Active — Not RecruitingNot Applicable

The Families and Middle School Success Project

United States300 participantsStarted 2022-05-01

Plain-language 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.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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). Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: baseline, 3 months, 6 months, 12 months, 24 months

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

Timeframe: baseline, 3 months, 6 months, 12 months, 24 months

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

Timeframe: baseline, 3 months, 6 months, 12 months, 24 months

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

Timeframe: baseline, 3 months, 6 months, 12 months, 24 months

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

Timeframe: baseline, 3 months, 6 months, 12 months, 24 months

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

Timeframe: baseline, 3 months, 6 months, 12 months, 24 months

Trial details

NCT IDNCT05400564

SponsorUniversity of Oregon

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-03-31

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