Can Family-Centered Prevention Programming Reduce Neuroimmune Vulnerabilities for Drug Use and Cardiometabolic Risk Among African American Adolescents? A Randomized Prevention Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 650
- 试验地点
- 2
- 主要终点
- Self-regulation (youth report)
研究概览
简要总结
The Health and Resilience Project (HARP): Foundations is investigating the efficacy of the Strong African American Families (SAAF) intervention in promoting the health and well being of African American adolescents. Youth age 10-13 and their primary caregivers are randomly assigned to receive SAAF or to a control group. Participants complete baseline and follow-up measures regarding vulnerability to substance use based on a neuroimmune model of stress coping.
详细描述
During childhood and adolescence, family relationships play critical roles in regulating physiological stress reactions. This protects the developing brain from the potentially deleterious effects of stress hormones and neurochemicals. In a series of proof-of-principle studies, the investigators studied the potential for the Strong African American Families (SAAF) drug use prevention program delivered when youth were age 11 to protect participants from the consequences of social adversity when they were transitioning to adulthood (ages 19-25). Effects were detected on a range of outcomes associated with neuroimmune (NIN) dysregulation including inflammation, the neural structure of limbic regions, prefrontal-limbic connectivity, and cardiometabolic health. Although these findings are provocative, the SAAF trial was not designed to evaluate mechanisms and outcomes that the NIN model suggested. Data on inflammation and neural activity were collected post hoc, many years after the intervention concluded. Thus these findings must be regarded as preliminary until a more rigorous study is performed with pretest and posttest measures of NIN processes. The proposed prevention trial of SAAF (N = 325) is designed to meet this need.
Our specific aims are to test hypotheses regarding:
- the influence of participation in SAAF on change in NIN-associated risk markers (neural circuitry subserving threat, reward, and executive control, as well as peripheral inflammation) across 2 years;
- the mediating role of protective parenting in linking intervention participation to NIN-associated risk markers;
- the influence of participation in SAAF on change in addictive behavior vulnerabilities associated with risky decision making, emotion regulation, early-onset substance use, unhealthy eating, and cardiometabolic risk markers; and
- the mediational chain linking SAAF to addictive behavior vulnerabilities via changes in parenting and NIN-associated risk markers.
A sample of 325 African American youth and their primary caregivers will be recruited from Athens, GA and surrounding areas. Inclusion criteria are (a) youth or parent self-designates as African American, Black, or biracial (including Black or African American), and (b) youth is in 5th grade and 10-13 years of age. Exclusion criteria include: (a) contraindications for MRI scanning (e.g., metal in body, traumatic brain injury, claustrophobia, pregnancy), (b) youth with chronic illnesses or medication regimens that would affect inflammatory panels (e.g., diabetes, congenital heart disease, asthma, cancers), and (c) parent or youth conditions (e.g., ADHD, psychoses) that would prevent participation in the SAAF intervention. Given the nonverbal nature of fMRI tasks, left-handed youth are not excluded. The investigators anticipate screening ~615 families over a 2.5-year period to obtain a sample of 325 families. Eligible participants will be scheduled for an assessment at UGA's Bioimaging Research Center. Youth will participate in a scan (~60 minutes), a blood draw, and youth and parents will complete self-report measures. At each data collection wave, parents consent in writing to their own and their children's participation and children provide written assent. At W2, a home visit is made with laptop computers to collect self-report data. After pretest, families will be assigned randomly to SAAF or control. Control families receive written information by mail regarding adolescent development.
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
- Single (Outcomes Assessor)
盲法说明
Assessment staff will be blind to families' experimental assignment at pretest.
入排标准
- 年龄范围
- 10 Years 至 13 Years(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Self reported African American or Black;
- •Age 10-13
- •Primary caregiver for youth,
- •Resides in same household as youth.
排除标准
- •Contraindications for MRI scanning (e.g., metal in body, traumatic brain injury, claustrophobia, pregnancy),
- •Youth with chronic illnesses or medication regimens that would affect inflammatory panels (e.g., diabetes, congenital heart disease, asthma, cancers).
- •Conditions (e.g., severe disability, psychoses) that would prevent participation in the SAAF intervention or completing self-report measures.
结局指标
主要结局
Self-regulation (youth report)
时间窗: Two years
Youth will complete the the Future-oriented Goals scale and Will's Self-Control scale. We will standardize scores from these two measures (mean =0, standard deviation =1) then average them together. We expect assignment to SAAF vs control to be associated with higher scores (more self-regulation).
Self-regulation (parent report)
时间窗: Two years
Parents will complete a 12 item scale (Humphrey's self control scale) about their youth. Items will be summed ranging from 0-36. We expect assignment to SAAF vs control to be associated with higher scores (more self-regulation).
Tolerance for Deviance Scale
时间窗: Two years
Youth will complete the Tolerance for Deviance scale. 19 Items are summed, ranging from 0-57. We expect assignment to SAAF vs Control to be associated with lower scores (reductions in risky attitudes).
Reward-based eating
时间窗: Two years
Youth will complete the 13 items Reward Based Eating Drive scale. Scores range from 13-65. SAAF youth are expected to have lower scores on reward based eating compared to control youth.
Substance use onset
时间窗: Two years
Lifetime use (yes or no) of alcohol, marijuana, or cigarettes per youth self-report. We will sum the items to form a composite onset index. We expect youth assigned to SAAF to report less substance use onset than youth assigned to control.
Unhealthy eating
时间窗: Two Years
Youth will complete the Adolescent Food Habits checklist. Items are summed. We expect SAAF youth to engage in less unhealthy eating than control youth.
Past 3 month substance use frequency
时间窗: Two years
Youth complete likert type items assessing alcohol, marijuana, and nicotine use in the past 3 months. Items are standardized and summed to form a substance use composite. We expect youth assigned to SAAF to report less substance use than youth assigned to control.
次要结局
- Executive control assessed via functional MRI assessment(Two years)
- Reward sensitivity via functional MRI assessment(Two years)
- Cultural socialization (parent report)(1 year)
- Communication about Risk Behavior (youth report)(1 year)
- Threat sensitivity via functional MRI assessment(Two years)
- Peripheral inflammation composite score(Two years)
- Involved Vigilant Parenting Scale (youth report)(1 year)
- Involved Vigilant Parenting (parent report)(1 year)
- Cultural socialization (youth report)(1 year)
- Communication about risk behavior (parent report)(1 year)
研究者
Gene H. Brody
Regents Professor
University of Georgia
