The Families and Middle School Success Project (FMSS)

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: Active, not recruiting
• Conditions: Depression; Parent-Child Relations; Parenting; Self-regulation; Problem Behavior in School; School Adjustment
• Intervention / Treatment: Behavioral: Family Check-Up

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
change from baseline in family conflict (parent and child report)	Measured with the CASEY	baseline, 3 months, 6 months, 12 months, 24 months
change from baseline in family relationships (parent and child report)	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)	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)	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)	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)	Obtained via school records	baseline, 3 months, 6 months, 12 months, 24 months
change from baseline in child's school attendance (school report)	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)	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)	Measured by the SDQ	baseline, 3 months, 6 months, 12 months, 24 months
change from baseline in youth self regulation (parent, and child report)	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)	Measured by the PASA	baseline, 3 months, 6 months, 12 months, 24 months
change from baseline in child's discipline referrals (school report)	Obtained via school records	baseline, 3 months, 6 months, 12 months, 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change from baseline in parent depression and anxiety (parent report)	Measured by the PHQ-9	baseline, 3 months, 6 months, 12 months, 24 months
change from baseline in parental stress (parent report)	Measured by the PSS	baseline, 3 months, 6 months, 12 months, 24 months
change from baseline in youth depression (parent and child report)	Measured by the PHQ-9	baseline, 3 months, 6 months, 12 months, 24 months
change from baseline in parental sense of competency (parent report)	Measured by the PSOC	baseline, 3 months, 6 months, 12 months, 24 months
change from baseline in positive parenting behaviors (parent report)	Measured by the PCA	baseline, 3 months, 6 months, 12 months, 24 months
change from baseline in limit setting and supervision skills (parent report)	Measured by the PCA	baseline, 3 months, 6 months, 12 months, 24 months
change from baseline in parenting involvement at school (parent report)	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

• Sponsor: University of Oregon
• Investigators: Principal Investigator: Elizabeth Stormshak, Ph.D., University of Oregon

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Estimated): March 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: May 27, 2022
• First Submitted That Met QC Criteria: May 27, 2022
• First Posted (Actual): June 1, 2022

Study Record Updates

• Last Update Posted (Actual): October 15, 2024
• Last Update Submitted That Met QC Criteria: October 10, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Problem Behavior
• Other Study ID 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