Testing and Evaluation of the Returning to the Land Intervention to Address and Prevent Substance Misuse
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Child social-emotional functioning as assessed by the Brief Infant Toddler Social Emotional Assessment (BITSEA)
研究概览
简要总结
This study aims to test the Returning to the Land intervention in partnership with a tribal community. The program is designed to address caregiver substance use and child emotional and behavioral 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
- None
入排标准
- 年龄范围
- 14 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Reside on or near the Rocky Boy Reservation (~50-mile round trip);
- •Aged 14-19 years;
- •Parent or primary caregiver to at least one child who will be age 1-5 years at the start of the intervention.
排除标准
- •Any condition preventing meaningful participation (e.g., lacking capacity to consent or planned relocation precluding attendance).
研究组 & 干预措施
Bio-diverse Outdoor Setting
Returning to the Land - Bio-diverse Outdoor Setting
干预措施: Returning to the Land - Biodiverse Outdoor Setting (Behavioral)
Control Group
Returning to the Land - Indoor Classroom Setting
干预措施: Control (Behavioral)
结局指标
主要结局
Child social-emotional functioning as assessed by the Brief Infant Toddler Social Emotional Assessment (BITSEA)
时间窗: Baseline, 1 month, 6 month, 12 month
Caregivers will complete the Brief Infant Toddler Social Emotional Assessment (BITSEA) for children ages 12-18 months. The total BITSEA Problems Score is the sum of responses, score range from 0-62. Higher scores indicate poorer functioning.
Child social-emotional functioning as assessed by the Child Behavior Checklist (CBCL 11/2-5)
时间窗: Baseline, 1 month, 6 month, 12 month
Caregivers will complete the Child Behavior Checklist (CBCL/1½-5) for children ages 18 months-5 years. Minimum score is 0, maximum score is 72. Higher scores indicates more of the behaviors.
Child social-emotional functioning as assessed by the Child Behavior Checklist (CBCL/6-18)
时间窗: Baseline, 1 month, 6 month, 12 month
Caregivers will complete the Child Behavior Checklist (CBCL/6-18) for children who turn age 6 or older. Minimum score is 0, maximum score is 72. Higher scores indicates more of the behaviors.
Caregiver alcohol use
时间窗: Baseline, 1 month, 6 month, 12 month
Measured using the Q-F substances \& screens. Scores rang from 0 to 450, with higher score indicating more drinks per day.
Caregiver cannabis use
时间窗: Baseline, 1 month, 6 month, 12 month
Measured using the Q-F substances \& screens. Scores rang from 0 to 150, with higher score indicating more cannabis per day.
Caregiver non-prescribed pain medicine use
时间窗: Baseline, 1 month, 6 month, 12 month
Measured using the Q-F substances \& screens. Scores rang from 0 to 11, with higher score indicating more non-prescribed pain medication per day.
次要结局
未报告次要终点