The Families and Middle School Success Project

Depression Clinical Trial

— FMSS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05400564
• Other study ID #: STUDY00000404
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: August 2023
• Source: University of Oregon
• Contact: Allison Caruthers, Ph.D.
• Phone: 503-412-3770
• Email: ascaru[@]uoregon.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Parent-Child Relations
• Parenting
• Problem Behavior
• School Adjustment
• Self-regulation

Intervention

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.

Locations

Country	Name	City	State
United States	University of Oregon Prevention Science Institute	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
University of Oregon

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change from baseline in family conflict (parent and child report)	Measured with the CASEY	baseline, 3 months, 6 months, 12 months, 24 months
Primary	change from baseline in family relationships (parent and child report)	Measured with the CASEY	baseline, 3 months, 6 months, 12 months, 24 months
Primary	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
Primary	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
Primary	change from baseline in child's school grades (school report)	Obtained via school records	baseline, 3 months, 6 months, 12 months, 24 months
Primary	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
Primary	change from baseline in child's school attendance (school report)	Obtained via school records	baseline, 3 months, 6 months, 12 months, 24 months
Primary	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
Primary	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
Primary	change from baseline in youth self regulation (parent, and child report)	Measured by the SDQ	baseline, 3 months, 6 months, 12 months, 24 months
Primary	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
Primary	change from baseline in child's discipline referrals (school report)	Obtained via school records	baseline, 3 months, 6 months, 12 months, 24 months
Secondary	change from baseline in parent depression and anxiety (parent report)	Measured by the PHQ-9	baseline, 3 months, 6 months, 12 months, 24 months
Secondary	change from baseline in parental stress (parent report)	Measured by the PSS	baseline, 3 months, 6 months, 12 months, 24 months
Secondary	change from baseline in youth depression (parent and child report)	Measured by the PHQ-9	baseline, 3 months, 6 months, 12 months, 24 months
Secondary	change from baseline in parental sense of competency (parent report)	Measured by the PSOC	baseline, 3 months, 6 months, 12 months, 24 months
Secondary	change from baseline in positive parenting behaviors (parent report)	Measured by the PCA	baseline, 3 months, 6 months, 12 months, 24 months
Secondary	change from baseline in limit setting and supervision skills (parent report)	Measured by the PCA	baseline, 3 months, 6 months, 12 months, 24 months
Secondary	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