Intervention to Improve Parent Communication About Sexuality
2026年7月13日 更新者：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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (推定)
476
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Dalmacio D Flores, PhD
- 電話番号：4043944593
- メール：dalmacio@nursing.upenn.edu
研究場所
-
-
Pennsylvania
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Philadelphia、Pennsylvania、アメリカ、19104
- 募集
- University of Pennsylvania
-
コンタクト：
- Dalmacio D Flores, PhD
- 電話番号：404-394-4593
- メール：dalmacio@nursing.upenn.edu
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
はい
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：単一グループの割り当て
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
他の名前：
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アクティブコンパレータ：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.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Parent-Adolescent Communication Quality
時間枠：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
|
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Parent-Adolescent Communication Quantity
時間枠：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)
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Baseline, 3 months, 6 months, 12 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Adolescent and Parent Mental Health (Depression)
時間枠：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)
時間枠：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)
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Baseline, 3 months, 6 months, 12 months
|
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Parent-Adolescent Health Behavior (Wellness Appointment)
時間枠：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).
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Baseline, 3 months, 6 months, 12 months
|
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Family Functioning
時間枠：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)
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Baseline, 3 months, 6 months, 12 months
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Dalmacio D Flores, PhD、University of Pennsylvania
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年5月1日
一次修了 (推定)
2028年12月30日
研究の完了 (推定)
2029年8月30日
試験登録日
最初に提出
2026年6月22日
QC基準を満たした最初の提出物
2026年6月22日
最初の投稿 (実際)
2026年6月26日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月15日
QC基準を満たした最後の更新が送信されました
2026年7月13日
最終確認日
2026年7月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- 856192 (24-1002)
- R01HD111516 (米国 NIH グラント/契約)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
IPD プランの説明
Only statistical information for primary and secondary outcomes will be shared.
Individual participant data will not be shared.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。