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Intervention to Improve Parent Communication About Sexuality

13 juillet 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

476

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • États-Unis
    • Pennsylvania
      • Philadelphia, Pennsylvania, États-Unis, 19104
        • Recrutement
        • University of Pennsylvania
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Enfant
  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Oui

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: La prévention
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Comportemental: Parents ASSIST
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.
Autres noms:
  • Parents Advancing Supportive and Sexuality Inclusive Sex Talks
Comparateur actif: 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.
Comportemental: Parents ASSIST
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.
Autres noms:
  • Parents Advancing Supportive and Sexuality Inclusive Sex Talks

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Parent-Adolescent Communication Quality
Délai: 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
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Adolescent and Parent Mental Health (Depression)
Délai: 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)
Délai: 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
Parent-Adolescent Health Behavior (Wellness Appointment)
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University of Pennsylvania

Collaborateurs

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Les enquêteurs

  • Chercheur principal: Dalmacio D Flores, PhD, University of Pennsylvania

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 mai 2026

Achèvement primaire (Estimé)

30 décembre 2028

Achèvement de l'étude (Estimé)

30 août 2029

Dates d'inscription aux études

Première soumission

22 juin 2026

Première soumission répondant aux critères de contrôle qualité

22 juin 2026

Première publication (Réel)

26 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

15 juillet 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

13 juillet 2026

Dernière vérification

1 juillet 2026

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • 856192 (24-1002)
  • R01HD111516 (Subvention/contrat des NIH des États-Unis)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

Only statistical information for primary and secondary outcomes will be shared. Individual participant data will not be shared.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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