이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

부모가 자녀의 성적 정체성 및 젠더 정체성 경험을 확인하도록 지원 (SPACES)

2026년 9월 28일 업데이트: Yale University

부모가 자녀의 성적 정체성 및 젠더 정체성 경험을 확인하도록 지원하기 위한 두 가지 간단한 개입의 개발 및 초기 시도

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.

연구 개요

상세 설명

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.

연구 유형

중재적

등록 (실제)

132

단계

  • 1단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • Connecticut
      • New Haven, Connecticut, 미국, 06510
        • Yale University
    • Maryland
      • College Park, Maryland, 미국, 20742
        • University of Maryland
    • Tennessee
      • Nashville, Tennessee, 미국, 37235
        • Vanderbilt University
      • Beersheba, 이스라엘, 84105
        • Ben-Gurion University

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

15년 이상 (어린이, 성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.

실험적: 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.

다른: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change in Parents' Rejecting and Supportive Behaviors Measured By the Parent Non-Acceptance Scale
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Change in Secondary Parental Acceptance and Rejection Measured By the Children's Report of Parent Behavior Inventory
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

수사관

  • 수석 연구원: John E Pachankis, Ph.D., Yale University
  • 수석 연구원: Lea Dougherty, Ph.D., University of Maryland

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

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)

2023년 11월 29일

기본 완료 (실제)

2026년 5월 12일

연구 완료 (실제)

2026년 5월 12일

연구 등록 날짜

최초 제출

2023년 6월 16일

QC 기준을 충족하는 최초 제출

2023년 6월 16일

처음 게시됨 (실제)

2023년 6월 26일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 10월 2일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 28일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 2000035266
  • 1R21HD110617-01A1 (미국 NIH 보조금/계약)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

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 공유 기간

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

IPD 공유 액세스 기준

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 공유 지원 정보 유형

  • 연구_프로토콜
  • 수액
  • ICF
  • ANALYTIC_CODE
  • CSR

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. .

구독하다