Confirmatory Efficacy of the Building a Strong Identity and Coping Skills Program for Low-income and Minoritized Young Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 360
- 试验地点
- 10
- 主要终点
- Suicide Risk Markers
研究概览
简要总结
The goal of this clinical trial is to the efficacy of the Building a Strong Identity and Coping Skills intervention within a sample of low-income and minoritized youth aged 11-14 who are seeking mental health treatment and have been placed on a waitlist to receive services.
The aims of this study are to: (1) confirm the efficacy of BaSICS by replicating previous findings, (2) Examine the changes of coping mechanisms and symptom change over the course of the BaSICS intervention, and (3) test models of physiologic stress reactivity and regulation to capture biological "risk" and recalibration.
Cohorts of 20 participants will randomly be enrolled in either the intervention (10) or control (10) groups. Participants enrolled in the intervention group will complete the BaSICS program and participants enrolled in the no intervention group will not be enrolled in the intervention program. The BaSICS program is designed to help treat anxiety, depression, and post-traumatic stress symptoms and disorders and have direct effects on physiologic stress response systems (hypothalamic-pituitary-adrenal (HPA) axis). Researchers will compare the intervention and no intervention groups to see if there is a difference in the reduction of markers for anxiety, depression, and suicide scores, changes in coping mechanism, and HPA reactivity profiles
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 11 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children ages 11-14 at intake
- •Family income at or below 200% federal poverty level
- •Child speaks English
- •Parent speaks English or Spanish
排除标准
- •Intellectual disability
- •Autism spectrum disorder
- •High suicidal risk (score of 17 or more on the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-Kid))
- •Severe depression (score of 19 or more on Patient health questionnaire (PHQ).
结局指标
主要结局
Suicide Risk Markers
时间窗: Pre-post (3 months) and Pre-follow up (6 and 12 months)
Changes in the number of suicide risk markers that children report. Suicide risk markers will be measured using the Child Trauma Screen (CTS) and Mini Kid.
Anxiety
时间窗: Pre-post (3 months) and Pre-follow up (6 and 12 months)
Changes in the number of anxiety problems that children report. Anxiety problems will be measured using the Screen for Child Anxiety Related Disorders (SCARED), Child Behavior Checklist (CBCL), and Youth Self Report (YSR).
Depression
时间窗: Pre-post (3 months) and Pre-follow up (6 and 12 months)
Changes in the number of depressive symptoms that children report. Depressive symptoms will be measured using the Patient Health Questionnaire (PHQ-9A), CBCL, and YSR.
次要结局
- Engagement Coping Skills Acquisition(Pre-post (3 months) and Pre-follow up (6 and 12 months))
- Collaborative Coping(Pre-post (3 months) and Pre-follow up (6 and 12 months))
- HPA Reactivity Profile(Pre-post (3 months) and Pre-follow up (6 and 12 months))
- Sociocultural Identity Development(Pre-post (3 months) and Pre-follow up (6 and 12 months))
研究者
Martha E. Wadsworth
Professor of Psychology
Penn State University