Intervention to Improve Parent Communication About Sexuality
2026년 7월 13일 업데이트: University of Pennsylvania
The study is centered on helping parents answer and meet the sexuality-specific questions and needs of gay or bisexual males.
This study seeks to test the efficacy of Parents ASSIST as a parent-child sexuality communication intervention that educates and trains parents to be purveyors of inclusive health information as gay or bisexual sons come of age at home.
연구 개요
상태
상태
모병
정황
정황
개입 / 치료
개입 / 치료
상세 설명
Parental acceptance after youth come out as gay or bisexual is a protective factor for the health of this youth group; however, parents lack support in initiating and sustaining sexuality discussions inclusive of their teens' attractions, behaviors and identities.
Thus, in the absence of skills and supports, adolescents' and parents' mental health, health behaviors and overall family functioning tend to be negatively impacted after sons come out as gay or bisexual.
The overall objective of this study is to test the efficacy of Parents ASSIST (Advancing Supportive and Sexuality Inclusive Sex Talks), a sexuality communication intervention for parents, after youth disclose gay or bisexual identities.
We will conduct a randomized controlled trial with parent and gay or bisexual youth dyads (N=476) to establish the efficacy of Parents ASSIST as a hybrid 5-session online intervention that educates parents about germane sexuality-specific topics and provide communication skills for family discussions.
Our Specific Aims are to (1) determine whether Parents ASSIST enhances parent-adolescent sexuality communication quality (e.g.
parent- and child-reported comfort) and quantity (e.g.
frequency and range of topics discussed) compared to the control group, (2) establish whether Parents ASSIST results in decreases in mental health symptomology (e.g.
depressive and anxiety symptoms) among parents and gay or bisexual youth, increases dyadic health behavior (e.g.
accessing preventive health services, health screening behaviors), and improves family functioning (e.g.
affective response, communication, general functioning) over 12 months of follow-up, and (3) examine how theory-based variables (e.g.
attitudes and norms, self-efficacy and intentions to discuss sexuality with gay or bisexual child) mediate the intervention effects on adolescent and parent mental health, parent-adolescent health behavior and family functioning over time.
연구 유형
연구 유형
중재적
등록 (추정된)
등록
476
단계
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
연구 연락처
- 이름: Dalmacio D Flores, PhD
- 전화번호: 4043944593
- 이메일: dalmacio@nursing.upenn.edu
연구 장소
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, 미국, 19104
- 모병
- University of Pennsylvania
-
연락하다:
- Dalmacio D Flores, PhD
- 전화번호: 404-394-4593
- 이메일: dalmacio@nursing.upenn.edu
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
예
설명
Youth participants are:
- identify as a cisgender sexual minority male (e.g., gay or bisexual)
- be between ages 12-18 years
- able to comprehend spoken English
- resides in the United States
- consents or assents to study participation
Parent participants are:
- the parent, legal guardians, legal custodians (hereinafter "parent") of gay or bisexual adolescent
- age 18 or older
- able to comprehend spoken English
- resides in the United States
- consents to study participation
- consents to their child's study participation
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 단일 그룹 할당
- 마스킹: 하나의
팔의 수
2
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: 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.
다른 이름들:
|
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활성 비교기: 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.
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Parent-Adolescent Communication Quality
기간: 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
기간: 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
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Adolescent and Parent Mental Health (Depression)
기간: 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
|
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Adolescent and Parent Mental Health (Anxiety)
기간: 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)
기간: 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
|
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Family Functioning
기간: 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
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
협력자
협력자
수사관
수사관
- 수석 연구원: Dalmacio D Flores, PhD, University of Pennsylvania
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
연구 시작
2026년 5월 1일
기본 완료 (추정된)
기본 완료
2028년 12월 30일
연구 완료 (추정된)
연구 완료
2029년 8월 30일
연구 등록 날짜
최초 제출
최초 제출
2026년 6월 22일
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
2026년 6월 22일
처음 게시됨 (실제)
처음 게시됨
2026년 6월 26일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
2026년 7월 15일
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 13일
마지막으로 확인됨
마지막으로 확인됨
2026년 7월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- 856192 (24-1002)
- R01HD111516 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
IPD 계획 설명
Only statistical information for primary and secondary outcomes will be shared.
Individual participant data will not be shared.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .