The Families and Middle School Success Project (FMSS)

October 10, 2024 updated by: University of Oregon

Preventing Emotional and Behavioral Problems in Middle School Youth At-risk of Disability After the Covid-19 Pandemic With the Family Check-up Online

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97209
        • University of Oregon Prevention Science Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: FCU Online + Coach
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.
Behavioral: Family Check-Up
This intervention includes access to the Family Check-Up app and telehealth coaching provided by trained mental health providers. Parents can contact their Coach as often as they like and a minimum of 3 coaching sessions will be scheduled.
No Intervention: Control
Parents in this arm will receive school support as usual.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
change from baseline in family conflict (parent and child report)
Time Frame: baseline, 3 months, 6 months, 12 months, 24 months
Measured with the CASEY
baseline, 3 months, 6 months, 12 months, 24 months
change from baseline in family relationships (parent and child report)
Time Frame: baseline, 3 months, 6 months, 12 months, 24 months
Measured with the CASEY
baseline, 3 months, 6 months, 12 months, 24 months
change from baseline in child academic competence (parent, child and teacher report)
Time Frame: baseline, 3 months, 6 months, 12 months, 24 months
Measured with the SSRS
baseline, 3 months, 6 months, 12 months, 24 months
change from baseline in child school engagement (parent, child and teacher report)
Time Frame: baseline, 3 months, 6 months, 12 months, 24 months
Measured with the school participation measure
baseline, 3 months, 6 months, 12 months, 24 months
change from baseline in child's school grades (school report)
Time Frame: baseline, 3 months, 6 months, 12 months, 24 months
Obtained via school records
baseline, 3 months, 6 months, 12 months, 24 months
change from baseline in child's achievement test scores/school records/IEP (school report)
Time Frame: baseline, 3 months, 6 months, 12 months, 24 months
Obtained via school records
baseline, 3 months, 6 months, 12 months, 24 months
change from baseline in child's school attendance (school report)
Time Frame: baseline, 3 months, 6 months, 12 months, 24 months
Obtained via school records
baseline, 3 months, 6 months, 12 months, 24 months
change from baseline in youth emotional problems (parent, child and teacher report)
Time Frame: baseline, 3 months, 6 months, 12 months, 24 months
Measured by the SDQ
baseline, 3 months, 6 months, 12 months, 24 months
change from baseline in youth behavior problems (parent, child and teacher report)
Time Frame: baseline, 3 months, 6 months, 12 months, 24 months
Measured by the SDQ
baseline, 3 months, 6 months, 12 months, 24 months
change from baseline in youth self regulation (parent, and child report)
Time Frame: baseline, 3 months, 6 months, 12 months, 24 months
Measured by the SDQ
baseline, 3 months, 6 months, 12 months, 24 months
change from baseline in youth social/peer relationships (parent and child report)
Time Frame: baseline, 3 months, 6 months, 12 months, 24 months
Measured by the PASA
baseline, 3 months, 6 months, 12 months, 24 months
change from baseline in child's discipline referrals (school report)
Time Frame: baseline, 3 months, 6 months, 12 months, 24 months
Obtained via school records
baseline, 3 months, 6 months, 12 months, 24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
change from baseline in parent depression and anxiety (parent report)
Time Frame: baseline, 3 months, 6 months, 12 months, 24 months
Measured by the PHQ-9
baseline, 3 months, 6 months, 12 months, 24 months
change from baseline in parental stress (parent report)
Time Frame: baseline, 3 months, 6 months, 12 months, 24 months
Measured by the PSS
baseline, 3 months, 6 months, 12 months, 24 months
change from baseline in youth depression (parent and child report)
Time Frame: baseline, 3 months, 6 months, 12 months, 24 months
Measured by the PHQ-9
baseline, 3 months, 6 months, 12 months, 24 months
change from baseline in parental sense of competency (parent report)
Time Frame: baseline, 3 months, 6 months, 12 months, 24 months
Measured by the PSOC
baseline, 3 months, 6 months, 12 months, 24 months
change from baseline in positive parenting behaviors (parent report)
Time Frame: baseline, 3 months, 6 months, 12 months, 24 months
Measured by the PCA
baseline, 3 months, 6 months, 12 months, 24 months
change from baseline in limit setting and supervision skills (parent report)
Time Frame: baseline, 3 months, 6 months, 12 months, 24 months
Measured by the PCA
baseline, 3 months, 6 months, 12 months, 24 months
change from baseline in parenting involvement at school (parent report)
Time Frame: baseline, 3 months, 6 months, 12 months, 24 months
Measured by a modified version of the home-based learning factor of the FIQ-EC
baseline, 3 months, 6 months, 12 months, 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Oregon

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Elizabeth Stormshak, Ph.D., University of Oregon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 27, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 27, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 1, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 15, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 10, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY00000404

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Per the terms of the funding contract from IES, de-identified study data will eventually be deposited at a public repository, Inter-university Consortium for Political and Social Research (ICPSR), to increase its utility to qualified individuals within the scientific community. Direct requests for data from other researchers and the public will be also considered, and data will be made available in accordance with local institution policies, IRB recommendations, local/state/federal laws and regulations, and considerations for publication. Any applicable data sharing will follow HIPAA rules.

IPD Sharing Time Frame

Data will be shared at the end of the grant.

IPD Sharing Access Criteria

In order to access these data, the ICPSR Data Archive will require a data use agreement (DUA), which will provide for (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed. The data sharing agreement will also assure that the analysis being proposed is appropriate given the design and data available. This data will be shared with ICPSR and approved scientists without additional informed consent from the research participants.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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