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临床试验/NCT05400564
NCT05400564进行中(未招募)不适用

Preventing Emotional and Behavioral Problems in Middle School Youth At-risk of Disability After the Covid-19 Pandemic With the Family Check-up Online

University of Oregon1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2022年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
300
试验地点
1
主要终点
change from baseline in child's school grades (school report)

研究概览

简要总结

The purpose of the proposed research is to conduct an efficacy trial of the Family Check-Up (FCU) Online to prevent emotional and behavioral disorders among middle-school students at-risk for disability during the transition back to school after the COVID-19 pandemic. Mental health and behavior problems are at epidemic proportions as a result of the COVID-19 pandemic, with the highest rates in adolescents and children with disabilities. We propose to evaluate the efficacy of the FCU Online, a school-based, ecological approach to family intervention and risk reduction, across a group of students at-risk or identified with disability during the middle school years. The FCU Online for middle school youth has been evaluated in a randomized trial in prior research during the development of the program but has never been tested as a large-scale, school-based intervention or delivered by providers working in schools. It has recently been adapted for COVID-19 and includes new modules on coping with stress and home-to-school engagement to support the return to school after COVID-19 for students at-risk. Students in schools will be identified for services using indicators that are natural to the school environment (attendance, office discipline referrals, and grades), and will be followed for 2 years. We predict that engagement in the FCU Online will be associated with student reductions in emotional and behavior problems, improvements in academic skills, and improvements in attendance. Parenting skills such as home-to-school communication, positive parenting, and behavioral routines will be tested as mediators of intervention efficacy.

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

性别
All
接受健康志愿者
是

入选标准

  • •A caregiver must have a child between the ages of 11 and 14
  • •The child must be a middle school student enrolled at a participating middle school including: Alder Creek Middle School in Milwaukee, Oregon, or Wilbur Rowe Middle School in Milwaukee, Oregon
  • •The caregiver must be the parent or legal guardian of the participating youth
  • •The caregiver must have a smartphone with text messaging capability and access to email
  • •The student must have one or more of the following risk factors: 1) two or more office discipline referrals; 2) grades below a 2.5 GPA; 3) poor attendance, i.e., missing more than 10% of school days; 4) IEP for emotional disturbance or related disabilities; or 5) concerns about the child on the behavioral and mental health screener (as indicated by a score of 3 on any one item, or a score of 2 or higher on at least two items).

排除标准

  • •The caregiver is unable to read in either English or Spanish
  • •The child is unable to complete the survey without parent's help
  • •The family is already participating in another study of the University of Oregon's Prevention Science Institute

研究组 & 干预措施

FCU Online + Coach

Experimental

Parents in this arm will receive access to the FCU app and telehealth coaching/ support provided by a trained mental health provider. The FCU app includes a brief 5-minute assessment, feedback on parents' responses, and online tools to support parenting in areas that were identified as challenges by the assessment. These tools include videos, animated videos, parenting tips, and interactives to help practice parenting skills. Telehealth coaching sessions will focus on Healthy Behaviors, Positive Parenting, Rules and Consequences, School Support, and Communication.

干预措施: Family Check-Up (Behavioral)

Control

No Intervention

Parents in this arm will receive school support as usual.

结局指标

主要结局

change from baseline in child's school grades (school report)

时间窗: baseline, 3 months, 6 months, 12 months, 24 months

Obtained via school records

change from baseline in child's school attendance (school report)

时间窗: baseline, 3 months, 6 months, 12 months, 24 months

Obtained via school records

change from baseline in family conflict (parent and child report)

时间窗: baseline, 3 months, 6 months, 12 months, 24 months

Measured with the CASEY

change from baseline in family relationships (parent and child report)

时间窗: baseline, 3 months, 6 months, 12 months, 24 months

Measured with the CASEY

change from baseline in child's achievement test scores/school records/IEP (school report)

时间窗: baseline, 3 months, 6 months, 12 months, 24 months

Obtained via school records

change from baseline in child school engagement (parent, child and teacher report)

时间窗: baseline, 3 months, 6 months, 12 months, 24 months

Measured with the school participation measure

change from baseline in child's discipline referrals (school report)

时间窗: baseline, 3 months, 6 months, 12 months, 24 months

Obtained via school records

change from baseline in child academic competence (parent, child and teacher report)

时间窗: baseline, 3 months, 6 months, 12 months, 24 months

Measured with the SSRS

change from baseline in youth behavior problems (parent, child and teacher report)

时间窗: baseline, 3 months, 6 months, 12 months, 24 months

Measured by the SDQ

change from baseline in youth social/peer relationships (parent and child report)

时间窗: baseline, 3 months, 6 months, 12 months, 24 months

Measured by the PASA

change from baseline in youth emotional problems (parent, child and teacher report)

时间窗: baseline, 3 months, 6 months, 12 months, 24 months

Measured by the SDQ

change from baseline in youth self regulation (parent, and child report)

时间窗: baseline, 3 months, 6 months, 12 months, 24 months

Measured by the SDQ

次要结局

  • change from baseline in parent depression and anxiety (parent report)(baseline, 3 months, 6 months, 12 months, 24 months)
  • change from baseline in youth depression (parent and child report)(baseline, 3 months, 6 months, 12 months, 24 months)
  • change from baseline in parental sense of competency (parent report)(baseline, 3 months, 6 months, 12 months, 24 months)
  • change from baseline in limit setting and supervision skills (parent report)(baseline, 3 months, 6 months, 12 months, 24 months)
  • change from baseline in parental stress (parent report)(baseline, 3 months, 6 months, 12 months, 24 months)
  • change from baseline in positive parenting behaviors (parent report)(baseline, 3 months, 6 months, 12 months, 24 months)
  • change from baseline in parenting involvement at school (parent report)(baseline, 3 months, 6 months, 12 months, 24 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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