The Families and Middle School Success Project (FMSS)

University of Oregon

Status: Active, not recruiting

Conditions: Parenting; Problem Behavior in School; School Adjustment; Parent-Child Relations; Depression; Self-regulation

Treatments: Behavioral: Family Check-Up

Study type: Interventional

Funder types: Other

Identifiers

NCT05400564

STUDY00000404

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

FCU Online + Coach

Experimental group

Description:

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.

Treatment:

Behavioral: Family Check-Up

Control

No Intervention group

Description:

Parents in this arm will receive school support as usual.