Development and Preliminary Trial of a Brief, Portable Health Intervention for Rural Sexual Minority Emerging Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 6
- 主要终点
- Change in Depression.
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 29 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Failure to meet inclusion criteria
结局指标
主要结局
Change in Depression.
时间窗: 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.
Change in Psychological Distress.
时间窗: 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.
Change in Suicidality - Suicidal Ideation.
时间窗: 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.
Change in Alcohol Use.
时间窗: 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.
Attempted Suicide
时间窗: 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".
Change in Drug Use.
时间窗: 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.
Change in Anxiety.
时间窗: 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.
Suicidal Intent
时间窗: 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".
次要结局
- Change in Minority Stress (Rejection)(Baseline, Post Intervention (day 5), and 3 Months.)
- Change in Discrimination - 9 Items (Part 1)(Baseline, Post Intervention (day 5), and 3 Months.)
- Change in Impulsiveness Total Score(Baseline, Post Intervention (day 5), and 3 Months.)
- Perceived Support(Baseline, Post Intervention (day 5), and 3 Months.)
- Hopelessness(Baseline, Post Intervention, 3 Months)
- Rumination(Baseline, Post Intervention (day 5), and 3 Months.)
- Change in Cortisol(1 and 4 months post baseline.)
- Self Injury.(Baseline, Post Intervention (day 5), and 3 Months.)
- Lesbian, Gay, Bisexual (LGB) Identity(Baseline, Post Intervention (day 5), and 3 Months.)
- Change in Impulsiveness- Motor(Baseline, Post Intervention (day 5), and 3 Months.)
- Change in Impulsiveness- Non-Planning(Baseline, Post Intervention (day 5), and 3 Months.)
- Change in Internalized Homophobia(Baseline, Post Intervention (day 5), and 3 Months.)
- Change in Victimization(Baseline, Post Intervention (day 5), and 3 Months.)
- Change in Religious Affiliation(Baseline, Post Intervention (day 5), and 3 Months.)
- Change in Religious Strain(Baseline, Post Intervention (day 5), and 3 Months.)
- Change in Stress(Baseline, Post Intervention (day 5), and 3 Months.)
- Change in Impulsiveness- Attentional(Baseline, Post Intervention (day 5), and 3 Months.)
- Change in Risk Taking(Baseline, Post Intervention (day 5), and 3 Months.)
- Change in Outness(Baseline, Post Intervention (day 5), and 3 Months.)
- Change in Parental Attitudes(Baseline, Post Intervention (day 5), and 3 Months.)
- Change in Discrimination - Item 1 (Part 2)(Baseline, Post Intervention (day 5), and 3 Months.)
- Change in Discrimination - Item 2 (Part 2)(Baseline, Post Intervention (day 5), and 3 Months.)