Development and Preliminary Trial of a Brief, Portable Health Intervention for Rural Sexual Minority Emerging Adults (Project LEAP)
27 de agosto de 2020 atualizado por: 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.
Visão geral do estudo
Status
Concluído
Descrição detalhada
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).
Tipo de estudo
Intervencional
Inscrição (Real)
108
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Connecticut
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New Haven, Connecticut, Estados Unidos, 06520
- Yale University
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Massachusetts
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Worcester, Massachusetts, Estados Unidos, 01610
- College of the Holy Cross
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Tennessee
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Johnson City, Tennessee, Estados Unidos, 37614
- East Tennessee State University
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos a 29 anos (Adulto)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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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.
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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.
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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.
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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.
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Comparador de Placebo: 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.
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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.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in Depression.
Prazo: Baseline, Post Intervention (day 5), and 3 Months.
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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.
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Baseline, Post Intervention (day 5), and 3 Months.
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Change in Psychological Distress.
Prazo: Baseline, Post Intervention (day 5), and 3 Months.
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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.
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Baseline, Post Intervention (day 5), and 3 Months.
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Change in Anxiety.
Prazo: Baseline, Post Intervention (day 5), and 3 Months.
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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.
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Baseline, Post Intervention (day 5), and 3 Months.
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Change in Suicidality - Suicidal Ideation.
Prazo: Baseline, Post Intervention (day 5), and 3 Months.
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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.
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Baseline, Post Intervention (day 5), and 3 Months.
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Change in Alcohol Use.
Prazo: Baseline, Post Intervention, 3 Months
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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.
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Baseline, Post Intervention, 3 Months
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Change in Drug Use.
Prazo: Baseline, Post Intervention (day 5), and 3 Months.
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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.
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Baseline, Post Intervention (day 5), and 3 Months.
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Suicidal Intent
Prazo: Baseline, Post Intervention (day 5), and 3 Months.
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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".
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Baseline, Post Intervention (day 5), and 3 Months.
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Attempted Suicide
Prazo: Baseline, Post Intervention (day 5), and 3 Months.
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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".
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Baseline, Post Intervention (day 5), and 3 Months.
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Self Injury.
Prazo: Baseline, Post Intervention (day 5), and 3 Months.
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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".
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Baseline, Post Intervention (day 5), and 3 Months.
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Rumination
Prazo: Baseline, Post Intervention (day 5), and 3 Months.
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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.
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Baseline, Post Intervention (day 5), and 3 Months.
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Perceived Support
Prazo: Baseline, Post Intervention (day 5), and 3 Months.
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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.
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Baseline, Post Intervention (day 5), and 3 Months.
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Hopelessness
Prazo: Baseline, Post Intervention, 3 Months
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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.
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Baseline, Post Intervention, 3 Months
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Lesbian, Gay, Bisexual (LGB) Identity
Prazo: Baseline, Post Intervention (day 5), and 3 Months.
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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.
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Baseline, Post Intervention (day 5), and 3 Months.
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Change in Cortisol
Prazo: 1 and 4 months post baseline.
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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.
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1 and 4 months post baseline.
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Change in Stress
Prazo: Baseline, Post Intervention (day 5), and 3 Months.
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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.
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Baseline, Post Intervention (day 5), and 3 Months.
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Change in Impulsiveness Total Score
Prazo: Baseline, Post Intervention (day 5), and 3 Months.
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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.
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Baseline, Post Intervention (day 5), and 3 Months.
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Change in Impulsiveness- Attentional
Prazo: Baseline, Post Intervention (day 5), and 3 Months.
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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.
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Baseline, Post Intervention (day 5), and 3 Months.
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Change in Impulsiveness- Motor
Prazo: Baseline, Post Intervention (day 5), and 3 Months.
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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.
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Baseline, Post Intervention (day 5), and 3 Months.
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Change in Impulsiveness- Non-Planning
Prazo: Baseline, Post Intervention (day 5), and 3 Months.
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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.
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Baseline, Post Intervention (day 5), and 3 Months.
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Change in Risk Taking
Prazo: Baseline, Post Intervention (day 5), and 3 Months.
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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.
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Baseline, Post Intervention (day 5), and 3 Months.
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Change in Minority Stress (Rejection)
Prazo: Baseline, Post Intervention (day 5), and 3 Months.
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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).
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Baseline, Post Intervention (day 5), and 3 Months.
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Change in Parental Attitudes
Prazo: Baseline, Post Intervention (day 5), and 3 Months.
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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).
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Baseline, Post Intervention (day 5), and 3 Months.
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Change in Outness
Prazo: Baseline, Post Intervention (day 5), and 3 Months.
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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.
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Baseline, Post Intervention (day 5), and 3 Months.
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Change in Internalized Homophobia
Prazo: Baseline, Post Intervention (day 5), and 3 Months.
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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.
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Baseline, Post Intervention (day 5), and 3 Months.
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Change in Discrimination - 9 Items (Part 1)
Prazo: Baseline, Post Intervention (day 5), and 3 Months.
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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.
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Baseline, Post Intervention (day 5), and 3 Months.
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Change in Discrimination - Item 1 (Part 2)
Prazo: Baseline, Post Intervention (day 5), and 3 Months.
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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.
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Change in Discrimination - Item 2 (Part 2)
Prazo: Baseline, Post Intervention (day 5), and 3 Months.
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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.
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Change in Victimization
Prazo: Baseline, Post Intervention (day 5), and 3 Months.
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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.
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Baseline, Post Intervention (day 5), and 3 Months.
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Change in Religious Affiliation
Prazo: Baseline, Post Intervention (day 5), and 3 Months.
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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.
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Baseline, Post Intervention (day 5), and 3 Months.
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Change in Religious Strain
Prazo: Baseline, Post Intervention (day 5), and 3 Months.
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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.
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Baseline, Post Intervention (day 5), and 3 Months.
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Publicações e links úteis
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Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
27 de outubro de 2017
Conclusão Primária (Real)
1 de janeiro de 2019
Conclusão do estudo (Real)
27 de junho de 2019
Datas de inscrição no estudo
Enviado pela primeira vez
25 de julho de 2018
Enviado pela primeira vez que atendeu aos critérios de CQ
19 de novembro de 2018
Primeira postagem (Real)
23 de novembro de 2018
Atualizações de registro de estudo
Última Atualização Postada (Real)
28 de agosto de 2020
Última atualização enviada que atendeu aos critérios de controle de qualidade
27 de agosto de 2020
Última verificação
1 de agosto de 2020
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 1512016952
- 1R21MH113860-01 (Concessão/Contrato do NIH dos EUA)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Sim
Descrição do plano IPD
De-identified individual participant data for all primary and secondary outcome measures will be made available.
Prazo de Compartilhamento de IPD
Data will be available 12 months after study completion for three years.
Critérios de acesso de compartilhamento IPD
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.
Tipo de informação de suporte de compartilhamento de IPD
- Protocolo de estudo
- Plano de Análise Estatística (SAP)
- Termo de Consentimento Livre e Esclarecido (TCLE)
- Código Analítico
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .