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NCT05400564 · ClinicalTrials.gov registry record · NA

The Families and Middle School Success Project

A NA study of Depression and Parenting, sponsored by University of Oregon.

Active
Registry status
NA
Development phase
300
Enrollment target
1
Study location

NCT05400564 is a NA study of Depression and Parenting that is active but no longer recruiting, run by University of Oregon. The registered enrollment target is 300 participants, below the 786-participant average among 679 other Depression trials with a reported enrollment target (62% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT05400564, a NA study of Depression and Parenting, is active but no longer recruiting, sponsored by University of Oregon.

ACTIVE NOT RECRUITING
Registry status
NA
Development phase
300 participants
Enrollment target
1
Study location

Study 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.

Interventions

  • BEHAVIORAL Family Check-Up

Study Locations (1)

Oregon

  • University of Oregon Prevention Science Institute - Portland

Trial Details

FieldValue
Enrollment Target 300 participants
Start Date 2022-05-01
Est. Completion 2025-12-31
Phase NA

Sponsor

University of Oregon

63 total trials

What the Registry Record Tells You About NCT05400564

The ClinicalTrials.gov registry entry for NCT05400564 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 786-participant average among 679 other Depression trials with a reported enrollment target (62% lower). The listed sponsor is University of Oregon, which has 63 total studies on file at ClinicalTrials.gov.

The record links to 6 conditions, with Depression appearing as the primary indexed condition, and to 1 intervention - of which Family Check-Up is the first listed.

NCT05400564 reports 1 study location spanning 1 distinct geographic area - top geographies include Oregon.

Frequently Asked Questions

What is clinical trial NCT05400564 about?

NCT05400564 is a clinical study titled "The Families and Middle School Success Project". 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 prob...

What is the current status of trial NCT05400564?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 300 participants. The study started on 2022-05-01. Estimated completion is 2025-12-31.

What conditions does trial NCT05400564 study?

This clinical trial studies the following conditions: Depression, Parenting, Parent-Child Relations, Self-regulation, Problem Behavior in School.

What interventions are being tested in trial NCT05400564?

The interventions under investigation include: Family Check-Up (BEHAVIORAL).

Who is sponsoring clinical trial NCT05400564?

This trial is sponsored by University of Oregon, which has 63 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05400564 being conducted?

This trial has 1 study location across Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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