Clinical Trial

The Families and Middle School Success Project

Study acronym: FMSS
Active, Not Recruiting
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Record status
This record was last updated October 15, 2024 (before its estimated March 31, 2025 completion). Its status may not reflect the trial's current state.
Summary
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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2022-05-27; most recent amendment 2024-10-10.
Status change: Recruiting → Active, Not Recruiting 2024-10-10
Trial Details
NCT Number NCT05400564
Lead Sponsor University of Oregon
Conditions Parenting, Parent-Child Relations, Self-regulation, Problem Behavior in School, School Adjustment, Depression
Enrollment 300 participants
Start Date 2022-05-01
Primary Completion 2025-03-31 (estimated)
Study Completion 2025-12-31 (estimated)
Updated on ClinicalTrials.gov 2024-10-15