Strengthening Child Social-Emotional Functioning and Healthy Lifestyle Behaviors Through Parent-Based Prevention in Families Experiencing Major Stressors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- Intervention feasibility--Attendance
研究概览
简要总结
This study evaluates feasibility and preliminary efficacy of a parent-based prevention program to promote social-emotional and lifestyle behavior health among 3- to 9-year-old children in families experiencing major stressors.
详细描述
Social-emotional difficulties and unhealthy lifestyle behaviors are prevalent among children in the U.S. and are associated with negative health outcomes. These challenges are even more pronounced among families who deal with major stressors, such as parental trauma history and mental health difficulties, parental chronic illness (e.g., HIV), parental substance use, economic disadvantage, and racial discrimination. The purpose of this study is to assess the feasibility, acceptability, and preliminary efficacy of a parent-based preventive intervention targeting parental self-regulation, stress reduction, and positive parenting, to promote child social-emotional and lifestyle behavior health, among families where the parents (a) have a child aged 3 to 9 years old, (b) have concerns about their child's behavior, mood, and/or lifestyle health, and (c) are experiencing major stressors. The intervention to be tested is based on Family Life Skills Triple P.
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)
入排标准
- 年龄范围
- 3 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Child between the ages of 3-9 years
- •Parent/caregiver willing to engage in the intervention who
- •is at least 18 years of age
- •is primary caregiver or guardian for the participating child
- •has concerns about the child's mood, behavior, and/or lifestyle health
- •is experiencing two or more major stressors of the following: trauma history, mental health difficulties, living with HIV, racial discrimination, substance misuse, and/or financial strain
- •is English speaking.
排除标准
- •a. Parent or child has
- •a significant cognitive disability, developmental delay, or pervasive developmental disorder
- •active suicidal or homicidal ideation
- •psychotic symptoms (active hallucinations, delusions, or impaired thought processes)
- •ongoing family violence occurring within the home and/or active involvement of child protect services related to child maltreatment allegations.
研究组 & 干预措施
Waitlist Control
Participants in the waitlist control arm will not receive any intervention during the clinical trial. They will be placed on a waitlist and then offered the intervention once post assessments are complete.
Intervention
Participants in the intervention arm will receive a 12-session parent-based prevention program based on Family Life Skills Triple P.
干预措施: Family Life Skills Triple P (Behavioral)
结局指标
主要结局
Intervention feasibility--Attendance
时间窗: Weekly throughout intervention period (Weeks 1-17)
Assessed as parent attendance at intervention sessions using weekly attendance logs
Child social-emotional difficulties: Strengths and difficulties
时间窗: baseline (T1, Weeks 0-2); post-intervention (T2, Weeks 16-18); follow-up (T3, Week 30)
Assessed as parent-reported agreement with statements about child strengths and difficulties on a 3-point response scale (higher scores indicate greater endorsement).
Trial-related feasibility--Recruitment capability
时间窗: Continuously throughout recruitment period, up to 156 weeks
Assessed as the proportion of eligible children who enroll in the study.
Trial-related feasibility--Retention
时间窗: Continuously through study period (Weeks 1-30)
Assessed as the proportion of enrolled children who remain in the study through the length of the intervention, with proportion who dropout and reasons for dropout also collected.
Child social-emotional difficulties: Problem behaviors
时间窗: baseline (T1, Weeks 0-2); post-intervention (T2, Weeks 16-18); follow-up (T3, Week 30)
Assessed as parent-reported frequency of child problematic behaviors on a 7-point response scale (higher scores indicate greater frequency).
Child physical activity
时间窗: baseline (T1, Weeks 0-2); post-intervention (T2, Weeks 16-18); follow-up (T3, Week 30)
Assessed as daily time spent sedentary and in various activity intensities using a wrist-worn accelerometer.
Child screen time
时间窗: baseline (T1, Weeks 0-2); post-intervention (T2, Weeks 16-18); follow-up (T3, Week 30)
Assessed as parent-reported average daily time spent engaging in screen time, including: watching TV; using a computer; gaming on a console or hand-held device; and using a tablet or smart phone for activities such as viewing videos, playing games, and browsing the internet.
Intervention appropriateness
时间窗: post-intervention (T2, Weeks 16-18)
Assessed as parent-reported applicability and suitability of the intervention on a 5-point response scale, with higher scores indicating greater appropriateness.
Intervention acceptability
时间窗: post-intervention (T2, Weeks 16-18)
Assessed as parent-reported liking and approval of the intervention on a 5-point response scale and satisfaction with the intervention on a 4-point response scale, with higher scores indicating greater acceptability.
Intervention feasibility--Implementability
时间窗: post-intervention (T2, Weeks 16-18)
Assessed as parent-reported ease of use and overall implementability of the intervention on a 5-point response scale, with higher scores indicating greater feasibility.
Child social-emotional difficulties: Depression and anxiety symptoms
时间窗: baseline (T1, Weeks 0-2); post-intervention (T2, Weeks 16-18); follow-up (T3, Week 30)
Assessed as parent-reported frequency of child depression and anxiety symptoms on a 4-point response scale (higher scores indicate greater frequency).
Child sleep
时间窗: baseline (T1, Weeks 0-2); post-intervention (T2, Weeks 16-18); follow-up (T3, Week 30)
Assessed using a wrist-worn accelerometer to calculate nighttime sleep duration and using a validated measure of parent-reported child sleep-wake behaviors on a 6-point response scale, with lower scores indicating more problematic behaviors.
次要结局
- Parenting self-regulation(baseline (T1, Weeks 0-2); post-intervention (T2, Weeks 16-18); follow-up (T3, Week 30))
- Parenting practices(baseline (T1, Weeks 0-2); post-intervention (T2, Weeks 16-18); follow-up (T3, Week 30))
- Parenting stress(baseline (T1, Weeks 0-2); post-intervention (T2, Weeks 16-18); follow-up (T3, Week 30))
研究者
Nada Goodrum
Assistant Professor
University of South Carolina