跳至主要内容
临床试验/NCT07091240
NCT07091240招募中不适用

Innovative Risk Calculator and Telehealth Delivered Parenting Program for Mental Health Promotion in Pediatric Primary Care: A Hybrid Type 3 Effectiveness-Implementation Study

Northwestern University1 个研究点 分布在 1 个国家目标入组 432 人开始时间: 2026年6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
招募中
入组人数
432
试验地点
1
主要终点
Psychiatric Symptoms and Diagnosis

研究概览

简要总结

In this study, caregivers of toddlers with a high likelihood of developing mental health challenges will participate in a parenting program, Family Check-Up® Online (FCU-O), and complete assessments related to their child's behavior and their caregiving practices. FCU-O is a parenting support program that offers tools and guidance to support children's emotional and behavioral development. The program is delivered through a secure website that can be accessed via computer or phone at participating caregivers' convenience. Caregivers will complete the Developmental Early Childhood Instrument for Deciding Effectively about Mental Health (DECIDE) tool, a risk calculator that screens for early signs of future mental health challenges, at their child's 24- or 30-month well-check visit with their pediatrician. Clinicians will use the DECIDE tool risk calculator score to refer caregivers of at-risk children to FCU-O. Caregivers may use FCU-O independently, or they may work with a trained coach who will facilitate their use of the program. Participation is open to caregivers who are referred to FCU-O based on their DECIDE risk calculator score by their child's pediatrician, and is available in English or Spanish. Participants will also complete assessments via survey and direct observation before beginning FCU-O, and 6- and 12-months after their referral to FCU-O.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Parents of toddler ages 22 month to 39 months who screen elevate on the Developmental Early Childhood Instrument for Deciding Effectively about Mental Health (DECIDE) tool risk calculator in a participating health center's pediatric practice

排除标准

  • •Unable to complete measures and consent process in English or Spanish

研究组 & 干预措施

Family Check-up Online (FCU-O)

Experimental

Caregivers of toddlers with a high likelihood of developing mental health challenges will participate in a parenting program, Family Check-Up® Online (FCU-O), and complete assessments related to their child's behavior and their caregiving practices. FCU-O is a parenting support program that offers tools and guidance to support children's emotional and behavioral development. The program is delivered through a secure website that can be accessed via computer or phone at participating caregivers' convenience. Caregivers will complete the Developmental Early Childhood Instrument for Deciding Effectively about Mental Health (DECIDE) tool, a risk calculator that screens for early signs of future mental health challenges, at their child's 24- or 30-month well-check visit with their pediatrician. Clinicians will use the DECIDE tool risk calculator score to refer caregivers of at-risk children to FCU-O. Caregivers may use FCU-O independently, or they may work with a trained coach.

干预措施: Behavioral Parent Training (Behavioral)

结局指标

主要结局

Psychiatric Symptoms and Diagnosis

时间窗: 12 month

Parent interview to assess psychiatric disorders in preschool age children also known as the PAPA.

次要结局

  • Early Regulation and Context Assessment (ERICA)(Baseline, 6- and 12 month)
  • Multidimensional Assessments Profile Scale (Temper Loss) (MAPS-TL)(12-month)
  • Strengths and Difficulties Questionnaire (SDQ)(Baseline, 6- and 12-month)
  • Early Childhood-Patient-Reported Outcomes Measurement Information System- Effortful Control (EC-PROMIS-EF)(6- and 12-month)
  • Minnesota Executive Function Scale (MEFS)(Baseline, 6- and 12-months)
  • Parenting Young Children (PARYC)(Baseline, 6-, 12 month)
  • Multidimensional assessment profiles- Early Assessment Screening for Irritability (MAPS-EASI) Impairment Plus(Baseline 6- and 12 months)
  • Child and Parent Relationship Scale (CPRS)(Baseline, 6-, and 12-month assessments)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Justin D. Smith

Professor

University of Utah

研究点 (1)

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