIST study site but will be assigned to the control group educational resources: alcohol use, bullying, sleep hygiene, tobacco use, and body image issues.
Individual participants will access via the website the videos on these non-sexual health focused conditions.
|
Parents ASSIST 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 the i 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 specific GBQ issues 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.
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 GBQ youth.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Parent-Adolescent Communication Quality
Time Frame: Baseline, 3 months, 6 months, 12 months
|
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)
|
Baseline, 3 months, 6 months, 12 months
|
|
Parent-Adolescent Communication Quantity
Time Frame: Baseline, 3 months, 6 months, 12 months
|
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)
|
Baseline, 3 months, 6 months, 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adolescent and Parent Mental Health (Depression)
Time Frame: Baseline, 3 months, 6 months, 12 months
|
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)
|
Baseline, 3 months, 6 months, 12 months
|
|
Adolescent and Parent Mental Health (Anxiety)
Time Frame: Baseline, 3 months, 6 months, 12 months
|
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)
|
Baseline, 3 months, 6 months, 12 months
|
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Parent-Adolescent Health Behavior (Wellness Appointment)
Time Frame: Baseline, 3 months, 6 months, 12 months
|
We will measure successful setting up by both parent and GBQ 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/GBQ child looked up LGBTQ-friendly health providers in your area?
(Yes/No); (2) Since the last survey, have you and your parent/GBQ child made an appointment for a wellness appointment?
(Yes/No); and (3) Since the last survey, have you and your parent/GBQ child seek out a healthcare provider to be screened for a sexually-transmitted infection?
(Yes/No).
|
Baseline, 3 months, 6 months, 12 months
|
|
Family Functioning
Time Frame: Baseline, 3 months, 6 months, 12 months
|
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)
|
Baseline, 3 months, 6 months, 12 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Dalmacio D Flores, PhD, University of Pennsylvania
Publications and helpful links
General Publications
- Flores DD, Hennessy K, Rosario A, Chung J, Wood S, Kershaw T, Villarruel A, Bauermeister J. Parents ASSIST: Acceptability and Feasibility of a Video-Based Educational Series for Sexuality-Inclusive Communication between Parents and Gay, Bisexual, and Queer Sons. Int J Environ Res Public Health. 2021 Dec 30;19(1):379. doi: 10.3390/ijerph19010379.
- Flores DD, Rosario AA, Bond KT, Villarruel AM, Bauermeister JA. Parents ASSIST (Advancing Supportive and Sexuality-Inclusive Sex Talks): Iterative Development of a Sex Communication Video Series for Parents of Gay, Bisexual, and Queer Male Adolescents. J Fam Nurs. 2020 May;26(2):90-101. doi: 10.1177/1074840719897905. Epub 2020 Jan 31.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 856192 (24-1002)
- R01HD111516 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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