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Family Check-Up for Disruptive Behaviors (FMSS Trial)

N/A
Recruiting
Led By Elizabeth Stormshak, Ph.D.
Research Sponsored by University of Oregon
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3 months, 6 months, 12 months, 24 months
Awards & highlights

FMSS Trial Summary

This trial will test the efficacy 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.

Who is the study for?
This trial is for middle school students aged 11-14 at Alder Creek or Wilbur Rowe Middle Schools in Milwaukee, Oregon, who show signs of emotional and behavioral issues. Eligible students have poor grades (below a 2.5 GPA), frequent absences, multiple discipline referrals, an IEP for emotional disturbance, or concerning mental health screener scores. Caregivers must have a smartphone with text and email access.Check my eligibility
What is being tested?
The Family Check-Up Online program is being tested to see if it can help reduce behavior and emotional problems in middle-schoolers at risk after COVID-19 disruptions. It's delivered through schools and includes modules on stress coping and improving home-to-school engagement.See study design
What are the potential side effects?
Since this intervention involves family-based online support rather than medication, traditional physical side effects are not expected. However, participants may experience changes in family dynamics as they work through the program.

FMSS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3 months, 6 months, 12 months, 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3 months, 6 months, 12 months, 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
change from baseline in child academic competence (parent, child and teacher report)
change from baseline in child school engagement (parent, child and teacher report)
change from baseline in child's achievement test scores/school records/IEP (school report)
+9 more
Secondary outcome measures
change from baseline in limit setting and supervision skills (parent report)
change from baseline in parent depression and anxiety (parent report)
change from baseline in parental sense of competency (parent report)
+4 more

FMSS Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: FCU Online + CoachExperimental Treatment1 Intervention
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.
Group II: ControlActive Control1 Intervention
Parents in this arm will receive school support as usual.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Family Check-Up
2021
N/A
~2480

Find a Location

Who is running the clinical trial?

University of OregonLead Sponsor
80 Previous Clinical Trials
46,606 Total Patients Enrolled
10 Trials studying Parenting
2,121 Patients Enrolled for Parenting
Elizabeth Stormshak, Ph.D.Principal InvestigatorUniversity of Oregon

Media Library

Family Check-Up Clinical Trial Eligibility Overview. Trial Name: NCT05400564 — N/A
Parenting Research Study Groups: FCU Online + Coach, Control
Parenting Clinical Trial 2023: Family Check-Up Highlights & Side Effects. Trial Name: NCT05400564 — N/A
Family Check-Up 2023 Treatment Timeline for Medical Study. Trial Name: NCT05400564 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research trial still recruiting participants?

"As indicated on clinicaltrials.gov, this investigation is actively seeking participants; the initial listing was posted on May 1st 2022 and it has been recently modernized as of July 12th 2022."

Answered by AI

What objectives is this research endeavor attempting to fulfill?

"This trial seeks to evaluate the alteration of child academic aptitude (as reported by parents, children and teachers) from baseline over a period spanning 24 months. Additionally, it aims to measure changes in parental competency (parent report), depression/anxiety (PHQ-9 parent report) and adolescent malaise (child/parent PHQ-9)."

Answered by AI

How many individuals have signed up to participate in this trial thus far?

"Affirmative. Clinicaltrials.gov reveals that this clinical research, which was first posted on May 1st 2022, is actively recruiting patients. 300 individuals need to be accepted from a single medical centre."

Answered by AI

Who else is applying?

What state do they live in?
Oregon
How old are they?
18 - 65
What site did they apply to?
University of Oregon Prevention Science Institute
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
The Families and Middle School Success Project
2022. "The Families and Middle School Success Project". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05400564.
~97 spots leftby Mar 2025
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