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Development and Preliminary Trial of a Brief, Portable Health Intervention for Rural Sexual Minority Emerging Adults (Project LEAP)

27. August 2020 aktualisiert von: Yale University
The purpose of this study is to test the feasibility of writing interventions specifically designed for lesbian, gay, and bisexual (LGB) emerging adults (ages 18-29) that are aimed at improving the outcomes: depression, suicidality, substance abuse and HIV risk behaviors.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

This study is considered the third part ("Phase 3") of a larger study where parts one and two were designed to utilize elicitation focus groups to develop effective intervention materials (Phase 1) and then refine the developed materials through structured interviews (Phase 2). Phase 3 will test feasibility and assess early signs of efficacy of writing interventions. To do this, participants will be randomized to one of three arms (one arm will serve as control). Those that choose to participate will be asked to complete outcome measures (depressive symptoms, suicidality, use of alcohol and illicit drugs, HIV risk behavior) and measures of proposed mediators (self-reported and biological stress, behavioral and emotional self-regulation) and moderators (e.g., social support, identity centrality) at baseline, post-intervention, and three-month follow-up. In addition, structured interviews with 15 intervention participants will be used to refine study procedures as the investigators scale up this intervention for a future randomized controlled trial (RCT).

Studientyp

Interventionell

Einschreibung (Tatsächlich)

108

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • Connecticut
      • New Haven, Connecticut, Vereinigte Staaten, 06520
        • Yale University
    • Massachusetts
      • Worcester, Massachusetts, Vereinigte Staaten, 01610
        • College of the Holy Cross
    • Tennessee
      • Johnson City, Tennessee, Vereinigte Staaten, 37614
        • East Tennessee State University

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 29 Jahre (Erwachsene)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  • Self-identify as lesbian, gay, or bisexual
  • Live in Washington county, Tennessee (TN), or any of its 6 contiguous counties in northeastern TN
  • Have personal Internet access
  • Hair at least 2cm in length

Exclusion Criteria:

  • Failure to meet inclusion criteria

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Verhütung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Expressive Writing (EW)
Expressive Writing (EW) prompts individuals to write about personally stressful events, potentially enabling cognitive processing of unresolved, psychological and physiological stressors.
Verhalten: Expressive Writing (EW) Intervention
The EW intervention will utilize the procedures piloted earlier with gay and bisexual male college students in urban and rural regions of the US. In this condition, participants will be instructed to write for 20 minutes across three consecutive days in a free-form manner about the most stressful or traumatic LGB-related event that they have encountered.
Experimental: Self-Affirmation (SA)
Self-Affirmation (SA) interventions prompt individuals to write advice to a (hypothetical) similarly stigmatized person regarding how best to cope with stigma-related stress. By affirming one's own stigmatized identity through the process of helping another similarly stigmatized person.
Verhalten: Self-Affirmation (SA) Intervention
The SA intervention will ask participants to read a brief description, over the course of 3 consecutive days, of a (hypothetical) LGB youth who is facing minority stress. Each day's description will contain a different LGB youth facing a different stigma-related stressor derived from Phase 1 and 2 interviews. Participants will then be asked to write a letter for 20 minutes to advise the LGB youth how best to cope with minority stress drawing on their personal experiences.
Placebo-Komparator: Control
Participants randomly assigned to the control condition will be asked to write about what they have done since waking up that morning for 20 minutes across 3 consecutive days.
Sonstiges: Control
Participants randomly assigned to the control condition will be asked to write about what they have done since waking up that morning for 20 minutes across 3 consecutive days. This control matches the time and activity of the EW and SA arms and has been implemented across dozens of EW and SA studies.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Depression.
Zeitfenster: Baseline, Post Intervention (day 5), and 3 Months.
Depression will be measured using the Center for Epidemiological Studies -- Depression Scale (CESD). An overall depression score is computed as the sum of 20 items, with items 3, 11, 14, and 16 reversed. In cases with internally missing data (items not answered), the sums are computed after imputation of the missing values: # items on scale / # actually answered, multiplied by the sum obtained from the answered items. A range of 0-60, with higher scores indicating more depressive symptomatology during the past week.
Baseline, Post Intervention (day 5), and 3 Months.
Change in Psychological Distress.
Zeitfenster: Baseline, Post Intervention (day 5), and 3 Months.
Psychological Distress will be measured using the Brief Symptom Inventory (BSI). The BSI consists of 18 items scored 0-4. Items are averaged to yield a final score of 0-4. The higher the score, the greater the psychological distress.
Baseline, Post Intervention (day 5), and 3 Months.
Change in Anxiety.
Zeitfenster: Baseline, Post Intervention (day 5), and 3 Months.
Anxiety will be measured using the Beck Anxiety Inventory (BAI). The BAI total score is reported, which is the sum of all 21 items; with no subscales. The range of scores is 0-63, with higher scores indicating higher anxiety.
Baseline, Post Intervention (day 5), and 3 Months.
Change in Suicidality - Suicidal Ideation.
Zeitfenster: Baseline, Post Intervention (day 5), and 3 Months.
Suicidal ideation will be measured using the Suicidal Ideation Attributes Scale (SIDAS) . Total SIDAS scores are calculated as the sum of the five items, with controllability reverse scored (10=0, 9=1, …, 0=10). Total scores range from 0 to 50.
Baseline, Post Intervention (day 5), and 3 Months.
Change in Alcohol Use.
Zeitfenster: Baseline, Post Intervention, 3 Months
Alcohol use in participants will be assessed using the Alcohol Use Disorders Identification (AUDIT) instrument. The AUDIT consists of 10 items. Each of the questions has a set of responses to choose from, and each response has a score ranging from 0 to 4. All response scores should be added and recorded as "Total". Total scores of 8 or more are recommended as indicators of hazardous and harmful alcohol use, as well as possible alcohol dependence. (A cut-off score of 10 will provide greater specificity but at the expense of sensitivity.) The score range is 0-40. Higher scores indicate greater hazardous drinking.
Baseline, Post Intervention, 3 Months
Change in Drug Use.
Zeitfenster: Baseline, Post Intervention (day 5), and 3 Months.
The Short Inventory of Problems-Modified for Drug Use (SIP-DU) is a 15-item scale that asks respondents to rate each item on a dichotomous scale ("No" = 0, "Yes" = 1). Total score reported, which is the sum of all items; no subscales: Range 0-15, higher scores indicate greater problems with drug use.
Baseline, Post Intervention (day 5), and 3 Months.
Suicidal Intent
Zeitfenster: Baseline, Post Intervention (day 5), and 3 Months.
Suicidal intent will be assessed using a single item that asks: Within the last 3 months/past week, have you seriously considered attempting suicide? [yes/no] Number of participants who reported suicidal intent is reported. Originally titled "Change in Suicidality - Suicidal Thoughts".
Baseline, Post Intervention (day 5), and 3 Months.
Attempted Suicide
Zeitfenster: Baseline, Post Intervention (day 5), and 3 Months.
Suicide attempts will be assessed using a single item that asks: Within the last past 3 months/past week, have you actually attempted suicide? [yes/no]. Reported are the number of participants who reported that they had attempted suicide. Original title: "Change in Suicidality: Suicide Attempts".
Baseline, Post Intervention (day 5), and 3 Months.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Self Injury.
Zeitfenster: Baseline, Post Intervention (day 5), and 3 Months.
Self injury behaviors will be assessed with the item that asks: How many times in the past 3 months/past week have you engaged in self-harm behavior (e.g., cutting, biting, burning, hitting self) with the intent of harming, but not killing, yourself? Reported are the frequency of self-harm behaviors/self-injury reported by participants. Original title: "Change in Self Injury".
Baseline, Post Intervention (day 5), and 3 Months.
Rumination
Zeitfenster: Baseline, Post Intervention (day 5), and 3 Months.
Rumination will be assessed using the Ruminative Response Scale - Brooding Subscale (RRS). This scale is modified from the original measure where only items 5, 10, 13, 15 and 16 are used. Each item is scored by respondents on a scale of 1 to 4. To get the overall score, the 5 items are summed; total scores range from 5-20, with higher scores indicating greater brooding and rumination (related to depression) in an individual.
Baseline, Post Intervention (day 5), and 3 Months.
Perceived Support
Zeitfenster: Baseline, Post Intervention (day 5), and 3 Months.
Perceived social support is measured using the Multidimensional Scale of Perceived Social Support (MSPSS). The MSPSS is a 12 item instrument that uses a scale 1-7 to rate each item. The scoring is done by taking the average of the items- therefore a score of 7 indicates the highest level of perceived social support.
Baseline, Post Intervention (day 5), and 3 Months.
Hopelessness
Zeitfenster: Baseline, Post Intervention, 3 Months
Hopelessness will be measured using the Beck Hopelessness Scale (BHS). The BHS is a 20-item dichotomous scale ("No" = 0, "Yes" = 1). Items 1, 3, 5, 6, 8, 10, 13, 15 and 19 are reverse-scored. The total score is out of 20, where 20 would be the highest score and considered a negative indicator of hopelessness.
Baseline, Post Intervention, 3 Months
Lesbian, Gay, Bisexual (LGB) Identity
Zeitfenster: Baseline, Post Intervention (day 5), and 3 Months.
LGB identity will be measured using the 'LGB Identity Centrality' instrument.The measure consists of 4 items that are rated on a scale of 1-7. The summed scores have a range of 4-28 and the higher score would indicate a stong agreement (positive) with the centrality of one's LGB identity.
Baseline, Post Intervention (day 5), and 3 Months.
Change in Cortisol
Zeitfenster: 1 and 4 months post baseline.
Participants will provide 50-100 hair strands (at least 2 cm in length) to be used to determine levels of stress based on the cortisol levels found in the analyses of the hair provided.
1 and 4 months post baseline.
Change in Stress
Zeitfenster: Baseline, Post Intervention (day 5), and 3 Months.
Stress will be assessed using the Perceived Stress Scale (PSS). Participants were asked to respond to the 14-item version. Participants respond to each item on a 0-4 scale and scores are obtained by reversing responses to the 7 positively stated items (items 4,5,6,7,9,10, & 13), and then summing across all scale items. Range = 0-56. Higher scores indicating higher perceived stress.
Baseline, Post Intervention (day 5), and 3 Months.
Change in Impulsiveness Total Score
Zeitfenster: Baseline, Post Intervention (day 5), and 3 Months.
Impulsiveness will be assessed using the Barratt Impulsiveness Scale (BIS). The BIS is a 30 item questionnaire that uses a 1-4 rating scale per item. The 30-item self-report questionnaire, can yield a total score where the range is 30-120. The highest score indicates the greatest the level of impulsiveness.
Baseline, Post Intervention (day 5), and 3 Months.
Change in Impulsiveness- Attentional
Zeitfenster: Baseline, Post Intervention (day 5), and 3 Months.
Impulsiveness will be assessed using the Barratt Impulsiveness Scale (BIS). The BIS is a 30 item questionnaire that uses a 1-4 rating scale per item. The 30-item self-report questionnaire, can yield a total score, as well as three factors: attentional (6, 5, 9, 11, 20, 24, 26, 28; motor (2, 3, 4, 16, 17, 19, 21, 22, 23, 25, 30); non-planning (1, 7, 8, 10, 12, 13, 14, 15, 18, 27, 29). The attentional scale has a range of 8-32, the greater the value, the greater the level of attentional impulsiveness.
Baseline, Post Intervention (day 5), and 3 Months.
Change in Impulsiveness- Motor
Zeitfenster: Baseline, Post Intervention (day 5), and 3 Months.
Impulsiveness will be assessed using the Barratt Impulsiveness Scale (BIS-11). The BIS-11 is a 30 item questionnaire that uses a 1-4 rating scale per item. The 30-item self-report questionnaire, can yield a total score, as well as three factors: attentional (6, 5, 9, 11, 20, 24, 26, 28; motor (2, 3, 4, 16, 17, 19, 21, 22, 23, 25, 30); non-planning (1, 7, 8, 10, 12, 13, 14, 15, 18, 27, 29). The motor scale has a range of 11-44, the greater the value, the greater the level of motor impulsiveness.
Baseline, Post Intervention (day 5), and 3 Months.
Change in Impulsiveness- Non-Planning
Zeitfenster: Baseline, Post Intervention (day 5), and 3 Months.
Impulsiveness will be assessed using the Barratt Impulsiveness Scale (BIS-11). The BIS-11 is a 30 item questionnaire that uses a 1-4 rating scale per item. The 30-item self-report questionnaire, can yield a total score, as well as three factors: attentional (6, 5, 9, 11, 20, 24, 26, 28; motor (2, 3, 4, 16, 17, 19, 21, 22, 23, 25, 30); non-planning (1, 7, 8, 10, 12, 13, 14, 15, 18, 27, 29). The non-planning scale has a range of 11-44, the greater the value, the greater the level of non-planning impulsiveness.
Baseline, Post Intervention (day 5), and 3 Months.
Change in Risk Taking
Zeitfenster: Baseline, Post Intervention (day 5), and 3 Months.
Risk taking impulse will be assessed using the Columbia Card Task. Participants are presented with 32 face-down cards. Some of these cards are "gain cards" (which add either +10 or +30 points to the participant's total score) and some of these cards are "loss cards" (which subtract either -250 or -750 points from the participant's total score). On each trial, the participant may turn over as many cards as desired until a loss card is encountered or the participant chooses to not turn over any more cards. As a participant turns over more cards, the probability of encountering a loss card increases. Therefore, turning over more cards constitutes greater risk taking.
Baseline, Post Intervention (day 5), and 3 Months.
Change in Minority Stress (Rejection)
Zeitfenster: Baseline, Post Intervention (day 5), and 3 Months.
To assess rejection as a form of minority stress, the Gay-Related Rejection Sensitivity Scale (GRRS) will be used.The Gay-related rejection sensitivity scale was adapted for this study to be gender-inclusive and has 12 items. Scale range 1-36, where higher scores indicate greater rejection sensitivity based on one's sexual orientation (worse outcome).
Baseline, Post Intervention (day 5), and 3 Months.
Change in Parental Attitudes
Zeitfenster: Baseline, Post Intervention (day 5), and 3 Months.
The participant's perception of their parent's attitudes towards their sexual orientation are assessed using the Parental Attitudes Toward Child's Sexual Orientation. This tool has 4 items- 2 that deal with mother/parent 1/closest female guardian, 2 that deal with father/parent 2/closest male guardian. The second item for each parent asks about their attitude towards the respondent's sexual orientation on a scale from 1 (completely tolerant and accepting) to 7 (completely hostile and rejecting). Scores for maternal and paternal attitude should be averaged for each participant. The score has a range from 1-7, where higher scores indicate greater rejection from parents (worse outcome).
Baseline, Post Intervention (day 5), and 3 Months.
Change in Outness
Zeitfenster: Baseline, Post Intervention (day 5), and 3 Months.
Participants openness about one's sexual orientation will be assessed using the Outness Inventory (OI). A respondent is asked to rate how open they are with various people in society (from family to strangers) on an 11 item questionnaire. The scale for responding is 0-7- where 7 indicates that a person is completely open with their sexual orientation status. The scale score is obtained by averaging the 11 items for a score range of 0-7, where higher scores indicate more openness about respondents' sexual orientation in different domains of their lives/different people. 0 indicates that an item does not apply/ there is no such group of people/person in the respondents' life. A score of 7 would indicate that one is completely open or "out" with respect to sexual orientation.
Baseline, Post Intervention (day 5), and 3 Months.
Change in Internalized Homophobia
Zeitfenster: Baseline, Post Intervention (day 5), and 3 Months.
Internalized homophobia in participants will be assessed using the Internalized Homophobia Scale (IHS). The IHS score is obtained by averaging the scores across the 9 items (rather than summing). Range is 1-4, with higher scores indicating higher internalized stigma related to one's sexual orientation.
Baseline, Post Intervention (day 5), and 3 Months.
Change in Discrimination - 9 Items (Part 1)
Zeitfenster: Baseline, Post Intervention (day 5), and 3 Months.
Everyday discrimination experienced by participants will be measured using the Everyday Discrimination - Sexual Orientation (EDSO) Part 1. Part 1 is a 9 item inventory where respondents rate statements on a scale of 1-6. The scale has a summed total score ranging from 9-54, higher scores indicate higher discrimination. The higher the score, the greater the feeling that one is discriminated against for one's sexual orientation.
Baseline, Post Intervention (day 5), and 3 Months.
Change in Discrimination - Item 1 (Part 2)
Zeitfenster: Baseline, Post Intervention (day 5), and 3 Months.

Everyday discrimination experienced by participants will be measured using the Everyday Discrimination - Sexual Orientation (EDSO) Part 2. Part 2 is a 2 item inventory where respondents rate statements on a scale of 0-3. The lower the score, the less the feeling that one is discriminated against overall for one's sexual orientation.

Item 1: Overall, how much has discrimination based on your sexual orientation interfered with you having a full and productive life?
Baseline, Post Intervention (day 5), and 3 Months.
Change in Discrimination - Item 2 (Part 2)
Zeitfenster: Baseline, Post Intervention (day 5), and 3 Months.

Everyday discrimination experienced by participants will be measured using the Everyday Discrimination - Sexual Orientation (EDSO) Part 2. Part 2 is a 2 item inventory where respondents rate statements on a scale of 0-3. The lower the score, the less the feeling that one is discriminated against overall for one's sexual orientation.

Item 2: Overall, how much harder has your life been because of discrimination based on your sexual orientation?
Baseline, Post Intervention (day 5), and 3 Months.
Change in Victimization
Zeitfenster: Baseline, Post Intervention (day 5), and 3 Months.
Feelings of victimization are captured using the LGBT Victimization Experiences measure. This questionnaire consists of 10 items. The LGBT victimization scale is rated on a 0 "Never" to 3 "3+ times" scale with a total score range 0-30. The total score reflects the amount of victimization one has experienced due to being known or thought to be LGBTQ. Higher scores indicate more negative experiences.
Baseline, Post Intervention (day 5), and 3 Months.
Change in Religious Affiliation
Zeitfenster: Baseline, Post Intervention (day 5), and 3 Months.
Tolerance of one's sexual orientation through the lense of one's practiced religion is measured using a single question. Respondents use a 1-7 scale to rate the question "How tolerant is your religion toward your sexual orientation?"- where 7 indicates total rejection and hostility.
Baseline, Post Intervention (day 5), and 3 Months.
Change in Religious Strain
Zeitfenster: Baseline, Post Intervention (day 5), and 3 Months.
Religious Strain Scale total score obtained by reverse scoring items 1-7 and then summing across the 20 items (range 0-60), higher scores indicate greater religious strain.
Baseline, Post Intervention (day 5), and 3 Months.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Yale University

Mitarbeiter

National Institute of Mental Health (NIMH)

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

27. Oktober 2017

Primärer Abschluss (Tatsächlich)

1. Januar 2019

Studienabschluss (Tatsächlich)

27. Juni 2019

Studienanmeldedaten

Zuerst eingereicht

25. Juli 2018

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

19. November 2018

Zuerst gepostet (Tatsächlich)

23. November 2018

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

28. August 2020

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

27. August 2020

Zuletzt verifiziert

1. August 2020

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 1512016952
  • 1R21MH113860-01 (US NIH Stipendium/Vertrag)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

Ja

Beschreibung des IPD-Plans

De-identified individual participant data for all primary and secondary outcome measures will be made available.

IPD-Sharing-Zeitrahmen

Data will be available 12 months after study completion for three years.

IPD-Sharing-Zugriffskriterien

Data access requests from qualified academic investigators for non-commercial research interests will be reviewed by study investigators. Requestors will be required to sign a data access agreement.

Art der unterstützenden IPD-Freigabeinformationen

  • Studienprotokoll
  • Statistischer Analyseplan (SAP)
  • Einwilligungserklärung (ICF)
  • Analytischer Code

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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