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親が子どもの性的アイデンティティとジェンダーアイデンティティの経験を肯定できるよう支援する (SPACES)

2026年9月28日 更新者:Yale University

親が子どもの性的アイデンティティとジェンダー・アイデンティティの経験を肯定するのを支援するための 2 つの簡単な介入の開発と初期試行

The purpose of this study is to develop and test two brief online writing interventions to improve parental acceptance of sexual and gender minority youth (SGMY) in the Southeast United States.

調査の概要

詳細な説明

The purpose of this study is to develop and test the acceptability, feasibility, and preliminary efficacy of two brief online writing interventions to improve parental acceptance of sexual and gender minority youth (SGMY) in the Southeast United States. Parental support represents the strongest predictor of sexual and gender minority youth's (SGMY) mental health. However, many parents react to their SGMY's disclosure with rejection. Even relatively accepting parents can experience discomfort, while SGMY often report lingering unmet needs from their parents into adulthood. Few interventions exist to help parents support their SGMY child and none has been tested in a randomized trial with efficacy for decreasing parental rejection and increasing support of their SGMY. This proposal will develop and test the efficacy of two theory-based interventions that aim to address this gap. Results will identify mechanisms contributing to parental rejection and develop scalable approaches to reduce these mechanisms to shrink the substantial mental health disparities affecting SGMY. If efficacious, these interventions can be scaled up through online platforms capable of bypassing barriers to parental support of SGMY across high-stigma regions.

The focus of this registration is the randomized controlled trial.

研究の種類

介入

入学 (実際)

132

段階

  • フェーズ 1

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。

研究場所

    • Connecticut
      • New Haven、Connecticut、アメリカ、06510
        • Yale University
    • Maryland
      • College Park、Maryland、アメリカ、20742
        • University of Maryland
    • Tennessee
      • Nashville、Tennessee、アメリカ、37235
        • Vanderbilt University
      • Beersheba、イスラエル、84105
        • Ben-Gurion University

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

15年歳以上 (子、大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

Inclusion Criteria:

  1. Parents are eligible if they meet the following criteria:

    1. Be a parent, grandparent, or any other family member who considers themselves a guardian of an SGMY between 15-29 years old,
    2. Live in the Southeast United States (Louisiana, Mississippi, Alabama, Georgia, South Carolina, North Carolina, Tennessee, Arkansas, Kentucky, Florida),
    3. Identify as heterosexual and cisgender, and
    4. Report non-acceptance of their SGMY.
  2. SGMY are eligible if they meet the following criteria:

    1. Self-identify as SGM,
    2. Are 15-29 years old,
    3. Live in the Southeast United States, and
    4. Have a parent enrolled in the trial

    Exclusion Criteria:

  3. Any individual who meets any of the following criteria will be excluded from participation in this study:

    1. Active mania, psychosis, or suicidality, and
    2. Unable to provide informed consent.

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:処理
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • 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:Expressive Writing (EW)

Participants in the expressive writing (EW) condition will be instructed to write in a free-form manner about the most stressful aspects of being a parent of an SGMY, following standard EW procedures.

Participants will be instructed to write for 20 minutes across 3 consecutive days. They will be writing based on the prompts given to them.

実験的:Attachment-Based Writing (ABW)

Participants in the attachment-based writing (ABW) condition will respond to distinct prompts created for the condition based on components of attachment-based family therapy (ABFT).

Participants will be instructed to write for 20 minutes across 3 consecutive days. They will be writing based on the prompts given to them.

他の:Neutral Writing (Control)

Participants in the control condition will be asked to write about what they have done since waking up that morning.

Participants will be instructed to write in order to control for time and writing engagement.

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
Change in Parents' Rejecting and Supportive Behaviors Measured By the Parent Non-Acceptance Scale
時間枠:Baseline, 5 Days Post-Baseline, and 3 Months Post-Baseline

The 10-item Parent Non-Acceptance Scale is a self-reported instrument assessing positive and negative indicators of parental acceptance of their SGMY. Parents report level of agreement on a scale from 1 (Strongly Disagree) to 6 (Strongly Agree), with a higher score on negative indicators representing a higher level of non-acceptance and a higher score on positive indicators representing a lower level of non-acceptance.

Baseline, 5 Days Post-Baseline, and 3 Months Post-Baseline

二次結果の測定

結果測定
メジャーの説明
時間枠
Change in Secondary Parental Acceptance and Rejection Measured By the Children's Report of Parent Behavior Inventory
時間枠:Baseline, 5 Days Post-Baseline, and 3 Months Post-Baseline

The Children's Report of Parent Behavior Inventory (CRPBI) is a 10-item rejection/support subscale assessing level of rejection/support. Parents report how much each statement describes the way they acted towards their SGMY ranging from 1 (not like you) to 3 (a lot like you), where Acceptance and Psychological Control scores are the totals of the individual items in the respective sub-scales, and Firm Control score is obtained by taking the sum of the Firm Control + subscale, adding 24, and by then subtracting the total of the Firm Control -- subscale.

Baseline, 5 Days Post-Baseline, and 3 Months Post-Baseline
Change in Secondary Parental Acceptance and Rejection Measured By the the Parental Acceptance/Rejection Questionnaire
時間枠:Baseline, 5 Days Post-Baseline, and 3 Months Post-Baseline

The 24-item Parental Acceptance/Rejection Questionnaire describes the way parents act towards their children. Parents report how true each statement is on a scale from 1 (almost always true of me) to 4 (almost never true of me) where a higher score indicates a higher level of rejection.

Baseline, 5 Days Post-Baseline, and 3 Months Post-Baseline
Change in Secondary Parental Acceptance and Rejection Measured By the Five-Minute Speech Sample
時間枠:Baseline, 5 Days Post-Baseline, and 3 Months Post-Baseline

The Five-Minute Speech Sample (FMSS) is a measure of parent-child dynamics where parents talk for 5 minutes about their thoughts and feelings about their SGMY. The qualitative interview is coded and scored appropriately to measure parental behavior towards their SGMY

Baseline, 5 Days Post-Baseline, and 3 Months Post-Baseline
Change in Parent-Child Relationship Quality and Stress Assessed by the Parental Environment Questionnaire Conflict, Involvement, and Regard for Child Subscales
時間枠:Baseline, 5 Days Post-Baseline, and 3 Months Post-Baseline

The Parental Environment Questionnaire Conflict (12-item), Involvement (12-item), and Regard for Child (5-item) Subscales assess perceptions of parent-child relationship quality. Parents rate how true each statement is on a scale from 1 (definitely true) to 5 (definitely false), where a high score on the conflict scale indicates greater parental conflict, a high score on the involvement scale indicates less parental involvement, and a high score on the regard for child scale indicates high regard for child.

Baseline, 5 Days Post-Baseline, and 3 Months Post-Baseline
Change in Parent-Child Relationship Quality and Stress Assessed by the McMaster Family Assessment Device General Functioning Subscale
時間枠:Baseline, 5 Days Post-Baseline, and 3 Months Post-Baseline

The 12-item McMaster Family Assessment Device General Functioning Subscale further assesses perceived parent-child relationship quality and stress on a scale of "strongly agree" (1) to "strongly disagree" (4), where a higher score indicates lower general family functioning.

Baseline, 5 Days Post-Baseline, and 3 Months Post-Baseline
Change in Parent Anti-SGM Bias Assessed Using the Social Distance Scale
時間枠:Baseline, 5 Days Post-Baseline, and 3 Months Post-Baseline

The Social Distance Scale assesses anti-LGBTQ (Lesbian, Gay, Bisexual, Trans, Queer) stigma by assessing parents' responses to different scenarios from 0 (definitely unwilling or completely uncomfortable) to 3 (definitely willing or completely comfortable), where a lower score indicates stronger anti-LGBTQ stigma.

Baseline, 5 Days Post-Baseline, and 3 Months Post-Baseline
Change in Parent Anti-SGM Bias Assessed Using the Lesbian, Gay, Bisexual Affiliate Stigma Measure
時間枠:Baseline, 5 Days Post-Baseline, and 3 Months Post-Baseline

The Lesbian, Gay, Bisexual Affiliate Stigma Measure (LGB-ASM) measures affiliate stigma faced by heterosexual family and friends of sexual minority people. Parents rate how much they agree with each statement on a scale from 1 (strongly disagree) to 6 (strongly agree), with the option to claim "not applicable." A higher score indicates stronger affiliate stigma.

Baseline, 5 Days Post-Baseline, and 3 Months Post-Baseline
Change in Parent-Child Unresolved Conflict Measured Using the Unfinished Business Scale
時間枠:Baseline, 5 Days Post-Baseline, and 3 Months Post-Baseline

The 11-item Unfinished Business Scale was adapted by Principal Investigator Pachankis with strong psychometric properties to measure parents' unresolved negative thoughts and feelings towards their SGMY. Parents rate statements about their SGM child on a scale from 1 (not at all) to 5 (very much), where a higher score represents greater unresolved parent-child conflict.

Baseline, 5 Days Post-Baseline, and 3 Months Post-Baseline
Change in Parent Depression and Anxiety Using the PROMIS (Patient-Reported Outcomes Measurement Information System®) Depression, Anxiety, and Anger Scales
時間枠:Baseline, 5 Days Post-Baseline, and 3 Months Post-Baseline

The 63-item PROMIS Depression, Anxiety, and Anger questionnaires measure parent-reported frequency of depression, anxiety, and anger symptoms over the past 7 days on a scale from 1 (never) to 5 (always), where higher scores indicate higher severity of symptoms.

Baseline, 5 Days Post-Baseline, and 3 Months Post-Baseline
Change in Parent Perceived Stress Using the Perceived Stress Scale
時間枠:Baseline, 5 Days Post-Baseline, and 3 Months Post-Baseline

The 10-item Perceived Stress Scale assesses parents' perceived stress by asking about frequency of thoughts and feelings during the past month on a scale from 0 (never) to 4 (very often), where a higher score indicates a higher level of perceived stress.

Baseline, 5 Days Post-Baseline, and 3 Months Post-Baseline
Change in Parent Report of Child Depression and Anxiety Using the PROMIS Depression and Anxiety Scales
時間枠:Baseline, 5 Days Post-Baseline, and 3 Months Post-Baseline

The 15-item proxy-report PROMIS Depression and Anxiety Scales measures parent report of their SGM child's depression and anxiety symptoms by asking frequency of the SGMY's symptoms over the past 7 days on a scale from 1 (never) to 5 (always), where higher scores indicate a greater severity of parent-reported symptoms.

Baseline, 5 Days Post-Baseline, and 3 Months Post-Baseline
Change in Parent Negative Emotion Using a Modified Positive and Negative Affect Schedule (PANAS)
時間枠:Baseline, 5 Days Post-Baseline, and 3 Months Post-Baseline

The 20-item Positive and Negative Affect Schedule (PANAS) inquires about parents' positive and negative affect towards their SGMY. Participants indicate how often they have felt either positive or negative indicators on a scale of 1 (very slightly or not at all) to 5 (extremely). A high score on positive affect indicators indicates a higher positive affect towards the SGMY, while a high score on negative affect indicates a higher negative affect towards the SGMY.

Baseline, 5 Days Post-Baseline, and 3 Months Post-Baseline
Change in Parent Empathy Measured By the Questionnaire of Cognitive and Affective Empathy
時間枠:Baseline, 5 Days Post-Baseline, and 3 Months Post-Baseline

The 31-item Questionnaire of Cognitive and Affective Empathy (QCAE) measures parent empathy toward their SGMY. Parents rate how much a statement relates to them on a scale of 1 (strongly disagree) to 4 (strongly agree), where a high score indicates a high level of empathy toward the SGMY.

Baseline, 5 Days Post-Baseline, and 3 Months Post-Baseline
Intervention Acceptability Measured By the Client Satisfaction Questionnaire
時間枠:3-Month-Post-Baseline

The Client Satisfaction Questionnaire is an 8-item measurement of perceived helpfulness, likelihood of recommending, and positive experience. Participants rate statements on a scale of 1 (most negative) to 4 (most positive), with a high score representing a higher level of satisfaction.

3-Month-Post-Baseline
Intervention Acceptability Measured By the Treatment Acceptability Survey
時間枠:3-Month-Post-Baseline

The 17-item Treatment Acceptability Survey assesses perceived helpfulness, likelihood of recommending, and positive experience of the interventions. Participants rate statements on a scale of 1(strongly disagree) to 4 (strongly agree), with a higher score representing a higher level of acceptability.

3-Month-Post-Baseline
Intervention Feasibility Measured By Percentage of Intervention Sessions Completed
時間枠:Measured Throughout Intervention (Up to 2 Weeks)

Intervention feasibility will be partially measured by the percentage of intervention sessions participants complete.

Measured Throughout Intervention (Up to 2 Weeks)
Intervention Feasibility Measured By Percentage of Fully Engaged Sessions
時間枠:Measured Throughout Intervention (Up to 2 Weeks)

Intervention feasibility will be partially measured by the percentage of fully engaged sessions, defined as the number of writing sessions that included at least 313 words.

Measured Throughout Intervention (Up to 2 Weeks)
Intervention Feasibility Measured By Number of Platform Technical/Accessibility Issues
時間枠:Measured Throughout Intervention (Up to 2 Weeks)

Intervention feasibility will partially be tracked by the number of platform technical or accessibility issues noted throughout the intervention.

Measured Throughout Intervention (Up to 2 Weeks)

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。

スポンサー

捜査官

  • 主任研究者:John E Pachankis, Ph.D.、Yale University
  • 主任研究者:Lea Dougherty, Ph.D.、University of Maryland

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

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)

2023年11月29日

一次修了 (実際)

2026年5月12日

研究の完了 (実際)

2026年5月12日

試験登録日

最初に提出

2023年6月16日

QC基準を満たした最初の提出物

2023年6月16日

最初の投稿 (実際)

2023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10月2日

QC基準を満たした最後の更新が送信されました

2026年9月28日

最終確認日

2026年9月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • 2000035266
  • 1R21HD110617-01A1 (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?

はい

IPD プランの説明

Aggregated baseline and follow-up data will be uploaded to the National Institute of Mental Health Data Archive (NDA) following the conclusion of the study. All participants will be informed of the study's confidential data sharing procedures at the time of consent. Given the personal and sensitive nature of data contained in the intervention writing samples, qualitative interviews, and the 5-minute speech task, these data will be uploaded in aggregate.

De-identified individual participant data (IPD) (i.e., questionnaires, data dictionaries) generated with funds from this grant will be freely distributed, as available, to qualified academic investigators for non-commercial research. The study investigators as well as their institutions will adhere to the NIH Grants Policy on Sharing of Unique Research Resources including the "Sharing of Biomedical Research Resources: Principles and Guidelines for Recipients of NIH Grants and Contracts" issued in 2003.

IPD 共有時間枠

All data will become available once study results are submitted by the study team.

IPD 共有アクセス基準

The data are available by request to qualified researchers. To access the data, a proposal should be submitted by an applicant with a Ph.D. or an equivalent degree. Proposals will be scrutinized and granted according to principles of ethical and scientific soundness, including:

  1. A commitment to using the data only for research purposes and to not identify any individual participant;
  2. A commitment to securing the data using appropriate information technology; and
  3. A commitment to destroying the data after analyses are completed.

IPD 共有サポート情報タイプ

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

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。

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